The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, 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 GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, 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 an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard / Requirement)	Reported Device Performance (GMC X3)
Accuracy (Pressure)	± 3 mmHg
Accuracy (Pulse)	± 5% of reading
ANSI/AAMI ES60601-1 (Basic safety & essential performance)	Meets all applicable requirements
IEC 60601-1-2 (Electromagnetic disturbances)	Meets all applicable requirements
IEC 60601-1-11 (Home healthcare environment)	Meets all applicable requirements
IEC 80601-2-30 (Automated non-invasive sphygmomanometers)	Meets all applicable requirements
ISO 10993-1 (Biocompatibility)	Materials are widely used in similar applications; evaluated accordingly.
ISO 81060-2 (Clinical validation of automated measurement type)	Clinical accuracy tested and documented in Clinical Investigation Report.

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

Sample Size for Test Set: 85 patients (39 males and 46 females).
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation studies for a new device are typically prospective.

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

The document implies that the ground truth for blood pressure measurements was established using the standard auscultation method. It does not specify the number of experts (e.g., clinicians, physicians) performing the auscultation, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It's standard practice for trained medical professionals to perform auscultation, but their specific experience level is not detailed here.

4. Adjudication Method for the Test Set:

The document states: "Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in #3-122 ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."
This suggests a direct comparison method between the device and the auscultation reference. The specific adjudication method (e.g., 2+1, 3+1) is not detailed. However, ISO 81060-2 has specific requirements for the number of observers and how their readings are handled to establish criteria for ground truth.

5. 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for this device. This is a blood pressure monitor, not an AI-powered diagnostic imaging device that would involve human readers interpreting cases. The study focuses on the accuracy of the automated measurement against a reference method.

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

Yes, the clinical testing described is primarily a standalone performance evaluation of the device's algorithm. The "GMC Upper Arm Automatic Blood Pressure Monitor, Model X3" is an automated device, meaning its algorithm determines the blood pressure readings without direct human interpretation of a raw signal, other than possibly initiating the measurement. The clinical study validates the accuracy of these automated readings against a standard reference.

7. The Type of Ground Truth Used:

The ground truth used was expert auscultation measurements. The document states, "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." Auscultation by a trained professional is considered a clinical gold standard for blood pressure measurement in this context.

8. The Sample Size for the Training Set:

The document does not provide information regarding a training set. This is typical for a device like a blood pressure monitor, which relies on established oscillometric principles and calibration, rather than a machine learning model that requires a distinct training phase.

9. How the Ground Truth for the Training Set was Established:

As no training set is mentioned or implied, the document does not provide information on how ground truth for a training set was established.

Summary

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April 4, 2019

GMC Inc. Yolanda Lin Director of Quality Management Div. No. 686, Su Chu Rd. Chuzhou, 239000 Cn

Re: K181931

Trade/Device Name: GMC Upper Arm Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 11, 2019 Received: January 11, 2019

Dear Yolanda Lin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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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Section 5- 510(k) Summary

Image /page/3/Picture/3 description: The image shows the logo for GMC 尚钧医疗. The logo consists of the letters "GMC" in a dark gray sans-serif font, followed by a red circle with a white plus sign inside. To the right of the circle are the Chinese characters 尚钧医疗, also in a dark gray color. The characters are written in a traditional Chinese calligraphy style.

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

510(k) Summary

510(k) owner's information:	GMC Inc.No. 686, Su Chu Rd., Chuzhou,Anhui, ChinaTel: +86-550-2172888Fax: +86-550-2172889
Official Contact:	Yolanda LinTel: +86-550-2172888Fax: +86-550-2172889E-mail: linyolanda23@gmail.com
Proprietary or Trade Name:	GMC Upper Arm Automatic BloodPressure Monitor, Model X3
Common/Usual Name:	Non-Invasive Blood Pressure Monitor
Classification Name:	System, Measurement, Blood-Pressure,Non-Invasive
Regulation	CFR 870.1130
Product Code	DXN
Device Class:	II
Predicate Device:	Omron HEM-7311 (K133379)
Date Summary Prepared:	07/16/2018

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Section 5- 510(k) Summary

Image /page/4/Picture/3 description: The image shows the logo for GMC 尚钧医疗. The logo consists of the letters "GMC" in a dark gray sans-serif font, followed by a red circle with a white plus sign in the center. To the right of the circle are four Chinese characters in a dark gray, traditional font.

No. 686, Su Chu Rd., Chuzhou Anhui, China

Device Description:

Intended Use:

Substantially Equivalent (SE) Comparison

The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3 is substantially equivalent to the Omron HEM-7311 (K133379).

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GMC0尚钩医疗

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

Model name	Predicate Device	Subject Device	Comparison
	Omron HEM-7311 (K133379)	GMC X3
510(k) submitter/holder	Omron Healthcare, Inc.	GMC Inc.
Intended use and Indicationsfor Use	The device is a digital monitor intendedfor use in measuring blood pressure andpulse rate in adult patient population.The device detects the appearance ofirregular heartbeats duringmeasurement and gives a warningsignal with readings.	The device is a non-invasive blood pressuremeasurement device that is used formeasuring systolic and diastolic bloodpressure and pulse rate using theoscillometric method for adults at home.The device has an irregular heartbeat (IHB)indicator. The device detects the appearanceof an irregular heartbeat duringmeasurement, and displays an IHB symbolon the LCD with the reading once theirregular heartbeat is detected.	Identical
Use Environment	Home use	Home use	Identical
Patient Population	Adult	Adult	Identical

