(224 days)
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
The 11 models of Beaverite body fat scales submitted in this 510(k) are plethysmograph body composition analyzers. The devices estimate percentages of body fat, body water and muscle mass (as noted in the Indications statement) based on bioelectrical impedance analysis (BIA).
Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition.
The submitted document is a 510(k) summary for the Beaverite Body Fat Scales, which is a traditional 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data for acceptance criteria. The document explicitly states that the "following table illustrates the substantial equivalence in technology and intended use to the predicate device."
Therefore, the document does not describe acceptance criteria in the typical sense of performance metrics with associated thresholds for a standalone device study, nor does it detail a study performed by Beaverite to prove the device meets such criteria. Instead, it presents a comparison to a predicate device to establish substantial equivalence.
However, based on the provided text, we can infer some information relevant to the original request by reinterpreting "acceptance criteria" as the features and performance characteristics that are deemed substantially equivalent to the predicate device, and "study" as the comparison made to the predicate.
Here's the information extracted and interpreted in the context of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
Since specific quantitative "acceptance criteria" and their corresponding "reported device performance" are not explicitly defined in terms of clinical study outcomes within this summary, the table below reflects the comparison points made to establish substantial equivalence with the predicate device. The "Acceptance Criteria" column refers to the characteristics of the predicate device that the Beaverite device aims to match or be substantially equivalent to, and "Reported Device Performance" refers to the characteristics of the Beaverite device as presented for comparison.
| Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (Beaverite Body Fat Scales Characteristics) |
|---|---|
| Classification #: 21 CFR 870.2770 | Classification #: 21 CFR 870.2770 |
| Product Code: MNW | Product Code: MNW |
| Indications for Use: Measures body weight and impedance, and estimates percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily caloric intake (DCI) and metabolic age using BIA. Intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. | Indications for Use: Models 8921, 8925, 8931, 8935 and 9576 measure body weight and impedance, and estimate percentages of body fat and total body water. Models 8919, 8923, 8929, 9580, 9583, and 9588 measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. All are intended for use by healthy adults. (Note: Beaverite's indications are slightly narrower, focusing on adults and fewer estimated parameters than the predicate, which can support substantial equivalence). |
| Device Description: Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition. | Device Description: Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition. |
| Analysis Method: BIA | Analysis Method: BIA |
| Operating Parameters: 54 KHz | Operating Parameters: 20 KHz (Models 8923, 8929); 54 KHz (Models 8919, 8921, 8925, 8931, 8935, 9576, 9580, 9583, 9588). (Note: Presence of 20 KHz models might require specific justification but falls within the general BIA technology). |
| Power source: AA batteries | Power source: Replaceable 9V or 3V batteries, depending on the model. |
| Operating keys: 13 | Operating keys: Range of 2 to 5, depending on the model. |
| Number of electrodes: 4 | Number of electrodes: 4 (except for Model 8929 = 2). (Note: The 2-electrode model might require specific justification for equivalence to a 4-electrode predicate, but is presented as equivalent). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided 510(k) summary does not contain information about a test set sample size, data provenance, or whether data was retrospective or prospective. This type of detail is typically associated with clinical studies for performance evaluation, which are not detailed in this particular summary for a traditional 510(k) based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Similar to point 2, the document does not provide any information regarding experts, ground truth establishment, or qualifications for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not provide any information regarding adjudication methods for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The device is a body fat scale using bioelectrical impedance analysis (BIA), not an imaging device that human readers would interpret. Therefore, an MRMC study is not applicable and no information regarding human reader improvement with or without AI assistance is present.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
The 510(k) summary does not describe a standalone performance study of the algorithm or device. The basis for clearance is substantial equivalence to a predicate, not independent performance validation in a clinical study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not describe the use of any specific "ground truth" in the context of a performance study for the Beaverite device. For BIA devices, ground truth for body composition is often established using methods like DEXA or hydrostatic weighing, but no such study is detailed here.
8. The sample size for the training set:
The document does not provide any information regarding a training set sample size. This is consistent with a traditional 510(k) based on substantial equivalence, which typically does not involve the development and training of new algorithms that require such data sets.
9. How the ground truth for the training set was established:
The document does not provide any information regarding the establishment of ground truth for a training set. As noted above, training sets are not typically part of a substantial equivalence claim for a device like this.
