AGE Automatic Upper Arm 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 upper arm. The cuff circumference is limited to 24~34 cm.

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 oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AGE Automatic Upper Arm Blood Pressure Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/AAMI SP10)	Reported Device Performance (AGE Automatic Upper Arm Blood Pressure Monitor)
Pressure Accuracy: ±3 mmHg	Pressure Accuracy: ±3 mmHg
Pulse Accuracy: ±5%	Pulse Accuracy: ±5%
Compliance with various safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, AAMI SP10)	Evaluation against all listed standards, with an explicit statement of compliance.

Note: The document explicitly states that the device is "complied with AAMI SP10," which implies that the device meets the quantitative accuracy requirements specified in that standard. The table above extracts these specific numerical accuracy criteria.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in the provided text. The document mentions evaluation against standards, particularly AAMI SP10, which typically specifies sample sizes for clinical validation (e.g., typically 85 subjects for blood pressure monitors as per AAMI/ISO 81060-2). However, the exact number of subjects used in the validation study for this specific device is not provided in this summary.
Data Provenance: The report is submitted by Ageless Health Industrial Ltd., located in Dongguan City, Guangdong Province, China. The document does not specify the country of origin of the data itself. It's a "510(k) submission report (V1.0), Chapter 6." The study appears to be prospective as it's a submission for pre-market clearance, implying new testing to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given text. For blood pressure monitor validation studies (e.g., per AAMI/ISO 81060-2), ground truth is typically established by trained observers (e.g., physicians or specially trained nurses) who take auscultatory blood pressure readings using a mercury sphygmomanometer or validated equivalent, often in triplicate, to establish reference values. However, the details of such experts and their qualifications are not present here.

4. Adjudication Method for the Test Set

This information is not provided in the given text. For clinical validation studies, adjudication methods (e.g., 2+1 for three readers with two agreeing) are common for establishing reference measurements, but the document does not detail this.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study (comparing human readers with and without AI assistance) is generally relevant for AI-powered diagnostic imaging devices, not for a standalone blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the performance described is a standalone (algorithm only) performance. The device itself is an "Automatic Upper Arm Blood Pressure Monitor" which uses an "oscillometric technique" to automatically measure and display blood pressure and pulse rate. The accuracy claims (±3 mmHg for pressure, ±5% for pulse) directly refer to the device's inherent measurement capabilities without human interpretation or intervention in the measurement process itself, beyond proper cuff placement and initiation. The compliance with AAMI SP10 is for the automated device's accuracy.

7. Type of Ground Truth Used

The ground truth, while not explicitly detailed in its establishment, would inherently be expert consensus or reference measurements as per the requirements of the ANSI/AAMI SP10 standard. This standard often requires comparison of the automated device's readings against simultaneously obtained auscultatory measurements performed by trained observers using a reference method (like a mercury sphygmomanometer).

8. Sample Size for the Training Set

This information is not applicable or not provided. This device is a traditional oscillometric blood pressure monitor, not an AI/machine learning-driven device in the sense that would require a distinct "training set" for an algorithm. Its operation is based on established physical principles and algorithms for oscillometric waveform analysis, rather than a learned model from a large dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention or indication of a "training set" for an AI algorithm in the provided document for this device.

Summary

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K123882 Page 1 of 5

Sponsor: Ageless Health Industrial Ltd. AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-803, Subject Device: BA-805, BA-806, BA-811, BA-812, BA-813 File No.: 510(k) submission report (V1.0), Chapter 6

Chapter 6. 510(k) Summary

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: 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, China

Contact Person: Victor Wan (Vice-president)

Phone: 0769-81158038

Fax: 0769-82289331 E-mail: victor@agelh.com / c.ceng@foxmail.com Web: www.agelh.com

2. Subject Device Information

Type of 510(k) submission:	Traditional
Common Name:	Noninvasive blood pressure measurement systems
Trade Name:	AGE Automatic Upper Arm Blood Pressure Monitor
Classification Name:	Noninvasive blood pressure measurement system
Review Panel:	Cardiovascular
Product Code:	DXN
Regulation Number:	21 CFR 870.1130
Regulation Class:	2

3. Predicate Device Information

Sponsor:	Fudakang Industrial Co., Ltd.
Common Name:	Noninvasive blood pressure measurement systems
Trade Name:	Arm Automatic Blood Pressure Meter

Report by Ageless Health Industrial Ltd.

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K123882 Page 2 of 5

Sponsor:	Ageless Health Industrial Ltd.
Subject Device:	AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813
File No.:	510(k) submission report (V1.0), Chapter 6
510(k) number:	K110281
Review Panel:	Cardiovascular
Product Code:	DXN
Regulation Number:	21 CFR 870.1130
Regulation Class:	2

4. Device Description

5. Intended 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 arm according to the instruction in the user's guide manual.

