(111 days)
Not Found
No
The description focuses on Bioelectrical Impedance Analysis (BIA) technology and standard data transmission via Bluetooth. There is no mention of AI or ML algorithms being used for data analysis or interpretation.
No
The device is intended to estimate body composition parameters for healthy adults, not to treat or diagnose a medical condition.
No
The device is described as a "Body Fat Analyzer" that measures weight and estimates body composition parameters. It is intended for use in the home setting for "generally healthy adults" to provide information about overall health and fitness. It does not state that it diagnoses conditions or diseases.
No
The device description explicitly states it is a "Transtek Body Fat Analyzer" which uses BIA technology and has an LCD display and a Bluetooth module. This indicates it is a physical device with hardware components, not solely software.
Based on the provided information, the Transtek Body Fat Analyzer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Transtek Body Fat Analyzer measures parameters of the body (weight, body fat, water, muscle, bone mass) using bioelectrical impedance, not by analyzing a biological specimen taken from the body.
- The intended use and device description clearly state it measures body composition using BIA technology applied externally to the body. There is no mention of analyzing any biological samples.
- The device is intended for home/domestic use in generally healthy adults. While some IVDs are used in home settings (like blood glucose meters), the fundamental mechanism of action for this device is not based on analyzing a biological sample.
Therefore, the Transtek Body Fat Analyzer falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Transtek 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 Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far 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 Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).
This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.
The Transtek Body Fat Analyzer embeds a Bluetooth (BT) module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.
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 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.
Proposed Body Fat Analyzer conforms to (including, but not limited to) the following standards:
IEC60601-1-2, Electromagnetic compatibility
IEC60601-1, Electrical safety
ISO14971, Risk management to medical devices
FCC Part 15, EMI tests of FCC Radiation & RF 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.
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K130311 Page 1 of 3
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Section 6 - 510(k) Summary
Date of Summary Preparation: 1/11/2013
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 528437, China Contact Person: Lisa Li Contact Email Address: lishal@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: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: Body Fat Analyzer Trade/Proprietary Name: Transtek Body Fat Analyzer Models: GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B Classification Panel: Cardiovascular Common/Usual Name: Body Composition Analyzer/Scales Product Code: MN W Device Classification: Class II
Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.
4. The Predicate Devices
".
Transtek Glass Body Fat Analyzer, Model GBF-950-D, K112932
5. Device Description
Transtek Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far 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
Section 6 - 510(k) Summary
Page 1 of 3
MAY 3 0 2013
1
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resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).
This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.
The Transtek Body Fat Analyzer embeds a Bluetooth (BT) module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.
6. Intended Use of Device
The Transtek 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 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.
Proposed Body Fat Analyzer conforms to (including, but not limited to) the following standards:
IEC60601-1-2, Electromagnetic compatibility
IEC60601-1, Electrical safety
ISO14971, Risk management to medical devices
FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations
8. Summary of Substantial Equivalence
- I Differences between proposed device and the predicate device
The only significant function difference between the two devices is that the modified device add-on a wireless data communication, what user option, which can transmit measurement results to receiving end equipment.
More modification details are described in this submission.
8.2 Discussion
The Transtek Body Fat Analyzer has identical indication for use, fundamental scientific technology, energy type, and similar performance specifications, dimensional specifications, software/firmware, functions, labeling to the predicate device.
Section 6 - 510(k) Summary
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The only function difference between proposed device and the predicate device is that the modified device provides user an optional wireless data transmission. It is an add-on function that is entirely independent to the body compositions analyzer function. Regardless of wireless connection status, the analyzer normal works to carry out a bioelectrical impedance analysis and display its results.
Thus the wireless data transmission function does not affect the safety and effectiveness of the body analyzer function.
9. Conclusions
The Transtek Body Fat Analyzer (GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B) is substantially equivalent to the predicate device, GBF-950-D, by having the identical indications for use, identical fundamental scientific technologies, and an add-on function which does not impact the safety and effectiveness of the device.
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{
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem, which is a stylized representation of an eagle or bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
Guandong Transtek Medical Electronics Co., Ltd. % Mr. Leo Wang Senior Consultant A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District, Chengdu Sichuan CHINA 610041
Re: K130311
Trade/Device Name: Transtek Body Fat Analyzer Models: GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: March 7, 2013 Received: March 7, 2013
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.
4
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5 - Indications for Use
510(k) Number (if known): K130311
Device Name:
Transtek Body Fat Analyzer Models: GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B
Indications for Use:
The Transtek 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
X 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)
Herbert - 2 - S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130311 510(k) Number
Section 5 - Indications for Use