ARIA WIFI SMART SCALE

K133872 · Fitbit, Inc. · MNW · Jun 2, 2014 · Cardiovascular

Device Facts

• Record ID: K133872
• Device Name: ARIA WIFI SMART SCALE
• Applicant: Fitbit, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Jun 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.

Device Story

ARIA WiFi Smart Scale is a body composition analyzer for home use. Device uses foot-to-foot bioelectrical impedance analysis (BIA) via 4 electrodes to measure body weight and estimate body fat percentage. User stands on scale; device passes low electrical current through body; impedance data processed to determine body composition. Scale automatically recognizes up to 8 users based on weight/fat readings; stores 16 most recent readings; transmits data via WiFi to fitbit.com account for trending. Healthcare providers or users view output via web interface to monitor body composition trends. Device benefits patients by providing automated, longitudinal tracking of weight and body fat metrics.

Clinical Evidence

Comparative clinical study of 50 subjects (25 male, 25 female) compared ARIA WiFi Smart Scale to predicate device. Subjects were generally healthy without acute/chronic illness or pregnancy. Results showed measurements were not statistically different (p>0.05) and body fat measurements varied by <8% between devices.

Technological Characteristics

Bioelectrical impedance analysis (BIA) at 50 KHz; 4-electrode configuration; 4-AA battery power; 802.11b WiFi connectivity; weight and body fat measurement; internal memory for 16 readings; user recognition algorithm.

Indications for Use

Indicated for generally healthy individuals 10 years of age or older for measurement of body weight and estimation of body fat percentage. Intended for home use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Smart Body Scale (Withings, K121971)

Submission Summary (Full Text)

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K133872 Page 1 of 2

* fitbit

#### JUN 0 2 2014 510(k) Summary of Safety and Effectiveness

## Manufacturer and Submitter

.

| Company Name: | Fitbit, Inc. |
|------------------------|------------------------------------------------------------------------------|
| Company Address: | 150 Spear Street, Suite 200<br>San Francisco, CA 94015<br>Tel [phone] |
| Contact Person: | Arndt Hufenbach |
| Date Summary Prepared: | December 2013 |

## Device Name and Classification

| Trade/Device Name: | ARIA WiFi Smart Scale |
|-----------------------|----------------------------|
| Common/Usual Name: | Analyzer, Body Composition |
| Classification Name: | Impedance Plethysmograph |
| Regulation Number: | 21 CFR §870.2770 |
| Product Code: | MNW |
| Classification Panel: | Cardiovascular Devices |
| Classification: | Class II |

## Substantial Equivalence

This 510(k) submission demonstrates that the ARIA WiFi Smart Scale is substantially equivalent to the Smart Body Scale (Withings, K121971) in both technology and intended use.

| Feature | ARIA WiFi Smart Scale<br>New Device | Withings Smart Body Scale<br>(Predicate) K121971 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product Code | MNW | MNW |
| Indication for Use | The ARIA WiFi Smart Scale is<br>a body analyzer that measures<br>body weight and uses<br>bioelectrical impedance<br>analysis (BIA) technology to<br>estimate body fat percentage<br>in generally healthy individuals<br>10 years of age or older. It is<br>intended for home use only. | The Withings WBS01 Smart<br>Body Scale measures weight<br>and uses bioelectrical<br>impedance analysis (BIA)<br>technology to estimate body<br>fat mass in generally healthy<br>adults 18 years of age or<br>older. It is intended for use in<br>the home/domestic setting<br>only. |
| Device Description | Fitbit ARIA WiFi Smart Scale<br>uses a "foot-to-foot"<br>bioelectrical impedance<br>analysis (BIA) technology to<br>determine internal body<br>composition | Withings WBS01 Smart Body<br>Scale utilizes a "foot-to-foot"<br>bioelectrical impedance<br>analysis (BIA) technology to<br>determine internal body<br>composition |
| Analysis method | BIA (Bioelectrical Impedance<br>Analysis) | BIA (Bioelectrical Impedance<br>Analysis) |
| Operating parameters | 50 KHz | 50 KHz |

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··· fitbit

K133872 Page 2 of 2

| Feature | ARIA WiFi Smart Scale<br>New Device | Withings Smart Body Scale<br>(Predicate) K121971 |
|----------------------|--------------------------------------|------------------------------------------------------|
| Number of electrodes | 4 | 4 |
| Power Source | 4-AA | 4-AAA |
| Operating Keys | None | No operating key, 1 unit<br>switch, 1 pairing button |
| IP Connectivity | 802.11b (WiFi) | 802.11b/g (WiFi) |
| Parameters Measured | Body weight, Body fat<br>composition | Body weight, Body fat<br>composition |

#### Device Description

ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.

