(115 days)
This device is intended to measure the systolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric technique. The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use. The proposed blood pressure monitor includes three models, which are W02S. W1102. W1102A. All models contain the same software. measurement principle and NIBP algorithm. The main differences are product appearance and the specification of solenoid Valve.
The provided text describes the acceptance criteria and the study that proves the device (Wrist Type Blood Pressure Monitor) meets those criteria, primarily focusing on its clinical accuracy.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's clinical accuracy was evaluated according to ISO 81060-2:2018 (Third edition 2018-11). This standard sets the clinical acceptance criteria for automated non-invasive sphygmomanometers. While the specific numerical acceptance criteria (e.g., mean difference and standard deviation limits) from ISO 81060-2 are not explicitly detailed in the provided text, the summary states:
"The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device W1102 in the group of 95 adult subjects (56 male and 39 female) with qualified distribution."
And under Accuracy in the comparison table:
| Criteria | Acceptance Criteria (Predicate) | Reported Performance (Subject Device) |
|---|---|---|
| Pressure Accuracy | ±3mmHg | ±3mmHg (±0.4kPa) |
| Pulse Accuracy | ±5% | ±5% BPM |
This is a direct comparison to the predicate device's accuracy, which the subject device matches. The clinical study further supports that these accuracy limits were met according to the ISO standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 95 patients (56 males and 39 females)
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "Clinical Test report" and mentions "95 patients were invited for the study." The manufacturer is based in Shenzhen, China, so it is highly probable the study was conducted there.
- Retrospective or Prospective: The wording "95 patients were invited for the study" strongly suggests a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the clinical accuracy study was established using the standard auscultation method as the reference blood pressure monitor. This method typically involves trained medical professionals (e.g., nurses, doctors) taking manual blood pressure measurements. However, the document does not specify the number of experts or their qualifications.
4. Adjudication Method for the Test Set
The document mentions that blood pressure measurements were "repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11." This standard outlines specific protocols for comparing automated devices to a reference method, often involving multiple measurements and averaging. However, it does not explicitly describe an adjudication method in the sense of resolving discrepancies between multiple expert readers for image interpretation (which is common for AI/ML device studies). For blood pressure measurement, the auscultation method itself serves as the direct reference.
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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI/ML-assisted diagnostic tool that would typically involve human readers interpreting AI output. The study focused on the device's accuracy compared to a gold standard (auscultation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?
Yes, a standalone performance evaluation was done. The clinical accuracy study assessed the device's ability to accurately measure blood pressure on its own, comparing its readings directly to those obtained via the auscultation method. This is a "standalone" evaluation of the device's measurement algorithm.
7. The Type of Ground Truth Used
The type of ground truth used was comparative measurement against a recognized gold standard: the standard auscultation method for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. For traditional medical devices like blood pressure monitors, the "training" (i.e., development and calibration) is typically done internally by the manufacturer during the product design phase, and the document focuses on the test set used for regulatory submission and clinical validation. There's no indication of an AI/ML model that would require a distinct training set in the context of this FDA submission.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a distinct training set for an AI/ML algorithm in the context of this blood pressure monitor, the question about "ground truth for the training set" is not applicable in the way it typically applies to AI/ML devices. The device's underlying algorithm for oscillometric measurement is part of its design, calibrated through internal processes. The submitted study focuses on the validation of the final device's performance against clinical standards.
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June 30, 2022
Shenzhen Jamr Medical Technology Co., Ltd % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu commercial building, Hongxing community, Songgang street Shenzhen, Guangdong 518000 China
Re: K220651
Trade/Device Name: Wrist Type Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 24, 2022 Received: June 2, 2022
Dear Reanny Wang:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220651
Device Name Wrist Type Blood Pressure Monitor
Indications for Use (Describe)
This device is intended to measure the systolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
Type of Use (Select one or both, as applicable)
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 requirements of SMDA and 21 CFR $807.92.
The assigned 510(k) number is: K220651 Data preparation: May 24, 2022
1.0 Information of Submitter
Shenzhen Jamr Technology Co., Ltd.
Address: A101-301, D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community,Guanlan Street, Longhua District, Shenzhen 518100, PEOPLE'S REPUBLIC OF CHINA Phone: +86-755-85292057 Fax: +86-755-61673107 Contact Person: Luo Fusheng E-mail: eng201 @cigii.net, reanny@reanny.com
2.0 Device Information
Type of 510(k) submission: Traditional Trade Name: Wrist Type Blood Pressure Monitor Model(s): W1102, W1102A, W02S Classification name: System, Measurement, Blood-Pressure, Non-Invasive Review Panel: Cardiovascular Product Code: DXN Device Class: II Regulation Number: 21 CFR 870.1130
3.0 Predicate Device Information
Sponsor: Shenzhen Combei Technology Co., LTD. Device: Digital Blood Pressure Monitor-Wrist Style 510(K) Number: K171833
4.0 Device Description
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of adults at wrist within its claimed range and accuracy via the oscillometric
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technique.
The device has data storage function for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The subject device is intended to be used in medical facilities or at home. And it is provided non-sterile, and not to be sterilized by the user prior to use.
The proposed blood pressure monitor includes three models, which are W02S. W1102. W1102A. All models contain the same software. measurement principle and NIBP algorithm. The main differences are product appearance and the specification of solenoid Valve.
5.0 Intended Use/Indication for use
This device is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult by using the wrist circumference 12.5-21.5cm, it can be used in medical facilities or at home. It is supplied for OTC use.
