(100 days)
The Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale SF-371 measures body weight, and estimates body fat, body water, body muscle mass and body bone mass using BIA (bioelectrical impedance analysis). The device is intended to be used by generally healthy people (from age 16 to age 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Body Fat Scale, Model SF-371 (K122976):
The provided 510(k) summary (K122976) for the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale, Model SF-371, is quite limited in detail regarding specific acceptance criteria and the clinical study. It states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." However, it does not provide specific metrics or outcomes from this clinical testing.
Therefore, much of the requested information cannot be directly extracted from the provided document. I will present what is available, and for missing information, I will explicitly state that it is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." However, no specific acceptance criteria or quantitative performance metrics (e.g., accuracy percentages, standard deviations, correlation coefficients) are provided in the document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All test results were satisfactory." |
| Not specified | No quantitative performance data provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical testing was used to validate the effectiveness and accuracy of the device," but it does not specify the sample size used for this test set.
Data Provenance: The document does not explicitly state the country of origin for the clinical testing data. Given that the submitting company is based in Shenzhen, China, it is plausible the testing was conducted locally, but this is not confirmed. It also does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The 510(k) summary does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for the clinical testing.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention any MRMC comparative effectiveness study involving human readers or AI assistance. The device is a "Body Fat Scale," which is a direct measurement device rather than an interpretive imaging or diagnostic system that would typically involve MRMC studies.
6. Standalone (Algorithm Only) Performance
The device itself is a standalone algorithm for calculating body composition based on bioelectrical impedance. The statement "Clinical testing was used to validate the effectiveness and accuracy of the device" implicitly refers to the standalone performance of the device's calculations. However, no specific performance metrics are provided.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for validation. For body fat scales, common ground truth methods include DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or air displacement plethysmography, but none of these are mentioned.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This type of device relies on internal algorithms based on established bioelectrical impedance principles and user-programmed variables, rather than a deep learning model requiring a distinct "training set" in the modern AI sense.
9. How Ground Truth for the Training Set Was Established
Since no training set is described in the context of an AI/machine learning model, this information is not applicable and therefore not provided in the document. The device's calculations are based on bioelectrical impedance method, using electrical impedance, height, weight, age, and gender, likely derived from scientific literature and established physiological models rather than a specific "training set" with ground truth in the typical AI development paradigm.
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K122976
PAGE 1 OF 3
JAN 0 4 2013
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: September 20, 2012
- Company and Correspondent making the submission:
Name - Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Address - 702/704, Block C, Tsinghua Unis Science Park, No. 13 Langshan Rd, Hi-Tech Industrial Park(north), Nanshan District, Shenzhen City, Guangdong Province
Telephone - +86-755-61869839
Fax - +86-755-61869122
Contact - Mr. Li Peiyong
Email - charliemack@irc-us.com
- Device :
Trade/proprietary name: Body Fat Scale, SF-371
: Analyzer, Body Fat Common Name
Classification Name : Impedance plethysmograph
- Predicate Devices :
Tanita BC-533, (K040778)
4. Classifications Names & Citations :
21CFR 870.2770, MNW, Body Fat Analyzer, Class 2
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5. Description :
- 5.1 General
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
5.2 Direction
As discussed in the General description, the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale is relatively simple to use. The user inputs the variable data of age, height, and gender. The user steps onto the scale and the devices measures the user weight and body impedance (via the Bioelectric Impedance through the four electrodes on the scale). The scale displays the user's body fat composition. Upon the user's selection, the device can also display the user's weight.
- Indication for use :
The Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale SF-371 measures body weight, and estimates body fat, body water, body muscle mass and body bone mass using BIA (bioelectrical impedance analysis). The device is intended to be used by generally healthy people (from age 16 to age 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
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-
- Comparison with predicate device :
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. believes that the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale is substantially equivalent to the Tanita BC-533 (K040778).
- Comparison with predicate device :
-
- Safety and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
- Safety and Performance Data :
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification TH Leaguer. Inc. concludes that The Shenzhen Beiter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
END
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human form or a caduceus, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4. 2013
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826
Re: K122976
Trade/Device Name: Body Fat Scale, Model SF-371 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 14, 2012 Received: December 20, 2012
Dear Mr. Mack:
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. Charlie Mack
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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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Indications for Use
510(k) Number (if known): K122917
Device Name: Body Fat Scale, Model SF-371
Indications for Use:
The Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale SF-371 measures body weight, and estimates body fat, body water, body muscle mass and body bone mass using BIA (bioelectrical impedance analysis). The device is intended to be used by generally healthy people (from age 16 to age 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
| Prescription Use | Commens promote the first the first the consisted on the consisted |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
• Concurrence of CDRH, Office of Device Evaluation (ODE)
| Benjamin R. Fisher -S | |
|---|---|
| 2013.01.04 14:08:35 -05'00' |
| (Division Sign-Off) | Page __ of __ |
|---|---|
| Division of Reproductive, Gastro-Renal, andUrological Devices | |
| 510(k) Number | K122976 |
13
§ 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.