Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.

Device Description

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 uA, at 50 kHz, the Wi-Fi body 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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria. The document is a 510(k) summary for a Wi-Fi body scale, focusing on its substantial equivalence to a predicate device and its intended use.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of acceptance criteria and reported device performance:

This information is not present in the provided text. The document states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory," but it does not specify what those "satisfactory" results were in terms of acceptance criteria or performance metrics.

2. Sample size used for the test set and the data provenance:

This information is not present in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not present in the provided text.

4. Adjudication method for the test set:

This information is not present in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not present in the provided text. The device is a "body analysis scale" and doesn't involve human readers interpreting medical images or data that would typically require an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device description implies standalone performance as it "calculates the body fat percentage" via internal software. However, there is no separate study explicitly described as a "standalone" evaluation with specific performance metrics. The statement "Clinical testing was used to validate the effectiveness and accuracy of the device" might refer to this, but details are lacking.

7. The type of ground truth used:

This information is not explicitly stated. For a body fat scale using Bioelectrical Impedance Analysis (BIA), the "ground truth" for validation would typically be a more accurate body composition measurement method (e.g., DEXA, hydrostatic weighing). However, the document only broadly mentions "Clinical testing was used to validate the effectiveness and accuracy of the device."

8. The sample size for the training set:

This information is not present in the provided text. The device uses "internal software" with "variables programmed in by the user," but there's no mention of a machine learning model that would require a separate training set.

9. How the ground truth for the training set was established:

This information is not present in the provided text, as there is no mention of a training set or machine learning model that would require such a ground truth. The device relies on a "Bioelectrical Impedance Method" calculation based on pre-programmed variables.

Summary

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510(k) Summary JUL 2 6 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Road, Ya'an street, Nankai District,Tianjin,P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Application:	03/21/2012

2.0 Device information

Trade name:	Wi-Fi body scale, model HS5
Common name:	Body Analysis scale/ Electronic Body Fat Scale
Classification name:	Impedance plethysmograph

3.0 Classification

Production code: MNW- Body Fat Analyzer. Regulation number: 870.2770 Classification: II Panel: Cardiovascular

4.0 Predict device information

Shenzhen Healthcare Electronic Technology Co., Ltd Manufacturer: Body Analysis Scale, Model BG 17 Device: 510(k) number: K110928

5.0 Device description

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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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

KI 20896

6.0 Intended use

7.0 Summary comparing technological characteristics with predicate device

	Wi-Fi body scale, model HS5	Body Analysis Scale, Model BG 17(K110928)	Same or not?
Intended use	Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.	Body Analysis Scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration	Same

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ProductDescription	Wi-Fi body scale, modelHS5 is indicated tomeasure body weight,estimate body fat,body waterpercentage, bodymuscle mass, bonesmass, visceral fatrating and daily calorieintake (DCI) using BIA(bioelectricalimpedance analysis).	Body Analysis Scale,Model BG 17 isindicated to measurebody weight,estimate body fat,body waterpercentage, bodymuscle mass, bonesmass, visceral fatrating and dailycalorie intake (DCI)using BIA(bioelectricalimpedance analysis).	Same
Analyticalmethod	BIA (bioelectricalimpedance analysis)	BIA (bioelectricalimpedance analysis)	Same

. . . . .

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Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-1-2. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.

9.0 Comparison to the predict device and the conclusion

Our device Wi-Fi body scale, model HS5 is substantially equivalent to the ody Analysis Scale, Model BG 17 whose 510(k) number is K110928.

The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Wi-Fi body, scale, model HS5 can be used with an iPod Touch, iPhone or iPad.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 26 2012

Mr. Liu Yi President Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya' An Road, Nankai District TIANJIN 300190 CHINA

Re: K120896

Trade/Device Name: Wi-Fi body scale, model HS5 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 9, 2012 Received: July 9, 2012

Dear Mr. Yi:

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 101 too manage 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.

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

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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,
Benjamin R. Tucker

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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Statement of Indications for Use

4120896 510(k) Number :

Device name:

Wi-Fi body scale, model HS5

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halulu

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K120896

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Regulation Number and Section

§ 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.