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GMC0尚钧医疗

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

Specifications / Features

Model name	Predicate DeviceOmron HEM-7311 (K133379)		Subject DeviceGMC X3	Comparison
Measurement method	Oscillometric methods		Oscillometric methods	Identical
Cuff fits arm circumference	17-22cm/ 22-32cm/ 22-42cm		24-40 cm (9.4"~15.7")	SimilarThis minor difference does not impactsafety and effectiveness of the device.
Measurement range	Pressure	0~299 mmHg	30~260 mmHg	SimilarThis minor difference does not impactsafety and effectiveness of the device.
	Pulse	40~180 beats/min	40~199 beats/min	SimilarThis minor difference does not impactsafety and effectiveness of the device.
Accuracy	Pressure	$\pm$ 3 mmHg or 2 % of reading	$\pm$ 3 mmHg	SimilarThere is no difference in theaccuracy range based on mmHgscale
	Pulse	$\pm$ 5% of reading	$\pm$ 5% of reading	Identical

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X3

GMC0尚钧医疗

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

Model name	Predicate DeviceOmron HEM-7311 (K133379)	Subject DeviceGMC X3	Comparison
Reusable	Yes	Yes	Identical
Display Type	LCD	LCD	Identical
Display Parameter	Current cuff pressure, Systolic bloodpressure, Diastolic blood pressure,Pulse rate, Error message,measurement results in the memory	Systolic pressure, Diastolic pressure,Pulse rate, Memory sequencenumber, Date/Time, memory zoneicons, pulse mark, weak battery mark,AVG, Hypertension ClassificationIndicator, IHB, Movement indicator	SimilarThe different display parameters do not impact safety and effectiveness of the device.
Inflation	Pump driven	Pump driven	Identical
Deflation	Automatic Air Release Valve	Automatic Air Release Valve	Identical
Pressure Sensor	Semi-conductor	Semi-conductor	Identical
Irregular Heart Beat detection	Yes	Yes	Identical
Body movement detection	Yes	Yes	Identical
Hypertension indicator	Yes	Yes	Identical
Average of latest threemeasurements	Yes	Yes	Identical

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X3

GMC0尚钧医疗

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

Model name		Predicate DeviceOmron HEM-7311 (K133379)	Subject DeviceGMC X3	Comparison
Multiple Users		Yes(2)	Yes(2)	Identical
Power Source		Battery as well as AC adaptor	Battery as well as AC adaptor	Identical
Dimension		183 X 230 X 99mm (Lx W x H)	96 X 139.7 X 63.2mm (L x W x H)	SimilarSize is not a factor in function of thedevice
Weight		Approx. 640g (1 lbs6 5/8 oz)(without batteries)	(without batteries)246g	SimilarWeight is not a factor in function of thedevice
Operating	Temperature	10~40℃ (50-104°F)	10~40℃ (50-104°F)	Identical
Environment	Humidity	15%~90% RH	15%~85% RH	SimilarThis minor difference does not impactsafety and effectiveness of the device.
	Ambientpressure	N/A	700-1060 hpa	DifferentThis feature does not impact safety andeffectiveness of the device

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X3

GMC0尚钧医疗

GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

Model name	Predicate DeviceOmron HEM-7311 (K133379)		Subject DeviceGMC X3	Comparison
StorageEnvironment	Temperature	-20~60°C (-4-140°F)	-10~60 ℃(14-140°F)	SimilarThis minor difference does not impactsafety and effectiveness of the device.
	Humidity	10%~95% RH	10%~90% RH	SimilarThis minor difference does not impactsafety and effectiveness of the device.
	Ambientpressure	700-1060 hpa	700-1060 hpa	Identical
Compliance Standards		ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30ISO81060-2ISO 10993-1	ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30ISO81060-2ISO 10993-1	Identical

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GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China

The subject device is viewed as substantially equivalent to the predicate devices Omron HEM-7311 because they have same intended use and use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. There are no significant diffect the safety or effectiveness of the intended device as compared to the predicate devices

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Image /page/11/Picture/3 description: The image shows the logo for GMC+. The logo consists of the letters "GMC" in a dark gray sans-serif font, followed by a red circle with a white plus sign inside. To the right of the circle are two Chinese characters, also in dark gray. The overall design is simple and modern, with a focus on the company's initials and a medical symbol.

No. 6

Performance Testing:

Bench testing was conducted to demonstrate that the device meets its requirements and specification.

The following performance tests were completed:

#19-4
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety

and essential performance (IEC 60601-1:2005, MOD)

#19-8 •
IEC 60601-1-2 Edition 4.0 2014-02

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

#19-14
IEC 60601-1-11 Edition 2.0 2015-01

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

#3-123
IEC 80601-2-30 Edition 1.1 2013-07

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3 meets all applicable requirements.

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Image /page/12/Picture/3 description: The image shows the logo for GMC+. The logo consists of the letters "GMC" in a dark gray sans-serif font, followed by a red circle with a white plus sign inside. To the right of the circle is a Chinese character, also in dark gray.

No. 6

Biocompatibility

The materials of construction are widely used in the same or similar applications; therefore, demonstrating the material's use in other medical devices and supporting existing biocompatibility.

It is evaluated according to #2-220 ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Clinical testing

Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Investigation Report. 85 patients (39 males and 46 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in #3-122 ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Conclusion

Based on the evaluations completed, there are no new safety or effectiveness issues introduced with this new medical device. Therefore, the GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, is substantially equivalent to the predicate devices Omron HEM-7311 (K133379).

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).