(112 days)
Not Found
No
The description focuses on Bioelectrical Impedance Analysis (BIA) and calculations based on measured values, with no mention of AI or ML.
No.
The device is used for body composition assessment, which involves measuring and estimating various body metrics, but it is not intended for diagnosis, treatment, or prevention of any disease or condition.
No
The device is intended for body composition assessment in generally healthy individuals and does not mention diagnosing any medical conditions or diseases. It measures and estimates various body composition parameters, which are indicators but not clinical diagnoses.
No
The device description explicitly states it is a "computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis)". BIA requires hardware components (electrodes, circuitry) to measure impedance, which is then used for calculations. This is not a software-only device.
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 TANITA Ironman Innerscan Body Composition Monitor measures physical characteristics (weight and impedance) and calculates body composition metrics based on these measurements. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is for body composition assessment in the home environment for generally healthy individuals. This is a wellness/fitness application, not a diagnostic one in the traditional IVD sense.
While the device provides information about the body, it does so through physical measurements and calculations, not through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
Product codes
MNW
Device Description
The TANITA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.
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
generally healthy children 7-17 years old and generally healthy adults
Intended User / Care Setting
Home environment
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the results of using the previously approved BIA methodobogy with our whole body BIA, it was concluded that the TANITA ironman Innerstan Body Composition Moritor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
SUMMARY
This summary of 510(k) safety and effectiveness information is accordance with the requirements of SMDA 1990 and 21 CFR 8807.92
Trade Name: Common Name:
TANITA Ironman Innerscan Body Composition Monitor: Model BC-558 Segmental Body Composition Monitor Classification Name: ANALYZER, BODY COMPOSITION 21 CFR §807.92
DEC 2 8 2006
Description of Applicant Device:
The TANTA Ironman Innerscan Body Composition Monitor BC-558 are a computer-operated body composition analyzer that utilizes BlA (bigledrical impedance analysis) to determine body fat percent, muscle mass, bone weight, visceral fat rating, Basal Metabolic Rate (BMR), metabolism age, physique rating, daily calorie intake (DCI), body water percent and segmental fat percent.
Intended Uses of Applicant Device:
The TANTA Ironnan Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental music news , bone mass, viseral fat bailed on bothere on bother on be becember and intake(OC) and metabolic age using Black on a natists). The device is ntended to be used by generally helthy hillfer ?-17 year old and generally healthy adults with active, to inactive lifestyles for body composition assessment in the home environment
Aculal measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, visce ratios be valoc baceratif frating with healthy rang, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
Predicate Devices
TANITA Body Fat Analyzer Professional and Consumer Models K040778 and K033157
Scientific Concepts and Significant Performance Characteristics: wn in SECTION 9 and APPENDIX 1 1St പ്പി
| *Same as shown in SECTION 9. and APPENDIX 1. (Substantial Equivalence Matrix) | ||||
|---|---|---|---|---|
| New | Predicate Device#: K040778 | Predicate Device#: K033157 | ||
| BC-558 Specification | BC-53X Specification | BC-418 Specification | ||
| Product Description | Body composition monitor/scale that | |||
| utilizes a segmental BIA technology to | ||||
| determine internal body composition. | Body composition monitor/scale that | |||
| utilizes a "foot-to-foot" BIA technology | ||||
| to determine internal body composition. | Body composition monitor/scale that | |||
| utilizes a segmental BIA technology to | ||||
| determine internal body composition | ||||
| Analytical Method / | ||||
| Measurement | Segmental BIA In house BIA and | |||
| DXEA reference | Foot-to Foot BIA In house BIA and | |||
| DXEA/Deuterium Dilution reference | Segmental BIA In house BIA and | |||
