(111 days)
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.
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.
Here's an analysis of the provided text regarding the Transtek Body Fat Analyzer and its acceptance criteria and study information:
Acceptance Criteria and Study Information for Transtek Body Fat Analyzer
Based on the provided 510(k) summary (K130311), here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for body fat, total body water percentage, muscle mass, or bone mass estimation. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and electrical standards.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | Not explicitly stated in the document |
The document primarily focuses on demonstrating that the Transtek Body Fat Analyzer (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B) is substantially equivalent to the predicate device, Transtek Glass Body Fat Analyzer, Model GBF-950-D (K112932). The key argument for substantial equivalence is that the only significant difference is the addition of a wireless data communication function, which is an add-on and does not affect the safety and effectiveness of the body composition analysis function.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size or provide details on a "test set" used for clinical validation of the body composition measurements. The assessment appears to rely on a demonstration of design control activities and performance tests focusing on adherence to electrical safety and electromagnetic compatibility standards, rather than a clinical trial with a defined test set for accuracy of body composition measurements.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. (The submitter is from China, but there's no indication of where any testing data, if clinical, would originate).
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no explicit clinical test set for body composition accuracy is described, there's no information regarding experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no explicit clinical test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the provided document. The focus is on device equivalence, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Body Fat Analyzer that directly measures and displays results. The concept of "standalone performance" in the context of an algorithm's output versus human interpretation (as often seen in imaging AI) is not applicable to this type of device based on the provided information. The device itself is the "algorithm" and produces the output for the user.
7. The Type of Ground Truth Used
The document does not specify a type of ground truth (e.g., pathology, outcomes data, expert consensus) for body composition measurements. The substantial equivalence argument implies reliance on the already accepted performance of the predicate device and adherence to relevant standards.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This implies that the device's algorithms for body composition measurement were either developed or previously validated, and this 510(k) focused on demonstrating equivalence and safety of the new wireless feature rather than re-validating the core body composition algorithms.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
Summary of Study Information Gaps:
The K130311 summary for the Transtek Body Fat Analyzer primarily focuses on demonstrating substantial equivalence to an existing predicate device, particularly concerning the addition of a wireless data transmission function. It emphasizes compliance with general electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2, FCC Part 15), and risk management (ISO14971) standards.
Crucially, the document does not provide details on specific clinical studies, test sets, sample sizes, or ground truth establishment related to the accuracy of the body composition measurements (body fat, water, muscle, bone mass). This is a common characteristic of 510(k) submissions where a device is deemed substantially equivalent to a predicate, and the modifications are considered not to raise new questions of safety or effectiveness regarding the core function. The assumption is that the predicate device's performance has already been established.
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K130311 Page 1 of 3
TRANSTEK
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
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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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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.
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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/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
§ 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.