TRANSTEK WRIST BLOOD PRESSURE MONITOR

• K Number: K122482
• Device Name: TRANSTEK WRIST BLOOD PRESSURE MONITOR
• Manufacturer: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
• Date Cleared: 2012-10-22 ( 69 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

This series of devices are digital monitors 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 series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Description

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries. The device 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 heartbeat when the difference of the time intervals is over 25%.

Predicate Devices

K042505

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details standard oscillometric blood pressure measurement technology and basic signal processing for irregular heartbeat detection. There is no mention of AI or ML algorithms, training data, or performance metrics typically associated with such technologies.

Therapeutic

No
The 'Intended Use / Indications for Use' section explicitly states, "Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device." Furthermore, their primary function is to measure blood pressure and heart rate, not to treat a condition.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single-mounted device of the main unit and cuff unit" and lists hardware components like a microprocessor, pressure sensor, pump, valve, and LCD. This indicates it is a physical device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
• Device Function: This device measures blood pressure and heartbeat 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 specimen taken from the body.
• Intended Use: The intended use clearly states it's for "measuring blood pressure and heartbeat rate in adult patient population". It also explicitly states that the devices "are not intended to be a diagnostic device". While it compares readings to hypertension guidelines and detects irregular heartbeats, these are measurements and indicators, not diagnostic tests performed on biological samples.

Therefore, based on the provided information and the definition of an IVD, this wrist blood pressure monitor is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Transtek Wrist Blood Pressure Monitor, Models TMB-895, TMB-988, TMB-1014, TMB-1117 are digital monitors 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).

The subject devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (Anierican Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device 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 heartbeat when the difference of the time intervals is over 25%.

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 patient 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 document states that "performance testing and assessment proved that the subject devices are safe and effective." However, it does not provide details on specific studies, sample sizes, or results like AUC or MRMC.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K042505

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

(122482

OCT 2 2

TRANSTEK

Section 5 - 510(k) Summary

Date of Summary Preparation: 07/25/2012

1. Submitter's Identifications

Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Lisa Li Contact Email Address: lisha!@transtek.cn Telephone: [phone] ext. 876 Fax: [phone]

2. Correspondent's Identifications

Correspondent's Name: A03 Lab of BTS Address: No. I Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: [e-mail] Telephone: [phone] Fax: [phone]

3. Name of the Device

Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: Wrist Blood Pressure Monitor Trade Name: Transtek

Models: TMB-895, TMB-988, TMB-1014, TMB-1117

Classification Panel: Cardiovascular

Common/Usual Name: Automatic Blood Pressure Monitor

Product Code: DXN

Device Classitication: Class II

Contraindications: None

4. The Predicate Devices

omron, digital wrist blood pressure monitor, MODEL HEM-609N, K042505

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5. Device Description

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

Transtek Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries.

The device 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 heartbeat when the difference of the time intervals is over 25%.

6. Intended Use of Device

Transtek Wrist Blood Pressure Monitor, Models TMB-895, TMB-988, TMB-1014, TMB-1117 are digital monitors 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).

The subject devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (Anierican Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

7. Summary of Substantial Equivalence

(Continued on next page)

Section 5 -- 510(k) Summary

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Table I : The difference between Transtek Wrist Blood Pressure Monitors

Feature	TMB-895/TMB-988/TMB-1014/TMB-1117 Performance Data
Power	2*AAA alkaline batteries (3V DC)
Display mode	Digital LCD V.A.
TMB-895: 41*44mm
TMB-988: 35*40mm
TMB-1014: 36*41mm
TMB-1117: 31.5*44mm
Measurement method	Oscillographic testing mode
Measurement range	Pressure: 0 to 300mmHg (0 to 40kPa)
Pulse value: 40 to 199 times/minute
Accuracy	Pressure: 5°C~40°C within ±3mmHg
0°C45°C (out of 5°C40°C) within ±5mmHg
Pulse value: ±5%
Normal working condition	Temperature: 5°C~40°C
Relative humidity: ≤80%
Storage and transportation
condition	Temperature: -20°C~60°C;
Relative humidity: 10%~93%
Measurement perimeter of
the wrist	About 13.5cm~21.5cm
Main unit weight	Approx. (Excluding the batteries)
TMB-895: 150g
TMB-988: 95g
TMB-1014: 120g
TMB-1117: 120g
Main unit dimensions	Approx. (Not including the wrist cuff)
TMB-895: 737032mm
TMB-988: 687522mm
TMB-1014: 806522mm
TMB-1117: 687531mm
Degree of protection	Internal type B powered equipment
Air Release	Exhaust valve
Pressure method	Motor pump
Pressure Detection	Semiconductor sensor
Pulse Detection	Semiconductor sensor

