The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to 18.9" (22cm-48cm)

Device Description

iHealth BPM1 Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.

AI/ML Overview

The provided text describes the iHealth Wireless Blood Pressure Monitor (BPM1) and its submission for 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of its performance against specific acceptance criteria.

However, based on the information provided, we can infer some aspects relevant to acceptance criteria and the "study" that proves the device meets them, largely through adherence to international standards and comparison to predicate devices.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from standards)	Reported Device Performance / Evidence
Accuracy (Blood Pressure Measurement)	Adherence to IEC 80601-2-30 standards for automated noninvasive sphygmomanometers. This standard typically specifies accuracy requirements (e.g., mean difference and standard deviation between device and reference measurements).	"Clinical data have been transferred from the predicates." and "iHealth BPM1 Wireless Blood Pressure Monitor conforms to the following standards: ... IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers" The document asserts that performance is "Similar" to predicate devices, which would have met these accuracy standards.
Electrical Safety	Adherence to IEC 60601-1 standards.	"Electrical safety according test to IEC 60601-1" was done. And "Electrical safety" is "Identical" to predicate devices.
Electromagnetic Compatibility (EMC)	Adherence to IEC 60601-1-2 standards.	"Electromagnetic compatibility test according to IEC 60601-1-2" was done. And "EMC" is "Identical" to predicate devices.
Mechanical Safety	Not explicitly detailed, but inferred from general safety and performance standards.	"Mechanical safety" is "Identical" to predicate devices.
Biocompatibility	Device materials that contact patients are biocompatible.	"Patients contact Materials" are "Similar" to predicate devices, and "Biocompatibility" is "Identical" to predicate devices.
Functionality	Ability to measure systolic and diastolic blood pressure, pulse rate, display results, and classify blood pressure.	"The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user." "Function" is "Similar" to predicate devices.
Connectivity	Ability to connect to iOS or Android devices for data transmission.	"The new devices can connect to iOS or Andriod devices to show the results." and "More over, the new device BPM1 can transmitting data to a mobile device via WiFi."

Study Details:

The document describes pre-market notification (510(k)) and focuses on demonstrating substantial equivalence rather than a new standalone clinical study for accuracy.

Sample size used for the test set and the data provenance:
- The document states: "Clinical data have been transferred from the predicates."
- This implies that no new clinical test set was used for the BPM1 specifically for primary accuracy evaluation. Instead, the clinical data and performance of the predicate devices (Andon Health Co., Ltd. KD-927, K141984, KD-936, K120672, and KD-931, K102939) are relied upon.
- The provenance of the original clinical data for the predicate devices is not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since clinical data were "transferred from the predicates," this information would pertain to the original studies for the predicate devices. This detail is not provided in the current document. Typically, accuracy studies for blood pressure monitors involve simultaneous measurements by trained observers (experts) using a reference method (e.g., mercury sphygmomanometer) and the device under test.
Adjudication method for the test set:
- As clinical data were transferred, the adjudication method (if any) used for the predicate device studies is not described in this document. Standard blood pressure monitor accuracy studies often involve multiple observers performing auscultation and comparing their readings to ensure consensus or inter-observer reliability in establishing ground truth.
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 blood pressure monitor, which does not involve "human readers" interpreting images or data with or without "AI assistance" in the typical sense of MRMC studies. Its function is to provide direct measurements.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance was evaluated by adherence to IEC 80601-2-30. This standard specifically defines requirements for automated noninvasive sphygmomanometers, meaning the device's accuracy in measuring blood pressure is assessed independently of human interpretation of the measurement process itself. The device operates automatically to produce a reading.
- The document mentions "Non-clinical Tests have been done as follows: ... c. Safety and performance characteristics of the test according to IEC 80601-2-30". This demonstrates standalone performance against established international standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For blood pressure monitors, the ground truth is typically established by simultaneous measurements by trained human observers using a validated reference method, such as a mercury sphygmomanometer, often following protocols like those outlined by the Association for the Advancement of Medical Instrumentation (AAMI) or the British Hypertension Society (BHS). This would be a form of expert reference measurement. As clinical data were transferred, this ground truth method would have been used for the predicate devices.
The sample size for the training set:
- The document implies that the device's development and validation primarily relied on its similarity to predicate devices and adherence to standards. It does not explicitly mention a "training set" in the context of machine learning (AI) for this specific device's accuracy. The device uses an oscillometric principle, which is a well-established algorithm. Therefore, there isn't a "training set" in the typical AI sense to teach the device to measure blood pressure. The underlying algorithms are developed and refined based on extensive physiological and engineering data, but not a "training set" as one might see for image classification AI.
How the ground truth for the training set was established:
- As there isn't a "training set" described for this device in the AI sense, this question is not directly applicable. The "ground truth" for the oscillometric method's development (which is the core of the device's function) would have been established through extensive research comparing oscillometric waveforms to directly measured intra-arterial pressures or auscultation by experts.

