(126 days)
Not Found
No
The description focuses on Bioelectrical Impedance Analysis (BIA) technology and Bluetooth connectivity, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is a body fat analyzer that measures various body composition metrics; it is not described as treating, preventing, or mitigating any disease or condition.
No
The device is a body composition analyzer that uses bioelectrical impedance analysis (BIA) to estimate body fat, water, muscle, and bone mass. While it provides health-related metrics, these are estimations for general health and fitness, not for diagnosing diseases or medical conditions. Diagnostic devices are typically used to identify the presence or absence of a disease or abnormality.
No
The device description explicitly states it uses Bioelectrical Impedance Analysis (BIA) technology and includes a physical device (Transtek Glass Body Fat Analyzer GLS203-B) with an LCD and a Bluetooth module for measurement and data transmission. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Transtek Glass Body Fat Analyzer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Transtek Glass Body Fat Analyzer measures weight and uses bioelectrical impedance analysis (BIA) to estimate body composition (fat, water, muscle, bone). It does this by passing a low electrical current through the body, not by analyzing a specimen taken from the body.
- Intended Use: The intended use is for estimating body composition in generally healthy adults in a home setting. This is a fitness/wellness application, not a diagnostic test performed on a biological sample.
Therefore, the device falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
home/domestic setting only
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
5. 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.
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
2
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.
--- End of this section ---
Section 6 - 510(k) Summary
3
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.
4
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:
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.
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
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