(88 days)
The Healthometer Professional Body Fat Monitor and Scale is indicated to measure body weight and impedance and estimate body fat percent.
The Bonso BFM is a portable device for measuring the percentage of body fat in human subjects. The device includes a platform-type weighing scale that utilizes internal strain gauges to electronically measure the weight of a subject standing on the scale platform.
The Bonso Electronics International Inc. Healthometer Professional Body Fat Monitor and Scale (Models BFM940, BFM945, and BFM960) measures body weight and impedance, and estimates body fat percentage. The device's substantial equivalence was established by comparing it to the Tanita BF-625/BF-626.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than defining specific performance acceptance criteria for the new device and then demonstrating performance against those. The basis for substantial equivalence is that the Bonso device "performs as labeled" and that testing directly comparing the Bonso and the predicate device showed substantial equivalence.
Acceptance Criteria (Implicit from Substantial Equivalence):
- Performance as Labeled: The device must accurately perform its stated functions: measure body weight, impedance, and estimate body fat percent.
- Comparable to Predicate Device: The device's measurements and estimations of body weight, impedance, and body fat percent should be substantially similar to those obtained from the Tanita BF-625/BF-626.
Reported Device Performance:
- "The 510(k) contains extensive bench data demonstrating that the Bonso device performs as labeled."
- "Additionally, testing directly comparing the Bonso and the predicate device was provided. This testing showed that the Healthometer Professional Body Fat Monitor and Scale is substantially equivalent to the Tanita BF-625/BF-626 that is also indicated for use to measure body weight and impedance and estimate body fat percent using the BIA method."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the comparative testing between the Bonso device and the Tanita predicate device. It only mentions "testing directly comparing the Bonso and the predicate device."
- Data Provenance: The data provenance is not specified. It is likely prospective as it involves "testing directly comparing" the devices, implying a new study was conducted. There is no information regarding the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment relies on the comparative performance against a predicate device, which itself is an established medical device. There's no indication that an independent panel of experts was used to establish ground truth for the test set.
4. Adjudication method for the test set:
- An adjudication method is not specified. Given that the study involves direct comparison of device measurements, it's unlikely a human-based adjudication method (like 2+1, 3+1) would be primarily used. The comparison would likely be statistical or direct measurement comparison.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. The Healthometer device is a direct measurement device (body fat monitor and scale), not an AI-assisted diagnostic imaging or interpretation system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance assessment was conducted (implicitly). The "extensive bench data demonstrating that the Bonso device performs as labeled" implies testing of the device's inherent measurement capabilities. The comparison to the predicate device also establishes its standalone performance relative to an existing device. The device itself (a body fat monitor and scale) operates in a standalone manner to provide measurements.
7. The type of ground truth used:
- The ground truth for the performance assessment is the measurements obtained from the predicate device, Tanita BF-625/BF-626, which is "also indicated for use to measure body weight and impedance and estimate body fat percent." It also implicitly relies on the device accurately performing its labeled functions, which assumes the internal strain gauges and BIA methods used are calibrated and accurate. In essence, the "ground truth" for the new device's performance is the performance of the legally marketed predicate device.
8. The sample size for the training set:
- This information is not applicable/not provided. The Healthometer Professional Body Fat Monitor and Scale is a measurement device that uses bioelectrical impedance analysis (BIA) and strain gauges. It is not an AI-driven image analysis or diagnostic system that requires a "training set" in the conventional machine learning sense. Its internal algorithms for converting impedance/weight to body fat percentage would have been developed and validated, but the term "training set" is not relevant here in the context of typical AI/ML studies.
9. How the ground truth for the training set was established:
- This information is not applicable/not provided for the reasons stated in point 8.
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MAY - 2 2003
PREMARKET NOTIFICATION 510(K) SUMMARY 8.0
| Sponsor | Bonso Electronics International Inc. |
|---|---|
| 1919 Yacht Colnia | |
| Newport Beach CA 92660 | |
| Contact Person | Mr. George O'Leary, Director |
| Phone | 949-760-7611 |
| Fax | 949-760-7607 |
| goleary@worldnet.att.net |
Device Name
| Trade Name of Device | Healthometer Professional Body Fat Monitor and Scale |
|---|---|
| (Models BFM940, BFM945, and BFM960) | |
| Common Name | Body Fat Analyzer |
| Classification name | Analyzer, Body Composition |
| Product Code | MNW |
| Regulation Class | Class II |
| Regulation Number | §870.2770 |
Indications for Use
The Healthometer Professional Body Fat Monitor and Scale is indicated to measure body weight and impedance and estimate body fat percent.
Device Description
--
The Bonso BFM is a portable device for measuring the percentage of body fat in human subjects. The device includes a platform-type weighing scale that utilizes internal strain gauges to electronically measure the weight of a subject standing on the scale platform.
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Image /page/1/Picture/1 description: The image shows the text "K030349 PAGE 2 OF 2 Bonso Electronics". The text appears to be handwritten or in a font that mimics handwriting. The phrase "PAGE 2 OF 2" indicates that this is the second page of a two-page document. The text "Bonso Electronics" is likely the name of a company or organization.
Basis for Substantial Equivalence
| Predicate Device | Tanita BF-625/BF-626 |
|---|---|
| 510(k) # | K014009 |
| Sponsor | Tanita Corp. of America2625 South Clearbrook DriveArlington Heights, IL 60005 |
The 510(k) contains extensive bench data demonstrating that the Bonso device performs as labeled. Additionally, testing directly comparing the Bonso and the predicate device was provided. This testing showed that the Healthometer Professional Body Fat Monitor and Scale is substantially equivalent to the Tanita BF-625/BF-626 that is also indicated for use to measure body weight and impedance and estimate body fat percent using the BIA method.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2003
Bonso Electronics Int'l., Inc. c/o Russell P. Pagano, Ph.D. Vice President M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002
Re: K030349
Trade/Device Name: Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 31, 2003 Received: February 3, 2003
Dear Dr. Pagano:
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 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_ K030349
Device Name: The Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960
Indications For Use: The Bonso Electronics Int'l., Inc., Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 are indicated to measure body weight and impedance and estimate body fat percent.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Samuel Mhando Sda NB
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
(Optional Format 3-10-98)
Over-the-Counter Use.
§ 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.