(115 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and explicitly states the use of a "NIBP algorithm," which is a traditional method for blood pressure calculation, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is intended to measure blood pressure and pulse rate, not to treat a condition. While monitoring can be part of managing a health condition, the device itself is for diagnostic/monitoring purposes, not therapeutic intervention.
Yes
The device is intended to measure systolic blood pressure and pulse rate, which provides information about a patient's physiological state. While it does not diagnose specific diseases, the measurement of vital signs falls under the umbrella of diagnostic information gathering.
No
The device description explicitly states it is a "battery driven automatic non-invasive blood pressure monitor" that performs inflation, deflation, and measurement using the oscillometric technique. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The described device is a Wrist Type Blood Pressure Monitor. It measures blood pressure and pulse rate directly from the patient's wrist using a non-invasive method (oscillometric technique). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, not to perform diagnostic tests on biological samples.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DXN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical facilities or at home. It is supplied for OTC 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
Not Found
Summary of Performance Studies
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
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:
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.
Key Metrics
Accuracy: Pressure: ±3mmHg; Pulse: ±5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
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.
1
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
4
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 of
Comparison | Predicate Device
(K171833) | Subject Device | Verdict |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name | Digital Blood Pressure
Monitor-Wrist Style | Wrist Type Blood Pressure
Monitor | -- |
| Device Model | BP800W, BP603W, BP880W,
BP885W, BPCB0A-2F,
BP850W, BP300W, BP810W,
BP602W, BP608W, BP606W,
BP660W, BP830W, BP866W | W1102, W1102A, W02S | -- |
| Manufacturer | Shenzhen Combei Technology
Co., LTD. | Shenzhen Jamr Technology Co.,
Ltd. | -- |
| Intended Use/
Indication for Use | The subject device intended to
measure the diastolic, systolic
blood pressures and pulse rate of
an adult individual in hospitals,
hospital-type facilities and
home environments by using a
non-invasive oscillometric
technique in which an inflatable
cuff (available size:
12.521.5cm(4.98.5in) is
wrapped around the single wrist.
The Subject device is not
intended to be diagnostic
device. | The Wrist Type Blood Pressure
Monitor 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. | Note 01 |
| Intended
Population | Adults | Adults | Same |
| Intended
Anatomical site | Wrist | Wrist | Same |
| Prescription &
OTC | OTC | OTC | Same |
| Working Principle | Oscillometric method | Oscillometric method | Same |
| Internal Power
supply | 2- size "AAA" alkaline
Batteries | 2- size "AAA" alkaline
Batteries | Same |
| Memory Function | 2×120 memory | 2×120 memory | Same |
| Cuff Size | 12.5cm21.5cm (4.5in8.5in) | 12.5-21.5cm | Same |
| Measuring range | Pressure: 30 to 280 mmHg (in 1
mmHg 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.