(272 days)
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 calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). 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.
The TANITA InnerScan Body Composition Monitor is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, body water percent, muscle mass, bone mass, visceral fat rating, metabolic age, physique rating and daily calorie intake.
The provided text is a 510(k) summary for the TANITA InnerScan Body Composition Monitor. It establishes substantial equivalence by comparing it to predicate devices. However, it does not include detailed information about specific acceptance criteria for performance metrics, nor does it describe a study specifically designed to prove the device meets those criteria with statistical rigor.
Instead, the submission relies on the established "Foot-to-Foot" BIA methodology, which was used in the predicate devices, and states that the InnerScan monitor "performs as well as the predicate devices and therefore have proven its safety and efficacy." This is a common approach in 510(k) submissions, where substantial equivalence often hinges on similar technology and intended use, rather than presenting new, detailed performance studies with explicit acceptance criteria.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a breakdown of what can be inferred or stated as missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary asserts that the device "performs as well as the predicate devices" based on the established BIA methodology, but it does not specify quantitative acceptance criteria (e.g., "accuracy of X% +/- Y kg") or report specific performance values for the InnerScan device against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "in-house BIA," "DEXA reference methods," "Deuterium Dilution and MRI reference methods" were used as analytical/measurement techniques, but it doesn't describe specific test sets, their sizes, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The 510(k) relies on reference methods like DEXA, Deuterium Dilution, and MRI, which are considered objective measurements for body composition. It does not mention human experts establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this device. The TANITA InnerScan Body Composition Monitor is a standalone device that provides direct measurements and estimations of body composition. It is not an AI-assisted diagnostic tool that aids human readers (e.g., radiologists interpreting images).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm (BIA methodology) that provides body composition measurements. The submission focuses on the performance of this system without human intervention in the measurement process, but it doesn't detail a specific "standalone performance study" in the modern sense of algorithm evaluation against a ground truth dataset with reported metrics. Its performance is implicitly compared to predicate devices using the same fundamental methodology.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions several reference methods that serve as a form of "ground truth" or highly accurate measurement techniques:
- DEXA (Dual-energy X-ray absorptiometry): A widely accepted clinical standard for body composition.
- Deuterium Dilution: A method for measuring total body water, which can be used to estimate body composition.
- MRI (Magnetic Resonance Imaging): Can be used to assess body fat distribution and muscle mass.
These are considered objective, quantitative body composition assessment methods.
8. The sample size for the training set
This information is not provided in the document. The BIA methodology is described as "patented in-house BIA," implying it's based on internal development, but details about training data are absent.
9. How the ground truth for the training set was established
This information is not provided in the document. While reference methods like DEXA, Deuterium Dilution, and MRI are mentioned, the document does not elaborate on how these were used to establish ground truth for any training data that might have been used to develop the "in-house BIA."
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2
TANITA InnerScan Body Composition Monitor 510(k) Submission
DEC 2 3 2004
510(k) SUMMARY
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
| Trade Name: | TANITA InnerScan Body Composition MonitorModels BC-533, BC-534 and BC-550 |
|---|---|
| Common Name: | Body Composition Analyzer / Body Fat Analyzer / Body Fat Monitor |
| ClassificationName: | ANALYZER, BODY COMPOSITION21 CFR $ 870.2770 |
Description of Applicant Device:
The TANITA InnerScan Body Composition Monitor is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, body water percent, muscle mass, bone mass, visceral fat rating, metabolic age, physique rating and daily calorie intake.
| Model Number | |||
|---|---|---|---|
| Body Composition Capabilities | BC-533 | BC-534 | BC-550 |
| Total Body Water % (TBW %) | ✓ | ✓ | ✓ |
| Visceral Fat Rating | ✓ | ✓ | ✓ |
| Bone Mass | ✓ | ✓ | ✓ |
| Muscle Mass / Physique Rating | ✓ | ✓ | |
| Daily Calorie Intake (DCI) / Metabolic Age | ✓ | ✓ | |
| Daily Calorie Intake (DCI) | ✓ |
Intended Uses of Applicant Device:
Intended to be used as a body fat analyzer that determines body weight and estimates body fat with the use of BIA (bioelectrical impedance analysis). Other outputs include total body water, DCI (daily calorie intake), bone mass, visceral fat rating, metabolic age, physique rating and muscle mass.
