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FDA 510(k) Submission ReportFor Ageless Health Industrial Ltd.AGE Automatic Wrist Blood Pressure Monitor Model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), TOCTable of Content PageChapter 1. Screening Checklist1-1Chapter 2. MDUFMA Cover Sheet2-1Chapter 3. CDRH Premarket Review Submission Cover Sheet3-1Chapter 4. 510(k) Cover Letter4-1Chapter 5. Statement of Indications for Use5-1Chapter 6. 510(k) Summary6-1Chapter 7. Truthful and Accuracy Statement7-1Chapter 8. Class III Summary and Certification8-1Chapter 9. Financial Certification or Disclosure Statement9-1Chapter 10. Declarations of Conformity and Summary Reports10-1Chapter 11. Executive Summary11-1Chapter 12. Device Description12-1Chapter 13. Substantial Equivalence Discussion13-1Chapter 14. Proposed Labeling14-1Chapter 15. Sterilization/Shelf Life15-1Chapter 16. Biocompatibility16-1Chapter 17. Software17-1Chapter 18. Electromagnetic Compatibility/Electrical Safety18-1Chapter 19. Performance Testing Bench19-1Chapter 20. Performance Testing Animal20-1Chapter 21. Performance Testing Clinical21-1Chapter 22. FORM FDA 3654, Standards Data Report for 510(k)s22-1Chapter 23. Kit Certification23-1Attachment Total PageAttachment 1. MDUFMA Cover Sheet 2Attachment 2. CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)16Attachment 3. User Manual17Attachment 4. Package Labeling6Attachment 5. ISO 10993 Test Report32Attachment 6. Risk Management Report15Attachment 7. IEC 60601-1 Test Report48Attachment 8. IEC 60601-1-2 Test Report31Attachment 9. SP10 Test Report84Attachment 10.Certification of compliance with clinical (Form FDA 3674) 1Attachment 11. Standard Data Report (Form FDA 3654) 10Attachment 12. Predicate Device Information24Attachment 13. Clean and Disinfection Validation Report33Report by Ageless Health Industrial Ltd. Page iiSponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 1Chapter 1. Screening ChecklistScreening Checklist for Traditional/Abbreviated PremarketNotification 510(k) Submissionsbased onGuidance for Industry and FDA StaffFormat for Traditional and Abbreviated 510(k)sTitleRelated InformationPresentInadequateN/A MDUFMA Cover SheetMedical Device User Fee Cover Sheet3Chapter 2, Attachment 1CDRH Premarket Review Submission Cover SheetCDRH Premarket Review Submission Cover Sheet4Chapter 3, Attachment 2510(k) Cover LetterAppendix A of Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s updated November 17, 2005Chapter 4Indications for Use StatementDevice Advice Content of a 510(k) Section D5Chapter 5510(k) Summary or 510(k) StatementDevice Advice Content of a 510(k) Section E6Chapter 6Truthful and Accuracy StatementDevice Advice “Content of a 510(k)” Section G7Chapter 7Class III Summary and CertificationClass III Summary and Certification Form8Chapter 8N/AFinancial Certification or Disclosure StatementFORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators9FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators10Financial Disclosure by Clinical Investigators11Chapter 9N/ADeclarations of Conformity and Summary Reports (Abbreviated 510(k)s)Use of Standards in Substantial Equivalence Determinations12FDA Standards program13Declaration of conformity14Required Elements for Declaration of Conformity to Recognized Standard15Chapter 10N/AExecutive SummarySee section 10 in Chapter II of “Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s” updated November 17, 2005Chapter 11Device DescriptionSee section 11 in Chapter II of “Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s updated November 17, 2005Chapter 12Substantial Equivalence DiscussionGuidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3)16Chapter 13Proposed LabelingDevice Advice “ Content of a 510(k)” Section H17Chapter 14Attachment 3, 4Sterilization/Shelf LifeUpdated 510(k) Sterility Review Guidance (K90-1)18For reuse of single use devices, see Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of 2002 Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices19Chapter 15N/ABiocompatibilityFDA Blue Book Memo, G95-1, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing20Chapter 16Attachment 5SoftwareGuidance for the Content of Premarket Submissions for Software Contained in Medical Devices21Chapter 17Attachment 6Electromagnetic Compatibility/Electrical SafetyCDRH Medical Device Electromagnetic Compatibility Program22See also IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007Chapter 18Attachment 7, 8Performance Testing BenchSee section 18 in Chapter II of Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s updated November 17, 2005Chapter 19Attachment 9Performance Testing AnimalSee section 19 in Chapter II of Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s updated November 17, 2005Chapter 20N/APerformance Testing ClinicalSee section 20 in Chapter II of Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s updated November 17, 2005FORM FDA 3454, Certification: Financial Interests and Arrangements of Clinical Investigators23FORM FDA 3455, Disclosure: Financial Interests and Arrangements of Clinical Investigators24 Chapter 21N/AFORM FDA 3654, Standards Data Report for 510(k)s25Standards Data Report Form Form 36541. No standard used - No Standards Form Required 2. Declaration of Conformity Yes Standards Form Required 3. Standard but no declaration Yes Standards Form Required Chapter 22,Attachment 11Kit CertificationDevice Advice26Chapter 23N/AReport by Ageless Health Industrial Ltd. Page 1-3Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 2Chapter 2. MDUFMA Cover SheetPlease refer to “Attachment 1. FDA User Fee Cover Sheet (Form FDA 3601)”.Report by Ageless Health Industrial Ltd. Page 2-1Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 3Chapter 3. CDRH Premarket Review Submission Cover SheetPlease refer to “Attachment 2. CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)”.Report by Ageless Health Industrial Ltd. Page 3-1Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 4Chapter 4. 