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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for an Automatic Upper Arm Blood Pressure Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on a clinical trial.

Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and human-in-the-loop performance are not available in this document, as they are typically associated with performance validation studies for AI/ML devices or new diagnostic methods, not blood pressure monitors seeking 510(k) clearance based on substantial equivalence to an existing device.

However, I can extract the relevant information regarding performance standards and comparisons that are mentioned:

1. A table of acceptance criteria and the reported device performance

The document references the standard AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type as the key performance standard.

While explicit acceptance criteria are not listed in a table, the standard itself defines accuracy requirements for blood pressure monitors. The device claims the following accuracy, which would implicitly be the performance criteria it aims to meet based on the standard:

Criterion	Acceptance / Target	Reported Performance
Pressure Accuracy	±3 mmHg	±3 mmHg
Pulse Accuracy	±5%	±5%

2. Sample size used for the test set and the data provenance

The document states that the device was evaluated for "safety and performance by lab bench testing" and refers to "Clinical Validation Of Automated Measurement Type" according to ISO 81060-2.

Sample Size: The document does not explicitly state the sample size (number of subjects/measurements) used for the clinical validation. ISO 81060-2 typically specifies minimum patient numbers (e.g., 85 subjects for validation). Without the full study report, the exact sample size cannot be determined from this document.
Data Provenance: Not explicitly stated. Clinical validation studies for such devices typically involve prospective data collection from human subjects. The document does not specify the country of origin.
Retrospective/Prospective: Clinical validation according to ISO 81060-2 is inherently prospective, involving live measurements on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For blood pressure monitor validation (ISO 81060-2), ground truth is established by simultaneous auscultatory measurements performed by trained observers (commonly two, with a third if disagreements arise) using a reference sphygmomanometer. These are not "experts" in the sense of radiologists interpreting images, but rather trained technicians or clinicians. The document does not specify the exact number of observers or their specific qualifications, but the standard mandates specific training and performance for these observers.

4. Adjudication method for the test set

The ISO 81060-2 standard typically employs an adjudication method for reconciling reference blood pressure measurements. Commonly, two trained observers simultaneously measure, and if their readings differ by more than a predefined threshold, a third observer might be used, or the measurements are discarded and re-taken. This is inherent to the standard's methodology, though not explicitly detailed in this summary document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often with AI assistance (e.g., radiology AI). This device is an automatic blood pressure monitor, not an interpretive diagnostic system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence. The primary performance evaluation for an automatic blood pressure monitor is its standalone accuracy against a reference method (auscultation). The device itself is designed to operate automatically, without continuous human intervention during the measurement cycle for interpretation. The reported accuracies (±3 mmHg for pressure, ±5% for pulse) reflect this standalone performance.

7. The type of ground truth used

The ground truth for non-invasive blood pressure monitors typically involves simultaneous auscultatory measurements performed by trained observers using a mercury or an equivalent validated reference sphygmomanometer. This is the "gold standard" for clinical validation of automated blood pressure devices as per ISO 81060-2.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. For traditional medical devices like blood pressure monitors, there isn't typically a distinct "training set" in the machine learning sense. The device's algorithm (oscillometric method) is developed based on physiological principles and engineering, not "trained" on a large dataset of patient readings in the way an AI algorithm learns. The validation is done on a "test set" or clinical study population.

9. How the ground truth for the training set was established

As there isn't a "training set" in the AI/ML sense, this question is not applicable. The device's internal algorithms are based on established oscillometric principles for blood pressure determination. Their accuracy is then validated (tested) against the clinical ground truth described in point 7.

