AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819

{0}------------------------------------------------ June 18, 2018 Ageless Health Industrial Co., Ltd. % Cassie Lee Manager Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510000 China Re: K172895 Trade/Device Name: AGE Automatic Upper Arm Blood Pressure Monitor with Models BA-815, BA-816, BA-818 and BA-819 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 8, 2018 Received: May 15, 2018 Dear Cassie Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, M. A. Wilhelm for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172895 Device Name AGE Automatic Upper Arm Blood Pressure Monitor with Models BA-815, BA-816, BA-819 Indications for Use (Describe) AGE Automatic Upper Arm 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 the cuff around the left upper arm according to the instruction in the user's guide manual. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Sponsor: | Ageless Health Industrial Co., Ltd | |-----------------|--------------------------------------------------------------------------------------| | Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-815, BA-816, BA-818, BA-819 | | File No.: | | File No.: ## Chapter 5. 510(k) Summary # 510(k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ## 1. Submitter's Information 510(k) Owner's 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, Dongquan, Guangdong, China Contact Person: Victor Wan (Vice-president) Email: victor@agelh.com ## Application Correspondent: Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com # 2. Subject Device Information Common Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name: AGE Automatic Upper Arm Blood Pressure Monitor Models: BA-815, BA-816, BA-818, BA-819 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 21 CFR 870.1130 Regulation Class: 2 ### 3. Predicate Device Information | Sponsor | Ageless Health Industrial Ltd. | |-------------------|------------------------------------------------| | Device Name | AGE Automatic Upper Arm Blood Pressure Monitor | | 510(k) Number | K153552 | | Product Code | DXN | | Regulation Number | 21 CFR 870.1130 | | Regulation Class | II | {4}------------------------------------------------ # 4. Device Description AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm 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 Use / Indications for Use AGE Automatic Upper Arm 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 the cuff around the left upper arm according to the instruction in the user's guide manual. # 6. Test Summary effectiveness. AGE Automatic Upper Arm Blood Pressure Monitor has been evaluated the safety and performance by lab bench testing according to the following standards: - ◆ IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012 - ◆ IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests, 2014 - ◆ IEC 60601-1-11, Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)] - ◆ IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers - � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009 - ◆ ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010 - ◆ AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. (Cardiovascular) # 7. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, and intended use is substantially equivalent to the predicate devices quoted above. The differences between the subject devices do not raise new issues of safety or {5}------------------------------------------------ | Sponsor: | Ageless Health Industrial Co., Ltd | |-----------------|--------------------------------------------------------------------------------------| | Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-815, BA-816, BA-818, BA-819 | | File No.: | K172895 | | Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Product<br>Name<br>Model Name | AGE Automatic Upper Arm Blood<br>Pressure Monitor<br>BA-815, BA-816, BA-818, BA-819 | AGE Automatic Upper Arm Blood<br>Pressure Monitor<br>BA-801X, BA-802X, BA-803X, BA-<br>805X, BA-806X, BA-811X, BA-<br>812X, BA-813X, BA-821X, BA-<br>822X, BA-823X, BA-826X | -- | | Intended Use | AGE Automatic Upper Arm Blood<br>Pressure Monitor is intended for use<br>by medical professionals or at home to<br>monitor and display diastolic, systolic<br>blood pressure and pulse rate on adult<br>each time, with the cuff around the left<br>upper arm according to the instruction<br>in the user's guide manual. | AGE Automatic Upper Arm