Summary

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Public Health Service

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

February 1, 2017

Andon Health Co., Ltd Mr. Liu Yi President No 3 Jinping Street Ya An Road Nankai District Tianjin, 300190 CHINA

Re: K162144

Trade/Device Name: iHealth Wireless Blood Pressure Monitor (BPM1) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 23, 2016 Received: December 27, 2016

Dear Mr. Liu Yi:

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 (reporting of medical device

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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 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

Sincerely,

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) K162144

Device Name

iHealth Wireless Blood Pressure Monitor (BPM1)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 801 Subpart D)	Over-The-Counter Use (81 CFR 801 Subpart C)
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_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information_

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street Ya An Road, Nankai District, Tianjin,
	P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Preparation: 7/27/2016

2.0 Device information

Trade name: iHealth BPM1 Wireless Blood Pressure Monitor

Device name: iHealth Wireless Blood Pressure Monitor

Classification name: Noninvasive blood pressure measurement system

3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Requlation number: 870.1130 Classification: II Panel: Cardiovascular

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd. KD-927 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K141984

Manufacturer: Andon Health Co., Ltd. Device: KD-936 Fully Automatic Wireless Blood Pressure Monitor 510(k) number: K120672

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Manufacturer: Andon Health Co., Ltd. KD-931 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K102939

5.0 Intended use

BPM1(Electronic Sphygmomanometer) is intended for use in a The professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6" to18 .9"(22cm-48cm) intended use and the indication for use of The iHealth BPM1 Wireless Blood Pressure Monitor, as described in its labeling are the same as the predicate device KD-927 (K141984).

6.0 Device description

iHealth BPM1 Wireless Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irreqular heartbeat is detected, it can be shown to the user. The new devices can connect to iOS or Andriod devices to show the results.

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Similar
Performance	Similar
Biocompatibility	Identical
Mechanical safety	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

7.0 Summary comparing technological characteristics with predicate device

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8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

b. Electrical safety according test to IEC 60601-1;
c. Safety and performance characteristics of the test according to IEC 80601-2-30

None of the test demonstrates that BPM1 Wireless Blood Pressure Monitor bring new questions of safety and effectiveness.

9.0 Performance summary

iHealth BPM1 Wireless Blood Pressure Monitor conforms to the following standards:

60601-1:2005/(R)2012 And A1:2012.C1:2009/(R)2012 And ● IEC A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
· IEC 60601-1-2:2014.Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers
Clinical data have been transferred from the predicates. .

10.0 Comparison to the predicatedeviceand theconclusion

BPM1 Wireless Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-927 whose 510(k) number is K141984.

The new device BPM1 is very similar with its predicate device in the intended use, the design principle, the material, the performance and the applicable standards.

Their appearance, the memory capacity, electrical power, memory average function, average measure function and the MCU are different, and a new

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software platform has been added. More over, the new device BPM1 can transmitting data to a mobile device via WiFi.

However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.

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).