(238 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor and its connectivity features. There is no mention of AI or ML in the device description, intended use, or performance studies. The method described is a well-established technique, not indicative of AI/ML.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, providing information about heart health. It does not actively treat or restore health.
No
The device measures blood pressure and pulse rate, which are physiological parameters, but it does not diagnose a disease or condition. It provides metrics related to heart health, which can be used for monitoring, but the device itself does not make a diagnosis.
No
The device description explicitly mentions physical components like an inflatable cuff, an electronic pressure sensor, and an LED matrix, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- This device measures physiological parameters on the human body. The device measures blood pressure and pulse rate directly from the upper arm using a non-invasive method. It does not analyze any bodily fluids or tissues.
The device described is a non-invasive blood pressure monitor, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.
Product codes
DXN
Device Description
The Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method".
When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:
- Systolic blood pressure
- Diastolic blood pressure
- Pulse rate
The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average).
Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.
WPM05 (BPM Connect)
The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.
WPM06 (BPM Connect Pro)
The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.
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
human adult population
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 135 qualified healthy adult subjects. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
June 30, 2023
Guangdong Transtek Medical Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K223374
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 7, 2022 Received: November 4, 2022
Dear Kevin 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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223374
Device Name Blood Pressure Monitor
Indications for Use (Describe)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2021/07/16
1. Submission sponsor
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Jerry Fan Title: RA Manager E-mail: jialong.fan(@transtekcorp.com
Submission correspondent 2.
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | WPM05 and WPM06 |
| Common Name | Automatic Blood Pressure Monitor |
| Regulatory Class | Class II |
| Product Code | DXN |
| Submission type | Traditional 510(K) |
Subject Device Information 3.
Predicate Device 4.
Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.
Device name: Blood Pressure Monitor, LS-802-GS
510(K) Number: K202891
5. Device Description
The Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic
4
blood pressure and calculating pulse rate, which is a well-known technique in the market called the "Oscillometric method".
When using the device, users will be able to monitor their blood pressure and their pulse rate. The device will give metrics about heart health:
- Systolic blood pressure
- Diastolic blood pressure
- Pulse rate
The device should be placed on the left upper arm during all the measurement duration. The measurement lasts between 30 seconds and 3 minutes depending on the selected mode by the user. The measurement can be longer if the user selects the triple measurement mode (three blood pressure measurements in a row to give an average).
Users will get an instant feedback after the measurement thanks to a LED matrix located on the tube part of the device.
WPM05 (BPM Connect)
The device synchronizes with Withings application and Withings server via Bluetooth or Wi-Fi connectivity.
WPM06 (BPM Connect Pro)
The device synchronizes with third-party applications by cellular, Wi-Fi or Bluetooth connectivity. On the mobile application, users have access to their historic and more contents around each metrics.
6. Intended use & Indication for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. The device is intended to be used in a human adult population with an arm circumference of 9 inches (22 cm to 42 cm). The device is intended for indoor use.
| Features | Subject Device
WPM05, WPM06 | Predicate Device K202891
LS802-GS | Remark |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Applicant | Guangdong Transtek Medical
Electronics Co., Ltd. | Guangdong Transtek Medical
Electronics Co., Ltd. | / |
| Classification
Regulation | 21CRF 870.1130 | 21CRF 870.1130 | Same |
| Classification and
Code | Class II,
DXN | Class II,
DXN | Same |
| Common
name | Automatic Arm Blood Pressure
Monitor | Automatic Arm Blood Pressure
Monitor | Same |
| Intended use | The device is a digital monitor
intended for use in measuring | The Transtek Blood Pressure
Monitor is digital monitors | Different (1) |
| Features | Subject Device
WPM05, WPM06 | Predicate Device K202891
LS802-GS | Remark |
| | blood pressure and pulse rate.