Blood<br>Pressure Monitor is intended for<br>use by medical professionals or at<br>home to monitor and display<br>diastolic, systolic blood pressure<br>and pulse rate on adult each time,<br>with the cuff around the left upper<br>arm according to the instruction in<br>the user's guide manual. | SE | | Power<br>Supply | DC 6V (4 X AA 1.5V alkline batteries) | 6Vdc (4 "AA" batteries) | SE | | Measuring<br>Method | Oscillometry | Oscillometry | SE | | Measuring<br>Range | Pressure: 0~280 mmHg<br>Pulse: 40~199 beats/minute<br>SYS(systolic pressure ): 60-255mmHg<br>DIA (diastolic pressure): 40-200mmHg | Pressure: 0~280 mmHg<br>Pulse: 40~199 beats/minute<br>SYS(systolic pressure ): 60-<br>255mmHg<br>DIA (diastolic pressure): 40-<br>200mmHg | SE | | Pressure<br>resolution | 1mmHg or 0.1kPa | 1mmHg or 0.1kPa | SE | | Accuracy | Pressure: ±3 mmHg<br>Pulse: ±5% | Pressure: ±3mmHg<br>Pulse: ±5% | SE | | Patient<br>Population | Adult | Adult | SE | | Measuremen<br>t Site of Body | Upper Arm | Upper Arm | SE | | Inflation and<br>Deflation | Automatic | Automatic | SE | | Memory Size | 2 x 90 sets record | 2 x 90 sets record | SE | | Software<br>Version | V01 | V01 | SE | | Indicators | Blood Pressure (Systolic and<br>Diastolic), Pulse, Date, Time, WHO BP<br>Classification Indicating Bar, Low<br>Battery Icon, Heart Icon, Memory | Blood Pressure (Systolic and<br>Diastolic), Pulse, Date, Time, WHO<br>BP Classification Indicating Bar,<br>Low Battery Icon, Heart Icon,<br>Memory | SE | {6}------------------------------------------------ | Sponsor: | Ageless Health Industrial Co., Ltd | |-----------------|--------------------------------------------------------------------------------------| | Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-815, BA-816, BA-818, BA-819 | | File No.: | K172895 | | Elements of<br>Comparison | Subject Device | Predicate Device | Verdict | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Cuff<br>Circumference | For BA-815: 22-34 cm;<br>For BA-816: 28-42 cm;<br>For BA-818 and BA-819, there are 6<br>size:<br>size A: 17cm--22cm (SMALL ADULT CUFF)<br>size B: 22cm--30cm (ADULT CUFF-1)<br>size C: 24cm--34cm (ADULT CUFF-2)<br>size D: 22cm--42cm (L-LARGE ADULT CUFF)<br>size E: 30cm--42cm (LARGE ADULT CUFF)<br>size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | Size A: 17cm--22cm (SMALL ADULT CUFF)<br>Size B: 22cm--30cm (ADULT CUFF-1)<br>Size C: 24cm--34cm (ADULT CUFF-2)<br>Size D: 22cm--42cm (L-LARGE ADULT CUFF)<br>Size E: 30cm--42cm (LARGE ADULT CUFF)<br>Size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | SE<br>Note 1 | | OPERATING & STORAGE CONDITIONS | | | | | Storage<br>Environment | Temperature: -20°C ~ +65°C<br>Humidity: 10~95%RH<br>Atmospheric Pressure:86 kPa~106 kPa | Temperature: -20°C ~ +65°C<br>Humidity: 10~95%RH<br>Atmospheric Pressure:86 kPa~106 kPa | SE | | Working<br>Environment | Temperature: 5°C ~ 40°C<br>Humidity: 15~90%RH<br>Atmospheric Pressure:86 kPa~106 kPa | Temperature: 5°C ~ 40°C<br>Humidity: 15~90%RH<br>Atmospheric Pressure:86 kPa~106 kPa | SE | | COMPLIANCE STANDARDS | | | | | Electrical,<br>Mechanical<br>and Thermal<br>Evaluation | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 80601-2-30 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 80601-2-30 | SE | | Biocompatibility Evaluation | All the patient contracting materials are<br>evaluated by the biocompatibility<br>standard ISO 10993 - 5, -10. | All the patient contracting materials<br>are evaluated by the<br>biocompatibility standard ISO<br>10993 - 5, -10. | SE | | Performance | ISO 81060-2-30 | ISO 81060-2-30 | SE | # Comparison in Detail(s): ## Note 1: Although there is difference for measurement cuff circumference of subject device and predicate device, both of them are complied with ISO 81060-2. This difference does not affect the safety and effectiveness. ### Conclusion: The subject device AGE Automatic Upper Arm Blood Pressure Monitor has all features of the predicate device. The differences between them do not affect the safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device. {7}------------------------------------------------ | Sponsor: | Ageless Health Industrial Co., Ltd | |-----------------|--------------------------------------------------------------------------------------| | Subject Device: | AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-815, BA-816, BA-818, BA-819 | | File No.: | K172895 | # 8. Date of the summary prepared: September 16, 2017