(442 days)
The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 20 to 80 years old.
The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.
AVITA BF1(Vitalio) Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
This 510(k) summary describes the AVITA BF1 (Vitalio) Body Fat Analyzer, which is a hand-held, non-sterile, reusable device intended for estimating body fat percentage in the home.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria (e.g., a specific percentage of agreement, a required correlation coefficient, or a defined accuracy margin). Instead, it states the overall conclusion of the study's performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical Repeatability | Statistically and clinically acceptable in all age/weight/height groups. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the comparison study.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. It merely mentions "A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention using experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method.
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:
This is not applicable to this device. The AVITA BF1 (Vitalio) Body Fat Analyzer is a standalone device for estimating body fat percentage, not an AI-assisted diagnostic tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was conducted. The "comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology" directly evaluates the performance of the AVITA BF1 device (algorithm only, as there's no human interpretation component) against a reference standard.
7. The Type of Ground Truth Used:
The ground truth used for the test set was obtained from a DEXA (Dual energy X-ray absorptiometry) device. DEXA is considered a highly accurate method for measuring body composition, including body fat percentage, and is often used as a reference standard in such studies.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. This suggests the device might be based on established bioimpedance principles and a pre-existing algorithm, rather than being a newly developed AI model requiring a separate training phase described in this submission.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned, information on how its ground truth was established is not provided.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance ith the requirements of SMDA and 21 CFR §807.92
| 1.0 | Submitter's Name: | AVITA Corp |
|---|---|---|
| Address: | 9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County,Taiwan, R.O.C. | |
| Phone: | 001-886-2-85121568 | |
| Fax: | 001-886-2-85121347 | |
| Contact: | Mr. Geo Lin, General Manager | |
| MAY 22 2003 | ||
| 2.0 | Device Name: | AVITA BF 1 BODY FAT ANALYZERModels |
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | AVITA BF1(Vitalio) Body Fat Analyzer has similar general designwith Omron HBF-306 Body Fat Aalyzer(K011652) marketed byOmron Healthcare INC. |
| 5.0 | Device Description: | AVITA BF1(Vitalio) Body Fat Analyzer is a hand-held, non-sterile,reusable Body Fat Analyzer intended for estimation of the body fatof percentage in the home. |
| 6.0 | Intended Use: | The AVITA Body Fat Analyzer is intended for estimation of thebody fat of percentage in the home. |
| 7.0 | PerformanceSummary: | In terms of operating specification, Safety & EMC requirements, thedevice conforms to applicable standards included IEC 60601-1 andIEC 60601-1-2 requirements. Moreover, A comparison study withdevice that use DEXA(Dual energy X-ray absorptiometry)technology was performed to validate the performance of the AVITABF1(Vitalio) Body Fat Analyzer. Subjects were grouped as male/female, ages. The comparison study demonstrated that the clinicalrepeatability of AVITA BF1(Vitalio) Body Fat Analyzer isstatistically and clinically acceptable in all age/weight/height groups. |
8. Conclusions:
The AVTA BF1(Vitalio) Body Fat Analyzer have the same intended use and similar technological characteristics as Omron HBF-306 Body Fat Aalyzer( K011652 )marketed by Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AViTA BF1(Vitalio) Body Fat Analyzer is substantially equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
AVITA Corporation c/o Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail FLAGSTAFF AZ 86001
Re: K020738
Trade/Device Name: BFI (Vitalio) Body Fat Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 30, 2003 Received: February 25, 2003
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 (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 your 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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| Attachment B | |
|---|---|
Page _________________________________________________________________________________________________________________________________________________________________________
510 (k) NUMBER (IF KNOWN): _ K020738
DEVICE NAME: AviTA BF1(Vitalio) Body Fat Analyzer AVITA Corp.
INDICATIONS FOR USE:
The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 20 to 80 years old.
The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter _ (Optional Format)
V
David R. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
§ 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.