(133 days)
No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) to calculate various body composition metrics. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The calculations appear to be based on established BIA formulas rather than learned algorithms.
No
The device is used for measurement and estimation of body composition parameters, not for treating or preventing disease.
No
Explanation: A diagnostic device is used to detect, diagnose, or monitor a disease or medical condition. This device measures various body composition parameters and estimates related metrics for healthy individuals, but it does not claim to diagnose any disease or condition.
No
The device description explicitly states it is a "composition analyzer that utilizes BIA (bioelectrical impedance analysis)," which is a hardware-based measurement technique. The device is described as a physical analyzer, not solely software.
Based on the provided information, the TANITA Body Composition Analyzer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The TANITA Body Composition Analyzer measures physical characteristics of the whole body (weight, impedance) and uses these to estimate body composition parameters. It does not analyze biological samples.
- The intended use and device description clearly state that it measures and estimates body composition using BIA on the whole body. This is a non-invasive method applied directly to the person, not to a specimen.
Therefore, the TANITA Body Composition Analyzer falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).
The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.
Product codes
MNW
Device Description
The TANTA Body Corposition Analyzer SC-331 is a composition analyzer that tillizes BA (biolectical inqedance analysis) to deternine body mass inter (BM), tata body tat percent, todal body water per cont and veine and smooth, plysique rating, bone mass, visceral lat rathy rang, boss) meabolic race (BMF), day caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.
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 5-17 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)
Suble by side compaison of the TANTA Body Compssition Analyzer SC-331 to the predical clements that the applicant trence are substantaly equivaler to those early marked devices.
eleased on the results of ission in the least of the II ANTA's whole body BA, the TANTA Body Composition Analyzer SC-331 performs equivaltity of the prelicate devicas and therefore is subtantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) SUMMARY
submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92
Trade Name Common Name: Classification Name:
JUL - 7 2009
Description of Applicant Device:
The TANTA Body Corposition Analyzer SC-331 is a composition analyzer that tillizes BA (biolectical inqedance analysis) to deternine body mass inter (BM), tata body tat percent, todal body water per cont and veine and smooth, plysique rating, bone mass, visceral lat rathy rang, boss) meabolic race (BMF), day caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.
Indications For Use:
The TANTA Body Composition is indicated tor use in the measure, and the estmain of tody mass index (BM), total boty valent, todal body vater percent and weight, must (skeletal and smooth), the mass, visceral lat raing with healty rare (BMP), daily cale (BMP), daire intake (DC), metablic intake (CC), metablic age, and target body fat percent with predicted weight and fat mass, using BlA (Binelectrical Impedance Analysis).
The device is indicated for use for healthy children 5-17 years old and healthy active, moderately active, to inaclive lifestyles.
Predicate Devices:
BMI - Indicator
TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778.
TANITA Bady Composition Analyzer: Model SC-331
ANALYZER, BODY COMPOSITION 21 CFR $807.92
Body Composition Analyzer
Scientific Concepts and Significant Performance Characteristics:
| *Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix) | ||||||
|---|---|---|---|---|---|---|
| Body Composition Analyzer | ||||||
| SC-331 Specification | Body Composition Analyzer | Body Composition Monitor | ||||
| TBF-215/300/310/410, BF-35D | BC-53X | |||||
| 510(k) number | New | |||||
| K014009 | K040778 | |||||
| Product Description | Body composition analyzer that utilizes a BIA | |||||
