(162 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a microprocessor and pressure sensor to analyze signals. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The irregular heartbeat detection is based on a simple comparison of time intervals, not an AI/ML algorithm.
No.
The device is intended for measuring blood pressure and detecting irregular heartbeats, which are diagnostic/monitoring functions, not therapeutic interventions.
Yes
The device measures blood pressure and heart rate, and can detect irregular heartbeat, which are diagnostic indicators of health conditions.
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, operation keys, electromagnetic deflation control valve, LCD, and an LTE Wireless network connections module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Transtek Blood Pressure Monitor measures blood pressure and pulse rate using a non-invasive method (a cuff on the upper arm). It analyzes physical signals (pressure changes) rather than biological samples.
- Intended Use: The intended use is to measure blood pressure and heartbeat rate, and detect irregular heartbeat, all of which are physiological measurements taken directly from the body.
The device operates on the body itself to gather information, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm (about 8¾"-17½"). The device can be used to detect irregular heartbeat. It is intended for adult indoor use only.
Product codes
DXN
Device Description
Blood Pressure Monitor, Models LS802-GS 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".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 450 mm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed an LTE Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
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
Adults
Intended User / Care Setting
Home
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 data: This device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 85 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, and the accuracy of subject device is better than predicate device. No adverse effect and/or complication is found in this study.
Key Metrics
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 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.
March 9, 2021
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: K202891
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: December 16, 2020 Received: February 10, 2021
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 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.
LT 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202891
Device Name Blood Pressure Monitor
The Transtek Blood Pressure Monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 45cm (about 8%"-17½").
The device can be used to detect irregular heartbeat.
It is intended for adult indoor use only.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2020/10/09
1. Submission sponsor
Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Endless Chan Title: RA Engineer E-mail: Endless.Chan@transtekcorp.com
Submission correspondent 2.
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, 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 | LS802-GS |
| Common Name | Automatic Arm Blood Pressure Monitor |
| Regulatory Class | Class II |
| Product Code | DXN |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
- Guangdong Transtek Medical Electronics Co., Ltd., TRANSTEK Blood Pressure Monitor under K131395.
The subject device has same intended use, same target patient population, same performance effectiveness, performance safety as the predicate devices and no question is raised regarding to effectiveness and safety. So, the conclusion is that the subject device is substantial equivalent to the predicate.
Device Description ട്.
Blood Pressure Monitor, Models LS802-GS 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
4
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".
The main components of the Blood Pressure Monitor is the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 450 mm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the electromagnetic deflation control valve and the LCD.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed an LTE Wireless network connections module that allows it to connect to receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol.
Intended use & Indication for use 6.
The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm (about 8¾"-17½"). The device can be used to detect irregular heartbeat. It is intended for adult indoor use only.
| Features | Subject Device
LS802-GS | Predicate Device K131395
Model: LS802-B | 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 Transtek Blood Pressure
Monitor is digital monitors
intended for use in measuring
blood pressure and heartbeat
rate with arm circumference
ranging from 22cm to 45cm
(about 8¾"-17½"). The
device can be used to detect
irregular heartbeat.
It is intended for adult indoor
use only. | Transtek Blood Pressure
Monitor LS802-B, LS805-B and
TMB-1018-BT are digital
monitors intended for use in
measuring blood pressure and
heartbeat rate with arm
circumference ranging from
22cm to 42cm (about 9-17
inches). | Different (1) |
| Features | Subject Device | Predicate Device K131395
Model: LS802-B | Remark |
| 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 | 4 * 1.5V AA Battery,
or by a DC 6V adapter | 4 * 1.5V AA Battery,
or by a DC 6V adapter | Same |
| Human factors | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic
blood pressure and pulse rate of
adult individual, Including
irregular pulse rhythm detection | 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:
$5°C$ 40°C,15%60°C, ≤93%RH. | Operation Environment:90%RH,106KPa.
Atmospheric: 70KPa
Storage Environment:
-20°C
$10°C$ ~ $40°C$ , ≤85%RH,
Atmospheric: 80KPa~106KPa.
Storage Environment:
$-20°C$ ~ $60°C$ , 10%~93%RH. | Different
(2) |
| These devices detect the
appearance of irregular
heartbeats during measurement
and give a warning signal with
readings.
The Blood Pressure Monitor
compares average blood
pressure results to pre-
established AHA (American
Heart Association) hypertension
guideline of 135/85 mmHg.
Transtek Blood Pressure
Monitor LS802-B, LS805-B and
TMB-1018-BT are not intended
to be a diagnostic device.
Contact your physician if
hypertensive values are
indicated. | | | |
| Features | Subject Device
LS802-GS | Predicate Device K131395
Model: LS802-B | Remark |
| Electrical safety | According to IEC60601-1-2
According to IEC60601-1 | According to IEC60601-1-2
According to IEC60601-1 | Same |
| Blood Pressure
Measurement | $0mmHg ~ 299mmHg,$
$5°C - 40°C within ±3mmHg$
$(0.4kPa)$ | $0 ~ 300 mmHg,$
$15°C - 25°C within ±0.4 kPa$
$(3 mm Hg)$
$10°C - 40°C (out of 15°C-25°C)$
within $±0.7 kPa (5 mm Hg);$ | Different
(3) |
| Pulse rate
measurement | 40-199 beat/minute, ±5% | 40 ~ 199 beat/minute, ±5% | Same |
| Cuff Deflation | Automatic deflation | Automatic deflation | Same |
| Memory Size | 60 | 60 | Same |
| Wireless | LTE | Bluetooth | Different
(4) |
7. Comparison to the Predicate Device
5
6
Justification of difference:
Different (1): The substantial difference of the intended use is the arm circumference ranging. The proposed device is wider than the predicate device. The proposed 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): Compared with the predicate device requires 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 (3): The subject device's blood pressure measurement range is restricted to 299 mmHg for safety purpose. Thus, the different does not raise different questions of safety and effectiveness.
Different (4): The wireless module is different. However, the wireless function is same. The monitor can transmit the measurement result through wireless and display 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 subject 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 battery of testing included the following tests:
- . Cytotoxicity
7
- Sensitization
- . Irritation
The subject device is considered surface contacting for a duration of exceed 24 hours but not 30 days.
Non-clinical data
The subject 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
- IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General requirements for safety -Collateral Standard: Usability.
- IEC 62366-1: Medical devices – Application of usability engineering to medical devices.
- FDA Guidance for Non-Automated Sphygmomanometer.
Wireless testing:
- Bluetooth test according to FCC CFR Title 47 Part 15 Subpart C. ●
- ANSI C63.27L: 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)
Reprocessing validation:
- . AAMI TIR12: 2010-designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufactures
- AAMI TIR30: 2011-A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff
Clinical data
This device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 85 qualified healthy adult
8
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, and the accuracy of subject device is better than predicate device. No adverse effect and/or complication is found in this study.
9. Conclusion
According to the 510(k) submission, the subject device and the predicate device has the same intended use, and the difference in technological features of the proposed devices and the predicate devices do not raise different questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device models are substantially equivalent to the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.