(121 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and data storage, with no mention of AI or ML algorithms for analysis or prediction. The clinical testing is for accuracy against a standard, not for validating an AI/ML model.
No
The device is intended for measurement and monitoring of blood pressure and pulse rate, not for treating a disease or condition.
Yes
The device is described as an "Upper Arm Type Blood Pressure Monitor" intended to measure "systolic and diastolic blood pressure as well as the pulse rate of adult." Blood pressure measurement is a diagnostic tool used to assess health status and identify potential medical conditions.
No
The device description explicitly states it is a "battery or AC adaptor driven automatic non-invasive blood pressure monitor" and includes components like an arm cuff and deflation valve, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Upper Arm Type Blood Pressure Monitor measures blood pressure and pulse rate directly from the body using a cuff on the arm. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) of an adult by applying a cuff to the arm. This is a direct measurement on the body, not an analysis of a sample.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Upper Arm 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 arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
Product codes
DXN
Device Description
The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor 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 the adult person at wrist within its claimed range and accuracy via the oscillometric technique.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed 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 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.
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
medical facilities or at home / 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
The results of this clinical investigation show that the required limits for mean error and standard deviation are fulfilled by the subject device F1701T in the group of 90 adult subjects (60 male and 30 female) with qualified distribution.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were conducted to verify the blood pressure accuracy of subject device. The clinical studies were conducted per following standards: ISO 81060-2: 2018, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type. 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 F1701T in the group of 90 adult subjects (60 male and 30 female) with qualified distribution. There was not adverse effects and complications 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.)
Pressure: ±3mmHg (±0.4kPa); Pulse Rate: ±5% BPM
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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and 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 ADMINISTRATION" in blue text.
July 27, 2022
Shenzhen Jamr Technology Co.,Ltd % Reanny Wang Senior consultant Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518000 China
Re: K220886
Trade/Device Name: Upper Arm 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: June 16, 2022 Received: June 27, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220886
Device Name Upper Arm Type Blood Pressure Monitor
Indications for Use (Describe)
The Upper Arm 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 arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
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: K220886
1. Submitter's information
Submitter's Names: 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: Luofs@jamr.com.cn; reanny@reanny.com
2. Device Information
Type of 510(k) submission: Traditional Trade Name: Upper Arm Type Blood Pressure Monitor Model(s): F1701T, F1701TA Classification name: System, Measurement, Blood-Pressure, Non-Invasive Review Panel: Cardiovascular Product Code: DXN Device Class: II Regulation Number: 21 CFR 870.1130
3. Predicate Device Information
510(K) Number: K160019 Trade Name: U80 series Electrical Blood Pressure Monitor Model(s): U80A, U80AH, U80B, U80BH Classification name: System, Measurement, Blood-Pressure, Non-Invasive Review Panel: Cardiovascular Product Code: DXN Device Class: II Regulation Number: 21 CFR 870.1130
4. Device Description
The proposed device, Upper Arm Type Blood Pressure Monitor, is a battery or AC adaptor 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 the adult person at wrist within its claimed range and accuracy via the oscillometric technique.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function,
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which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed 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 2 models, which are F1701T, F1701TA. All models follow the same software, measurement principle and NIBP algorithm. The main difference is the deflation valve.
5. Intended Use/Indication for use
The Upper Arm 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 arm cuff (22-42cm), it can be used in medical facilities or at home. It is supplied for OTC use.