The device is intended to be
used in a human adult
population with an arm
circumference of 9 inches to 17
inches (22 cm to 42 cm). The
device is intended for indoor
use. | intended for use in measuring
blood pressure and heartbeat rate
with arm circumference ranging
from 22cm to 45cm (about 8¾"-
17½")
It is intended for adult indoor
use only. | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| Patient
Populations | Adults | Adults | Same |
| Principle | Oscillometric method | Oscillometric method | Same |
| Target population | Adult | Adult | Same |
| Anatomical sites | Upper Arm | Upper Arm | Same |
| Where used
(hospital, home,
ambulance, etc.) | Home | Home | Same |
| Energy used and /
or delivered | 5V rechargeable Li-Polymer
battery | 4 * 1.5V AA Battery,
or by a DC 6V adapter | Different (2) |
| Human factors | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic
blood pressure and pulse rate of
adult individual | Measuring systolic and diastolic
blood pressure and pulse rate of
adult individual, Including
irregular pulse rhythm detection | Same |
| Biocompatibility | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Same |
| Compatibility with
the environment
and other devices | Operation Environment:
5℃~ 40℃, up to 90%RH,
Atmospheric: 86KPa~106KPa.
Storage Environment:
-20℃60℃, up to 95%RH.106KPa. | Operation Environment:
Atmospheric: 86KPa
5℃~40℃,15%90%RH,106KPa.
Atmospheric: 70KPa
Storage Environment:
-20℃~60℃, ≤93%RH. | Different (3) |
| Electrical safety | According to IEC60601-1-2
According to IEC60601-1 | According to IEC60601-1-2
According to IEC60601-1 | Same |
| Blood Pressure
Measurement | 0mmHg ~ 285mmHg,
within ±3mmHg (0.4kPa) or
2% of reading | 0mmHg ~ 299mmHg,
within ±3mmHg (0.4kPa) | Different (4) |
| Pulse
measurement | 40-180 beat/minute, ±5% of
reading | 40-199 beat/minute, ±5% of
reading | Different (5) |
| Cuff Deflation | Automatic deflation | Automatic deflation | Same |
| Features | Subject Device
WPM05, WPM06 | Predicate Device K202891
LS802-GS | Remark |
| Wireless | WPM05: Bluetooth and Wi-Fi
WPM06: Bluetooth, Wi-Fi and
Cellular | LTE | Different
(6) |
Comparison to the Predicate Device 7.
5
6
Justification of difference:
Different (1): The substantial difference of the intended use is the arm circumference ranging. The subject device is within the range of the predicate device. The subject device was validated according to ISO 80601-2-30 and ISO 81060-2. The performance data can demonstrate this difference does not raise different questions of safety and effectiveness.
Different (2): The battery is different. The IEC 60601-1 test report can demonstrate that the subject device can maintain the safety and performance with the battery. Thus, this difference does not raise different questions of safety and effectiveness.
Different (3): Compared with the predicate device reguires less strict operation and storage environment. The IEC 60601-1-11 test report can demonstrate that the subject device can maintain the safety and performance within the operation and storage environment. Thus, this difference does not raise different questions of safety and effectiveness.
Different (4) (5): The blood pressure measurement range and accuracy are different. The pulse rate measurement range and accuracy are different. The IEC 80601-2-30 can demonstrate that the subject device can maintain the safety and performance within the measurement range. Thus, the difference does not raise different questions of safety and effectiveness.
Different (6): The wireless module is different. However, the wireless function is same. The monitor can transmit the measurement result through wireless and display the measurement on the mobile application. Thus, this difference does not raise different questions of safety and effectiveness.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- . Cytotoxicity
- Sensitization .
- Irritation .
The subject device is considered surface contacting for a duration of exceed 24 hours but not exceed 30 days.
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Non-clinical data
The device has been tested according to the following standards:
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic Safety . and essential performance
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety . and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 80601-2-30: Medical electrical equipment Particular requirements for the basic safety and . essential performance of automated non-invasive sphygmomanometers.
- IEC 60601-1-11: 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
- FDA Guidance for Non-Automated Sphygmomanometer. .
Wireless testing:
- ANSI C63.27: 2017: American National Stand for Evaluation of Wireless Coexistence. .
- . AAMI TIR69: 2017 Risk management of radio-frequency wireless coexistence for medical devices and systems.
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food . and Drug Administration Staff (August 14, 2013)
Clinical data
The device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 135 qualified healthy adult subjects. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.