(191 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a standard oscillometric blood pressure measurement technique. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements for monitoring health, not for treating a disease or condition.
Yes
Explanation: The device measures systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "battery driven automatic noninvasive blood pressure monitor" and mentions hardware components like a pump and battery, indicating it is a physical device with integrated software, not software only.
No, 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.
- Device function: This device measures blood pressure and pulse rate non-invasively by applying a cuff to the wrist. It does not analyze any samples taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate of adults using the wrist circumference. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
DXN
Device Description
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive 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 two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.
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. 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
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 (which we adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site) 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (which we adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site) 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 60601-1:2005+Amd 1:2012+A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-11:2015, IEC 80601-2-30:2018.
Clinical investigation 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 which we adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ± 3 mmHg, Pulse rate: ± 5 % BPM
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2023
Shenzhen Jamr Technology Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai, 200122 China
Re: K230409
Trade/Device Name: Wrist Type Blood Pressure Monitor (W05,W1101L) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 28, 2023 Received: July 28, 2023
Dear Eva 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.
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 mediation-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.
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Wrist Type Blood Pressure Monitor (W05, W1101L)
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 1 of 1
3
Shenzhen Jamr Technology Co., Ltd. A 101-301,D 1-201,Jamr Science & Technology Park,No.2 Guiyuan Road, Guixiang Community,Guanlan Street,Longhua District, Shenzhen,518100,CN
005_510(K) Summary
The assigned 510(k) number is: K230409 Data preparation: August 15, 2023
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,CN Tel: +86-755-27982057 Mobile: +86 18675539961 Mail: RA.dept(@jamrmed.com Contact person: Haiyu Zhang
2.0 Device Information
Type of 510(k) submission: Traditional Trade Name: Wrist Type Blood Pressure Monitor Model(s): W05, W1101L 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 Jamr Technology Co., Ltd. Device: Wrist Type Blood Pressure Monitor 510(K) Number: K220651
4.0 Device Description
The subject device, Wrist Type Blood Pressure Monitor, is a battery driven automatic noninvasive 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 two models, which are W05, W1101L. All models contain the same software, measurement principle and NIBP algorithm. The main differences are product appearance, specification of pump and specification of the battery. W05 is alkaline battery driven device and W1101L is lithium battery driven device.
4
Shenzhen Jamr Technology Co., Ltd.
A101-301,D101-201,Jamr Science & Technology Park,No.2 Guiyuan Road, Guixiang Community,Guanlan Street,Longhua District, Shenzhen,518100,CN
The subject device is used for adult that age is more than 12 years old, and the intended populations are the patients with hypertension or need blood pressure monitoring. It is Not suitable for neonatal and infants; Not suitable for pregnant, including pre-eclamptic patients, not suitable for self-use in public areas, Not intended for use in the emergency medical services environment; Not be used together with HF surgical equipment.
5.0 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 (which we adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site) 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 60601-1:2005+Amd 1:2012+A2:2020 IEC 60601-1-2:2014+A1:2020 IEC 60601-1-11:2015 IEC 80601-2-30:2018
| Elements of
Comparison | Subject Device | Predicate device(K220651) | Comparison
Result |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name | Wrist Type Blood
Pressure Monitor | Wrist Type Blood Pressure
Monitor | Same |
| Device Model | W05, W1101L | W1102, W1102A, WO2S | -- |
| Manufacturer | Shenzhen Jamr
Technology Co., Ltd. | Shenzhen Jamr Technology
Co., Ltd. | Same |
| Indication for
Use | This device is
intended to measure
the systolic and
diastolic blood
pressure as well as the | The Wrist Type Blood
Pressure Monitor is
intended to measure the
systolic and diastolic blood
pressure as well as the | Same |
| | 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. | 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. | |
| 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 | W05: 2- size "AAA" alkaline Batteries
W1101L: lithium battery - d.c.3.7V 300mAh | 2- size "AAA" alkaline Batteries | Different1 |
| Memory Function | 2×120 memory | 2×120 memory | Same |
| Cuff Size | 12.5-21.5cm | 12.5-21.5cm | Same |
| Measuring range | DIA: 40-130mmHg;
SYS: 60-230mmHg | Pressure: DIA: 40-130mmHg, SYS:60-230mmHg | Same |
| | Pulse Rate: 40 to 170 bpm | Pulse Rate: 40-180 bpm | Similar1 |
| Accuracy | Pressure: $\pm$ 3 mmHg
Pulse rate: $\pm$ 5 % BPM | Pressure: $\pm$ 3mmHg ( $\pm$ 0.4kPa); Pulse Rate: $\pm$ 5% BPM | Same |
7.0 Comparison to predicate device and conclusion
5
Shenzhen Jamr Technology Co., Ltd.
A101-301,D101-201,Jamr Science & Technology Park,No.2 Guiyuan Road, Guixiang Community,Guanlan Street.Longhua District. Shenzhen.518100.CN
Discussion:
Different*1: The subject device W05 has the same power source supply with the predicate
device. The subject device W1101L has the different power source supply- lithium battery. The W1101L passed the related EMC and electrical safety testing. And the lithium battery also passed the related safety testing. So this different will not raise any safety and effectiveness concerns.
Similar*1: 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. 0 Discussion of Clinical Tests Performed
6
Shenzhen Jamr Technology Co., Ltd.
A101-301,D101-201,Jamr Science & Technology Park,No.2 Guiyuan Road, Guixiang Community,Guanlan Street,Longhua District, Shenzhen,518100,CN
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 which we adequately accounting for demographic variables, such as age, gender, limb size, blood pressure, population characteristics and measurement site 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.
9.0 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+Amd 1:2012+A2:2020, 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+A1:2020, 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
7
Shenzhen Jamr Technology Co., Ltd. A101-301,D101-201,Jamr Science & Technology Park,No.2 Guiyuan Road, Guixiang Community,Guanlan Street,Longhua District, Shenzhen,518100,CN 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".
10.0 Conclusions
Wrist Type Blood Pressure Monitor, models W05, W1101L, 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, K220651, and any differences in their characteristics do not raise any safety and effectiveness issues.