6. Comparisons of technological characteristics with the predicate device
The subject device is substantially equivalent to predicate device, K212171. The substantial equivalence chart is provided as follows:
| Elements of
Comparison | Predicate Device
(K160019) | Subject Device | Verdict |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name | U80 sereis Electrical Blood
Pressure Monitor | Upper Arm Type Blood
Pressure Monitor | -- |
| Device
Model | U80A, U80AH, U80B, U80BH | F1701T, F1701TA | -- |
| Manufacturer | Shenzhen Urion Technology Co.,
Ltd. | Shenzhen Jamr Technology
Co., Ltd. | -- |
| Intended
Use/
Indication for
Use | U80 Series Electronic Blood
Pressure Monitor is intended to
measure the systolic and
diastolic blood pressure as well
as the pulse rate of adult person
via non-invasive oscillometric
technique in which an inflatable
cuff is wrapped around the upper
arm. It can be used at medical
facilities or at home. The
intended upper arm
circumference is 22-36 cm. | The Upper Arm 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 arm cuff
(22-42cm), it can be used in
medical facilities or at home. It
is supplied for OTC use. | Same |
| Intended
Population | Adults | Adults | Same |
| Intended
Anatomical
site | Upper arm | Upper arm | Same |
| Prescription
& OTC | OTC | OTC | Same |
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| Working
| Principle | Oscillometric method | Oscillometric method | Same |
|---|---|---|---|
| Power supply | d.c 6.0V, 4*1.5 V AAA batteries | d.c.4.5V AA battery | |
| or d.c.5V 1A AC adapter | Same | ||
| Cuff Size | 22cm~36cm | 22cm~42cm | Different |
| Model of | |||
| operation | Continuous operation | Continuous operation | Same |
| Degree of | |||
| protection | |||
| against | |||
| electric | |||
| shock | Type BF applied part | Type BF applied part | Same |
| Measuring | |||
| range | Systolic pressure: 0~299mmHg; | ||
| Diastolic pressure: 0~299mmHg | Systolic pressure: | ||
| 60-270mmHg; | |||
| Diastolic pressure: | |||
| 40-220mmHg | Different | ||
| Pulse Rate: 40-199 pulses/min | Pulse Rate: 40-180 bpm | Different | |
| Accuracy | Pressure: ±3mmHg (±0.4kPa); | ||
| Pulse Rate: ±5% BPM | Pressure: ±3mmHg | ||
| (±0.4kPa); | |||
| Pulse Rate: ±5% BPM | Same | ||
| Bluetooth | |||
| and APP | No | Yes | Different |
| Safety and | |||
| essential | |||
| performance | IEC 60601-1; IEC 60601-1-2; | ||
| IEC 60601-1-11; IEC | |||
| 80601-2-30; ISO81060-2; | IEC 60601-1; IEC 60601-1-2; | ||
| IEC 60601-1-11; IEC | |||
| 80601-2-30; ISO81060-2; | Same | ||
| Biocompatibil | |||
| ity | ISO 10993-1; ISO 10993-5; ISO | ||
| 10993-10 | ISO 10993-1; ISO 10993-5; | ||
| ISO 10993-10 | Same |
Remark: the subject device and the predicate device have the same indications for use, intended population, application site and working principle; although "Power supply", "Function", "Cuff Size", "Measuring range" and "Bluetooth and APP" of the subject device are different from the predicate device, but the differences do not raise any new issues of safety and effectiveness based on series tests, trials and validations.
7. Brief discussions of the nonclinical tests
The proposed device conforms to the following standards:
7.1 Biocompatibility evaluation
The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and FDA biocompatibility guidance, the proposed devices will be classified as external communication devices-tissue contact, and considering the cumulative exposure, the contact time will be permanent. The testing standards include the following:
| Standard | Descriptions |
|---|---|
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and |
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| 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 |
7.2 Electrical safety, essential performance and EMC tests
-IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-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
-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 80601-2-30:2018, Medical Electrical Equipment - Part 2-30: Particular Requirements for The Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers
7.3 Wireless and cybersecurity
-Bluetooth test according to FCC CFR Title 47 Part 15 Subpart C.
-ANSI C63.27: 2017: American National Stand for Evaluation of Wireless Coexistence.
-Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
-Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
7.4 Software validation
-Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
8. Discussion of Clinical Tests Performed
Clinical studies were conducted to verify the blood pressure accuracy of subject device. The clinical studies were conducted per following standards:
-ISO 81060-2: 2018, Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type.
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 F1701T in the group of 90 adult subjects (60 male and 30 female) with qualified distribution. There was not adverse effects and
complications 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. Conclusions
The subject device-Upper Arm Type Blood Pressure Monitor, models of F1701T and F1701TA, have the same intended use and similar characteristics as the predicate device. Form the
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above information, we conclude the subject devices are substantially equivalent to the predicate device, K160019, and any differences in their characteristics do not raise any new safety and effectiveness issues.