(90 days)
The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, age range is 10 to 80 years old. The device is to be used in a home environment having normal temperature and humidity conditions.
AQ-830 Slim Body, Body Fat Monitor is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
The provided document describes a 510(k) premarket notification for the "AQ-830 Slim Body, Body Fat Monitor." The document indicates that a comparative study was conducted to demonstrate the device's performance.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operating Specifications | Conforms to applicable standards: IEC 60601-1 and IEC 60601-1-2 requirements. |
| Safety & EMC Requirements | Conforms to applicable standards: IEC 60601-1 and IEC 60601-1-2 requirements. |
| Statistical and Clinical Acceptability | Repeatability of AQ-830 Slim Body, Body Fat Monitor is statistically and clinically acceptable in all age/weight/height groups. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states "Subjects were grouped as male/female, ages." However, it does not specify the total number of subjects or the breakdown of subjects within those groups.
- Data Provenance: The study involved a "comparison study with device that met absorptiometry (DEXA) technology." The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document explicitly states that the comparison study was performed using "DEXA (Dual Energy X-ray Absorptiometry) technology" as the reference method. DEXA itself is considered a gold standard for body composition measurement, so direct human experts establishing ground truth for individual measurements in the test set are not mentioned as being involved in this capacity. The DEXA measurements served as the ground truth.
4. Adjudication Method for the Test Set
Not applicable. As DEXA technology was used as the ground truth, there's no mention of human expert adjudication for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study described is a comparison of the AQ-830 device's measurements against DEXA, not a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes. The study described focuses on the "repeatability of AQ-830 Slim Body, Body Fat Monitor" against DEXA, indicating a standalone performance evaluation of the device itself.
7. Type of Ground Truth Used
The ground truth used was DEXA (Dual Energy X-ray Absorptiometry) technology, which is a widely accepted and accurate method for measuring body composition and body fat percentage.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The description of the study focuses on the comparison study performed to demonstrate performance, implying this data was used for validation rather than training a separate algorithm that needed a training set. This is a medical device that likely relies on established bioimpedance principles and calibration, rather than a deep learning model requiring a large training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct training set for an algorithm is not described. The device's calibration and underlying algorithms would be based on established scientific principles of bioimpedance and potentially data from previous research, but this document doesn't detail a specific training set for the current device's development. The "ground truth" mentioned in the context of the study relates to the reference method (DEXA) for validating the device's performance.
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DEC 27 2005
Image /page/0/Picture/2 description: The image shows the text "K052678 PAGE 1 OF 2". The text appears to be handwritten. The phrase "PAGE 1 OF 2" indicates that this is the first page of a two-page document.
This summary of 510(k) safety and effectiveness information is being submitted in accordance , the requirements of SMDA and 21 CFR §807.92
- Submitter's Name: Limax ELECTRONICS CO., LTD. 1.0 5 F-1, No. 176, Keelung Road, Sec. 1 , 11069, Taipei , Taiwan Addross '
| Address: | ST. 1, No. 110, Hsing Lung Rd. |
|---|---|
| Phone: | 886-2-2769 9969 |
| Fax: | 886-2-2769 9558 |
| Contact: | Mr. William Chiu / President |
- AQ-830 Slim Body, Body Fat Monitor 2.0 Device Name:
- LONG WELL LW-6Dxx Body Fat Analyzer (K030203) marketed by 3.0 Predicate Device: LONG WELL ELECTRONICS CORP. &
- Omron HBF-306 Body Fat Analyzer ( K011652 )marketed by Omron Healthcare INC.
- 4.0 Device Description: AQ-830 Slim Body, Body Fat Monitor is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
The AQ-8303 Slim Body, Body Fat Monitor is intended for estimation of 5.0 Intended Use: the body fat of percentage in the home..
In terms of operating specification, Safety & EMC requirements, the 6.0 Performance m terms of operating op-sandards included IEC 60601-1 and IEC Summary: device conforms to applicable on.
60601-1-2 requirements. Moreover, A comparison study with device that 00001-192 requiromono.net met absorptiometry) technology was performed use DEXA(Dual Shorgy A Tay STA) STAJ STAT Body, Body Fat Monitor.
Subjects were grouped as male/ female, ages. The comparison study Subjects were grouped as a line a repeatability of AQ-830 Slim Body, Body Fat Monitor is statistically and clinically acceptable in all age/weight/height groups.
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7. Conclusions:
2 CE 4052678
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The AQ-830 Slim Body, Body Fat Monitor have the same intended use and similar to 1991 rhe T& 000 Onlin Dody Loady Fat Analyzer (K030203) marketed by LONG rations as 2012 - 11:15 and Omron HBF-306 Body Fat Analyzer( K011652 )marketed by , Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing Omroh realineare INO.. Morovo, before, between and and ender is and raise and supplied demonstrate that any american .
new questions of safety or effectiveness. Thus, the AQ-830 Slim Body, Body Fat Monitor is substantially equivalent to the predicate devices.
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Image /page/2/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a bird-like figure with three lines representing the wings and a snake-like figure at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.
DEC 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LIMAX ELECTRONICS CO., LTD. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive FLAGSTAFF AZ 86001
Re: K052678
Trade/Device Name: AQ-830 Slim Body, Body Fat Monitor Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 27, 2005 Received: September 28, 2005
Dear Ms. Reich:
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.
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 clectronic 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 Scetion 5 (t(k) This letter will allow you to begin marketing your dones of your device of your device to a legally premarket notification. The FDA midnig of stossantal common 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 If you desire specific advice for your device on our laboring organise (
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to prematic notification" (21 CFR Also, please note the regulation entired, "rinsolation on your responsibilities under the Act from the 807.97). You may obtain other general monmation on Jour September Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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):_____________________________________________________________________________________________________________________________________________________
Device Name: AQ-830 Slim Body, Body Fat Monitor Limax ELECTRONICS CO., LTD.
Indications For Use:
The device is a noninvasive bioimpedance meter used to estimate body fat
. The device is a noninvasive built peading more as a mormal, healthy people only,
percentage in the home setting. The device is for normal, healthy people only,
percentage in the rege range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
V
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Cr. Leggett
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K052678
510(k) Number
Page 1 of 1
§ 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.