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Beaverite Body Fat Scales Traditional 510(k)
Section 5.0 510(k) Summary
Beaverite Body Fat Scales
| Submitter Name: | Beaverite International Ltd |
|---|---|
| Submitter Address: | West Wing, 8/FCNT Group Building822 Lai Chi Kok RoadCheung Sha Wan, Kowloon, Hong Kong |
| Contact Person: | Patsy J. Trisler, J.D., RACRegulatory Consultant - Medical Devices |
| Phone Number: | 301-652-5344 |
| Fax Number: | 301-654-6976 |
| Date: | September 25, 2006 |
| Device Trade Name: | Beaverite Body Fat Scales |
| Device Common Name: | Analyzer, Body Composition |
| Classification Name: | Impedance Plethysmograph |
| Classification Number: | 21 CFR 870.2770 |
| Product Code: | MNW |
| Predicate Device: | Tanita Innerscan Body Composition Monitor, K040778 |
| Statement ofIntended Use: | The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935and 9576 -- measure body weight and impedance, and estimatepercentages of body fat and total body water. They are intended foruse by healthy adults.The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580,9583, and 9588 -- measure body weight and impedance, andestimate percentages of body fat, total body water, and total musclemass. They are intended for use by healthy adults. |
| Device Description,Summary ofTechnologicalCharacteristics, andComparison to thePredicate Device | The 11 models of Beaverite body fat scales submitted in this 510(k)are plethysmograph body composition analyzers. The devicesestimate percentages of body fat, body water and muscle mass (asnoted in the Indications statement) based on bioelectrical impedanceanalysis (BIA). The following table illustrates the substantialequivalence in technology and intended use to the predicate device. |
OCT 1 0 2006
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| Feature | Proposed Device:Beaverite Body Fat Scales | Predicate Device:Tanita InnerScan Body CompositionMonitor (Model BC-533) |
|---|---|---|
| 510(k) Number | K040778 | |
| Manufacturer | Beaverite International Ltd | Tanita Corp of America |
| Classification #Product CodeIndications forUse | 21 CFR 870.2770MNWThe Beaverite Body Fat Scales -- Models8921, 8925, 8931, 8935 and 9576 --measure body weight and impedance,and estimate percentages of body fatand total body water. They are intendedfor use by healthy adults.The Beaverite Body Fat Scales -- Models8919, 8923, 8929, 9580, 9583, and 9588-- measure body weight and impedance,and estimate percentages of body fat,total body water, and total muscle mass.They are intended for use by healthy adults. | 21 CFR 870.2770MNWThe Tanita family of InnerScan BodyComposition Monitors measure bodyweight and impedance and estimatepercentage of body fat and body water,visceral fat rating, bone mass, musclemass, physique rating, daily caloric intake(DCI) and metabolic age using BIA. Theyare intended for use by healthy children 7-17 years old and healthy adults with active,moderately active, to inactive lifestyles forbody composition assessment in the homeenvironment. |
| Devicedescription | Body composition analyzer/scale thatutilizes a 'foot-to-foot' bioelectricalimpedance (BIA) technology to determineinternal body composition. | Body composition analyzer/scale thatutilizes a 'foot-to-foot' bioelectricalimpedance (BIA) technology to determineinternal body composition. |
| AnalysisMethod | BIA | BIA |
| OperatingParameters | 20 KHz (Models 8923, 8929)54 KHz (Models 8919, 8921, 8925, 8931,8935, 9576, 9580, 9583, 9588) | 54 KHz |
| Power source | Replaceable 9V or 3V batteries,depending on the model. | AA batteries |
| Operating keys | Range of 2 to 5, depending on the model. | 13 |
| Number ofelectrodes | 4 (except for Model 8929 = 2) | 4 |
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT 1 @ 2006
Patsy J. Trisler, J.D., R.A.C. Regulatory Consultant - Medical Devices Beaverite International Ltd. 5600 Wisconsin Avenue., Suite 509 CHEVY CHASE MD 20815
Re: K060538
Trade/Device Name: Beaverite Body Fat Scales; Models 8919, 8921, 8923, 8925, 8929, 8931, 8935, 9576, 9580, 9583 and 9588 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 25, 2006 Received: September 25, 2006
Dear Ms. Trisler:
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.
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Page 2 -
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 C. Brogdon
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): K060538
Device Name: __ Beaverite Body Fat Scales
Indications for Use:
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Eva
Rata Rall,
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060538
(Posted November 13, 2003)
Section 4.0, 09/25/06
§ 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.