(211 days)
The GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, 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 appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.
The GMC Wrist Automatic Blood Pressure Monitor, Model BO705, 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.
The provided text describes the GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, and includes information about its performance testing and clinical investigation.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document explicitly states that the device complies with several standards, including IEC 80601-2-30 and ISO 81060-2, which define performance criteria for non-invasive blood pressure monitors. The "Accuracy" row in the comparison table indicates the performance:
| Acceptance Criteria | Reported Device Performance (GMC BQ705) |
|---|---|
| Accuracy (Pressure) | ±3 mmHg (Similar to predicate) |
| Accuracy (Pulse) | ±5% of reading (Identical to predicate) |
| Compliance Standards | ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 81060-2, ISO 10993-1 (Complied with the latest Recognized Consensus Standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: 85 patients (38 males and 47 females) were invited for the clinical study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the phrasing "were invited for the study" and the mention of a "Clinical Investigation Report," it strongly implies a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth was established using the "Standard auscultation method." While it doesn't specify the number or qualifications of the individuals performing the auscultation, for clinical studies involving blood pressure, the auscultatory method typically involves trained medical professionals. The mention of "standard auscultation method" implies adherence to established clinical practices for blood pressure measurement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for reconciling differences between experts for establishing ground truth. The "Standard auscultation method" implies a direct measurement taken by a trained individual, which serves as the reference, rather than a consensus approach among multiple independent observers for establishing 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
There is no indication of an MRMC comparative effectiveness study in the provided text. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The device itself is designed to automatically measure blood pressure and pulse rate using the oscillometric method. The clinical testing comparing its measurements against the standard auscultation method demonstrates its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was "Standard auscultation method" measurements. This serves as a direct clinical reference standard for blood pressure.
8. The sample size for the training set
The document does not provide information on the sample size used for the training set of the device's algorithm. The provided information focuses on the clinical validation of the device.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for the training set was established. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries.
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February 14, 2019
GMC Inc. Yolanda Li Director of Quality Management Div. No. 686, Su Chu Rd. Chuzhou, 239000 CHINA
Re: K181930
Trade/Device Name: GMC Wrist Automatic Blood Pressure Monitor, Model B0705 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 Li:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Stephen C. Browning -S5
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) K181930
Device Name
GMC Wrist Automatic Blood Pressure Monitor, Model BQ705
Indications for Use (Describe)
The GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, 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 appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5- 510(k) Summary
Image /page/3/Picture/4 description: The image shows the logo for GMC 尚 钉 医疗. The logo consists of the letters "GMC" in gray, followed by a red circle with a white plus sign in the center. To the right of the circle are the Chinese characters 尚 钉 医疗, also in gray. The logo appears to be for a medical company.
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 LinBus. Phone: 86-550-2172888Fax: 86-550-2172889E-mail: linyolanda23@gmail.com |
| Proprietary or Trade Name: | GMC Wrist Automatic Blood PressureMonitor, Model BQ705 |
| Common/UsualName: | 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 BP652N (K142917) |
| Date Summary Prepared: | 07/16/2018 |
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Section 5- 510(k) Summary
No. 686, Su Chu Rd., Chuzhou, Anhui, China
Device Description:
The GMC Wrist Automatic Blood Pressure Monitor, Model BO705, 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 Wrist Automatic Blood Pressure Monitor, Model BQ705, 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 Wrist Automatic Blood Pressure Monitor, Model BO705 is substantially equivalent to the Omron BP652N (K142917).
