(84 days)
No
The description details a standard oscillometric blood pressure measurement method and a rule-based algorithm for irregular pulse detection. There is no mention of AI or ML techniques.
No.
The device measures blood pressure and pulse rate, which are diagnostic functions, not therapeutic. It does not provide treatment or alleviate symptoms.
Yes
A diagnostic device is one that helps identify or measure a condition. This device measures blood pressure and pulse rate, which are physiological parameters used in diagnosing health conditions. It also has a function to detect irregular pulse rate, which is a diagnostic indicator.
No
The device description explicitly lists multiple hardware components including a main unit, wrist cuff, PCB, thermistor, pressure pump, motor, release valve, and pressure sensor. It also describes a physical method of measurement using an inflatable cuff.
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 Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using an oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample in vitro (in glass or outside the body).
- Intended Use: The intended use is for measuring blood pressure and pulse rate, which are physiological parameters, not for analyzing biological samples.
Therefore, this device falls under the category of a non-invasive medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blood Pressure Monitor is a digital monitor in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 51/3"-81/2"). It is intended for adult indoor use only.
Product codes
DXN
Device Description
Blood Pressure Monitor TMB-2285-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult population by a non-invasive technique, with an inflatable cuff wrapped around the wrist. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and wrist cuff. For the outer housing of the main unit, it's made of ABS material. The cuff model is WC1321-04, suitable for adults with wrist circumference of 13.5cm to 21.5cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor.
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data: device was tested according to ISO 81060-2:2018/Amd.1:2020. The clinical study aimed to validate the accuracy of TMB-2285-BT blood pressure monitor with cuff WC1321-04. 258 datasets were collected from 86 subjects. There are 86 adult subjects with aged 55.7±11.5, 58.1% male and 41.9% female. The mean differences between reference BPs and device readings were -0.27±3.18/-0.80±2.51mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and -0.27±2.60/-0.80±2.06mmHg for SBP/DBP of criterion 2. TMB-2285-BT with cuff ranging from 13.5-21.5cm fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
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 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.
December 20, 2023
Guangdong Transtek Medical Electronics Co., Ltd. Jerry Fan RA Manager Zone A, No. 105, Dongli Road, Torch Development District Zhongshan, Guangdong 528437 China
Re: K233130
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: September 15, 2023 Received: September 27, 2023
Dear Jerry Fan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Stephen C. Browning -S
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
3
Indications for Use
510(k) Number (if known) K233130
Device Name Blood Pressure Monitor
Indications for Use (Describe)
The Blood Pressure Monitor is a digital monitor in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 51/3"-81/2").
It is intended for adult indoor use only.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
Prepared in accordance with the requirement of 21 CFR Part 807.92
Prepared Date: 09/15/2023
Submitter 1.
| Name: | Guangdong Transtek Medical Electronics Co., Ltd. |
|---|---|
| Address: | Zone A, No. 105, Dongli Road, Torch Development District, 528437 Zhongshan |
| Guangdong, China | |
| Contact: | Jerry Fan |
| Title: | RA Manager |
| E-mail: | gt-rateam@transtekcorp.com |
| TEL: | +86 15728668528 |
Subject Device 2.
| Trade/Device Name | Blood Pressure Monitor |
|---|---|
| Model | TMB-2285-BT |
| Common Name | Blood Pressure Monitor |
| Classification | Class II |
| Product Code | DXN |
| Submission Type | Traditional 510(k) |
3. Predicate Device
| Manufacturer: | Zhongshan Transtek Electronics Co., Ltd. |
|---|---|
| Device Name/Model: | Blood Pressure Monitor / TMB-1014-BT |
| 510(k) Number: | K123669 |
| Classification | Class II |
| Product Code | DXN |
4. Device Description
Blood Pressure Monitor TMB-2285-BT is designed to measure systolic pressure, diastolic pressure and pulse rate of adult population by a non-invasive technique, with an inflatable cuff wrapped around the wrist. The method to define systolic and diastolic pressure is similar to auscultatory method, though it uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alternations of cuff pressure into electrical signals. Based on analysis of these signals, the systolic and diastolic blood pressure is defined, and the pulse rate is calculated. This is an extensively used technique applied in blood pressure monitors, also known as "oscillometric method".