Summary

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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

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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

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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)

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)

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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

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4. Device Description

5. Intended Use / Indications for Use

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

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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 ofComparison	Subject Device	Predicate Device	Verdict
ProductNameModel Name	AGE Automatic Upper Arm BloodPressure MonitorBA-815, BA-816, BA-818, BA-819	AGE Automatic Upper Arm BloodPressure MonitorBA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X	--
Intended Use	AGE Automatic Upper Arm BloodPressure Monitor is intended for useby medical professionals or at home tomonitor and display diastolic, systolicblood pressure and pulse rate on adulteach time, with the cuff around the leftupper arm according to the instructionin the user's guide manual.	AGE Automatic Upper Arm BloodPressure Monitor is intended foruse by medical professionals or athome to monitor and displaydiastolic, systolic blood pressureand pulse rate on adult each time,with the cuff around the left upperarm according to the instruction inthe user's guide manual.	SE
PowerSupply	DC 6V (4 X AA 1.5V alkline batteries)	6Vdc (4 "AA" batteries)	SE
MeasuringMethod	Oscillometry	Oscillometry	SE
MeasuringRange	Pressure: 0~~280 mmHgPulse: 40~~199 beats/minuteSYS(systolic pressure ): 60-255mmHgDIA (diastolic pressure): 40-200mmHg	Pressure: 0~~280 mmHgPulse: 40~~199 beats/minuteSYS(systolic pressure ): 60-255mmHgDIA (diastolic pressure): 40-200mmHg	SE
Pressureresolution	1mmHg or 0.1kPa	1mmHg or 0.1kPa	SE
Accuracy	Pressure: ±3 mmHgPulse: ±5%	Pressure: ±3mmHgPulse: ±5%	SE
PatientPopulation	Adult	Adult	SE
Measurement Site of Body	Upper Arm	Upper Arm	SE
Inflation andDeflation	Automatic	Automatic	SE
Memory Size	2 x 90 sets record	2 x 90 sets record	SE
SoftwareVersion	V01	V01	SE
Indicators	Blood Pressure (Systolic andDiastolic), Pulse, Date, Time, WHO BPClassification Indicating Bar, LowBattery Icon, Heart Icon, Memory	Blood Pressure (Systolic andDiastolic), Pulse, Date, Time, WHOBP Classification Indicating Bar,Low Battery Icon, Heart Icon,Memory	SE

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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 ofComparison	Subject Device	Predicate Device	Verdict
CuffCircumference	For BA-815: 22-34 cm;For BA-816: 28-42 cm;For BA-818 and BA-819, there are 6size:size A: 17cm--22cm (SMALL ADULT CUFF)size B: 22cm--30cm (ADULT CUFF-1)size C: 24cm--34cm (ADULT CUFF-2)size D: 22cm--42cm (L-LARGE ADULT CUFF)size E: 30cm--42cm (LARGE ADULT CUFF)size F: 42cm--50cm (EXTRA LARGE ADULT CUFF)	Size A: 17cm--22cm (SMALL ADULT CUFF)Size B: 22cm--30cm (ADULT CUFF-1)Size C: 24cm--34cm (ADULT CUFF-2)Size D: 22cm--42cm (L-LARGE ADULT CUFF)Size E: 30cm--42cm (LARGE ADULT CUFF)Size F: 42cm--50cm (EXTRA LARGE ADULT CUFF)	SENote 1
OPERATING & STORAGE CONDITIONS
StorageEnvironment	Temperature: -20°C ~ +65°CHumidity: 10~~95%RHAtmospheric Pressure:86 kPa~~106 kPa	Temperature: -20°C ~ +65°CHumidity: 10~~95%RHAtmospheric Pressure:86 kPa~~106 kPa	SE
WorkingEnvironment	Temperature: 5°C ~ 40°CHumidity: 15~~90%RHAtmospheric Pressure:86 kPa~~106 kPa	Temperature: 5°C ~ 40°CHumidity: 15~~90%RHAtmospheric Pressure:86 kPa~~106 kPa	SE
COMPLIANCE STANDARDS
Electrical,Mechanicaland ThermalEvaluation	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30	SE
Biocompatibility Evaluation	All the patient contracting materials areevaluated by the biocompatibilitystandard ISO 10993 - 5, -10.	All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 - 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.

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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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).