(224 days)
Not Found
No
The description focuses on bioelectrical impedance analysis (BIA) and does not mention AI or ML.
No
The device measures body weight, impedance, and estimates body fat, water, and muscle mass. It is intended for use by healthy adults to provide information about their body composition, not to treat or diagnose a disease or condition.
No
The device measures body weight, impedance, and estimates body fat, total body water, and total muscle mass. While these measurements provide health-related information, they are stated as being for "healthy adults" and estimate body composition, rather than diagnosing a disease or condition. Diagnostic devices are typically used to identify the presence of a disease, condition, or an abnormal health state, which is not the stated intended use here.
No
The device description explicitly states it is a "Body composition analyzer/scale" that utilizes "foot-to-foot bioelectrical impedance (BIA) technology," indicating it is a physical hardware device with integrated technology, not software only.
Based on the provided information, the Beaverite Body Fat Scales are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease.
- Beaverite Body Fat Scales Function: The Beaverite Body Fat Scales measure body weight and impedance using bioelectrical impedance analysis (BIA) through contact with the feet. They estimate body composition parameters like body fat, water, and muscle mass. This process does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for "healthy adults" to measure body composition, not for diagnosing or monitoring a disease through analysis of bodily fluids or tissues.
Therefore, the Beaverite Body Fat Scales fall under the category of a general wellness or body composition analysis device, not an IVD.
N/A
Intended Use / Indications for Use
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
Product codes
MNW
Device Description
The 11 models of Beaverite body fat scales submitted in this 510(k) are plethysmograph body composition analyzers. The devices estimate percentages of body fat, body water and muscle mass (as noted in the Indications statement) based on bioelectrical impedance analysis (BIA).
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
Adults
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tanita Innerscan Body Composition Monitor, K040778
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Beaverite Body Fat Scales Traditional 510(k)
Section 5.0 510(k) Summary
Beaverite Body Fat Scales
| Submitter Name: | Beaverite International Ltd |
|---|---|
| Submitter Address: | West Wing, 8/F |
| CNT Group Building | |
| 822 Lai Chi Kok Road | |
| Cheung Sha Wan, Kowloon, Hong Kong | |
| Contact Person: | Patsy J. Trisler, J.D., RAC |
| Regulatory Consultant - Medical Devices | |
| Phone Number: | 301-652-5344 |
| Fax Number: | 301-654-6976 |
| Date: | September 25, 2006 |
| Device Trade Name: | Beaverite Body Fat Scales |
| Device Common Name: | Analyzer, Body Composition |
| Classification Name: | Impedance Plethysmograph |
| Classification Number: | 21 CFR 870.2770 |
| Product Code: | MNW |
| Predicate Device: | Tanita Innerscan Body Composition Monitor, K040778 |
| Statement of | |
| Intended Use: | The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 |
| and 9576 -- measure body weight and impedance, and estimate | |
| percentages of body fat and total body water. They are intended for | |
| use by healthy adults. | |
| The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, | |
| 9583, and 9588 -- measure body weight and impedance, and | |
| estimate percentages of body fat, total body water, and total muscle | |
| mass. They are intended for use by healthy adults. | |
| Device Description, | |
| Summary of | |
| Technological | |
| Characteristics, and | |
| Comparison to the | |
| Predicate Device | The 11 models of Beaverite body fat scales submitted in this 510(k) |
| are plethysmograph body composition analyzers. The devices | |
| estimate percentages of body fat, body water and muscle mass (as | |
| noted in the Indications statement) based on bioelectrical impedance | |
| analysis (BIA). The following table illustrates the substantial | |
| equivalence in technology and intended use to the predicate device. |
OCT 1 0 2006
1
| Feature | Proposed Device:
Beaverite Body Fat Scales | Predicate Device:
Tanita InnerScan Body Composition
Monitor (Model BC-533) |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K040778 |
| Manufacturer | Beaverite International Ltd | Tanita Corp of America |
| Classification #
Product Code
Indications for
Use | 21 CFR 870.2770
MNW
The Beaverite Body Fat Scales -- Models
8921, 8925, 8931, 8935 and 9576 --
measure body weight and impedance,
and estimate percentages of body fat
and total body water. They are intended
for use by healthy adults.
The Beaverite Body Fat Scales -- Models
8919, 8923, 8929, 9580, 9583, and 9588
-- measure body weight and impedance,
and estimate percentages of body fat,
total body water, and total muscle mass.
They are intended for use by healthy adults. | 21 CFR 870.2770
MNW
The Tanita family of InnerScan Body
Composition Monitors measure body
weight and impedance and estimate
percentage of body fat and body water,
visceral fat rating, bone mass, muscle
mass, physique rating, daily caloric intake
(DCI) and metabolic age using BIA. They
are intended for use by healthy children 7-
17 years old and healthy adults with active,
moderately active, to inactive lifestyles for
body composition assessment in the home
environment. |
| Device
description | Body composition analyzer/scale that
utilizes a 'foot-to-foot' bioelectrical
impedance (BIA) technology to determine
internal body composition. | Body composition analyzer/scale that
utilizes a 'foot-to-foot' bioelectrical
impedance (BIA) technology to determine
internal body composition. |
| Analysis
Method | BIA | BIA |
| Operating
Parameters | 20 KHz (Models 8923, 8929)
54 KHz (Models 8919, 8921, 8925, 8931,
8935, 9576, 9580, 9583, 9588) | 54 KHz |
| Power source | Replaceable 9V or 3V batteries,
depending on the model. | AA batteries |
| Operating keys | Range of 2 to 5, depending on the model. | 13 |
| Number of
electrodes | 4 (except for Model 8929 = 2) | 4 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 @ 2006
Patsy J. Trisler, J.D., R.A.C. Regulatory Consultant - Medical Devices Beaverite International Ltd. 5600 Wisconsin Avenue., Suite 509 CHEVY CHASE MD 20815
Re: K060538
Trade/Device Name: Beaverite Body Fat Scales; Models 8919, 8921, 8923, 8925, 8929, 8931, 8935, 9576, 9580, 9583 and 9588 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 25, 2006 Received: September 25, 2006
Dear Ms. Trisler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, there is some text that reads "noting Public Health". The text is written in a decorative font. The image appears to be a scan of a document.
3
Page 2 -
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060538
Device Name: __ Beaverite Body Fat Scales
Indications for Use:
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Eva
Rata Rall,
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060538
(Posted November 13, 2003)
Section 4.0, 09/25/06