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%.

AI/ML Overview

The provided text is a 510(k) summary for the Transtek Wrist Blood Pressure Monitor. It does not contain information about a specific study comparing the device's performance against acceptance criteria beyond the general statement that "performance testing and assessment proved that the subject devices are safe and effective."

The document primarily focuses on establishing substantial equivalence to a predicate device (Omron, MODEL HEM-609N, K042505) by comparing features and performance parameters.

However, based on the Accuracy section in "Table 1: The difference between Transtek Wrist Blood Pressure Monitors" and "Table 2: The difference between Transtek Wrist Blood Pressure Monitor and Predicate HEM 609N", we can infer the acceptance criteria for accuracy.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

Based on the "Accuracy" row in the provided tables, the acceptance criteria for accuracy are:

Feature	Acceptance Criteria	Reported Device Performance (Transtek TMB-895/TMB-988/TMB-1014/TMB-1117)
Pressure Accuracy	Similar to Predicate (Omron HEM-609N): Within ±3mmHg. The Transtek devices report: - 5°C~~40°C: within ±3mmHg - 0°C~~45°C (out of 5°C~40°C): within ±5mmHg. The summary states this is "Similar" to the predicate, implying the predicate itself has a ±3mmHg accuracy. It also implicitly sets these as the performance criteria for the Transtek device.	5°C~~40°C: within ±3mmHg 0°C~~45°C (out of 5°C~40°C): within ±5mmHg
Pulse Value/Rate	Similar to Predicate (Omron HEM-609N): Within ±5% of reading.	Within ±5% of reading

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary only states that "performance testing and assessment proved that the subject devices are safe and effective" without detailing the methodology, sample sizes, or data provenance of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard like a mercury sphygmomanometer following a validated protocol (e.g., ISO 81060-2), but the details are not included here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of device (a wrist blood pressure monitor). This kind of study is typically used for medical imaging devices where human interpretation of images is a key component. This device directly measures physiological parameters.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device is a standalone automaticsensing device. Its performance is evaluated based on its direct measurements without human intervention as part of the measurement process. The document implicitly refers to standalone performance through its accuracy claims.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth. However, for blood pressure monitors, the ground truth for accuracy testing is typically established by simultaneous measurements using a validated reference standard (e.g., a mercury sphygmomanometer or an equivalent oscillometric device that has been rigorously validated, applied by trained observers) alongside the device under test. This is standard practice for blood pressure monitor validation.

8. The sample size for the training set

This information is not provided in the document. Blood pressure monitors developed using the oscillometric method usually involve algorithms trained and validated on a diverse set of real-world blood pressure readings. However, no details on "training sets" are mentioned in this 510(k) summary.

9. How the ground truth for the training set was established

This information is not provided in the document, as no "training set" is explicitly mentioned for this device.

Summary

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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: 086-760-88282982 ext. 876 Fax: 086-760-85339231

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: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-20-80727399

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

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.

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: 4144mmTMB-988: 3540mmTMB-1014: 3641mmTMB-1117: 31.544mm
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 ±3mmHg0°C~~45°C (out of 5°C~40°C) within ±5mmHgPulse value: ±5%
Normal working condition	Temperature: 5°C~40°CRelative humidity: ≤80%
Storage and transportationcondition	Temperature: -20°C~60°C;Relative humidity: 10%~93%
Measurement perimeter ofthe wrist	About 13.5cm~21.5cm
Main unit weight	Approx. (Excluding the batteries)TMB-895: 150gTMB-988: 95gTMB-1014: 120gTMB-1117: 120g
Main unit dimensions	Approx. (Not including the wrist cuff)TMB-895: 737032mmTMB-988: 687522mmTMB-1014: 806522mmTMB-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 PressureMonitor	Similar
Indication foruse	Measure the blood pressure andheartbeat rate.Irregular heartbeat detection.	Measure the blood pressure andheartbeat rate.Irregular heartbeat detection.	Similar
Components	Main Unit, Cuff, InstructionManual, 2*AAA batteries,Storage Case and Warranty Card	Main Unit, Cuff, InstructionManual, 2*AAA batteries,Storage Case and Warranty Card	Similarcomponentsand materials
Measurementmethod	Oscillographic	Oscillographic	Similar
Labeling	Company name and addressSpecificationsProduct descriptionIndication for useContraindications for usePrecautionsWarnings	Company name and addressSpecificationsProduct descriptionIndication for useContraindications for usePrecautionsWarningsSafety terms and conditionsSafety alert descriptionsSafety and performancestandards and so on	Similar
	Safety terms and conditionsSafety alert descriptionsSafety and performancestandards and so on
Energy used	Battery (2*AAA, 3V DC)	Battery (2*AAA, 3V DC)	Similar
Display	Liquid crystal digital display	Liquid crystal digital display	Similar
Main unitdimensions	Approx. (Not including the wristcuff)TMB-895: 737032mmTMB-988: 687522mmTMB-1014: 806522mmTMB-1117: 687531mm	Approx. (Not including the wristcuff)705437mm	Similar
Applicablecuff	Wrap around cuff	Wrap around cuff	Similar
Measurementrange	Pressure: 0 to 300 mmHgPulse value: 40 to 199 beats/min	Pressure: 0 to 299 mmHgPulse Rate: 40 to 180 beats/min	Similar
Feature	TMB-895 /TMB-988/TMB-1014 /TMB-1117	Predicate: HEM-609N	Comparison
Accuracy ofpressureindicator	5°C~~40°C within ±3mmHg0°C~~45°C (out of 5°C~40°C)within ±5mmHg	Within ±3mmHg	Similar
Accuracy ofpulse rate	Within ±5% of reading	Within ±5% of reading	Similar
Cuff inflation	Automatic inflation with airpump	Automatic inflation with airpump	Similar
Deflation ofpressure	Automatic air release	Automatic rapid deflation	Similar
Operatingvoltage	3V DC	3V DC	Similar
Measurementperimeterof wrist	13.5cm~21.5cm	13.5cm~21.5cm	Similar
Operationenvironment	Temperature: 5°C~~40°CRelative humidity: ≤80%Barometric pressure:86~~106 kPa	Temperature: 10°C~~40°CRelative humidity: 30~~85%Barometric pressure:80~105 kPa	Similar
Transport andstorageenvironment	Temperature: -20°C~60°CRelative humidity: 10%~93%	Temperature: -20°C~~60°CRelative humidity: 10~~95%	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

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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 (800) 638-2041 or (301) 796-7100 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 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

Page 1 of 1

Section 4 -- Indications for Use

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).