Sec Description Req FDA Description Needs And Responsibility
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSec1DescriptionUser Fee or 3rd PartyReviewReqFDA DescriptionY1. Medical Device User Fee Cover Sheet (Form FDA3601)The Medical Device User Fee Cover Sheet andreceipt of the user fee payment, allow FDA to beginprocessing your submission; therefore, you shouldprovide a Medical Device User Fee Cover Sheetwith your 510(k) submission, unless it is a thirdparty review submission. Third-party reviewsubmissions are exempt from user fees.Although the following 510(k) submissions are alsoexempt from user fees, we recommend you includea Medical Device User Fee Cover Sheet, and use itto indicate the type of exemption that applies in thecase of 510(k) submissions:.intended solely for pediatric use (a change inthe intended use from pediatric useto adult use requires the submission of a new510(k) in accordance with 21 CFR807.81 (a)(3); and an associated fee)submitted by a state or Federal governmententity (exempt from the FDA user fee unlessthe device is to be distributed commercially).The Medical Device User Fee Form may be obtainedat www.fda.gov/oc/mdufmalcoversheet.html.See alsoGuidance for Industry and FDA Staff - User Fees andRefunds for Premarket Notification Submissions.(510(k)s) at1 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Needs and ResponsibilityDCG and Client. Client must sendpayment to FDA.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and 1.html.2CDRH Cover SheetsYCDRH Premarket Review Submission Cover SheetDCG will produce w/client input onStandardsThe CDRH Pre-market Review Submission Cover Sheetis a voluntary form used to help provide basicadministrative information for all types of pre marketnotification submissions. The Cover Sheet may beobtained pdf.3510(k) Cover LetterYDCG will produce. Will Need copies ofClient Letterhead510(k) Cover LetterWe recommend that you include a 510(k) Cover Letterwith your submission. Guidance describes key informationthat may be useful to FDA in the initial processing andreview of the 510(k) submission. In contrast with theCDRH Premarket Review Submission Cover Sheet fromSection 2, the 510(k) Cover Letter described in Section 3is intended to be more descriptive of a 510(k) submission.4Indications for UseStatementYWe recommend that you use this section to provide theindications for use statement, which is a documentwhere you identify and describe the specific indicationsfor use statement for the device(s) included in the 510(k)submission.Your indications for use statement should be exactly thesame as the indications for use listed throughout the rest ofyour 510(k) submission, including the indications for use inthe device labeling. We recommend that you use theIndications for Use Statement2 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client to provide data.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and ResponsibilityFormat atwww.fda.gov/cdrh/devadvice/3l4312.h I?11#link,",,6. Webelieve that in order for FDA to adequately review yoursubmission you should identify whether the device isintended for prescription use and/or over-the-counter use.5SummaryY510(k) Summary or S10(k) StatementDCG will produce from Client data.In accordance with 21 CFR 807.87(h), each 510(k)submission must include either a 510(k) Summary (21 CFR807.92) or 510(k) Statement (21 CFR 807.93). Werecommend that you use Section 5 to provide the 510(k)Summary or 510(k) Statement.6Truthful and AccuracyStatementYTruthful and Accuracy StatementDCG will produceIn accordance with 21 CFR 807.87(k), all 510(k)s mustinclude a statement certifying that all information submittedin the 10(k) is truthful and accurate and that no materialfact has been omitted.The submitter should sign and date the statement. The510(k) holder rather than a consultant or correspondentworking for the holder should sign the Truthful andAccuracy Statement.7Class III Summary andCertification?Class III Summary and CertificationIf your 510(k) is for a device type classified into class III forwhich we have not called for PMAs, it must contain a ClassIII Summary and Certification in accordance with 21CFR 807.870) and 807.94. The Class III Summary andCertification provide a review of the risks and adverseevents known and associated with the general category ofdevices3 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021As required
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and Responsibilityinto which the proposed device falls. We recommend thatyou use the Class III Summary and Certification format atwww.fda.gov/cdrh/manual/stmnciii.htmi.8Financial Certificationor DisclosureStatement?Financial Certification or Disclosure StatementAs requiredIn accordance with 21 CFR 807.87(i), if you submitinformation from clinical studies, you must submit afinancial certification and/or a disclosure statement foreach clinical investigator who participated in your study.The following forms are available on ourweb site:FORM FDA 3454, Certification: Financial Interestsand Arrangements of Clinical rms/FDA-3454.pdfFORM FDA 3455, Disclosure: Financial Interestsand Arrangements of Clinical rms/FDA-3455.pdfSee also 21 CFR Part 54 and the guidance entitled,Financial Disclosure by Clinical Investigators rations ofConformity andSummary ReportsYDeclarations of Conformity and SummaryReportsIf your 510(k) is an Abbreviated 510(k) submission, werecommend that you use this section to provide theinformation regarding any declarations of conformity to astandard or4 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021DCG will produce.