(162 days)
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No
The summary does not mention AI, ML, deep learning, or any related concepts, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a bioimpedance analyzer that estimates body fat counts and percentage. Its intended use is to provide information about body composition, not to treat or alleviate a disease or condition.
No
Explanation: The device is described as a noninvasive bioimpedance analyzer for estimating body fat percentage and counts, which is a measurement or assessment, not a diagnostic determination of a disease or condition.
No
The device is described as a "noninvasive bioimpedance analyzer," which typically involves hardware components to measure electrical impedance. The summary does not explicitly state it is software-only.
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 Description: The description states the device is a "noninvasive bioimpedance analyzer for use in providing the human's body fat counts (index) and percentage by estimating body fat in athletic subjects."
- Method of Operation: Bioimpedance analysis is a non-invasive method that measures the body's resistance to a small electrical current to estimate body composition. This does not involve analyzing samples taken from the body.
Therefore, since the device operates non-invasively and does not analyze samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is noninvasive bioimpedance analyzer for use in Indications for Use : The device is nonlineasive blommpoumes and percentage by estimating numan's bouy far vounts (indes) and proving the proving weight. The applicable ago frange in athletic subjects.
Product codes
74 MNW
Device Description
Omron Body Fat Analyzer HBF-306
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
human's boy
Indicated Patient Age Range
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Intended User / Care Setting
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2001 NOV
Mr. Iwao Kojima Director of Technology Omron Healthcare, Inc. 300 Lakeview Parkway VERNON HILLS, ILLINOIS 60061
Received: September 14, 2001
Re: K011652 Trade/Device Name: HBF 306 Body Fat Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: undated
Dear Mr. Kojima:
This letter corrects our substantially equivalent letter of November 7, 2001, regarding the HBF 306 Body Fat Analyzer, which listed the device model number incorrectly as the HBF 1000 Body Composition Analyzer.
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). 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.
1
Page 2 - Mr. Kojima
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 that I Dr lass intess and regulations administered by other Federal agencies. You must of any I oderal statures including, but not limited to: registration and listing comply with and Not Not (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), 1200mmg (25) regulation (21 CFR Part 820); and if applicable, the electronic fordination control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) This ictier wifi anow you to consideratial equivalence of your device of your device to a legally premarket notineation: "The 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet 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
2
KD11652
3. INDICATION FOR USE
Omron Healthcare, Inc. Applicant's Name :
K011652 510(k) Number :
Omron Body Fat Analyzer HBF-306 Device Name :
The device is noninvasive bioimpedance analyzer for use in Indications for Use : The device is nonlineasive blommpoumes and percentage by estimating numan's bouy far vounts (indes) and proving the proving weight. The applicable ago frange in athletic subjects.
Nancy C brigdon
Division Sign. tive. Ahdo Division of Renro and Radiological Devices 510(k) Numb
Over-The-Counter Use