3/5

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| Feature | TMB-895 /TMB-988
/TMB-1014 /TMB-1117 | Predicate: HEM-609N | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | Wrist Blood Pressure Monitor | Digital Wrist Blood Pressure
Monitor | Similar |
| Indication for
use | Measure the blood pressure and
heartbeat rate.
Irregular heartbeat detection. | Measure the blood pressure and
heartbeat rate.
Irregular heartbeat detection. | Similar |
| Components | Main Unit, Cuff, Instruction
Manual, 2AAA batteries,
Storage Case and Warranty Card | Main Unit, Cuff, Instruction
Manual, 2AAA batteries,
Storage Case and Warranty Card | Similar
components
and materials |
| Measurement
method | Oscillographic | Oscillographic | Similar |
| Labeling | Company name and address
Specifications
Product description
Indication for use
Contraindications for use
Precautions
Warnings | Company name and address
Specifications
Product description
Indication for use
Contraindications for use
Precautions
Warnings
Safety terms and conditions
Safety alert descriptions
Safety and performance
standards and so on | Similar |
| | Safety terms and conditions
Safety alert descriptions
Safety and performance
standards and so on | | |
| Energy used | Battery (2AAA, 3V DC) | Battery (2AAA, 3V DC) | Similar |
| Display | Liquid crystal digital display | Liquid crystal digital display | Similar |
| Main unit
dimensions | Approx. (Not including the wrist
cuff)
TMB-895: 737032mm
TMB-988: 687522mm
TMB-1014: 806522mm
TMB-1117: 687531mm | Approx. (Not including the wrist
cuff)
705437mm | Similar |
| Applicable
cuff | Wrap around cuff | Wrap around cuff | Similar |
| Measurement
range | Pressure: 0 to 300 mmHg
Pulse value: 40 to 199 beats/min | Pressure: 0 to 299 mmHg
Pulse Rate: 40 to 180 beats/min | Similar |
| Feature | TMB-895 /TMB-988
/TMB-1014 /TMB-1117 | Predicate: HEM-609N | Comparison |
| Accuracy of
pressure
indicator | 5°C40°C within ±3mmHg
0°C45°C (out of 5°C40°C)
within ±5mmHg | Within ±3mmHg | Similar |
| Accuracy of
pulse rate | Within ±5% of reading | Within ±5% of reading | Similar |
| Cuff inflation | Automatic inflation with air
pump | Automatic inflation with air
pump | Similar |
| Deflation of
pressure | Automatic air release | Automatic rapid deflation | Similar |
| Operating
voltage | 3V DC | 3V DC | Similar |
| Measurement
perimeter
of wrist | 13.5cm21.5cm | 13.5cm21.5cm | Similar |
| Operation
environment | Temperature: 5°C40°C
Relative humidity: ≤80%
Barometric pressure:
86106 kPa | Temperature: 10°C40°C
Relative humidity: 3085%
Barometric pressure:
80105 kPa | Similar |
| Transport and
storage
environment | Temperature: -20°C60°C
Relative humidity: 10%93% | Temperature: -20°C60°C
Relative humidity: 1095% | Similar |

I able 2: The difference between Transtek Wrist Blood Pressure Monitor and Predicate HEM 609N

Section 5 -- 510(k) Summary

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8. Conclusions

The subject devices have all similar features of the predicate device HEM-609N. Those subtle I the subject es if performance parameter do not affectiveness of the subject devices.

In other sections of this submission, those performance testing and assessment proved that the subject devices are safe and effective.

Thus, the subject devices are substantially equivalent to the predicate device.

--- End of this section ---

Section 5 - 510(k) Summary

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 22 2012

Zhongshan Transtek Electronics Co., Ltd. c/o Mr. Leo Wang Senior Consultant No.1 Fanghua Street, Hi-Tech Zone Chengdu, Sichuan 610041 (China)

Re: K122482

Trade/Device Name: Transtek Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: September 22, 2012 Received: September 25, 2012

Dear Mr. 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. 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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Page 2 - Mr. Leo Wang

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm1.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use

510(k) Number (if known):

Device Name: Transtek Wrist Blood Pressure Monitor Model Numbers: TMB-895, TMB-988, TMB-1014, TMB-1117

Indications for Use:

This series of devices are digital monitors 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 series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.

The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg.

Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for B Zuckermain
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122482

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Section 4 -- Indications for Use