This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).

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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Description

Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 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 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 heartbeat rate, which is a well-known technique in the market called the "Oscillometric method".

Transtek Blood Pressure Monitor is single-mounted devices of 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 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists 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 four AAA or AA alkaline batteries or by a DC 6V 400mA adapter.

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

This looks like a 510(k) submission for a non-invasive blood pressure monitor. Here's an analysis of the acceptance criteria and the study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate or general standards for oscillometric BP monitors)	Reported Device Performance (Transtek Models TMB-986, TMB-987, TMB-995)
Accuracy (Pressure)	Predicate: Within ±3mmHg or 2% of reading	Transtek: - Within ±0.4kpa / 3mmHg (at 15℃ to 25℃) - Within ±0.65kpa / 5mmHg (at 10℃ to 40℃, out of 15℃ to 25℃)
Accuracy (Heartbeat Rate)	Predicate: Within ±5% of reading	Transtek: Within ±5% of reading
Cuff Inflation	Automatic inflation with air pump	Automatic inflation with air pump
Deflation of Pressure	Deflation rate controlled by an active electronic control valve (4-11 mmHg/s)	Automatic air release
Measurement Perimeter of Upper Arm	22cm~42cm	22cm~42cm
Operating Voltage	DC 6V	DC 6V
Operating Environment (Temperature)	10℃~40℃	10℃~40℃
Operating Environment (Relative Humidity)	30-80%	≤80%
Operating Environment (Barometric Pressure)	105~80 kPa (790-600 mmHg)	105~80 kPa (790-600 mmHg)
Transport and Storage Environment (Temperature)	-20℃~60℃	-20℃~60℃
Transport and Storage Environment (Relative Humidity)	10~95%	10~93%

Note: The document explicitly states that the Transtek devices' accuracy for pressure and heartbeat rate are "similar" to the predicate device (HEM 780N3), implying they meet the predicate's acceptance criteria. The specific numerical values for temperature ranges and humidity are slightly different but considered "similar."

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not contain details about a specific clinical study conducted for the Transtek Blood Pressure Monitor models TMB-986, TMB-987, and TMB-995 regarding the sample size, data provenance (country of origin, retrospective/prospective), or the specific methodology used to validate the accuracy.

The submission relies heavily on demonstrating substantial equivalence to the OMRON Automatic Blood Pressure Monitor, Model HEM 780N3 (K061822). The "Performance Tests" section vaguely mentions "Biocompatibility, Electromagnetic Compatibility and Electrical Safety" tests, which are typically bench/engineering tests, not clinical performance studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. As there's no detailed clinical study described, there's no mention of experts establishing ground truth. For blood pressure monitors, ground truth is typically established using a reference standard like a mercury manometer or another validated oscillometric device, with measurements taken by trained technicians.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or at least not described in this submission. This type of study is more common for imaging devices where human interpretation is a critical component and AI is introduced to assist. For a blood pressure monitor, the performance is primarily based on the accuracy of its direct measurements against a reference standard.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of the algorithm's measurement accuracy would have implicitly been done as part of the overall device validation (to ensure it meets the accuracy criteria). However, the document does not detail a specific standalone study separate from the overall device performance claim, nor does it explicitly state the methodology for such a study. The "Oscillometric method" is a known technique, and the device's accuracy is reported, which implies direct measurement capability.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validating the Transtek device's accuracy. However, for blood pressure monitors of this type, the established ground truth for accuracy testing typically involves:

Reference standard measurements: Usually performed by trained professionals using a validated auscultatory method (e.g., using a mercury sphygmomanometer or another clinically validated device) against which the test device's readings are compared. This is implied by the accuracy criteria (e.g., ±3mmHg).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set. This is not surprising as these blood pressure monitors typically rely on established "Oscillometric method" algorithms rather than deep learning models that require extensive training data. The algorithms are usually developed based on physiological principles and validated through clinical testing rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned (as per point 8), the method for establishing its ground truth is also not applicable/provided.

Summary

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Section 5 - 510(k) Summary

Date of Summary Preparation: 11/09/2010

1. Submitter's Identifications

Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. Address: Jinbiao Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Guo Zhiping Contact Email Address: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231

2. Correspondent's Identifications

Correspondent's Name: A03 Lab of BTS Address: No.1 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: 086-4006070050 ext. 8

3. Name of the Device

Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: Blood Pressure Monitor Trade Name: Transtek Models: TMB-986, TMB-987, TMB-995 Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: None

4. The Predicate Devices

OMRON, Automatic Blood Pressure Monitor, Model HEM 780N3, K061822

5. Device Description

Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses

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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".

6. Intended Use of Device

Transtek Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches).

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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

