TRANSTEK GLASS BODY FAT ANALYZER by GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD

The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

Device Description

Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS203-B.

This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.

Transtek Glass Body Fat Analyzer GLS203-B embeds a Bluetooth module that allows it to connect to nearby BT receiving terminal. Once measurement is over, the LCD of device displays measurement results, and the device will start to send out measurement data to paired BT terminal at the same time. Thus users can receive, display, and storage measurement results from LS203-B unit through mobile BT terminal.

AI/ML Overview

The provided text describes a 510(k) summary for the Transtek Glass Body Fat Analyzer Model LS203-B. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for its intended body composition measurements.

The document focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781) by highlighting that the only significant difference is the wireless communication technology (Bluetooth vs. RF). It asserts that this change does not raise new questions of safety and effectiveness, and therefore, no clinical performance testing was deemed necessary for the comparison of the two devices.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

Not provided. The document states: "Explanation: The wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This indicates that no specific performance metrics comparing the LS203-B to a gold standard were conducted or reported in this summary.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No clinical performance test set or data provenance is mentioned. The only "tests" referred to are "bench tests," "risk management," and "design verification tests" for the modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No ground truth establishment experts are mentioned because no clinical performance study was conducted.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned because no clinical performance study was conducted.

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

Not applicable. This device is a body composition analyzer, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.

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

Not applicable/Not provided. While the device itself is a standalone measurement tool, the document doesn't present a study assessing its standalone performance against a clinical ground truth. It relies on the substantial equivalence to the predicate device, which presumably had established performance.

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

Not applicable/Not provided. No ground truth is mentioned in the context of a performance study for the LS203-B. Its substantial equivalence argument implies that the predicate device's performance, likely validated against some form of ground truth (e.g., DEXA or other established body composition methods for the predicate), is assumed to apply.

8. The sample size for the training set

Not applicable/Not provided. This document doesn't describe the development or training of an AI algorithm in the contemporary sense. It's an impedance-based device, and while it uses algorithms for calculation, it's not discussed in terms of a "training set" like a machine learning model.

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

Not applicable/Not provided. As there's no mention of a training set, there's no information on how its ground truth might have been established.

Summary of the Study (as described in the document):

The document describes a submission for a modified device (LS203-B) that is substantially equivalent to a predicate device (LS206-E). The "study" here is primarily a design control activity and substantial equivalence comparison, not a clinical performance validation of the LS203-B's accuracy in measuring body composition.

Objective: To demonstrate that the modified device (LS203-B) is substantially equivalent to the predicate device (LS206-E) and does not raise new questions of safety and effectiveness.
Key Finding: The only significant difference is the use of Bluetooth instead of RF for wireless data transmission.
Conclusion: This modification does not impact the safety and effectiveness of the device, and therefore, no clinical performance tests were considered necessary for this 510(k) submission. The device is deemed substantially equivalent.

Summary

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Section 6 - 510(k) Summary

Date of Summary Preparation: 05/08/2013

SEP 18 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.cn 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: 086-028-86083300 Fax: 086-20-80727399

3. Name of the Device

Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: Glass Body Fat Analyzer Trade Name: TRANSTEK Models: LS203-B Classification Panel: Cardiovascular Common/Usual Name: Body Composition Analyzer/Scales Product Code: MNW Regulation No.: 870.2770 Device Classification: Class II

4. The Predicate Devices

TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781

Section 6 - 510(k) Summary

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5. Device Description

This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.

6. Intended Use of Device

The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, muscle mass, and bone mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

7. Design Control Activities and Performance Tests Summary

Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness.

LS203-B conforms to the following standards:

ISO14971, Risk management to medical devices

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

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

Explanation: The wireless function does not affect body analyzer 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 the two devices is that modified device uses Bluetooth instead of RF which the original device used.

More modification details are described in this submission.

Section 6 - 510(k) Summary

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8.2 Discussion

Transtek Glass Body Fat Analyzer LS203-B has identical indication for use, fundamental scientific technology, dimensional specifications, and similar performance specifications, software/firmware, functions, labeling to the predicate device.

The only significant difference between LS203-B and the predicate device is that the modified device's wireless data transmission function achieved by a BT module instead of original's RF module. The Bluetooth does not raise any 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 regulations. We found that the modified device does not create new significant risk.

9. Conclusions

Transtek Glass Body Fat Analyzer LS203-B is substantially equivalent to the predicate device LS206-E by having identical indication for use, identical fundamental scientific technologies, and similar wireless data communications that does not impact the safety and effectiveness of the device.

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Section 6 - 510(k) Summary

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Public Health Service

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

September 18, 2013

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

Re: K131394

Trade/Device Name: Transtek Glass Body Fat Analyzer Model LS203-B Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph (Body Composition Analyzer/Scales) Regulatory Class: Class II Product Code: MNW Dated: Undated Received: August 19, 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.

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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

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

Sincerely yours.

Bram D. Zuckerman -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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Section 5 - Indications for Use

K131394 510(k) Number (if known):

Device Name:

Transtek Glass Body Fat Analyzer Model: LS203-B

Indications for Use:

It is intended for use in the home/domestic setting only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use X

(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)

Bram-D.Zuckerman -S
2013:09.18 13:24:47
-04'00'

LUNCH

Section 5 - Indications for Use

Page 1 of 1

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.