GMC Upper Arm Automatic Blood Pressure Monitor

• K Number: K181931
• Device Name: GMC Upper Arm Automatic Blood Pressure Monitor
• Manufacturer: GMC Inc.
• Date Cleared: 2019-04-04 ( 260 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

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.

Predicate Devices

K133379

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard oscillometric blood pressure measurement and an irregular heartbeat detection based on a fixed percentage deviation, with no mention of AI or ML algorithms.

Therapeutic

No.
The device is for measuring blood pressure and pulse rate, not for treating any condition. Its function is diagnostic/monitoring, not therapeutic.

Diagnostic

Yes.
The device measures blood pressure and pulse rate, and indicates irregular heartbeat, which are used to assess physiological states and detect potential abnormalities.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions an "electronic pressure sensor" and a "cuff pressure," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The GMC Upper Arm Automatic Blood Pressure Monitor, Model X3, is a non-invasive device that measures blood pressure and pulse rate directly from the body (on the upper arm) using physical principles (oscillometric method). It does not analyze samples taken from the body.

Therefore, based on the provided information, the device falls under the category of a non-invasive medical device rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper Arm

Indicated Patient Age Range

Adult

Intended User / Care Setting

Home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy: Pressure ± 3 mmHg or 2 % of reading for predicate, ± 3 mmHg for subject.
Accuracy: Pulse ± 5% of reading

Predicate Device(s)

Omron HEM-7311 (K133379)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

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

1

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 ([e-mail]) or phone [phone] 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

2

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3

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

X3

510(k) Summary

| 510(k) owner's information: | GMC Inc.
No. 686, Su Chu Rd., Chuzhou,
Anhui, China
Tel: [phone]
Fax: [phone] |
|-----------------------------|-----------------------------------------------------------------------------------------------------------|
| Official Contact: | Yolanda Lin
Tel: [phone]
Fax: [phone]
E-mail: [e-mail] |
| Proprietary or Trade Name: | GMC Upper Arm Automatic Blood
Pressure 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 |

4

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

X3

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.

Intended Use:

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.

Substantially Equivalent (SE) Comparison

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

5

GMC0尚钩医疗

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

X3

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 Indications
for Use	The device is a digital monitor intended
for use in measuring blood pressure and
pulse rate in adult patient population.
The device detects the appearance of
irregular heartbeats during
measurement and gives a warning
signal with readings.	The device 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.	Identical
Use Environment	Home use	Home use	Identical
Patient Population	Adult	Adult	Identical

6

GMC0尚钧医疗

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

Specifications / Features

| Model name | Predicate Device
Omron HEM-7311 (K133379) | | Subject Device
GMC 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") | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| Measurement range | Pressure | 0299 mmHg | 30260 mmHg | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| | Pulse | 40180 beats/min | 40~199 beats/min | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| Accuracy | Pressure | $\pm$ 3 mmHg or 2 % of reading | $\pm$ 3 mmHg | Similar
There is no difference in the
accuracy range based on mmHg
scale |
| | Pulse | $\pm$ 5% of reading | $\pm$ 5% of reading | Identical |

7

X3

GMC0尚钧医疗

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

| Model name | Predicate Device
Omron HEM-7311 (K133379) | Subject Device
GMC X3 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Reusable | Yes | Yes | Identical |
| Display Type | LCD | LCD | Identical |
| Display Parameter | Current cuff pressure, Systolic blood
pressure, Diastolic blood pressure,
Pulse rate, Error message,
measurement results in the memory | Systolic pressure, Diastolic pressure,
Pulse rate, Memory sequence
number, Date/Time, memory zone
icons, pulse mark, weak battery mark,
AVG, Hypertension Classification
Indicator, IHB, Movement indicator | Similar
The 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 three
measurements | Yes | Yes | Identical |

8

X3

GMC0尚钧医疗

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

| Model name | | Predicate Device
Omron HEM-7311 (K133379) | Subject Device
GMC 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) | Similar
Size is not a factor in function of the
device |
| Weight | | Approx. 640g (1 lbs6 5/8 oz)
(without batteries) | (without batteries)
246g | Similar
Weight is not a factor in function of the
device |
| Operating | Temperature | 1040℃ (50-104°F) | 1040℃ (50-104°F) | Identical |
| Environment | Humidity | 15%~90% RH | 15%~85% RH | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| | Ambient
pressure | N/A | 700-1060 hpa | Different
This feature does not impact safety and
effectiveness of the device |

9

X3

GMC0尚钧医疗

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

| Model name | Predicate Device
Omron HEM-7311 (K133379) | | Subject Device
GMC X3 | Comparison |
|------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Storage
Environment | Temperature | -2060°C (-4-140°F) | -1060 ℃(14-140°F) | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| | Humidity | 10%~95% RH | 10%~90% RH | Similar
This minor difference does not impact
safety and effectiveness of the device. |
| | Ambient
pressure | 700-1060 hpa | 700-1060 hpa | Identical |
| Compliance Standards | | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 80601-2-30
ISO81060-2
ISO 10993-1 | ANSI/AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 80601-2-30
ISO81060-2
ISO 10993-1 | Identical |

10

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

11

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.

12

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).