(191 days)
No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) and does not mention AI or ML in the intended use, device description, or performance studies. The calculations are based on established BIA methodology.
No
The device is a body composition analyzer used for measurement and estimation of body metrics, not for treating or preventing diseases or conditions.
No
The device measures body composition parameters but does not diagnose any disease or condition. Its purpose is to quantify body components, not to identify medical issues.
No
The device description explicitly states it is a "computer-operated body composition analyzer" that "utilizes BIA (bioelectrical impedance analysis)". This indicates the device includes hardware components (the analyzer itself and the BIA technology) in addition to any software that processes the data.
Based on the provided information, this device 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.
- Device Function: The device described measures body composition (weight, impedance, fat percentage, muscle mass, etc.) 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 to analyze body composition in healthy individuals, not to diagnose diseases or conditions based on analysis of bodily samples.
Therefore, the TANITA BC-418, Segmental Body Composition Analyzer falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended to be used as a body fat analyzer that determines body weight and estimates body fat and skeletal muscle mass with the use of BIA (bioelectrical impedance analysis). Other outputs include BMR (basal metabolic rate), TBW (total body water), and BMI (body mass index).
A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.
Product codes
74 MNW
Device Description
The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.
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
healthy children (7-17 years old) and healthy 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 Body Fat Analyzer Professional Model TBF-410 K014009
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR = 8 2004
SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
| Trade Name: | TANITA BC-418, Segmental Body Composition Analyzer |
|---|---|
| Common Name: | Body Composition Analyzer / Body Fat Analyzer |
| Classification Name: | ANALYZER, BODY COMPOSITION |
| 21 CFR § 870.2770 |
Description of Applicant Device:
The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.
Intended Uses of Applicant Device:
Intended to be used as a body fat analyzer that determines body weight and estimates body fat and skeletal muscle mass with the use of BIA (bioelectrical impedance analysis). Other outputs include BMR (basal metabolic rate), TBW (total body water), and BMI (body mass index).
Predicate Device:
TANITA Body Fat Analyzer Professional Model TBF-410 K014009
Scientific Concepts and Significant Performance Characteristics:
| | Body Fat Analyzer
Model TBF-410
K014009 | Segmental Body Composition
Analyzer
Model BC-418 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | A combination non-invasive
device, which determines weight
and estimates body fat
composition using BIA
(bioelectrical impedance
analysis). | A combination non-invasive
device, which determines weight
and estimates body fat
composition and muscle mass
using BIA (bioelectrical
impedance analysis). |
| PRODUCT DESCRIPTION: | Body composition analyzer/scale
that utilizes a "foot-to-foot" BIA
(bio- electrical impedance)
technology to determine internal
body composition. | Body composition analyzer/scale
that utilizes segmental BIA (bio-
electrical impedance) technology
to determine internal body
composition. |
| ANALYTICAL
METHOD/MEASUREMENT | • Foot-to-Foot BIA
• In-house BIA and DEXA
reference methods | • Segmental BIA
• In-house BIA and DEXA
reference methods |
1
510(k) SUMMARY, continued
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Side by side comparisons of the TANITA BC-418, Segmental Body Composition Analyzer to the predicate device Body Fat Analyzer Professional Model TBF-410 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.
Based on the results of using the previously approved BIA methodology with our whole body BIA, it was concluded that the TANITA BC-418, Segmental Body Composition Analyzer performs as well as the predicate device and therefore have proven its safety and efficacy.
Rhoda Lynn Valera TANITA Corporation of America Requlatory Affairs Specialist
Phone: (847) 434-3966 (847) 640-7978 Fax:
September 26, 2003
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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Ms. Rhoda Lynn N. Valera Regulatory Affairs Specialist Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005
Re: K033157
Trade/Device Name: Tanita Segmental Body Composition Analyzer BC-418 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 9, 2004 Received: January 12, 2004
Dear Ms. Valera:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatived of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1978, are cance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allo Cosmette Her (110) that to novice, subject to the general controls provisions of the Act. The r ou may, dicrolore, mains of the Act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 and 10) . 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 i that FDA has made a determination that your device complies with other requirements of the Act that I D.A has made a actuations administered by other Federal agencies. You must or any I ederal statutes and registements, including, but not limited to: registration and listing comply with and rice broquent (FR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), assemis (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quant) 05 sections (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin markering of substantial equivalence of your device to a legally prematication. The PDF maily to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desite specific advice for your control to the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Augulany, for questions on the personal prosse note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releasence to premarked notification (er the Act may be obtained from the Division of Small Information on your responsionaliss and Consumer Assistance at its toll-five number (800) 638-2041 or Mandiacturers, Theemadonal ans Colless http://www.fda.gov/cdrl/dsmaldsmamain.html.
Sincercly yours,
Nancy C. Brogdon
Srogdon Nancy C. F Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number: | K033157 |
|---|---|
| Device Name: | TANITA BC-418, Segmental Body Composition Analyzer |
| Indications for Use: | A body composition analyzer that measures body weight and |
| impedance and estimates total and segmental body fat | |
| percent, body mass index (BMI), fat mass, fat-free mass, | |
| regional muscle mass, basal metabolic rate, and total body | |
| water using BIA (bioelectrical impedance analysis) in healthy | |
| children (7-17 years old) and healthy adults. |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)
Nancy Hodgson
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number