Predicate Devices:
TANITA Body Fat Analyzer Professional and Consumer Models K014009
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510(k) SUMMARY, continued
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Scientific Concepts and Significant Performance Characteristics:
| Tanita Body CompositionAnalyzerProfessional ModelsK014009 | Tanita Body CompositionAnalyzerConsumer ModelsK014009 | Tanita InnerScan BodyComposition MonitorModels BC-533, BC-534 &BC-550 | |
|---|---|---|---|
| INTENDED USE: | A combination non-invasivedevice, which determinesweight and estimates bodyfat andtotal body water using BIA(bioelectrical impedanceanalysis). | A combination non-invasive device, whichdetermines weight andestimates body fat usingBIA (bioelectricalimpedance analysis). | A combination non-invasive device, whichdetermines weight andestimates total body fat,visceral fat rating, bonemass, total body water,muscle mass, metabolicage, physique rating anddaily calorie intake withthe use of BIA(bioelectrical impedanceanalysis). |
| PRODUCTDESCRIPTION: | Body compositionanalyzer/scale that utilizesa "foot-to-foot" BIA(bioelectrical impedance)technology to determineinternal body composition. | Body compositionanalyzer/scale that utilizesa "foot-to-foot" BIA(bioelectrical impedance)technology to determineinternal body composition. | Body compositionmonitor/scale that utilizesa "foot-to-foot" BIA(bioelectrical impedance)technology to determineinternal body composition. |
| ANALYTICALMETHOD/MEASUREMENT | - Foot-to-Foot BIA- In-house BIA and- DEXA referencemethods | - Foot-to-Foot BIA- In-house BIA and- DEXA referencemethods | - Foot-to-Foot BIA- In-house BIA, DEXA,- Deuterium Dilutionand MRI referencemethods |
Side by side comparison of the TANITA InnerScan Body Composition Monitor to the predicate devices clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices.
Based on the results of using the previously approved "Foot-to-Foot" BlA methodology with our patented inhouse BIA, it was concluded that the TANITA InnerScan Body Composition Monitor performs as well as the predicate devices and therefore have proven its safety and efficacy.
Rhoda Lynn Valera, RAC TANITA Corporation of America Regulatory Affairs Specialist
2625 S. Clearbrook Dr. Arlington Heights, IL 60005 Phone: (847) 434-3966 (847) 640-7978 Fax:
December 20, 2004
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, stacked vertically. The emblem is rendered in black, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Ms. Rhoda Lynn N. Valera Regulatory Affairs Specialist TANITA Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005
Re: K040778
Trade/Device Name: TANITA InnerScan Body Composition Monitor BC-533, BC-534 and BC-550 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 10, 2004 Received: November 12, 2004
Dear Ms. Valera:
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); 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.
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This letter will allow you to begin marketing your device as described in your Scetion 510(k) I ms letter will anow you to organism
premarket notification. The FDA finding of substantial equivalence of your device to a legally premaired predicated on: "The PDF maxing sification 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 11 you dosire specific act 100 of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot, production other general information on your responsibilities under the Act from the 601:27). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DIVISION of Unian Hallacturers address http://www.fda.gov/cdrh/dsma/dsmamain.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
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TANITA InnerScan Body Composition Monitor 510(k) Submission
INDICATIONS FOR USE
| 510(k) Number: | K040778 |
|---|---|
| Device Name: | TANITA InnerScan BC-533, BC-534 and BC-550 Body Composition Monitor |
| Indications for Use: | 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 calorie intake (DCI) and metabolic age using BIA (bioelectrical impedance analysis). 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. |
Model Number
| Body Composition Capabilities | BC-533 | BC-534 | BC-550 |
|---|---|---|---|
| Total Body Water % (TBW %) | ✓ | ✓ | ✓ |
| Visceral Fat Rating | ✓ | ✓ | ✓ |
| Bone Mass | ✓ | ✓ | ✓ |
| Muscle Mass / Physique Rating | ✓ | ||
| Daily Calorie Intake (DCI) / Metabolic Age | ✓ | ✓ | |
| Daily Calorie Intake (DCI) | ✓ |
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)
David h. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Page 1
§ 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.