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA Descriptiona summary report recommended in any relevant devicespecific guidance. As mentioned in the definitions section ofthis guidance, an Abbreviated 510(k) is a type of 510(k) inwhichyou choose to declare conformance to a recognized standardfor any part of the device design or testing or you choose toprepare a summary report to a guidance. More informationabout the FDA standards program, including a current list ofFDA recognizedstandards may be obtained atwww.fda.gov/cdrh/stdsprog.html.See also the guidancestitled The New S10(k) Paradigm - Alternate Approaches toDemonstrating Substantial Equivalence in PremarketNotifications - Final Guidance atwww.fda.gov/cdrh/ode/parad510.htmland Use of Standardsin Substantial EquivalenceDeterminations atwww.fda.gov/cdrh/ode/guidanceI1131.html.If you choose to rely on a recognized standard or aguidance for any part of the device design or testing,you may include either a:declaration of conformity to the standard" orsummary report recommended inany relevant device-specific guidance; ora statement that testing will be conducted andmeet specified acceptance criteriabefore the device is marketed.Because a declaration of conformity is based on resultsfrom testing, we believe you cannot properly submit a5 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Needs and Responsibility
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and Responsibilitydeclaration of conformity until you have completed thetesting the standard describes. For more information,please refer to section 514(c)(l)(B) of the act. Additionalinformation regarding the use of declarations ofconformity may beobtained at tive SummaryYIn this section of your 510(k), we recommend that youprovide an executive summary of the 510(k), whichshould include a:DCG will produce from Client data.concise description of the device,including the indications for use andtechnology;device comparison table; andconcise summary for any performance testing inthe submission.The description, although concise, should be sufficient toprovide an overall understanding of the device. Thedevice comparison table should outline the differencesand similarities between your device and the predicate.We recommend that you also provide a discussion ofhow this comparison supports substantial equivalence.The summary for each performance testing section (i.e.,sections 18, 19, and 20) should be sufficient to provide abroad understanding of the type of testing performed,the methods used, and your conclusion from the results.11Device DescriptionYWe recommend that you describe the performancespecifications and include a brief description of thedevice design requirements in this section. We also6 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021DCG will produce with input from Client.Require pictures, drawing (top level),etc.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and Responsibilityrecommend that you identify all models, as well as allaccessories or components, included in thesubmission.If diagrams, dimensions, tolerances, and/or schematicsare useful to fully describe and characterize the device,we recommend that you include them for each device,accessoryor component included in the 510(k) submission. We alsorecommend that you provide a list of all patient contactingcomponents and their respective materials.12SubstantialEquivalenceDiscussionYIn the substantial equivalence section, we recommend thatyou identify the predicate and identify its trade name, modelnumber, 510(k) submitter/holder, and 510(k) number, ifavailable. You may choose to identify, compare, and testagainst more than onepredicate, if, for example, your device has two features orindications not previously combined in a single predicate.Our substantial equivalence determination is based on the510(k) Substantial Equivalence Decision-MakingProcess Flowchart.We recommend that you provide a detailed comparisonbetween your device and the predicate sufficient todemonstrate the substantial equivalence of the devices, asapplicable, in terms of:indications for use;technology; andperformance specifications, including any testing.For additional background on making determinations ofsubstantial equivalence we recommend that you refer to7 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021DCG will produce.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and ResponsibilityBlue Book Memorandum K86-3 entitled Guidance on theCenter for Devices and Radiological Health'sPremarket Notification Review Program #K86-3 atwww.fda.gov/cdrh/k863.html.13Proposed LabelingY14Sterilization?The 510(k) must include proposed labeling in sufficient detailto satisfy the requirements of 21 CFR 807.87(e). If thedevice is an in vitro diagnostic device, the labeling shouldadditionally satisfy the requirements of 21 CFR 809.10.Generally, the term "labeling" includes the device label,instructions for use, and any patient labeling. See alsoLabeling Requirements, atwww.fda.gov/cdrh/devadvice/314312.html#link 10and device specific guidance, where available, for moreinformation about labeling your device.Sterilization and Shelf LifeFor devices sold as sterile, we recommend that you followthe guidance, Updated 510(k) Sterility Review GuidanceK90-1; Final Guidance for Industry and FDA, atwww.fda.gov/cdrh/ode/guidance/361.html.For devices that are reprocessed single use devices,please refer to Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of2002 Validation Data in Premarket NotificationSubmissions (S10(k)s) for reprocessed Single-UseMedical Devices atwww.fda.gov/cdrh/ode/guidance/1216.html. For asubmission that identifies a shelf life for the device, yourshelf life should besupported by appropriate bench tests and/or sterilization8 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client input of labels on device andUser Instructions. DCG will edit. Needcopy of User Instructions in MicrosoftWord format.Required if device is shipped sterile orcan be sterilized.