The main components of the Blood Pressure Monitor include main unit and wrist cuff. For the outer housing of the main unit, it's made of ABS material. The cuff model is WC1321-04, suitable for adults with wrist circumference of 13.5cm to 21.5cm. The cuff is consisted of fabric and an inflatable bladder inside. For critical electronic components, there is PCB, thermistor, pressure pump, motor, release valve and pressure sensor.
The device also enjoys a function of detecting irregular pulse rate. When measurements were performed, the monitor will record all pulse intervals and calculate the average. If two or more pulse
Guangdong Transtek Medical Electronics Co., Ltd. 006_510(k) Summary
5
intervals were recorded, and the difference between each interval and the average is larger than ±25% of the average; or if four or more pulse intervals were recorded, and the difference between each interval and the average is larger than ±15% of the average, the irregular pulse symbol will be displayed along with measurement results.
An embedded Bluetooth wireless connection module in the device allows it to connect with matching receiving ends. When a measurement is done, the results will be displayed on LCD, and the measured data will be transferred to the APP via Bluetooth.
5. Indications for use
The Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate with a wrist circumference ranging from 13.5cm to 21.5cm (about 5½"-8½"). It is intended for adult indoor use only.
| Elements of
Comparison | Subject Device | Predicate Device
(K123669) | Judgement |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Model | TMB-2285-BT | TMB-1014-BT | / |
| Company | Guangdong Transtek
Medical Electronics Co.,
Ltd. | Zhongshan Transtek
Electronics Co., Ltd. | / |
| Device Name | Blood Pressure Monitor | TRANSTEK Wrist Blood
Pressure Monitor | / |
| Product Code | DXN | DXN | Same |
| Classification | Class II | Class II | Same |
| Regulation # | 21 CFR870.1130 | 21 CFR870.1130 | Same |
| Type of Use | OTC | OTC | Same |
| Intended Use /
Indication for
Use | The Blood Pressure Monitor
is a digital monitor intended
for use in measuring blood
pressure and pulse rate with
a wrist circumference
ranging from 13.5cm to
21.5cm (about $5\frac{1}{2}$ "-8½").
It is intended for adult
indoor use only. | Transtek Wrist Blood
Pressure Monitor TMB-1014-
BT is a digital monitor
intended for use in
measuring blood pressure and
heartbeat rate in adult patient
population with wrist
circumference
ranging from 13.5 cm to 21.5
cm (about 5 1/4 – 8 1/2
inches).
This device detects the
appearance of irregular
heartbeats during | Similar,
refer to
Note¹ |
| | | | |
| Patient
Population | Adult | Adult | Same |
| Working
principle | Oscillometric method | Oscillometric method | Same |
| Anatomical Site | Wrist | Wrist | Same |
| Where used
(hospital, home,
ambulance, etc.) | Home | Home | Same |
| Power Supply | Battery (2AAA, 3V DC) | Battery (2AAA, 3V DC) | Same |
| Human Factors | Blood pressure | Blood pressure | Same |
| Measurement
Items | Measuring systolic and
diastolic blood pressure and
pulse rate of adult
individual. | Measuring systolic and
diastolic blood pressure and
pulse rate of adult individual. | Same |
| Cuff Deflation | Automatic deflation with air
pump | Automatic deflation with air
pump | Same |
| Deflation of
pressure | Automatic air release | Automatic air release | Same |
| Measurement
perimeter of
wrist | $13.5cm21.5cm$ | $13.5cm21.5cm$ | Same |
| Blood Pressure
Measurement
Range | 0299mmHg40°C);
±3mmHg (5°C
±5mmHg (0°C45°C [out40°C]) | 0
of 5°C300mmHg40°C);
±3mmHg (5°C
±5mmHg (0°C45°C [out of40°C]) | Similar,
5°C
refer to
Note2 |
| Pulse Rate
Measurement | 40199 beat/minute, ±5% of199 beat/minute, ±5% of
reading | 40
reading | Same |
| Display | LCD | LCD | Same |
| Memory | 199*2 | 60 | Different,
refer to
Note3 |
| Operation
Environment | Temperature: 5°C40°C60°C
Relative humidity:
15%90%, non-condensing,106kPa | Similar,
but not requiring a water
vapor partial pressure
greater than 50hPa
Atmospheric: 700hPa
1060hPa | Temperature: 5°C40°C
Relative humidity: ≤80%
Atmospheric: 86
refer to
Note4 |
| Transport and
Storage
Environment | Temperature: -20°C
Relative humidity: ≤93%,
non-condensing, at a water
vapor pressure up to 50hPa
Atmospheric pressure:
500hPa ~ 1060hPa | Temperature: -20°C60°C93% | Similar,
Relative humidity: 10
refer to
Note5 |
| Performance | Compliance with IEC
80601-2-30 | Compliance with IEC 80601-
2-30 | Same |
| Clinical | Compliance with ISO
81060-2 | Compliance with ISO 81060-
2 | Same |
| Biocompatibility | All patient contact parts
meet the requirements of
ISO 10993-1/5/10/23 | All patient contact parts meet
the requirements of ISO
10993-1/5/10 | Similar,
refer to
Note6 |
| Electrical Safety | Compliance with IEC
60601-1 and IEC 60601-1-
11 | Compliance with IEC 60601-
1 and IEC 60601-1-11 | Same |
| EMC | Compliance with IEC
60601-1-2 | Compliance with IEC 60601-
1-2 | Same |
| Wireless
technology | Bluetooth | Bluetooth | Same |
Comparison to Predicate Device 6.
