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 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.

These Blood Pressure Monitor compare 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.

Device Description

Transtek Blood Pressure Monitor, LS802-B, LS805-B and TMB-1018-BT 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.

Measurement 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 jused to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22cm and 42cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is powered by four AA/AAA 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%.

Transtek Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT embed a Bluetooth module that allows it to connect with nearby BT receiving terminal. Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the paired BT terminal. Thus users can receive, display, and storage measurement data of Transtek Blood Pressure Monitor unit through their terminal devices that embedded BT module.

AI/ML Overview

The provided text describes a 510(k) submission for a blood pressure monitor, focusing on substantial equivalence to a predicate device. It contains very limited information regarding the performance study that would typically establish acceptance criteria and device performance. The device is a "TRANSTEK Blood Pressure Monitor" (Models: LS802-B, LS805-B, and TMB-1018-BT).

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for TRANSTEK Blood Pressure Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics for blood pressure measurement accuracy. It primarily focuses on the substantial equivalence of the new models to a predicate device, with the key difference being the use of Bluetooth instead of RF for wireless data transmission.

The document states compliance with standards, notably:

AAMI/ANSI/IEC 80601-2-30, Safety and performance characteristics
ISO 14971, Risk management to medical devices

Compliance with AAMI/ANSI/IEC 80601-2-30 would imply that the device meets the performance requirements for blood pressure monitors as outlined in that standard. This standard typically defines accuracy requirements (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method). However, the specific results from a study demonstrating this compliance are not presented in this document.

The document states: "All required design control activities have been implemented and all applicable performance tests have been done according with demands of FDA guidance document "Non-Invasive Blood Pressure (NIBP) Monitor Guidance" FDA March 10, 1997." This indicates that performance testing was conducted, but the results are not explicitly detailed.

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

The document does not specify the sample size used for any clinical or performance test set related to blood pressure measurement accuracy.

It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical data because it explicitly states that a clinical test for blood pressure measurement accuracy was not done for this submission.

The document includes the following crucial statement: "Explanation: The wireless coexistence tests provide to demonstrate the reliability of wireless connection and wireless coexistence of BT data communication function. Meanwhile the BT data communication function does not affect blood pressure monitors' measurement function. Therefore we have not done the Clinical test."

This indicates that the submission relies on the substantial equivalence of the core measurement technology to the predicate device (TRANSTEK, Blood Pressure Monitor, Model LS802-E, K123780), and the performance of the blood pressure measurement function itself was not re-evaluated clinically for this specific submission.

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

Since a clinical test for blood pressure measurement accuracy was not conducted for this submission (as stated in the document), there is no information provided regarding experts or ground truth establishment for a clinical test set.

4. Adjudication Method for the Test Set

As no clinical test set for blood pressure measurement accuracy was established for this submission, there is no information regarding an adjudication method.

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

No MRMC multi-reader comparative effectiveness study was done. This device is an automated blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. The comparison is between automated measurements and a "reference" (likely auscultatory or invasive arterial pressure, as per NIBP standards), not between human readers.
Therefore, no effect size for human readers improving with AI vs. without AI assistance is applicable or reported.

6. Standalone (Algorithm Only) Performance

The device itself is a standalone algorithm-based device for measuring blood pressure using the oscillometric method. The discussion implies that the basic measurement function (algorithm for detecting systolic and diastolic pressure) is identical to the predicate device. However, specific standalone performance metrics are not reported in this summary. The focus of the current submission is the change in wireless transmission technology.

7. Type of Ground Truth Used

For non-invasive blood pressure monitors, the "ground truth" in performance studies typically involves comparison with either:

Auscultatory measurements performed simultaneously by trained observers using a mercury sphygmomanometer, often with double or triple auscultation for observer bias reduction.
Invasive arterial pressure monitoring (intra-arterial catheter), considered the most accurate reference but less common for routine device validation.

Given the statement that an AAMI/ANSI/IEC 80601-2-30 compliant test would be expected, the ground truth would likely be established through one of these methods at the time the predicate device (K123780) was validated. For this submission, no new ground truth was established for blood pressure measurement accuracy, as no clinical test was performed.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the device's algorithms. As the device uses the "oscillometric method," which is a well-established technology, the core algorithm was likely developed and validated prior to the predicate device's clearance. The current submission is for a modification (Bluetooth) to an already cleared device.

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

The document does not describe how the ground truth for any training set was established. This information would typically be part of the original development and validation of the oscillometric algorithm, which predates this specific 510(k) submission.

