(449 days)
Not Found
No
The document describes a device that uses Bioelectrical Impedance Analysis (BIA) and standard calculations to estimate body composition. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used to measure and estimate various body composition metrics but does not provide any therapeutic intervention or treatment.
No
The device measures body composition parameters like weight, impedance, fat percentage, muscle mass, etc., and estimates BMI and BMR using Bioelectrical Impedance Analysis (BIA). While these measurements can be used by healthcare professionals as part of screening or assessment, the device itself is not described as diagnosing a disease, condition, or anomaly. Its indication is for "measurement" and "estimation" of body composition parameters, not diagnosis.
No
The device description explicitly states it is a "computer-operated body composition analyzer" that makes "actual measurements" of "body weight and bioelectrical impedance," indicating it includes hardware components for measurement.
Based on the provided information, the Tanita Body Composition Analyzer 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.
- Tanita device function: The Tanita Body Composition Analyzer measures physical parameters like weight and bioelectrical impedance directly from the body. It then uses these measurements and algorithms to estimate body composition components. It does not analyze biological samples taken from the body.
Therefore, while it's a medical device used for health assessment, it falls outside the definition of an In Vitro Diagnostic.
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 and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), 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.
For subjects 17 years old and younger, only fat % is displayed.
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a computer-operated body composition analyzer that utilizes bioelectrical impedance analysis (BIA) to estimate body composition of fat, muscle and bone, water compartments, and basal metabolic rate (BMR).
Actual measurements made by the MC-180MA include body weight and bioelectrical impedance. BIA is used to make estimates based upon these measured values.
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)
Comparison of these intended-use and technological characteristics demonstrate that the Model MC-180MA is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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K100183 1 OF 2 PAGE
APR 1 5 2011
510(k) Summary
The following information is provided in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92
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- Submitter: Tanita Corporation 14-2, 1-Chome, Maeno-cho, Itabashi-ku Tokyo 174-8630 Japan Telephone: +81 3 3968 2118 Fax: +81 3 3968 1550 E-mail: takeuchi@tanita.co.jp Data of summary: April 13, 2011
| 2. Name of the Device: | MC-180MA Multi-frequency Body Composition Analyzer |
|---|---|
| Trade / Proprietary Name: | MC-180MA Multi-frequency Body Composition Analyzer |
| Common or Usual Name: | Body Composition Analyzer |
| Classification Name: | Analyzer, Body Composition |
| 21 CFR §870.2770 | |
| Class II | |
| Product Code: MNW |
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- Predicate devices to claim substantial equivalence:
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- Description of the Device:
The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a computer-operated body composition analyzer that utilizes bioelectrical impedance analysis (BIA) to estimate body composition of fat, muscle and bone, water compartments, and basal metabolic rate (BMR).
Actual measurements made by the MC-180MA include body weight and bioelectrical impedance. BIA is used to make estimates based upon these measured values.
-
- Intended Use Statement:
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 and
- Intended Use Statement:
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Image /page/1/Picture/0 description: The image shows the text "K100183 PAGE 2 OF 2". The text is written in a handwritten style. The text appears to be a page number or document identifier.
segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), 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.
For subjects 17 years old and younger, only fat % is displayed.
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- Summary of technological characteristics compared to predicate devices:
Both the Tanita Model MC-180MA and predicate devices (Item 3 above) are intended for use to measure weight and bioelectrical impedance, and estimate body composition (fat, muscle, bone and water) by BIA in healthy children and in healthy adults.
- Summary of technological characteristics compared to predicate devices:
The technology underlying BIA estimation for the Model MC-180MA and predicate devices is the same. Design considerations-computer-operation with visual-display user interface; use of multiple-regression algorithms to predict body composition based upon body weight and segmental bioelectrical impedance measurements-and energysource considerations-multipolar surface electrodes; alternating current in the 5- to 500-kilohertz range at levels of 90 microamperes (Tanita models) to 250 microamperes (Biospace model)-are the same. Multiple-frequency measurement of bioelectrical impedence values used in estimation of percent fat, fat-free mass, total body water and extracellular water was verified in clinical testing.
Comparison of these intended-use and technological characteristics demonstrate that the Model MC-180MA is substantially equivalent to predicate devices.
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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "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 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tanita Corporation c/o Mr. Toshihiko Ishikawa Product Manager Tanita Corporation of America, Inc. 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005
APR 1 5 2011
Re: K100183
Trade/Device Name: Tanita MC-180MA Multi-frequency Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: April 13, 2011 Received: April 14, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related
3
Page 2
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K100183
Device Name: Tanita MC-180MA Multi-frequency Body Composition Analyzer
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 and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), 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.
For subjects 17 years old and younger, only fat % is displayed.
(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 _____________________________________________________________________________________________________________________________________________________________ ×
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