(140 days)
The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition.
The provided text describes the "Scaleman Body Fat Scales" and its substantial equivalence to a predicate device, the "Tanita Innerscan Body Composition Monitor, K040778". However, it does not clearly define specific acceptance criteria in a quantitative manner or provide a detailed study that explicitly proves the device meets such criteria with numerical performance data.
Instead, the document states: "A comparative clinical study, submitted in this notification (Section 20), showed that body fat (%) and FFM (kg) in normal and athlete modes, body water (%) muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated by test and predicate devices were significantly correlated (P<. 05)." This indicates that the study focused on correlation with a predicate device, rather than explicit acceptance thresholds (e.g., accuracy within X% against a gold standard).
Given this limitation, I will extract the available information and structure it to best answer your questions based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide explicit numerical acceptance criteria or detailed performance metrics beyond a statement of "significant correlation." The table below reflects the information available within the text.
| Measure | Acceptance Criteria (as implied by document) | Reported Device Performance |
|---|---|---|
| Body Fat (%) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
| Fat-Free Mass (FFM) (kg) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
| Body Water (%) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
| Muscle Mass (kg) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
| Bone Mass (kg) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
| Weight (kg) | Significant correlation (P<.05) with predicate device | Significantly correlated (P<.05) with predicate device |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document only mentions "A comparative clinical study."
- Data Provenance: Not specified in the provided text. (e.g., country of origin, retrospective or prospective)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth appears to be based on correlation with a predicate device, not expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or specified. The study relied on comparing measurements from the test device to those of a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC study was not done. The device is a body composition analyzer, not an imaging device requiring human reader interpretation. No human-in-the-loop performance is mentioned or implied.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Standalone Performance: Yes, the described study evaluates the standalone performance of the Scaleman Body Fat Scales by comparing its measurements directly to those of a predicate device. There is no indication of human intervention in the measurement or interpretation process for the device itself.
7. The type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the comparative clinical study was established by the measurements from the predicate device (Tanita Innerscan Body Composition Monitor, K040778). The study aimed to show "significant correlation" between the test device and this predicate. This is a form of comparative effectiveness against a legally marketed device rather than an absolute gold standard (e.g., DEXA for body fat).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not describe the development or training of the BIA algorithm itself, only the clinical comparison to a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not specified. The document focuses on the clinical performance study for regulatory submission, not the initial development or training data for the BIA algorithm.
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| 510(k) Summary | |
|---|---|
| Scaleman Body Fat Scales |
CONFIDENTIAL
| Submitter Name: | Fook Tin Technologies Ltd. | MAY 12 2009 |
|---|---|---|
| Submitter Address: | 4/F Eastern Center, 1065 King's Road, Quarry Bay, Hong Kong | |
| Contact Person: | Dr. John Chai, Managing Director | |
| Phone Number: | (852) 2960 7288 | |
| Fax Number: | (852) 2565 9672 | |
| Date: | October 30, 2008 | |
| Device Trade Name: | Scaleman Body Fat Scales | |
| Device Common Name: | Impedance plethysmograph (body composition analyzer/scales) | |
| Classification Name: | Impedance plethysmograph | |
| Classification Number: | 21 CFR 870.2770 | |
| Product code: | MNW | |
| Predicate Device: | Tanita Innerscan Body Composition Monitor, K040778 | |
| Statement of Intended Use: | The Scaleman Body Fat Scales - Models in "Family Model List 1A" is a series of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. |
The Scaleman Body Fat Scales - Models in "Family Model List 1B" is a series of body composition analyzers that measure body weight and
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CONFIDENTIA
impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Device Description, Summary of Technologica! Characteristics, and Comparison to the Predicate Device
The models in Scaleman body fat scales' Family Model List 1A and 1B submitted in this 510(k) are body composition analyzers. The devices estimate percentages of body fat, body water, bone mass and muscle mass (as noted in the indications statement) based on bioelectrical impedance analysis (BIA). The following table illustrates the substantial equivalence in technology and intended use to the predicate device.
| Feature | Proposed Device:Scaleman Body Fat Scales(Model FS-148BW1) | Predicate Device:Tanita InnerScan Body CompositionMonitor (Model BC-533) |
|---|---|---|
| 510(k) Number | NIL | K040778 |
| Manufacturer | Fook Tin Technologies Ltd. | Tanita Corp of America |
| Classification # | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product code | MNW | MNW |
| Indication for use | The Scaleman Body Fat Scales -Models in "Family Model List 1A" is aseries of body composition analyzersthat measure body weight andimpedance and estimate percentageof body fat and body water using BIA(bioelectrical impedance analysis).They are intended for use by healthychildren 10-17 years old and healthyadults with active, moderately active,to inactive lifestyles for bodycomposition assessment in the homeenvironment.The Scaleman Body Fat Scales -Models in "Family Model List 1B" is aseries of body composition analyzers | The 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 calorieintake (DCI) and metabolic age usingBIA. They are intended for use byhealthy children 7-17 years old andhealthy adults with active, moderatelyactive, to inactive lifestyles for bodycomposition assessment in the homeenvironment. |
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UUINFIDEN I IAL
| that measure body weight andimpedance and estimate percentageof body fat and body water, bonemass and muscle mass using BIA(bioelectrical impedance analysis).They are intended for use by healthychildren 10-17 years old and healthyadults with active, moderately active,to inactive lifestyles for bodycomposition assessment in the homeenvironment. | ||
|---|---|---|
| Device description | Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition. | Body composition analyzer/scale that utilizes a “foot-to-foot” bioelectrical impedance (BIA) technology to determine internal body composition. |
| Analysis method | BIA | BIA |
| Operating parameters | 50 KHz | 50 KHz |
| Power source | Replaceable 9V or CR2032 or AAA batteries, depending on the model | AA batteries |
| Operating keys | Range of 3 to 6, depending on the model | 13 |
| Number of electrodes | 4 or 2 | 4 |
| Clinical performance | A comparative clinical study, submitted in this notification (Section 20), showedthat body fat (%) and FFM (kg) in normal and athlete modes, body water (%)muscle mass (kg), bone mass (kg) and weight (kg) measured or estimated bytest and predicate devices were significantly correlated (P<. 05). |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
MAY 12 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Fook Tin Technologies Ltd c/o Dr. John Chai Managing Director 4/F Eastern Center 1065 King's Road Quarry Bay, Hong Kong
Re: K083838
Trade/Device Name: Scaleman Body Fat Scales Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Codes: MNW Dated: April 18, 2009 Received: May 5, 2009
Dear Dr. Chai:
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. Iisting 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 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 – Dr. John Chai
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Dima R. Willing
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO83838
Device Name: Scaleman
Indications For Use:
Family Model List 1A
A scries of body composition analyzers that measure body weight and impedance and estimate percentage of body fat and body water, using BIA (bioelectrical impedance analysis).
They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
Family Model List 1B
A series of body composition analyzers that measure hody weight and impedance and estimate percentage of body fat and body water, bone mass and muscle mass using BIA (bioelectrical impedance analysis). They are intended for use by healthy children 10-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment.
NO Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
YES Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Holmes
n of Cardiovascular Devices
510/k) Numbe
Page 1 of
§ 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.