6
7
8
Justification for difference:
Note 1:
The intended use of the subject device is essentially same as that of the predicate device, that is to measure blood pressure and pulse rate of adult population with a wrist circumference of 13.5cm to 21.5cm. There is only difference in expression. Besides, the safety and effectiveness of the subject device used on its intended population has also validated according to IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2. IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Note 2:
There is a tiny difference regarding blood pressure measuring range of the subject device and predicate device, but the accuracy tolerance is same. The blood pressure measurement function as well as its accuracy has been validated according to IEC 80601-2-30 and ISO 81060-2. As demonstrated in relevant test reports, the difference here does not raise any issue concerning safety and effectiveness.
Note 3:
The subject device enjoys a larger memory room for storing measured data than the predicate device. This difference, however, won't affect the normal measuring function of the devices, the subject device has also been validated according to IEC 60601-1-2 and ISO 80601-2-30. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
Note 4:
There is timy difference regarding operation environment between the subject device and predicate device. The subject device has been validated to normally work at the claimed operation environment according to IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30. As demonstrated in relevant test reports, the difference her does not raise any issue concerning safety and effectiveness.
Note 5:
There is timy difference regarding transport and storage environment between the subject device and predicate device. The subject device has been validated to be safely transported and stored at the claimed environment according to IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30. As demonstrated in relevant test reports, the difference her does not raise any issue concerning safety and effectiveness.
Note 6:
The wrist cuff of both the subject and predicate device are in compliance with international Guangdong Transtek Medical Electronics Co., Ltd. 006_510(k) Summary
9
standards of compatibility. The difference displayed above is caused by the update of standards. The new cuffs are tested and proved to meet requirements of ISO 10993-5/10/23, in terms of cytotoxicity, sensitization and irritation respectively. As demonstrated in relevant test reports, the difference here does not raise any issues concerning safety and effectiveness.
7. 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 includes the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject device is considered as surface contacting for a duration of exceed 24 hours but not exceed 30 days.
Non-clinical data
The device has been tested according to 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 requirement for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 80601-2-30: Medical electrical equipment – Particular requirements for 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
- 47 CFR Part 15, Subpart C
- Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013)
Clinical data
device to ISO The was tested according Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The clinical study aimed to validate the accuracy of TMB-2285-BT blood pressure monitor with cuff WC1321-
Guangdong Transtek Medical Electronics Co., Ltd. 006_510(k) Summary
10
K233130
- 258 datasets were collected from 86 subjects. There are 86 adult subjects with aged 55.7±11.5, 58.1% male and 41.9% female. The mean differences between reference BPs and device readings were -0.27±3.18/-0.80±2.51mmHg for systolic BP (SBP)/diastolic BP (DBP) of criterion 1, and -0.27±2.60/-0.80±2.06mmHg for SBP/DBP of criterion 2. TMB-2285-BT with cuff ranging from 13.5-21.5cm fulfilled both validation criteria 1 and 2 of the ISO 81060-2:2018/Amd.1:2020.
8. Conclusion
With performance testing results and compliance with voluntary standards, a conclusion can be drawn that the proposed subject device is substantially equivalent to the predicate device.