(84 days)
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body. 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 WBS01 Smart Body Scale.
WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.
The provided text describes a 510(k) summary for the Withings WBS01 Smart Body Scale, which is a body analyzer that uses bioelectrical impedance analysis (BIA) to estimate body fat mass. The submission aims to demonstrate substantial equivalence to a predicate device, the TRANSTEK Glass Body Analyzer (Model: GBF-830).
However, the document does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance values. It primarily focuses on comparing the proposed device to the predicate device and asserting substantial equivalence based on similar technology and intended use, with the main difference being the addition of Wi-Fi connectivity, which is described as not impacting the safety or effectiveness of the body analyzer function.
Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert ground truth, and comprehensive study designs are not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
Acceptance Criteria and Study Information for Withings WBS01 Smart Body Scale
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Body Fat Mass Estimation | Not explicitly stated in terms of specific thresholds (e.g., accuracy, precision, bias compared to a gold standard). | Not reported in the document. The submission implies that since it uses the same BIA technology as the predicate, its performance is considered equivalent. |
| Weight Measurement | Not explicitly stated in terms of specific thresholds (e.g., accuracy, precision). | Not reported in the document. |
| Wireless Connectivity (Wi-Fi) | User electrical safety and acceptable wireless radiation emission in use environment. | Bench tests performed to ensure these. FCC ID certification cited as basis for low risk of thermal injury or interference. (No specific numerical criteria or performance values are given, only a qualitative statement of compliance). |
| Substantial Equivalence to Predicate | Similar indication for use, same BIA technology, and technological difference (Wi-Fi) that does not impact safety or effectiveness. | Stated as concluded by the submitter and accepted by the FDA (as per the 510(k) clearance letter). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document does not describe a clinical performance study using a "test set" in the traditional sense for evaluating body fat accuracy.
- Data Provenance: Not applicable, as a test set study with performance data is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No direct clinical performance study where expert ground truth was established for a test set is described in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone algorithm/device for measuring body composition. However, the document does not describe a specific standalone performance study to quantify its accuracy against a gold standard (e.g., DEXA or underwater weighing). Instead, it relies on substantial equivalence to a predicate device. The "display results" are what the user sees, and these are presented as the "only reference values."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated for the proposed device's performance. For BIA devices, ground truth for body fat estimation typically involves methods like DEXA, underwater weighing, or MRI. The document does not mention the use of such a ground truth for testing the WBS01. It relies on the predicate device's established performance using BIA.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not a machine learning model that would require a "training set" in the context of deep learning or advanced AI. The BIA technology itself is a well-established method using physics principles and calibrated algorithms, not a dynamically trained AI system.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of a machine learning algorithm being developed or presented in this submission. The BIA technology uses physical measurements and equations.
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Section 5 - 510(k) Summary
SEP 27 2012
Date of Summary Preparation: 06/28/2012
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Lisa Li Contact Email Address: lisha1@transtek.cn_ Tclephone: +86(760)88282982 ext. 876 Fax: +86(760)85339231
2. Correspondent's Identifications
Correspondent's Name: A03 Lab of BTS Address: No. I 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: 086-20-80727399
3. Name of the Device
Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph)
Product Name: Smart Body Scale
Trade Name: Withings
Model: WBS01
Classification Panel: Cardiovascular
Common/Usual Name: Body Composition Analyzer/Scales
Product Code: MNW
Device Classification: Class II
Contraindications: Do not use the Body Scale if you have a pacemaker or other internal medical device.
4. The Predicate Devices
TRANSTEK, Glass Body Analyzer, Model GBF-830, K102191
- Device Description
5.1 Technology of the device:
Bioclectrical Impedance:
WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body.
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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 WBS01 Smart Body Scale.
Wireless Connectivity:
WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.
5.2 Device functions-
A, Measuring weight, BMI and body fat:
Sten on the scale and the scale will display your weight, BMI and body fat. Unit Switch function: Change the weight unit among KG/LB/ST LB
B, Automatic recognition function:
The scale can automatically recognize you based on your weight reading. Later on, the scale keeps in memory your last weight reading to recognize you. The scale can however only determine your correct identity if no other user weighs within 6.6 pound range, otherwise the scale can only narrow down the choices and displays the various identity options on screen. The appropriate identity is selected by bending left or right.
C. Warning messages Function:
Lo == Low battery warning: Replace the batteries, always replace all batteries at the same time.
D. Wi-Fi Connectivity:
Easily create your profile in Withings' web application and the scale will automatically retrieve it thanks to its Wi-Fi connectivity. You must enter your height, date of birth, gender and activity level (athlete/ non-athlete) while creating your profile. Benefit from a complementary interfact to view the history of your weight and body fat readings.
Key function: profile definition, complementary interface.
