The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The device detects the appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

Device Description

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. The irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

AI/ML Overview

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701, underwent performance testing to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP10 compliance	Meets all applicable requirements
IEC/EN 60601-1 compliance	Meets all applicable requirements
IEC/EN 60601-1-2 compliance	Meets all applicable requirements
IEC/EN 60601-1-4 compliance	Meets all applicable requirements
Biocompatibility (ISO 10993): In vitro cytotoxicity	No cytotoxicity
Biocompatibility (ISO 10993): Sensitivity	No sensitivity
Biocompatibility (ISO 10993): Irritation	No irritation

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

The provided document does not specify the exact sample size or data provenance details (e.g., country of origin, retrospective or prospective) for the performance testing. It generally states that "Bench testing was conducted to demonstrate that the device meets its Requirements Specification." For biocompatibility, it states "Testing was performed for in vitro cytotoxicity, sensitivity, and irritation according to ISO 10993 requirements."

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

This information is not provided in the document. The performance testing appears to be based on adherence to recognized standards (ANSI/AAMI SP10, IEC/EN 60601 series, ISO 10993) rather than an expert-driven ground truth establishment for a specific clinical dataset.

4. Adjudication method for the test set:

Not applicable, as the evaluation was based on compliance with established technical and biological standards, not on subjective interpretations requiring adjudication.

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

This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

Yes, the performance testing described for the Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701, is a standalone evaluation of the device's technical specifications and biological safety without human-in-the-loop performance in a comparative study context. The device utilizes an "oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate." This is an algorithm-driven process.

7. The type of ground truth used:

The ground truth used for this device is based on established, well-known technical and biological standards:

ANSI/AAMI SP10: This standard specifies requirements for non-invasive sphygmomanometers. Compliance with this standard indicates the device's accuracy in measuring blood pressure against accepted methods and criteria.
IEC/EN 60601-1, -1-2, -1-4: These are general standards for the safety and essential performance of medical electrical equipment, including electromagnetic compatibility and programmable electrical medical systems. Compliance demonstrates adherence to fundamental safety and performance requirements.
ISO 10993: This standard series deals with the biological evaluation of medical devices. Biocompatibility testing (cytotoxicity, sensitivity, irritation) ensures the materials in contact with the patient (e.g., the cuff) are safe and do not elicit adverse biological reactions.

8. The sample size for the training set:

Not applicable. This device is a measurement device that uses a pre-defined algorithm (oscillometric method) rather than a machine learning model that requires a training set. The "software algorithm" for determining blood pressure is cited as "well known" and not described as being developed through a data-driven training process.

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

Not applicable, as there is no mention of a training set for a machine learning algorithm. The device relies on the established principles of the oscillometric method.

Summary

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K 11 2270 1/3

NOV 2 2 2 2011

Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

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Accumed

510(k) Summary

510(k) owner's information:	Accumed Healthcare (Shanghai) Inc.No. 6133, Huyi Rd., Waigang, JiadingDistrict, Shanghai, China.Tel: +86-21-69519220Fax: +86-21-69519221
Official Contact:	Cindy Green, Authorized RepresentativeP.O. Box 1277; Maple Valley, WA 98038Tel: (425) 432-8623
Proprietary or Trade Name:	Accumed Wrist Automatic Blood PressureMonitor, Model ABA-701
Common/Usual Name:	Non-Invasive Blood Pressure Monitor
Classification Name:	System, Measurement, Blood-Pressure,Non-Invasive
Regulation	CFR 870.1130
Product Code	DXN
Predicate Device:	Citizen CH-609, K100055
Date Summary Prepared:	November 7, 2011

Device Description:

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Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

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Accumed

Intended Use:

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 is a noninvasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

Comparison to Predicate Device

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 is substantially equivalent to the Citizen CH-609 (K100055).

The Accumed ABA-701 and the Citizen CH-609 predicate have the same:

· Intended use
· Intended use environment
· Intended patient population
· Display type
· Accuracy
· Measurement range
· Pulse range measurement
· Memory capacity
· Well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse
· Same semi-conductor pressure sensor technology used to translate the pressure variations to electrical signals that can be interpreted by the microprocessor
· Irregular heart beat detection function

The subject device and the predicate devices CH-609 are similar; however, not identical with regards to operating environment, storage environment, dimensions, and weight.

The subject device is substantially equivalent to the Citizen CH-609 (K100055). There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

Performance Testing:

Bench testing was conducted to demonstrate that the device meets its Requirements Specification. The following performance tests were completed:

ANSI/AAMI SP10 .
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 60601-1-4 .

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Accumed Healthcare(Shanghai) Inc. No. 6133, Huyi Rd., Waigang, Jiading District, Shanghai, China

Accumed

The Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 meets all applicable requirements.

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Biocompatibility

Testing was performed for in vitro cytotoxicity, sensitivity, and irritation according to ISO 10993 requirements. Test results demonstrate that there is no cytotoxicity, sensitivity, or irritation caused by the Blood Pressure Monitor Cuff.

Conclusion:

Based on the evaluations completed there are no new safety or effectiveness issues introduced with this new medical device. Therefore, the Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 is substantially equivalent to the predicate device; Citizen CH-609 (K100055).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol appears to be an abstract representation of a human figure or a caduceus. The logo is presented in black and white.

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

JAN 11 2012

Accumed Healthcare (Shanghai) Inc. c/o Cindy Green Authorized Representative P.O. Box 1277; Maple Valley, WA 98038

Re: K112270

KT12270
Trade/Device Name: Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 8, 2011 Received: November 10, 2011

Dear Ms. Green:

This letter corrects our letter of November 22, 2011 regarding the incorrect name identified on the Indications for Use statement form.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the onerosale) to regard cate of the Medical Device Amendments, or to commerce provision of May 20, 1977, and occordance with the provisions of the Federal Food, DNA devices that have occh roomsoried in actre approval of a premarket approval application (PMA). and Costine Act (710c) that Go not required to the general controls provisions of the Act. The I ou may, incretore, market the act include requirements for annual registration, listing of general controls provisions of the fice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (000 acove). Existing major regulations affecting your device can be may be subject to additional ochaons. "Bhoung and to any and 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 I least be advised that I Dri i securities your device complies with other requirements of the Act

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Page 2 - Ms. Cindy Green

or any Federal statutes and regulations administered by other Federal agencies. You must or any I callul statures and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY art 607); adoling (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (2) OFF 003), good in and if applicable, the electronic forth in the quality by croms (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 11 you desire specific advisor ser your Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. W. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . the Center 10 Devices and Parison ing by reference to premarket notification" (21CFR Part note the regulations 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 I ou may obtain of Scheral memational 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.g. Hilleber

Bram D. Žuckerman, 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):

Device Name: Accumed Wrist Automatic Blood Pressure Monitor, Model ABA-701

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Hillelson

ion of Cardiovascular Devices

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Number K112270

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).