| technology to determine internal body | ||||||
| composition. | Body composition analyzer that utilizes a BIA | |||||
| technology to determine internal body | ||||||
| composition. | Body composition analyzer that utilizes a BIA | |||||
| technology to determine internal body | ||||||
| composition. | ||||||
| Analytical Method / Measurement | Patented "Foot-to-Foot" BIA, In house BIA and | |||||
| DEXA reference | Patented "Foot-to-Foot" BIA, In house BIA and | |||||
| DEXA reference | Patented "Foot-to-Foot" BIA, In house BIA and | |||||
| DEXA reference | ||||||
| Measurement Frequency | 50kHz | 50kHz | 50kHz | |||
| Number of Electrodes | 4 | 4 | 4 | |||
| Specifications | ||||||
| Weight Capacity | 600 lb / 270 kg or 450 kg / 1,000 lb | 270 kg / 600 lb | 150 kg / 330 lb | |||
| Weight Increments | 0.2 lb / 100 g or 0.1 lb / 50 g | 100 g / 0.2 lb | 100 g / 0.2 lb | |||
| Body Fat % Increments | 0.1% | 0.1% | 0.1% | |||
| User Memory | 4 | 4 | 4 | |||
| Input Age | 5 - 99 | |||||
| 5-17: Child | ||||||
| 18-99: Adult | 7 - 99 | |||||
| 7-17: Child | ||||||
| 18-99: Adult | 7 - 99 | |||||
| 7-17: Child | ||||||
| 18-99: Adult | ||||||
| Input Height | 3' - 7' 11.5" / 90 - 249.9cm | 3' - 7' 11.5" / 90 - 249.9cm | 3' 4.0" - 7' 3.0" / 100-220cm | |||
| Input Activity Level | 1 - 3 | |||||
| Input Body Type | Standard / Athlete | Standard / Athlete | Standard / Athlete | |||
| Recall Function | ✓ | |||||
| Power Supply | AC Adapter / DC7V | AC Adapter / DC5V | AA Batteries | |||
| Printer Function | ✓ | ✓ | ||||
| Computer Interface | RS-232C & USB | RS-232C | ||||
| Indicate for Use | ||||||
| Print-Out | Display | Print-Out | Display | Print-Out | Display | |
| Actual: | ||||||
| Weight | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Impedance | ✓ | - | ✓ | - | - | - |
| Estimated: | ||||||
| FAT % | ✓ | ✓ | ✓ | ✓ | - | ✓ |
| FAT Mass | ✓ | - | ✓ | - | - | - |
| FAT % - Indicator | ✓ | - | In the manual | - | - | - |
| Predicated Fat Mass | ✓ | - | ✓ | - | - | - |
| Predicated Weight | ✓ | - | ✓ | - | - | - |
| FFM | ✓ | - | ✓ | - | - | ✓ |
| Muscle Mass | ✓ | - | ✓ | - | - | ✓ |
| Muscle Mass - Indicator | ✓ | - | ✓ | - | - | In the manual |
| Physique Rating | ✓ | - | ✓ | - | - | ✓ |
| Total Body Water | ✓ | - | ✓ | - | - | ✓ |
| Total Body Water % | ✓ | - | ✓ | - | - | ✓ |
| BMR / DCI | ✓ | - | ✓ | - | - | ✓ |
| BMR - Indicator | ✓ | - | - | - | - | In the manual |
| Metabolic Age | ✓ | - | ✓ | - | - | ✓ |
| Visceral Fat Rating | ✓ | - | ✓ | - | - | ✓ |
| Visceral Fat Level - Indicator | ✓ | - | - | - | - | ✓ |
| Bone Mass | ✓ | - | ✓ | - | - | ✓ |
| BMI | ✓ | - | ✓ | - | - | - |
in the manual
1
K090479
PAGE 2 OF 2
510(k) SUMMARY
submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92
Suble by side compaison of the TANTA Body Compssition Analyzer SC-331 to the predical clements that the applicant trence are substantaly equivaler to those early marked devices.
eleased on the results of ission in the least of the II ANTA's whole body BA, the TANTA Body Composition Analyzer SC-331 performs equivaltity of the prelicate devicas and therefore is subtantially equivalent.
Toshihiko Ishikawa
TANITA Corporation of America Product Manager
Tel: (847) 640-9241 Fax (847) 640-9261
Սսո 30th, 2009
্
. * .
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines representing the department's commitment to health, services, and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 7 2009
Mr. Toshihiko Ishikawa Product Manager Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005
Re: K090479
Trade/Device Name: TANITA Body Composition Analyzer Model SC-331 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Codes: MNW Dated: June 30, 2009 Received: July 1, 2009
Dear Mr. Ishikawa:
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 (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 of medical
3
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting 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): K 090479
Device Name:
TANITA Body Composition Analyzer Model SC-331
Indications For Use:
The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).
The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.
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)
(vers 6/25/05)
Hebert Lerner
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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