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6. Intended Use of Device
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioclectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
It is not intended for being used by pregnant women or children under the age of 18.
7. Summary of Substantial Equivalence
- 7.1 Difference between proposed device and the predicate device
Table: The comparison of Withings WBS01 Smart Body Scale and the predicate device, TRANSTEK Glass Body Analyzer (Model: GBF-830)
| Feature | Proposed Device:Withings WBS01 Smart BodyScale | Predicate Device:TRANSTEK Glass Body AnalyzerModel: GBF-830 |
|---|---|---|
| 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 Withings WBS01 Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat 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 Analyzer measures 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. |
| Device description | Withings WBS01 Smart Body Scale utilizes a “foot-to-foot” bioelectrical impedance analysis (BIA) technology to determine internal body composition. | TRANSTEK Glass Body Analyzer utilizes a “foot-to-foot” bioelectrical impedance analysis (BIA) technology to determine internal body composition. |
| Analysis method | BIA(Bioelectrical Impedance Analysis) | BIA(Bioelectrical Impedance Analysis) |
| Operating parameters | 50 KHz | 50 KHz |
| Number of electrodes | 4 | 4 |
| Power source | 4*AAA | 4*AAA |
| Operating keys | No operating key, 1 unit switch, 1 pairing button | 4 |
| IP Connectivity | 802.11b/g (Wi-Fi) | No IP connectivity |
The differences between the two devices are WBS01, I) disable these measure functions, total, body water percentage, bone mass, and muscle mass; 2) add-on a Wi-Fi (IEEE 802.11 b/g) data communication, what user option, which can transmit measurement results to PC or cellular.
| Section 5 - 510(k) Summary | ||
|---|---|---|
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7.2 Discussion
The Withings WBS01 Smart Body Scale has an indication for use and BIA technology similar to the predicate device. The only technological difference between Withings WBS01 Smart body Scale and the predicate device is that the WBS01 embeds a 802.11 b/g (Wi-Fi) module. It is an add-on function that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results.
The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display.
By design, the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi inmediately gets turned off therefore allowing the display and body analysis function to be enabled.
The users profile details are stored.locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and therefore not impacting the safety and effectiveness of the body analyzer function.
Design control activities for the modification were performed and bench tests have been done to ensure that user electrical safety and wireless radiation emission is acceptable in use environment. Particular attention has been paid to those concerns and issues highlighted in the " Radio-Frequency Wireless Technology in Medical Devices Draft Guidance" FDA January 3, 2007.
Wi-Fi technology is widely used and proved to be safe and reliable. The use of the industry standard IEEE 802.11 b/g provides a high degree of confidence to the users that the coexistence of Withings WBS01 Smart Body Scale within a domestic/home environment is predictable, easily operation, and provides a high degree of assurance that there is a low risk that intentional electromagnetic radiation from the device will result in unacceptable interference with other electrical equipment in the immediate vicinity.
There is an acceptable, low risk that the radio frequency emissions will result in thermal injury to a patient or user. This is based on our FCC ID certification.
Therefore, the device does not create new significant risk.
As a result, the technological difference of the device does not impact its safety and effectiveness vs. the predicate device.
8. Conclusions
The Withings WBS01 Smart Body Scale is substantially equivalent to the predicate device by having the similar indication for use, same BIA technologics and a technological difference that does not impact the safety or effectiveness of the device.
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Section 5 - 510(k) Summary ーーーーー
Page 4 of 4
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The overall design is simple and conveys a sense of official government branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. % Mr. Leo Wang, Senior Consultant A03 Lab of BTS No. 1 Fanghua Street, Hi-tech Zone Chengdu Sichuan 610041 CHINA
Re: K121971
Trade/Device Name: Withings Smart Body Scale Model: WBS01 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 30, 2012 Received: August 30, 2012
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscate for use stated in the enclosure) to regarly management date of the Medical Device Amendments, or to comments that have been reclassified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassified in door daily in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, uicierore, market mo do recorporation of the montal registration, listing of general controls provisions of the tise, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract lability adulteration. Thease note. ODAL active labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) in isting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the Ood of I oderal resguinening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDPS Stissumice of a receive complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that IDA has made a dolorimations administered by other Federal agencies. You must of any reachar statutes and regulations, but not limited to: registration and listing of modi comply with an the Act 3 requirements, merical device reporting (reporting of medical
SEP 27 2012
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evice-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 11 you dosiro sportio any 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 note the rogaliations 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 Tou may obtain 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,.
Benjamin K-tiska
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 4 - Indications for Use
510(k) Number (if known):
K 12 1971
Device Name:
Withings Smart Body Scale Model: WBS01
Indications for Use:
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat 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
メ 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)
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
uctive. Gastro-Rena
Section 4 - 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.