(164 days)
Not Found
No
The description focuses on bioelectrical impedance analysis (BIA) and user recognition based on weight, with no mention of AI or ML techniques.
No
The device measures body weight and body fat percentage, which are diagnostic indicators of health status, not therapeutic interventions.
Yes
The device estimates body fat percentage using bioelectrical impedance analysis and provides body weight information, contributing to an assessment of a user's bodily state. While not diagnosing a disease, it provides data about a person's physiological condition which aligns with the broad definition of diagnostic devices that identify or measure physiological states.
No
The device description clearly states it is a "body weight scale and a body fat analyzer" that uses bioelectrical impedance analysis (BIA) technology, which involves hardware components to generate and measure electrical currents. While it has a WiFi module for data transmission, the core function relies on physical hardware.
Based on the provided information, the ARIA WiFi Smart Scale is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ARIA's Function: The ARIA scale measures body weight and estimates body fat percentage using bioelectrical impedance analysis (BIA). This is a non-invasive method that does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for "body analysis" and estimating body fat percentage in "generally healthy individuals." This is for general wellness and fitness tracking, not for diagnosing or monitoring diseases.
Therefore, the ARIA WiFi Smart Scale falls outside the scope of In Vitro Diagnostics.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
10 years of age or older
Intended User / Care Setting
Home use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
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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 |
| San Francisco, CA 94015 | |
| Tel 1.650.333.4001 | |
| 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
New Device | Withings Smart Body Scale
(Predicate) K121971 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product Code | MNW | MNW |
| Indication 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. | 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. |
| Device Description | Fitbit ARIA WiFi Smart Scale
uses a "foot-to-foot"
bioelectrical impedance
analysis (BIA) technology to
determine internal body
composition | Withings WBS01 Smart Body
Scale 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 |
1
1
··· fitbit
K133872 Page 2 of 2
| Feature | ARIA WiFi Smart Scale
New Device | Withings Smart Body Scale
(Predicate) K121971 |
|----------------------|--------------------------------------|------------------------------------------------------|
| Number of electrodes | 4 | 4 |
| Power Source | 4-AA | 4-AAA |
| Operating Keys | None | No operating key, 1 unit
switch, 1 pairing button |
| IP Connectivity | 802.11b (WiFi) | 802.11b/g (WiFi) |
| Parameters Measured | Body weight, Body fat
composition | Body weight, Body fat
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