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BQ705
GMC0尚钧医疗
| Model name | Predicate Device | Subject Device | |
|---|---|---|---|
| Omron BP652N (K142917) | GMC BQ705 | Comparison | |
| 510(k) submitter/holder | Omron Healthcare, Inc. | GMC Inc. | |
| Intended use and Indicationsfor Use | The device is a digital monitor intended | The device is a non-invasive blood pressure | Similar |
| for use in measuring blood pressure and | measurement device that is used for | No difference of intended | |
| pulse rate in adult patient population | measuring systolic and diastolic blood | purpose. The proposed | |
| with wrist circumference ranging from | pressure and pulse rate using the | indication for use is the same as | |
| 5 1/4 inches to 8 1/2 inches (13.5cm to | oscillometric method for adults at home. | the cleared indication for use of | |
| 21.5 cm). The device detects the | The device has an irregular heartbeat (IHB) | the predicate device. The wrist | |
| appearance of irregular heartbeats | indicator. The device detects the appearance | circumference is slightly | |
| during measurement and gives a | of an irregular heartbeat during | different between the two | |
| warning signal with readings. | measurement, and displays an IHB symbol | devices, but this difference does | |
| on the LCD with the reading once the | not affect safety or | ||
| irregular heartbeat is detected. | effectiveness. | ||
| 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 BP652N (K142917) | Subject DeviceGMC BQ705 | Comparison |
|---|---|---|---|
| Measurement method | Oscillometric methods | Oscillometric methods | Identical |
| Cuff fits wrist circumference | 13.5 to 21.5cm | 13.5~22cm(5.3"~8.7") | 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 ±3 mmHg or 2 % of reading | ±3 mmHg | SimilarThere is no difference in theaccuracy range based on mmHgscale |
| Pulse ±5% of reading | ±5% of reading | Identical |
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BQ705
GMC0尚钧医疗
| Model name | Predicate DeviceOmron BP652N (K142917) | Subject DeviceGMC BQ705 | 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, pulsemark, weak battery mark, AVG,Hypertension Classification Indicator,IHB, Movement indicator | SimilarThe different display parameters donot impact safety and effectiveness ofthe 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 |
| Advanced positioning sensor | Yes | No | DifferentThis feature does not impact safety |
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Section 5- 510(k) Summary
BQ705
GMC0尚钧医疗
| Model name | Predicate DeviceOmron BP652N (K142917) | Subject DeviceGMC BQ705 | Comparison |
|---|---|---|---|
| and effectiveness of the device | |||
| Average of latest threemeasurements | Yes | Yes | Identical |
| Memory | Similar | ||
| 100 readings | 120 reading(60memories*2 zones) | This feature does not impact safetyand effectiveness of the device | |
| Multiple Users | No | Yes(2) | DifferentThis feature does not impact safetyand effectiveness of the device |
| Power Source | AAA Battery*2 pcs | AAA Battery*2 pcs | Identical |
| Dimension | 89 mm × 61 mm × 13 mm (L x W x H) | 67×75.7×30mm (L x W x H) | SimilarSize is not a factor in function of thedevice |
| Weight | Approx. 80g (2 7/8 oz)(without batteries) | 81g(without batteries) | SimilarWeight is not a factor in function ofthe device |
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BQ705
GMC0尚钧医疗
| Model name | Predicate DeviceOmron BP652N (K142917) | Subject DeviceGMC BQ705 | Comparison | |
|---|---|---|---|---|
| OperatingEnvironment | Temperature | 10~40℃ (50-104°F) | 10~40℃ (50-104°F) | Identical |
| Environment | Humidity | 15%~85% RH | 15%~85% RH | Identical |
| Ambientpressure | N/A | 700-1060 hPa | DifferentThis feature does not impact safetyand effectiveness of the device | |
| StorageEnvironment | Temperature | -20~60℃ (14-140°F) | -10~60 ℃(14-140°F) | Identical |
| Environment | 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 |
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GMC Inc. No. 686, Su Chu Rd., Chuzhou, Anhui, China
| Model name | Predicate DeviceOmron BP652N (K142917) | Subject DeviceGMC BQ705 | Comparison |
|---|---|---|---|
| Compliance Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-11AAMI SP10ANSI/AAMI/ISO81060-2ISO 10993-1 | ANSI/AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30ISO 81060-2ISO 10993-1 | SimilarBQ705 complied with the latestRecognized Consensus Standards |
The subject device is viewed as substantially equivalent to the predicate devices Omron BP652N because intended use and use the well known oscillometric method within 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/4 description: The image shows the logo for GMC 尚钧医疗. The logo consists of the letters "GMC" in gray, followed by a red circle with a white plus sign inside. To the right of the circle are four Chinese characters in gray. The characters are 尚钧医疗.
No. 686, Su Chu Rd., Chuzhou, Anhui, China
Performance Testing:
Bench testing was conducted to demonstrate that the device meets its requirements and specification.
The following performance tests were completed:
- ANSI AAMI ES60601-1
- IEC 60601-1-2
- · IEC 60601-1-11
- IEC 80601-2-30
The GMC Wrist Automatic Blood Pressure Monitor, Model BQ705 meets all applicable requirements.
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.
Clinical testing
Testing to insure clinical accuracy of the device in accordance with ISO 81060-2 as documented in Clinical Investigation Report. 85 patients (38 males and 47 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 ISO 81060-2.
Conclusion
Based on the evaluations completed, there are no new safety or effectiveness issues introduced with this new medical device. Therefore, the GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, is substantially equivalent to the predicate devices Omron BP652N (K142917)
§ 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).