| DXEA reference | ||||
| Measurement Frequency | 50kHz | 50kHz | 50kHz | |
| Measurement Current | Max. 500μA | Max. 500μA | Max. 90 μ A | |
| Number of Electrodes | 8 | 4 | 8 | |
| Specifications | ||||
| Capacity | 150 kg / 330 lb | 150 kg / 330 lb | 200 kg / 440 lb | |
| Increments | 100 g / 0.2 lb or 50 g / 0.1 lb | 100 g / 0.2 lb | 100 g / 0.2 lb | |
| Body Fat % | 0.1% | 0.1% | 0.1% | |
| User Memory | 4 | 4 | ||
| Input Age | 7-99 | |||
| 7-17: Child | ||||
| 18-99: Adult | 7-99 | |||
| 7-17: Child | ||||
| 18-99: Adult | 7-99 | |||
| 7-17: Child | ||||
| 18-99: Adult | ||||
| Input Height | 90cm~220cm | 100 cm - 220 cm | 90 cm - 249 cm | |
| Input Activity Level | 1 - 3 | 1 - 3 | ||
| Input Body Type | Standard / Athlete | Standard / Athlete | Standard / Athlete | |
| Data Memory | 31days / 1day average | |||
| 52weeks / 1week average | ||||
| 36months / 1month average | 4weeks / 1week average | |||
| 2months / 1month average | ||||
| Power Supply | AA Batteries | AA Batteries | AC Adapter / DC5V 3.5A | |
| Printer Function | ✓ | |||
| Computer Interface | - | RS-232 | ||
| Functions | ||||
| Weight | ✓ | ✓ | ✓ | |
| Full body | ✓ | ✓ | ✓ | |
| Right arm | ✓ | - | ✓ | |
| Body Fat % | Left arm | ✓ | - | ✓ |
| Right feet | ✓ | - | ✓ | |
| Left feet | ✓ | - | ✓ | |
| Trunk | ✓ | ✓ | ||
| % Fat Judge | ||||
| Body Water% | ✓ | ✓ | ✓ | |
| Full body | ✓ | ✓ | ✓ | |
| Right arm | ✓ | ✓ | ||
| Muscle Mass | Left arm | ✓ | ✓ | |
| Right feet | ✓ | ✓ | ||
| Left feet | ✓ | - | ✓ | |
| Trunk | ✓ | - | ✓ | |
| Physique Rating | ✓ | ✓ | - | |
| Bone mass | ✓ | ✓ | - | |
| Visceral Fat | ✓ | ✓ | ✓ | |
| Visceral Fat Judge | ✓ | ✓ | - | |
| BMR | ✓ | ✓ | ✓ | |
| DCI | ✓ | ✓ | ✓ | |
| Metabolic Age | ✓ | ✓ | - |
1
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92
Side by side comparison of the TANITA Ironman Innerscan Body Composition Monitor BC-558 to the predicate that the applicant devices are substantially equivalent to those legally marketed devices.
Based on the results of using the previously approved BlA methodobogy with our whole body BlA, it was concluded that the TANITA i ronman Innerstan Body Composition Moritor BC-558 performs as well as the predicate devices and therefore have proven its safety and efficacy.
Beth Mackey
TANITA Corporation of America Marketing Director
Tel: (847)434-3981
Fax: (847)640-7978
July 7, 2006 Revised in red. December 14. 2006
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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 stylized depiction of a human figure embracing a globe, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
DEC 2 8 2006
Ms. Beth Mackey Marketing Director TANITA Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005
Re: K062652
Trade/Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 14, 2006 Received: December 15, 2006
Dear Ms. Mackey:
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 is a circular logo or emblem. The central element is the letters "FDA" in a stylized font, with the word "Centennial" written below it in a cursive font. Above the letters "FDA" are the numbers "1906 - 2006". The entire design is surrounded by a circular border with text, and there are three stars below the word "Centennial".
ing and Promoting Public
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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 Cbrogdon
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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Indications for Use
510(k) Number (if known): K 062652
Device Name: TANITA Ironman Innerscan Body Composition Monitor Model BC-558 Indications For Use: The TANITA Ironman Innerscan Body Composition Monitor measures body weight, impedance and estimates total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate(BMR), daily caloric intake(DCI) and metabolic age using BIA (Bioelectrical Impedance Analysis). The device is intended to be used by generally healthy children 7-17 years old and generally healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. Actual measurements made by the BC-558 include weight and impedance. Based upon these measured values, values are calculated for: total and segmental body fat percentage, body water, total and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI) and metabolic age.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(vers 6/25/05)(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062652
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