(442 days)
Not Found
No
The summary describes a bioimpedance analyzer and a comparison study with DEXA, but there is no mention of AI, ML, or related concepts.
No.
The device is a body fat analyzer used for estimation of body fat percentage, not for treating or diagnosing a medical condition.
No
The device is a body fat analyzer used to estimate body fat percentage in healthy individuals. It is not intended for the diagnosis or treatment of any disease or condition. The "Indications for Use" explicitly states it's for estimating body fat percentage, not for diagnosing medical conditions.
No
The device description explicitly states "AVITA BF1(Vitalio) Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer". This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a noninvasive bioimpedance analyzer that estimates body fat percentage by sending a small electrical current through the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to estimate body fat percentage in healthy individuals for home use. This is a measure of body composition, not a diagnostic test for a disease or condition.
Therefore, the device falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AVITA Body Fat Analyzer is intended for estimation of the body fat of percentage in the home.
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.
Product codes
74 MNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
20 to 80 years old.
Intended User / Care Setting
home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements. Moreover, A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed to validate the performance of the AVITA BF1(Vitalio) Body Fat Analyzer. Subjects were grouped as male/ female, ages. The comparison study demonstrated that the clinical repeatability of AVITA BF1(Vitalio) Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 ANALYZER |
| Models | ||
| 3.0 | Classification: | Class II |
| 4.0 | Predicate Device: | AVITA BF1(Vitalio) Body Fat Analyzer has similar general design |
| with Omron HBF-306 Body Fat Aalyzer(K011652) marketed by | ||
| Omron 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 fat | ||
| of percentage in the home. | ||
| 6.0 | Intended Use: | The AVITA Body Fat Analyzer is intended for estimation of the |
| body fat of percentage in the home. | ||
| 7.0 | Performance | |
| Summary: | In terms of operating specification, Safety & EMC requirements, the | |
| device conforms to applicable standards included IEC 60601-1 and | ||
| IEC 60601-1-2 requirements. Moreover, A comparison study with | ||
| device that use DEXA(Dual energy X-ray absorptiometry) | ||
| technology was performed to validate the performance of the AVITA | ||
| BF1(Vitalio) Body Fat Analyzer. Subjects were grouped as male/ | ||
| female, ages. The comparison study demonstrated that the clinical | ||
| repeatability of AVITA BF1(Vitalio) Body Fat Analyzer is | ||
| statistically 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.
1
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.
2
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
3
| 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