The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.

#### Intended Use/Indications for Use

The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.

### Performance - Bench Testing

The ARIA WiFi Smart Scale has been tested according to IEC 60601-1, IEC 60601-1-2 and was found to meet all requirements. Performance data (reliability testing and human factors testing) also support that the ARIA device meet its specified criteria.

#### Performance - Clinical Performance Testing

A small comparative clinical study was conducted to compare body fat composition (%) in 25 male and 25 female subjects using the ARIA WiFi Smart Scale vs. the predicate device. This study was conducted in generally healthy subjects (without acute or chronic illness, disease, or condition such as pregnancy). Results of this study lead to the conclusion that the measurements from ARIA were not statistically different from the predicate device (p>0.05) and body fat measurements varied by <8% from one another.

Date of summary: April 2, 2014

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

June 2, 2014

Fitbit, Inc. % Diane Horwitz, Ph.D. Regulatory Affairs Consultant Mandell Horwitz Consultants, LLC 2995 Steven Martini Drive Fairfax, VA 22031

Re: K133872 Trade/Device Name: ARIA WiFi Smart Scale Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: April 4, 2014 Received: April 4, 2014

Dear Diane Horwitz,

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(t) premaited is substantially equivalent (for the indications
referenced above and have determined the device is subscreenced in interstate referenced above and have determined the devices noredicate devices marketed in interstate for use stated in the encrosine) to legally manced provide Medical Device Amendments, or to commerce prior to May 28, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been recolusined in accordance with approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general cannus massessio You may, therefore, market the device, subject to the gentralize annual registration, listing of
general controls provisions of the Act include requirements michmoding and general controls provisions of the Fet mendate required misbranding and devices, good manufacturing practice, labelian information related to contract liability.
adulteration. Please note: CDRFI does not evaluate in the success to tracted adulteration. Please note: CDNFI does not evaluate information of misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in be If your device is classified (sec and of microsoft (spines affecting your device can be
may be subject to additional controls. Exist 800 to addition FDA may may be subject to additional controls. Existing major regardent on and interest of and in the corporations of the may be found in the Code of Tederal Regilations, This 20, vice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substination with other requirements of the Act
that FDA has made a determination that your device with other agencies that FDA has made a determination mavy only other Federal agencies.

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Page 2 - Diane Horwitz, Ph.D.

You must comply with all the Act's requirements, including, but not limited to: registration and I va must compy man 7); labeling (21 CFR Part 801); medical device reporting (reporting of nsting (21 CFR ratt 007), accomig (2) CFR 803); good manufacturing practice requirements micular device-related as velos of the regulation (21 CFR Part 820); and if applicable, the as set form in the quality of 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 If you desire specific advice to: your dorners offices/CDRH/CDRHOffices/ucm115809.htm for go to mp3/7www.ba.gov/About D7. Corners) Office of Compliance. Also, please, and Radio Color Collection (2010) Port the Center for Devices and Radionaling by reference to premarket notification" (21CFR Pation (1 note the regulation entined, "Misoraneing of restrative 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 You may obain other general information on your icopediater Assistance at its toll-free number [phone] or [phone] or at its Internet address [phone] of [phone] er un no mores for You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Benjamin R Fisher-S" in a stylized font. The text is mostly black, with some parts of the letters filled with a pattern of smaller text or symbols. The overall impression is of a logo or signature.

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): _K133872

ARIA WiFi Smart Scale Device Name:

Indications For Use:

The ARIA WiFi Smart Scale is a body analyzer that measures body weight and The ARTA WIFT Smart Scale is a bouj unling to estimate body fat uses bloelectively individuals 10 years of age or older. It is intended for home use only.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -2014.06.02 21:44:47 -04'00'