(29 days)
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.
The TRANSTEK Glass Body Fat Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 or 8 users. As well as being an analyzer, this device can be used as a conventional scale.
The provided text describes a 510(k) premarket notification for the TRANSTEK Glass Body Fat Analyzer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case comparative effectiveness study.
The document states:
"The subject devices have all features of the predicate device, Transtek Glass Body Analyzer (Model GBF-950) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices. BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Glass Body Analyzer (Model GBF-950). Thus, the subject devices are substantially equivalent to the predicate devices."
This indicates that the submission relies on the established safety and effectiveness of the predicate device, rather than providing new performance data against specific acceptance criteria for the new models.
Therefore, I cannot populate the requested table and information based on the provided text.
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NOV - 1 2011
Section 5 - 510(k) Summary
Date of Summary Preparation: 08/25/2011
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan 528441, Guangdong, China Contact Person: Lisa Li Contact Email Address: lishal@transtek.cn Telephone: +86(760)88282982 ext. 876 Fax: +86(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: 086-4006070050 ext. 8
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3. Name of the Device
Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph)
Product Name: TRANSTEK Glass Body Fat Analyzer
Trade Name: TRANSTEK
Models: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D
Classification Panel: Cardiovascular
Common/Usual Name: Body Composition Analyzer/Scales
Product Code: MNW
Device Classification: Class 11
Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.
4. The Predicate Devices
TRANSTEK, Glass Body Analyzer, Model GBF-950, K102191
5. Device Description
The TRANSTEK Glass Body Fat Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water
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and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.
This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness.
This scale stores the personal data of up to 4 or 8 users. As well as being an analyzer, this device can be used as a conventional scale.
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, 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.
7. Summary of Substantial Equivalence
Table 1: The difference between TRANSTEK Glass Body Fat Analyzer and the predicate device, Transtek Glass Body Analyzer (Model GBF-950)
| Feature | Proposed Device:TRANSTEK Glass Body Fat AnalyzerModels: BF-1039, BF-1041-AGBF-1012, GBF-733-W1, GBF-950-D | Predicate Device:Transtek Glass Body AnalyzerModel: GBF-950 |
|---|---|---|
| 510(k) Number | K102191 | |
| Manufacturer | ZHONGSHAN TRANSTEKELECTRONICS CO., LTD | ZHONGSHAN TRANSTEKELECTRONICS CO., LTD |
| Classification | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product Code | MNW | MNW |
| Indication for use | The TRANSTEK Glass Body Fat Analyzermeasure weight and uses bioelectricalimpedance analysis (BIA) technology toestimate body fat, total body waterpercentage, bone mass, and muscle mass ingenerally healthy adults 18 years of age orolder. It is intended for use in thehome/domestic setting only. | The TRANSTEK Glass BodyAnalyzer measure weight anduses bioelectrical impedanceanalysis (BIA) technology toestimate body fat, total bodywater percentage, bone mass, andmuscle mass in generally healthyadults 18 years of age or older. Itis intended for use in thehome/domestic setting only. |
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Image /page/2/Picture/0 description: The image shows the word "TRANSTEK" in a stylized, sans-serif font. The letters are outlined with a dark, textured fill, giving them a slightly rough or industrial appearance. The word is presented horizontally, with each letter evenly spaced and clearly legible.
| Feature | Proposed Device:TRANSTEK Glass Body Fat AnalyzerModels: BF-1039, BF-1041-AGBF-1012, GBF-733-W1, GBF-950-D | Predicate Device:Transtek Glass Body AnalyzerModel: GBF-950 |
|---|---|---|
| Devicedescription | TRANSTEK Glass Body Fat Analyzerutilizes a "foot-to-foot" bioelectricalimpedance analysis (BIA) technology todetermine internal body composition. | TRANSTEK Glass BodyAnalyzer utilizes a "foot-to-foot"bioelectrical impedance analysis(BIA) technology to determineinternal body composition. |
| Analysis method | BIA(Bioelectrical Impedance Analysis) | BIA(Bioelectrical ImpedanceAnalysis) |
| Operatingparameters | 50 KHz | 50 KHz |
| Power source | BF-1039, 2CR2032 lithium batteriesBF-1041-A, 2CR2032 lithium batteriesGBF-1012, 4AAA batteriesGBF-733-W1, 2CR2032 lithium batteriesGBF-950-D, 4*AAA batteries | 6V, 4*AAA batteries |
| Operating keys | 4 | 4 |
| Number ofelectrodes | 4 | 4 |
8. Conclusions
The subject devices have all features of the predicate device, Transtek Glass Body Analyzer (Model GBF-950) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices. BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Glass Body Analyzer (Model GBF-950). Thus, the subject devices are substantially equivalent to the predicate devices.
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Section 5 – 510(k) Summary
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. % Mr. Leo Wang, Consulting Manager A03 Lab of BTS No. I Fanghua Street, Hi-tech District CHENGDU SICHUAN 610041 CHINA
NOV - 1 2011
Re: K112932
Trade/Device Name: Transtek Glass Body Fat Analyzer Models: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: October 3, 2011 Received: October 3, 2011
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. Th 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
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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/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,
Herbert Lemur MD
erbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use
510(k) Number (if known):
Device Name:
Transtek Glass Body Fat Analyzer Models: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, GBF-950-D
Indications for Use:
Prescription Use _
(Part 21 CFR 801 Subpart D)
.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112932
Section 4 - Indications for Use
Page I of I
×
Over-The-Counter Use __
(21 CFR 801 Subpart C)
§ 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.