(89 days)
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No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) to estimate body composition. There is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The estimation is based on the BIA method, which is a standard, non-AI technique.
No
The device is described as a body composition analyzer for assessment of body fat, water, and muscle mass in healthy individuals in a home environment, not for treating or rehabilitating any medical condition.
No
The device is described as an analyzer for body composition (body fat, body water, skeletal muscle mass) intended for healthy people for body composition assessment in a home environment. It measures body weight and impedance. There is no indication that it is used for diagnosing diseases or conditions.
No
The device description explicitly states it is a "stand-on, non-invasive, reusable analyzer" that measures body weight and impedance, indicating it is a physical hardware device, not software only.
Based on the provided information, the DUTECK (MicHealth) Body Composition Analyzer, BSA series 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 description clearly states that this device is a "stand-on, non-invasive, reusable analyzer" that measures body weight and impedance to estimate body composition. It does not involve taking any samples from the body.
- Intended Use: The intended use is for "body composition assessment in the home environment" for healthy people. This is a general wellness or fitness application, not a diagnostic test for disease.
Therefore, the DUTECK (MicHealth) Body Composition Analyzer, BSA series falls under the category of a general wellness device or a body composition analyzer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
Product codes
MNW
Device Description
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
10 to 80
Intended User / Care Setting
healthy people / home environment
Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 7 2006
Mr. Joseph Chen President Duteck Industrial Co., Ltd. 3F-2, No. 26, Lane 513 Jui-Kuang Road Taipei, Taiwan 114 R.O.C.
Re: K060642
Trade/Device Name: DUTECK (MicHealth) Body Composition Analyzer, Model BSA Series (BSA-1505, -1506, -1508, -1605, -1606, -1608, -1705, -1706, -1708) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: February 24, 2006 Received: March 10, 2006
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottoned your Docurer of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suned in the enactment date of the Medical Device Amendments, or to devices that provision 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 therefore, mainter and 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 Apploval), It they of be baciFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text emphasizes the organization's mission to safeguard and improve the well-being of the 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Duteck Body Composition Analyzer 510(k) submission
000642 Page _ 1_of 510(k) Number: DUTECK (MicHealth) Body Composition Analyzer, Model BSA series Device Name: ( BSA-1505, BSA-1506, BSA-1508, BSA-1605, BSA-1606, BSA-1608, BSA-1705, BSA-1706, BSA-1708. )
Indications For Use:
DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use_X (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4-1
Nancy C. Brogdon
Renroductive. Abdomi and Radiological 510(k) Number