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 13.5cm~19.5cm.

Device Description

AGE Automatic Wrist 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 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.

AI/ML Overview

Here’s a breakdown of the acceptance criteria and study information for the AGE Automatic Wrist Blood Pressure Monitor, models BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, and BW-613, based on the provided document:

Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (from ISO 81060-2)	Reported Device Performance (Subject Device)
Accuracy (Pressure)	Not explicitly stated as acceptance criteria, but standard clinical validation requires meeting specific thresholds (e.g., mean difference ≤ ±5 mmHg, standard deviation ≤ 8 mmHg for paired measurements between the device and a reference measurement, across a patient population per ISO 81060-2).	±3 mmHg (claimed accuracy)
Accuracy (Pulse)	Not explicitly stated as acceptance criteria.	±5% (claimed accuracy)
Measuring Range (Pressure)	Standard requirements per ISO 81060-2 apply.	0 ~ 294 mmHg
Measuring Range (Pulse)	Standard requirements per ISO 81060-2 apply.	40 ~ 199 beats/minute
Patient Population	Adult	Adult
Measurement Site	Wrist	Wrist
Cuff Circumference	Relevant to performance validation with specific ranges.	13.5 ~ 19.5 cm
Compliance Standards	ISO 81060-2 (for clinical validation and performance)	Complies with ISO 81060-2

Study Information

Sample size used for the test set and the data provenance:
- The document states that the device was evaluated according to "AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
- ISO 81060-2 (which this document specifies compliance with) typically requires a minimum of 85 subjects for clinical validation to demonstrate agreement between the test device and a reference standard (e.g., a trained observer using a stethoscope). The document does not explicitly state the exact sample size used in the clinical study, but it is implied to be sufficient to meet the ISO 81060-2 standard.
- Data provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For clinical validation studies compliant with ISO 81060-2, at least two (and preferably three) trained observers are typically required to obtain simultaneous auscultatory reference measurements. These observers must be trained in the standard auscultatory technique for blood pressure measurement and follow the specified protocol (e.g., using a double stethoscope).
- Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this document, but they would be healthcare professionals (e.g., physicians, nurses, or trained technicians) proficient in blood pressure measurement to serve as reference observers.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Clinical validation studies following ISO 81060-2 use simultaneous measurements with multiple observers. The standard outlines specific procedures for comparing the automated device's readings with those from the trained observers. For example, if two observers' readings differ by more than a specified amount, a third measurement or a re-measurement might be required, or the data point might be excluded. The standard's methodology effectively serves as an adjudication method.
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 comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. Therefore, there is no effect size related to human reader improvement with/without AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The clinical validation per ISO 81060-2 specifically evaluates the algorithm/device's performance (its automated measurements) against reference measurements taken by trained human observers. The device itself operates as a standalone system to provide blood pressure readings.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical validation was established through expert auscultatory measurements performed simultaneously with the device's readings. This is the standard "reference measurement" method described in ISO 81060-2.
The sample size for the training set:
- This document describes a premarket notification (510(k)) for a medical device. Blood pressure monitors like this typically use established algorithms based on oscillometric principles, not machine learning that requires a "training set" in the sense of AI models. Therefore, a specific "training set" sample size for an AI algorithm is not applicable here. The underlying algorithms are developed and refined through engineering, calibration, and extensive testing, but not typically "trained" on a dataset in the way an AI model would be.
How the ground truth for the training set was established:
- As mentioned above, a "training set" in the AI sense is not applicable for this type of device. The accuracy and performance of the oscillometric algorithm are established through rigorous engineering design, mathematical modeling, and validation studies against established reference methods (like auscultation) in accordance with standards like ISO 81060-2.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2015

Dongguan Ageless Health Industrial Co., Ltd c/o Ms. Cecilia Ceng Regulatory Manager Suite 306, Kecheng Mansion, No.121 Science Road, Guahgzhou Science Park Guangzhou, 510663 CN

Re: K151281

Trade/Device Name: AGE Automatic Wrist Blood Pressure Monitor, Models BW-601, BW-602. BW-603. BW-605. BW-606. BW-611. BW-612. BW-613 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 20, 2015 Received: May 14, 2015

Dear Ms. Cecilia Ceng,

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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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K151281

Page __ 1_ of 1

510(k) Number (if known): K151281

De vice Name : 605, BW -606, BW -611, BW -612, and 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 13.5cm.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

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510(k) Summary

This 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 Information

Sponsor Name: Dongguan Ageless Health Industrial Co.,Ltd. Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: +86-769-81158038 Fax: +86-769-82289331 E-mail: victor@agelh.com

Application Correspondent:

Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: regulatory@glomed-info.com

Subject Device Information 2.