6. Test Summary

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, 1988+A1:1991+A2:1995
� 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, 2007
� 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
. ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008

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K123882

Page 3 of 5

Sponsor:	Ageless Health Industrial Ltd.
Subject Device:	AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803BA-805, BA-806, BA-811, BA-812, BA-813
File No.:	510(k) submission report (V1.0), Chapter 6

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
Manufacturer	Ageless Health Industrial Ltd.	Fudakang Industrial Co., Ltd.	--
Product Name	AGE Automatic Upper Arm BloodPressure Monitor	Arm Automatic Blood PressureMeter	--
	Intended Use and Indications for Use
Intended Use	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 armaccording to the instruction in theuser's guide manual.	Fudakang Arm Automatic BloodPressure Meter is intended for useby 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
Indications forUse	AGE Automatic Upper Arm 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 upper arm. The cuffcircumference is limited to 24~34cm.	Fudakang Arm Automatic BloodPressure Meter 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 upper arm. The cuffcircumference is limited to 22cm-30cm.	SENote 1
ELECTRICAL REQUIREMENT
Power Supply	6Vdc (4 "AA" batteries)	6Vdc (4 "AA" batteries)	SE
	PERFORMANCE SPECIFICATION
MeasuringMethod	Oscillometry	Oscillometry	SE
MeasuringRange	Pressure: 0~~280 mmHgPulse: 40~~199 beats/minute	Pressure: 0~~300 mmHgPulse: 30~~180 beats/minute	Note 2
Accuracy	Pressure: ±3 mmHgPulse: ±5%	Pressure: ±3mmHgPulse: ±5%	SE
PatientPopulation	Adult	Adult	SE

Report by Ageless Health Industrial Ltd.

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K123882 Page 4 of 5

Sponsor:	Ageless Health Industrial Ltd.
Subject Device:	AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813
File No.:	510(k) submission report (V1.0), Chapter 6

Elements ofComparison	Subject Device	Predicate Device	Verdict
MeasurementSite of Body	Arm	Arm	SE
CuffCircumference	24-34 cm	22~30 cm	SENote 1
Inflation andDeflation	Automatic	Automatic	SE
Memory Size	2 x 90 sets record	60 or 90 sets record	SENote 3
OPERATING & STORAGE CONDITIONS
StorageEnvironment	Temperature: -20℃ ~ +65℃Humidity: 10~95%RH	Temperature: -20℃ ~ +60 ℃Humidity: < 95%RH	Note 3
WorkingEnvironment	Temperature: 5℃~ 40℃Humidity: 10~90%RH	Temperature: 5℃ ~ 40℃Humidity: < 90%RH	Note 3
COMPLIANCE STANDARDS
Electrical,Mechanical andThermalEvaluation	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC 60601-1-2	SE
BiocompatibilityEvaluation	All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -5, -10.	All the patient contracting materialsare evaluated by thebiocompatibility standard ISO10993 -5, -10.	SE
Performance	AAMI SP10	AAMI SP10	SE

Note 1

Although there is little difference for measurement cuff circumference of subject device and predicate device, both of them are complied with AAM SP10. 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. 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.

Report by Ageless Health Industrial Ltd.

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K123882 Page 5 of 5

Sponsor:	Ageless Health Industrial Ltd.
Subject Device:	AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813
File No.:	510(k) submission report (V1.0), Chapter 6

8. Conclusion

The subject device AGE Automatic Upper Arm 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

31 March 2013

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine, with a staff and two snakes.

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

August 14, 2013

Ageless Health Industrial c/o Mr. Victor Wan 3F, A 1 bldg, Dongshen Sima Industrial Area No. 33 Shenbai Road Changping, Dongguan, Guangdong, China 523570

Re: K123882

Trade/Device Name: AGE Automatic Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 27, 2013 Received: August 2, 2013

Dear Mr. Victor Wan:

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

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Page 2 - Mr. Victor Wan

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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Owen P. Faris -S

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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Sponsor:	Ageless Health Industrial Ltd.
Subject Device:	AGE Automatic Upper Arm Blood Pressure Monitor, Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813
File No.:	510(k) submission report (V1.0), Chapter 5

Chapter 5. Statement of Indications for Use

Indications for Use

510(k) Number (if known): Applying

Device Name: AGE Automatic Upper Arm Blood Pressure Monitor Model: BA-801, BA-802, BA-803, BA-805, BA-806, BA-811, BA-812, BA-813

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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_

Digitally signed by
Owen P. Faris -S
Date: 2013.08.14
15:45:49-04'00'

Page 1 of 1

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).