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and Responsibility(packaging) validation.15Biocompatibility?If your device contains components that come into direct orindirect contact with patients, you should evaluate thebiocompatibility of the patient-contacting materials. Pleaserefer to the guidance documents titled Blue Book Memo,G95-1, Use of International Standard ISO-I0993, andBiological Evaluation of Medical Devices Part 1: Evaluationand Testing at www.fda.gov/cdrh/g951.html.You shouldselect biocompatibility tests for the duration and type ofcontact appropriate to your device design and submit thepass/fail criteria or in some cases, a summary of theresults.Client to provide if required.If identical materials are used in a predicate with the sametype and duration of patient contact, you may identify thepredicate in lieu of performing biocompatibility testing andstate that your device is comprised of identical materialsand that are processed by identical manufacturingmethods. This is most appropriate if you are themanufacturer of the predicate and you have completedocumentation with respect to the manufacturing methodsand materials employed.16Software?This section should include the appropriate softwaredocumentation as described in the guidance titled Guidancefor the Content of Pre market Submissions for SoftwareContained in Medical Devices atwww.fda.gov/cdrh/ode/guidance/337.html.As discussedin the guidance, we recommend that you identify the "level ofconcern," (minor, moderate, or major) associated with yourdevice and provide documentation consistent with that level.9 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client to provide is device has software
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReq17ECI and Safety Testing?FDA DescriptionIf your device design includes an electronic component, werecommend that you evaluate its electromagneticcompatibility (EMC). EMC encompasses both emissions(interference with electronic products) and immunity(interference with device performance created byemissions from other electronic products). We recommendyou test your device according to lEC 60601-1- 2 MedicalElectrical Equipment -- Part 1: General Requirements forSafety; Electromagnetic Compatibility -- Requirements andTests (Second Edition, 2001) or equivalent method todemonstrate the EMC characteristics of your device.Needs and ResponsibilityClient to supplyIf your device design results in patient contact with anyelectrically powered component, FDA recommends thatyou follow lEC 60601 1 (1988): Medical electricalequipment Part 1: General requirements for safety, includingAmendment 1 (1991) and Amendment 2 (1995) or anequivalent method.18Performance TestingBenchYIf you submit bench test results to support substantialequivalence, we recommend you include the followinginformation in this section. If the device is an in vitrodiagnostic device, refer to Appendix B.You should describe the bench testing and provide theresults that support theperformance characteristics of your device. Generally,all submissions should includethe information below; however, if a relevant devicespecific guidance is available, youshould follow the recommendations in that guidancedocument.10 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client to supply
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and Responsibilitylist the specific bench tests conducteddescribe each test protocolsummarize the resultsdescribe your analysisdiscuss your conclusionsThe description of test protocols should identify the:objective of the testtest articles used in the testtest methods and procedures (including any specifictest conditions)study endpoint, i.e., the specific parametermeasuredpre-defined acceptance or pass/fail criteria.In the summary of your results and analysis, werecommend that you briefly present the data derived fromtesting in a clear and concise form, such as a table.We also recommend that your conclusions describeany comparison testing with the predicate in terms ofsubstantial equivalence.19Performance Testing –Animal?If you submit animal test results to support substantialequivalence, we recommend you include the followinginformation in this section.I f you conducted animal testing, we recommend that you11 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client to supply .
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA Descriptiondescribe the tests and providethe results that support the performance characteristics ofyour device. Generally, all submissions that describeanimal testing should include the information below;however, if a relevant device-specific guidance is available,you should follow the recommendations in that guidancedocument. The branch or team responsible for the reviewof your device is also available to assist you with anyquestions about animal testing.list the specific animal tests conducteddescribe each test protocolsummarize the resultsdescribe your analysisdiscuss your conclusionsThe description of test protocols should identify the:objective of the testtest articles used in the testtest methods and procedures (including anyspecific test conditions)study endpoint, i.e., the specific parametermeasuredpre-defined acceptance or pass/fail criteria.In the summary of your results and analysis, werecommend that you briefly present the data derived fromtesting in a clear and concise form, such as a table.12 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Needs and Responsibility
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA DescriptionNeeds and ResponsibilityWe also recommend that your conclusions describeany comparison testing with the predicate device interms of substantial equivalence.20Performance Testing –Clinical?If you submit results from clinical studies to demonstratesubstantial equivalence, we recommend you include thefollowing information in this section. If the device is an invitro diagnostic device, refer to Appendix B.FDA will always consider alternatives to clinical studieswhen the proposed alternatives are supported by anadequate scientific rationale. Our recommendations forclinical testing typically depend on many factors includingdevice type, intended use, design, safety profile, andclinical experience.Generally, all submissions that describe clinical studiesshould include the information below; however, if a relevantdevice-specific guidance is available, you should follow therecommendations in that guidance document. The branch orteam responsible for the review of your device is alsoavailable to assist you with any questions about studies.21Other - Usability ifrequired.?CDRH considers human factors testing a valuable component ofproduct development for medical devices. CDRH recommends thatmanufacturers consider human factors testing for medical devicesas a part of a robust design control subsystem. However, in aneffort to make CDRH's premarket submission expectations clear,CDRH has identified circumstances under which human factorsvalidation testing should be submitted in a premarket submission.These devices noted below were selected because they have clearpotential for serious harm resulting from use error. Thisidentification was based on knowledge gleaned through MedicalDevice Reporting (MDRs) and recall information. Human factorsdata should be included in premarket submissions for these devices13 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Client to supply .