510(k) Cover LetterDate of Submission: 2012-11-02User Fee Payment ID Number: MD6064951-9567331 Type of 510(k) submission Traditional2 510 (k) submitter Company Name: Ageless Health Industrial Ltd. Establishment Registration Number: Applying Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, Chinaw Phone: +86-769-81158038 Fax: +86-769-82289331 Contact Person (including title): Victor Wan (Vice-president) E-mail: , 3 Subject Device Information: Type of 510(k) submission: Traditional Common Name: Noninvasive blood pressure measurement systems Trade Name: AGE Automatic Wrist Blood Pressure Monitor Classification Name: Noninvasive brood pressure measurement system Review Panel: Cardiovascular Product Code: DXN Regulation Number: 21 CFR 870.1130 Regulation Class: 24 Predicate Device Information: Sponsor: Fudakang Industrial Co., Ltd Common Name: Noninvasive blood pressure measurement systems Trade Name: Wrist Fully Automatic Blood Pressure Meter 510(k) number: K110013 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 21 CFR 870.1130 Regulation Class: 25 Intended Use (from labeling):AGE Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around ones wrist according to the instruction in the users guide manual.6 Design and Use of the DeviceQuestionYesNoIs the device intended for prescription use (21 CFR 801 Subpart D)?XIs the device intended for over-the-counter use (21 CFR 807 Subpart C)?XDoes the device contain components derived from a tissue or other biologic source?XIs the device provided sterile?XIs the device intended for single use?XIs the device a reprocessed single use device?XIf yes, does this device type require reprocessed validation data?XDoes the device contain a drug?XDoes the device contain a biologic?XDoes the device use software?XDoes the submission include clinical information?XIs the device implanted?X7 Substantially Equivalent (SE) ClaimThe subject device AGE Automatic Wrist Blood Pressure Monitor has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.Report by Ageless Health Industrial Ltd. Page 4-2Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 5Chapter 5. Statement of Indications for UseIndications for Use510(k) Number (if known): ApplyingDevice Name: AGE Automatic Wrist Blood Pressure MonitorModel: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.Indications for Use:AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm19.5cm.Prescription Use _(Part 21 CFR 801 Subpart D) AND/OROver-The-Counter Use _ X_(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE) 510(k) Number_Page _1_ of _1_Report by Ageless Health Industrial Ltd. Page 5-1Sponsor:Ageless Health Industrial Ltd.Subject Device: AGE Automatic Wrist Blood Pressure Monitor, model: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613.File No.:510(k) submission report (V1.0), Chapter 6Chapter 6. 510(k) Summary510(k) SummaryThis summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 870.1130.1. Submitter InformationSponsor Name: Ageless Health Industrial Ltd.Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, ChinaContact Person: Victor Wan (Vice-president)Phone: +86-769-81158038Fax: +86-769-82289331E-mail: , 2. Subject Device InformationType of 510(k):TraditionalCommon Name:Noninvasive blood pressure measurement systemsTrade Name:AGE Automatic Wrist Blood Pressure MonitorClassification Name:Noninvasive brood pressure measurement systemReview Panel:CardiovascularProduct Code:DXNRegulation Number:21 CFR 870.1130Regulation Class:23. Predicate Device InformationSponsor:Fudakang Industrial Co., Ltd.Common Name:Noninvasive blood pressure measurement systemsTrade Name:Wrist Fully Automatic Blood Pressure Meter510(k) number:K110013Review Panel:CardiovascularProduct Code:DXNRegulation Number:21 CFR 870.1130Regulation Class:24. Device Description AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.5. Intended UseAGE Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around ones wrist according to the instruction in the users guide manual.6. Test SummaryAGE Automatic Wrist Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards:w IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995w IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2007w ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, 2009w ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, 2010w ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)20087. Comparison to Predicate DeviceCompare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.Elements of ComparisonSubject DevicePredicate DeviceVerdictProduct NameAGE Automatic Wrist Blood Pressure MonitorWrist Fully Automatic Blood Pressure Meter-Intended Use and Indications for UseIntended UseAGE Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around ones wrist according to the instruction in the users guide manual.Wrist Fully Automatic Blood Pressure Meter is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around ones wrist according to the instruction in the users guide manual.SEIndications for UseAGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm19.5cm.Fudakang Wrist Fully Automatic Blood Pressure Meter is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.SENote 1ELECTRICAL REQUIREMENT Power Supply3Vdc (2 “AAA” batteries)3Vdc (2 “AAA” batteries) SEPERFORMANCE SPECIFICATIONMeasuring MethodOscillometryOscillometrySEMeasuring RangePressure: 0280 mmHg Pulse

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