The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-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 Upper Arm Automatic Blood Pressure Monitor, Model AAE-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. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document refers to meeting established standards, rather than defining specific numerical acceptance criteria within the 510(k) summary itself. The reported device performance is that it met these standards.

Acceptance Criteria (Standard Met)	Reported Device Performance
ANSI/AAMI SP10	Met all applicable requirements
IEC/EN 60601-1	Met all applicable requirements
IEC/EN 60601-1-2	Met all applicable requirements
IEC/EN 60601-1-4	Met all applicable requirements

(Note: ANSI/AAMI SP10 is the standard for non-invasive sphygmomanometers, covering accuracy requirements for blood pressure devices. The IEC/EN 60601 series covers medical electrical equipment safety. The specific numerical accuracy criteria are contained within the ANSI/AAMI SP10 standard, but are not explicitly listed in this 510(k) summary.)

Missing Information: The document does not explicitly state the numerical acceptance criteria from ANSI/AAMI SP10, nor does it provide the exact performance metrics (e.g., mean difference and standard deviation) for blood pressure measurements and pulse rate as specified in that standard. It only states that the device "meets all applicable requirements."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Bench testing was conducted" and refers to meeting standards, but does not provide details on the number of subjects or measurements included in these tests for accuracy evaluation.
Data Provenance: Not explicitly stated. It's likely prospective data collected during the bench testing, but the country of origin is not mentioned.

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

This information is not provided in the document. For blood pressure monitors, ground truth is typically established against a reference method (e.g., auscultatory method with a trained observer using a mercury sphygmomanometer) and not usually by "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the performance testing of an automated blood pressure monitor. Accuracy is assessed by comparing the device's readings against a validated reference measurement, not through expert adjudication of images or diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on reader performance. This device is an automated blood pressure monitor.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, a standalone performance study was done. The "Bench testing" against ANSI/AAMI SP10 (which includes clinical validation protocols) assesses the algorithm's performance in automatically measuring blood pressure and pulse rate without human intervention beyond device operation. The device is designed to operate autonomously to produce readings.

7. The Type of Ground Truth Used

The ground truth used for the performance testing (specifically, for conforming to ANSI/AAMI SP10) would be a validated reference measurement method, such as the auscultatory method performed by trained observers using a reference sphygmomanometer (e.g., mercurial or laboratory-grade aneroid manometer). This is implied by the reference to the ANSI/AAMI SP10 standard.

8. Sample Size for the Training Set

This information is not provided. Blood pressure monitors using the oscillometric method rely on algorithms that are developed and validated over time, likely with extensive datasets from various populations. The specific training set for this particular product is not detailed in the summary.

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

This information is not provided. For oscillometric algorithms, the development process generally involves comparing numerous oscillometric waveforms to simultaneous reference blood pressure measurements (established via auscultation or intra-arterial monitoring) across a diverse patient population to train and refine the algorithm's ability to accurately derive systolic and diastolic pressures from the oscillations.

Summary

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

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 Upper Arm Automatic BloodPressure Monitor, Model AAE-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-101, K100553,Citizen CH-609, K100055
Date Summary Prepared:	Nov 7, 2011

Device Description:

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

Accumed

Intended Use:

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-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 Upper Arm Automatic Blood Pressure Monitor, Model AAE-701 is substantially equivalent to the Citizen CH-101 (K100553) and Citizen CH-609 (K100055).

The Accumed AAE-701 and the Citizen CH-101 and CH-609 predicates have the same:

· Intended use
· Intended use environment
· Intended patient population
· Display type
· Accuracy
· Pulse range measurement
· Well known oscillometric method within the software algorithm used to determine the systolic and diastolic blood pressure and pulse
· Semi-conductor pressure sensor technology used to translate the pressure variations to electrical signals that can be interpreted by the microprocessor

The Accumed AAE-701 and the Citizen CH-609 have an irregular heart beat detection function and the same memory capacity.

The subject device and the predicate devices Citizen CH-101and CH-609 are not identical with regards to arm circumference, display parameters, dimensions, and weight, The Citizen CH-609 is intended for use on the wrist; as opposed to the arm. Therefore, the Citizen CH-609 has a different pressure range measurement, operating environment, and storage environment.

The subject device is substantially equivalent to the Citizen CH-101 (K100553) and Citizen CH-609 (K100055). There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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

Accumed

Performance Testing:

The started on the commended on the first comments of the comments of the

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

The Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-701 meets all applicable requirements.

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 Upper Arm Automatic Blood Pressure Monitor, Model AAE-701, is substantially equivalent to the predicate devices; Citizen CH-101 (K100553) and Citizen CH-609 (K100055).

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

NOV 2 2 2011

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

Re: K112273 ·

Trade/Device Name: Accumed Upper Arm Automatic Blood Pressure Monitor, AAE-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:

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.

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 (reporting of medical

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Page 2 - Ms. Cindy Green

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm117800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) Page 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ram D. Zutshi, M.D.

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):

Device Name: Accumed Upper Arm Automatic Blood Pressure Monitor, Model AAE-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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K112273
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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).