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” DocumentSecDescriptionReqFDA Descriptiontasks, user interface, or use environments from those of thepredicates. Ablation generators (associated with ablation systems, e.g.,LPB, OAD, OAE, OCM, OCL) Anesthesia machines (e.g., BSZ) Artificial pancreas systems (e.g., OZO, OZP, OZQ) Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC) Automated external defibrillators (e.g., MKJ, NSA ) Duodenoscopes (on the reprocessing; e.g., PDT) with elevatorchannels Gastroenterology-urology endoscopic ultrasound systems (on thereprocessing; e.g., ODG) with elevator channels Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT,FKX, KDT, KPF ODX,ONW) Implanted infusion pumps (e.g., LKK, MDY) Infusion pumps (e.g., FRN, LZH, MEA, MRZ) Insulin delivery systems (e.g., LZG, OPP) Negative-pressure wound therapy (e.g., OKO, OMP) intended foruse in the home Robotic catheter manipulation systems (e.g., DXX) Robotic surgery devices (e.g., NAY) Ventilators (e.g., CBK, NOU, ONZ) Ventricular assist devices (e.g., DSQ, PCK)Note that FDA may recommend or require that human factors databe included in premarket submissions for additional device typesthough product specific guidance documents, special controlsguidance or guideline documents, or special controlscontained in medical devices classification regulations.Premarket reviewers may also determine that human factorsdata are needed in specific premarket submissions on acase-by-case basis14 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021Needs and Responsibility
Matrix of needs for Traditional 510(k) SubmissionFor a Medical Device Release to MarketA DCG “iSubmission” Document15 of 15Provided by: Delphi Consulting Group, www.delphiconsulting.com832-675-9281 or Skype 832-532-8021
Sec Description Req FDA Description Needs and Responsibility 1 User Fee or 3rd Party Review Y 1. Medical Device User Fee Cover Sheet (Form FDA 3601) The Medical Device User Fee Cover Sheet and receipt of the user fee payment, allow FDA to begin processing your submission; therefore,
rope High Knee Jog Push ups Over head Slam Dips Kettle Bell Swing Goblet Squat Split Jump Mountain Climbers Alt Lunge Crunches Plank Reverse Curl Cycle Legs Warm up: Rowing Machine 500 meters 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec 20 sec Stop watch required. Complete each
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JBoss EAP (Java EE) 2 - 3 sec 3 sec 40 MB 200 - 400 MB 23K req/sec JBoss EAP (Spring) 2 - 3 sec 7 sec 40 MB 500 - 700 MB 9K req/sec JBoss WS/Tomcat (Spring) 0 - 1 sec 8 sec 40 MB 0.5 - 1.5 GB 8K req/sec Fat JAR (Spring Boot) N/A 3 sec 30 MB 0.5 - 2.0 GB 11K r
Jean Mary Raimondi, req. Pat McNally Parishioners Monday—August 2 8:30—Joseph Cunningham, req. Family Roger Alva, req. Wife & Family Tuesday—August 3rd 8:30—Poor Souls in Purgatory, req. Heidorn Family Roger Alva, req. Wife & Family Wednesday—August 4th 8:30—Roger Alva, req. Wife & Family Ann Deutsch, req. Mr. & Mrs. Czajkowskyj
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8:00 AM Verna Kenely req by Friends at St. Francis 10:00 AM Joseph A. Szczesny, Jr. req by The Roos Family 12:00 PM Kathleen Krone req by The Schmidt Family 09- Monday - People of the Parish 10 - Tuesday 8:30 AM For the Intenons of Jimmy & Sandra Leo rale req by Tom Moroney 11 - Wednesday 8:30 AM Richard J. Ippolito, Sr. req by Joanne & Ed Connell 12-Thursday 8:30 AM People of the Parish 13 .
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