6.0 Performance Summary
Clinical Test Summary
Testing to ensure clinical accuracy of the device in accordance with ISO 81060-2 Third edition 2018-11 as documented in Clinical Test report. 95 patients (56 males and 39 females) were invited for the study. Standard auscultation method was used as the reference blood pressure monitor measuring in the arm. Blood pressure measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in ISO 81060-2 Third edition 2018-11.
Non-Clinical Test Summary
The Subject Device has performed several non-clinical tests to show that all requirement specifications and standard requirements are met. The tests include the follows:
IEC 60601-1 Edition 2005+Amd 1:2012
IEC 60601-1-2 Edition 4.0 2014-02
IEC 60601-1-11 Edition 2.0 2015-01
IEC 80601-2-30: Edition 2.0 2018-03
7.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate device, K171833. The substantial equivalence chart is provided as follows:
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Shenzhen Jamr Technology Co., Ltd.
| Elements ofComparison | Predicate Device(K171833) | Subject Device | Verdict |
|---|---|---|---|
| Device Name | Digital Blood PressureMonitor-Wrist Style | Wrist Type Blood PressureMonitor | -- |
| Device Model | BP800W, BP603W, BP880W,BP885W, BPCB0A-2F,BP850W, BP300W, BP810W,BP602W, BP608W, BP606W,BP660W, BP830W, BP866W | W1102, W1102A, W02S | -- |
| Manufacturer | Shenzhen Combei TechnologyCo., LTD. | Shenzhen Jamr Technology Co.,Ltd. | -- |
| Intended Use/Indication for Use | The subject device intended tomeasure the diastolic, systolicblood pressures and pulse rate ofan adult individual in hospitals,hospital-type facilities andhome environments by using anon-invasive oscillometrictechnique in which an inflatablecuff (available size:12.5 | The Wrist Type Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulse rateof adult by using the wristcircumference 12.5-21.5cm, itcan be used in medical facilitiesor at home. It is supplied forOTC use. | Note 01 |
| IntendedPopulation | Adults | Adults | Same |
| IntendedAnatomical site | Wrist | Wrist | Same |
| Prescription &OTC | OTC | OTC | Same |
| Working Principle | Oscillometric method | Oscillometric method | Same |
| Internal Powersupply | 2- size "AAA" alkalineBatteries | 2- size "AAA" alkalineBatteries | Same |
| Memory Function | 2×120 memory | 2×120 memory | Same |
| Cuff Size | 12.5cm | 12.5-21.5cm | Same |
| Measuring range | Pressure: 30 to 280 mmHg (in 1mmHg increment); | Pressure: DIA: 40-130mmHg,SYS:60-230mmHg | Note 02 |
| Pulse: 40 to 200 beat/minute | Pulse Rate: 40-180 bpm | Note 02 | |
| Accuracy | Pressure: ±3mmHg;Pulse: ±5% | Pressure: ±3mmHg (±0.4kPa);Pulse Rate: ±5% BPM | Same |
Note 01:
There are only some descriptive differences between the intended uses of Predicate Device and the subject device, including: 1. the intended use of Predicate Device add information of the Working Principle (i.e. by using a non-invasive oscillometric technique); 2. the intended use of Predicate Device add: The Subject device is not intended to be diagnostic device.
The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
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Note 02:
The measuring range of the subject device is within that of the predicate device. The difference between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
8. Discussion of Clinical Tests Performed
Our blood pressure monitor and cuff have been conducted clinical testing to verify the accuracy according to ISO 81060-2: Third Edition 2018-11, Non-invasive sphygmomanometers- Part 2: Clinical investigation of intermittent automated measurement type. The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device W1102 in the group of 95 adult subjects (56 male and 39 female) with qualified distribution. There was not adverse effects ad complication during clinical testing. Thus, all the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met.
9. Discussion of Non-Clinical testing and Clinical Trial
The subject device was tested to evaluate its safety and effectiveness, including the following testing:
Biocompatibility Testing:
The biocompatibility evaluation for the body-contacting component (cuff) was conducted in accordance with the "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Device -- Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The cuff has passed the Biocompatibility test by complying with the following standards:
ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process:
ISO 10993-5: 2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity;
ISO 10993-10:2010, Biological Evaluation of Medical Devices -- Part 10: Tests For Irritation And Skin Sensitization.
Electrical and EMC Safety:
The electrical safety and EMC safety testing have passed by complying with:
IEC 60601-1:2005+A1:2012, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance:
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IEC 60601-1-11:2015, 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: 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.
Performance:
The performance testing has passed by complying with the following standards:
IEC 80601-2-30:2018, Medical Electrical Equipment -- Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers ISO 81060-2:2018, Non-Invasive Sphygmomanometers -- Part 2: Clinical Validation of Automated Measurement Type;
Accuracy of Blood pressure measurement:
ISO 81060-2 Third edition 2018-11, Non-Invasive Sphygmomanometers -- Part 1: Requirements and Test Methods For Non-Automated Measurement Type.
Software:
We have also conducted Software verification and validation test according to the requirements of the FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices".
Summary:
Based on the above performance as documented in this application, the Wrist Type Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.
10.0 Conclusions
Wrist Type Blood Pressure Monitor, models W1102, W1102A, W02S, have the same intended use and similar characteristics as the predicate device. Form the above information, we conclude the subject devices are substantially equivalent to the predicate device, K171833, and any differences in their characteristics do not raise any safety and effectiveness issues.
§ 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).