Summary

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K131395

TRANSTEK

JUN 1 9 2013

Section 6 - 510(k) Summary

Date of Summary Preparation: 05/08/2013

1. Submitter's Identifications

Submitter's Name: Guangdong Transtek Medical Electronics Co., Ltd

Address: Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District,

Zhongshan, Guangdong, China 528437

Contact Person: Ada Zhang

Contact Email Address: adazhang@transtek.com

Telephone: 086-760-88282982 ext. 876

Fax: 086-760-85339231

2. Correspondent's Identifications

Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu 610041, 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: TRANSTEK Blood Pressure Monitor Trade Name: TRANSTEK Models: LS802-B, LS805-B, TMB-1018-BT Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II

4. The Predicate Devices

TRANSTEK, Blood Pressure Monitor, Model LS802-E, K123780

Section 6 -- 510(k) Summary

Page 1 of 4

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TRANSTEK

5. Device Description

6. Intended Use of Device

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 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. LS802-B, I.S805-B and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Section 6 - 510(k) Summary

Page 2 of 4

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TRANSTEK

7. Design Control Activities and Performance Tests Summary

Design control activities for this modification have been implemented and performance tests of modified devices have been done. These performance tests, risk management, and design verification tests provide demonstration that the differences do not raise any new questions of safety and effectiveness.

LS802-B, LS805-B and TMB-1018-BT conform to the following standards:

ISO 14971, Risk management to medical devices

AAMI/ANSI/IEC 80601-2-30, Safety and performance characteristics

IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility

FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations

Radio-Frequency Wireless Technology in Medical Devices, Wireless coexistence

Explanation: The wireless coexistence tests provide to demonstrate the reliability of wireless connection and wireless coexistence of BT data communication function. Meanwhile the BT data communication function does not affect blood pressure monitors' measurement function. Therefore we have not done the Clinical test.

8. Summary of Substantial Equivalence

8.1 Difference between proposed devices and the predicate device

The only significant difference between LS802-B, LS805-B and TMB-1018-BT and the predicate device is that these modified devices use Bluetooth instead of RF which the original device used.

More modification details are described in this submission.

8.2 Discussion

The Transtek Blood Pressure Monitor LS802-B, LS805-B, and TMB-1018-BT have identical indication for use, fundamental scientific technology, performance specifications, energy type, Cuff type, functions, and similar dimensional specifications, environmental specifications, software/firmware, labeling to the predicate device.

The only difference between LS802-B, LS805-B and TMB-1018-BT and the predicate device is that these modified devices' wireless data transmission achieved by a BT module instead of original's RF module. The Bluetooth does not raise new questions of safety and effectiveness.

All required design control activities have been implemented and all applicable performance tests have been done according with demands of FDA guidance document "Non-Invasive Blood Pressure (NIBP) Monitor Guidance" FDA March 10, 1997. We found that the modified device does not create new significant risk.

Section 6 - 510(k) Summary

Page 3 of 4

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TRANSTEK

9. Conclusions

Transtek Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT are substantially equivalent to the predicate device LS802-E, by having the identical indication for use, identical technologies, performance specification, cuff, and the similar wireless data communications, in which RF replaced by Bluetooth that does not impact the safety and effectiveness of these devices.

--- End of this section ---

Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

June 19, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Guangdong Transtek Medical Electronics Co., Ltd C/O Leo Wang No. 1 Fanghua Street, Hi-tech District Chengdu, Sichuan, 610041 CH

Re: K131395

Trade/Device Name: Transtek blood pressure monitor (models: LS802-B, LS805-B, and TMB-1018-BT) Regulation Number: 21 CFR 870.1130 Regulation Name: System, Measurement, Blood-Pressure, Non-Invasive Regulatory Class: Class II Product Code: DXN Dated: May 15, 2013 Received: May 20, 2013

Dear Leo 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.

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); 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.

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ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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.htm. 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 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

for

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

Sincerely yours.

OwenPFaris -S

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

Enclosure 。

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K131395

TRANSTEK

Section 5 - Indications for Use

510(k) Number (if known);

Device Name:

Transtek Blood Pressure Monitor Models: LS802-B, LS805-B, and TMB-1018-BT

Indications for Use:

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

These Blood Pressure Monitor compare 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.

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)

Owen P. Faris -S
2013.06.19
15:34:06 -04'00'

Section 5 - Indications for Use

Page 1 of 1

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).