7. Summary of Substantial Equivalence

Table 1: The difference between Transtek Blood Pressure Monitor

	The Similarities and Difference among TMB-986, TMB-987 and TMB-995
	Feature	TMB-986	TMB-987	TMB-995	Comparison
1	Power supply	Battery powered mode:
		6VDC 4*AAAalkaline batteries	6VDC 4*AAAalkaline batteries	6VDC 4*AAalkaline batteries	similar
		AC adaptor powered mode:
		AC 100-240V,50-60Hz, 400mA	AC 100-240V,50-60Hz, 400mA	AC 100-240V,50-60Hz, 400mA	similar
	Feature	TMB-986	TMB-987	TMB-995	Comparison
2	Display mode	Digital LCDV.A.128*50mm	Digital LCDV.A.150*34mm	Digital LCDV.A.128*50mm	TMB-986, andTMB-995:12850mmTMB-987:15034mm
3	Measurementmode	Oscillographictesting mode	Oscillographictesting mode	Oscillographictesting mode	similar
4	Accuracy	Pressure:$15℃~25℃$ :within±0.4kpa /3mmHg$10℃~40℃$ (out of$15℃~25℃$ ):Within ±0.65kpa /5mmHgHeartbeat:value:±5%	Pressure:$15℃~25℃$ :within±0.4kpa /3mmHg$10℃~40℃$ (out of$15℃~25℃$ ):Within ±0.65kpa /5mmHgHeartbeat:value:±5%	Pressure:$15℃~25℃$ :within±0.4kpa /3mmHg$10℃~40℃$ (out of$15℃~25℃$ ):Within ±0.65kpa /5mmHgHeartbeat:value:±5%	similar
5	Normalworkingcondition	Temperature: $10℃$$~40℃$Relative humidity≤80%	Temperature: $10℃$$~~40℃$Relative humidity≤80%Barometric pressure: 105~~80 kPa (790~600 mmHg)	Temperature: $10℃$$~40℃$Relative humidity≤80%	similar
6	Storage &transportationcondition	Temperature: - $20℃~60℃$
		Relativehumidity:10~93%	Relativehumidity: 10~93%	Relativehumidity:10~93%	similar
7	Measurementperimeterof upper arm	22cm~42cm	22cm~42cm	22cm~42cm	similar
8	Weight	Approx.300g(Excluding thebatteries)	Approx.300g(Excluding thebatteries)	Approx.300g(Excluding thebatteries)	similar
9	Externaldimensions	Approx.18010039mm	Approx.2006056mm	Approx.18010039mm	TMB-986,andTMB-995:Approx.18010039mmTMB-987:Approx.2006056mm
10	Mode ofoperation	Continuousoperation	Continuousoperation	Continuousoperation	similar

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Feature	TMB-986, TMB-987,TMB-995	Predicate: HEM 780N3	Comparison
Device name	Blood Pressure Monitor	Automatic Blood PressureMonitor	Similar
Indication for use	Measure the blood pressureand heartbeat rate.Irregular heartbeat detection.	Measure the blood pressureand heartbeat rate.	Add newfeatures
Components	Main Unit, Cuff, Adapter,Instruction Manual, 4AAA/4AA batteries, StorageCase and Warranty Card	Main Unit, Cuff, Adapter,Instruction Manual,4"AA"batteries, StorageCase and Warranty Card	Similarcomponentsand materials
Performance Tests	BiocompatibilityElectromagneticCompatibility and ElectricalSafety	BiocompatibilityElectromagneticCompatibility and ElectricalSafety	Similar
Labeling	Company name and addressSpecificationProduct descriptionIndication for useContraindications for usePrecautionsWarningsSafety terms and conditionsSafety alert descriptionsSafety and performancestandards and so on	Company name and addressSpecificationProduct descriptionIndication for useContraindications for usePrecautionsWarningsSafety terms and conditionsSafety alert descriptionsSafety and performancestandards and so on	Similar
Energy used	Battery (4AAA/4AA) orAC adapter (DC 6V Output)	Battery (4*AA) or ACadapter (DC 6V Output)	Similar
Display	Liquid crystal digital display	Liquid crystal digital display	Similar
Dimensions	TMB-986, TMB-995:180(W)100(D)39(H)mmTMB-987:200(W)60(D)56(H)mm	131(W)155(D)85(H)mm	Similar
Applicable cuff	Wrap around cuff	Wrap around cuff	Similar
Accuracy ofpressure indicator	Within ±3mmHg(15~~25℃)Within ±5mmHg(10°C~~40°C(out of15℃~25℃))	Within ±3mmHg or 2% ofreading	Similar
Accuracy ofheartbeat rate	Within ±5% of reading	Within ±5% of reading	Similar
Feature	TMB-986, TMB-987,TMB-995	Predicate: HEM 780N3	Comparison
Cuff inflation	Automatic inflation with airpump	Automatic inflation with airpump	Similar
Deflation ofpressure	Automatic air release	Deflation rate is controlled byan active electronic controlvalve by 4 to 11 mmHg/sdepending on pulse rate	Similar
Operating voltage	DC 6V	DC 6V	Similar
Measurementperimeterof upper arm	22cm~42cm	22cm~42cm	Similar
Operationenvironment	Temperature: 10℃~~40℃Relative humidity: ≤80%Barometric pressure:105~~80 kPa(790-600 mmHg)	Temperature: 10℃~~40℃Relative humidity: 30-80%Barometric pressure:105~~80 kPa(790-600 mmHg)	Similar
Transport andstorage environment	Temperature: -20℃~~60℃Relative humidity:10~~93%	Temperature: -20℃~~60℃Relative humidity: 10~~95%	Similar

Table 2: The difference between Transtek Blood Pressure Monitor and Predicate HEM 780N3

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8. Conclusions

The subject devices have all features of the predicate device HEM 780N3 except the new features of irregular heartbeat detection, some specification of arm cuff and battery. These differences do not affect the safety and effectiveness of the subject devices.

Irregular heartbeat detection technology is same as what is used in Automatic Blood Pressure Monitor with Com Fit™ Cuff Model HEM-780. Thus, the subject devices are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines forming the body and wings. Below the bird, there are wavy lines that represent water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Zhongshan Transtek Electronic Co., Ltd. c/o Mr. Leo Wang A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu City, Sichuan CHINA

MAY 2 7 2011

Re: K101681

Trade/Device Name: Transtek Blood Pressure Monitor Models TMB-986, TMB-987 and TMB-995

Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: May 13, 2011

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 10 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.

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/CDRH0ffices/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.fdagov/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

D. Zahariev, M.D.

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): K101681

Device Name: Blood Pressure Monitor

Models: TMB-986, TMB-987, TMB-995

Indications for Use:

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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Prescription Use

AND/OR

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C) メ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number

11/0168

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).