Type of 510(k):	Traditional
-----------------	-------------

Common Name: Noninvasive blood pressure measurement systems

Trade Name: AGE Automatic Wrist Blood Pressure Monitor, Models BW-601,

BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613

Classification Name: Noninvasive brood pressure measurement system

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K151281 Page 2 of 6

Review Panel:	Cardiovascular
Product Code:	DXN
Regulation Number:	21 CFR 870.1130
Regulation Class:	2

3. Predicate Device Information

Sponsor:	Health & Life Co.,Ltd.
Common Name:	Noninvasive blood pressure measurement systems
Trade Name:	Full Automatic (NIBP) Blood Pressure Monitor, Model HL158LA
510(k) number:	K130564
Review Panel:	Cardiovascular
Product Code:	DXN
Regulation Number:	21 CFR 870.1130
Regulation Class:	2

4. Device Description

5. Intended Use

6. Test Summary

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K151281 Page 3 of 6

AGE Automatic Wrist 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
� 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

Compare 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 ofComparison	Subject Device	Predicate Device	Verdict
Product Name	AGE Automatic Wrist BloodPressure Monitor	Full Automatic (NIBP) BloodPressure Monitor, Model HL158LA	--
Intended Use and Indications for Use
Intended Use	AGE Automatic Wrist BloodPressure Monitor is intended for useby medical professionals or at hometo monitor and display diastolic,systolic blood pressure and pulserate on adult each time, with an aircuff buckled around one's wrist	HL158LA automatically measureshuman's Systolic, Diastolic bloodpressure and heart rate by using theoscillometric method. All values canbe read out in one LCD panel.Measurement position is at humanbeing's wrist. The intended use of	SENote 1
Elements ofComparison	Subject Device	Predicate Device	Verdict
Indications forUse	according to the instruction in theuser's guide manual.	this over-the-counter device is foruse by people over the age of 18with wrist circumference rangingfrom approx. 5.3 to 7.7 inches(13.5cm to 19.5 cm) and for home use.
	AGE Automatic Wrist BloodPressure Monitor is for use bymedical professionals or at homeand is a non-invasive bloodpressure measurement systemintended to measure the diastolicand systolic blood pressures andpulse rate of an adult individual byusing a non-invasive technique inwhich an inflatable cuff is wrappedaround the wrist. The cuffcircumference is limited to13.5cm~19.5cm.	HL158LA automatically measureshuman's Systolic, Diastolic bloodpressure and heart rate by using theoscillometric method. All values canbe read out in one LCD panel.Measurement position is at humanbeing's wrist. The intended use ofthis over-the-counter device is foruse by people over the age of 18with wrist circumference rangingfrom approx. 5.3 to 7.7 inches(13.5cm to 19.5 cm) and for home use.	SENote 1

ELECTRICAL REQUIREMENT
Power Supply	3Vdc (2 "AAA" batteries)	3Vdc (2 "AAA" batteries)	SE
PERFORMANCE SPECIFICATION
MeasuringMethod	Oscillometry	Oscillometry	SE
MeasuringRange	Pressure: 0~~294 mmHgPulse: 40~~199 beats/minute	Pressure: 0~~300 mmHgPulse: 40~~199 beats/minute	SENote 2
Accuracy	Pressure: ±3 mmHgPulse: ±5%	Pressure: ±3mmHgPulse: ±5%	SE
PatientPopulation	Adult	Adult	SE
MeasurementSite of Body	Wrist	Wrist	SE
CuffCircumference	13.5 ~ 19.5 cm	13.5 ~ 19.5 cm	SE
Inflation andDeflation	Automatic	Automatic	SE
Memory Size	2 x 90 sets record	3×40 sets record	SENote 3
StorageEnvironment	OPERATING & STORAGE CONDITIONS
	Temperature: -20°C ~ +65°CHumidity: 15~~95%RHAtmospheric Pressure:86 kPa~~106	Temperature: -25°C ~ +70 °CHumidity: ≤ 93%RH	SENote 3
Elements ofComparison	Subject Device	Predicate Device	Verdict
	kPa
WorkingEnvironment	Temperature: 5°C ~ 40°CHumidity: 15~~90%RHAtmospheric Pressure:86 kPa~~106 kPa	Temperature: 5°C ~ 40°CHumidity: 15~93%RH	SENote 3
COMPLIANCE STANDARDS
Electrical,Mechanical andThermalEvaluation	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2IEC 60601-11	SENote 4
BiocompatibilityEvaluation	All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -5, -10.	All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -1, 5, -10.	SENote 5
Performance	ISO 81060-2	AAMI SP10	SENote 6

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Note 1

Although there is little difference for measurement cuff circumference of subject device and predicate device, both of them are complied with AAMI SP10 or ISO 81060-2. This difference does not affect the safety and effectiveness.

Note 2

Although the measuring range of pressure and pulse of subject device and predicate device are different, both of them are complied with AAMI SP10 or ISO 81060-2. The difference of their measuring range does not affect the safety and effectiveness.

Note 3

Although some specifications of operating & storage conditions, memory size are different for subject device and predicate device, they are both complied with IEC 60601-1. The differences do not affect the safety and effectiveness.

Note 4

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K151281 Page 6 of 6

Although the electrical, mechanical and thermal evaluation of subject device and predicate device are different, they are both complied with IEC 60601-1 and IEC 60601-1-2. The differences do not affect the safety and effectiveness.

Note 5

Although the biocompatibility evaluation of subject device and predicate device are different, they are both complied with ISO 10993-5 and ISO 10993-10. The differences do not affect the safety and effectiveness.

Note 6

Although the standards of performance have updated and substituted from AAMI SP10 to ISO 81060-2, all of the requirements in these three standards are intended for blood pressure monitor. Therefore, both of them met the requirements. The differences do not affect the safety and effectiveness.

8. Conclusion

The 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.

9. Summary Prepared Date

29 June 2015

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).