(347 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets, which are typically associated with AI/ML-powered medical devices. The device description focuses on basic measurements (weight, impedance) and calculations.
No
The device measures weight and body impedance to estimate fat mass and lean mass, which are diagnostic or monitoring functions, not therapeutic.
No
The device measures weight and body impedance to calculate an estimated value for fat mass and lean mass, which are typically for general health and fitness tracking rather than diagnosing a medical condition.
No
The device description is not available, but the intended use clearly states it measures weight and body impedance, which are physical measurements requiring hardware (a scale and impedance measurement components). Therefore, it is not a software-only device.
Based on the provided information, the Rowenta Bodypartner VISION/SCALE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to measure weight and body impedance to estimate fat mass and lean mass. This is a measurement of physical characteristics of the body, not an analysis of samples taken from the body (like blood, urine, tissue, etc.).
- IVD Definition: IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Rowenta Bodypartner does not analyze such specimens.
The device is a personal scale with body composition analysis capabilities, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Rowenta Bodypartner VISION/SCALE is intended to measure weight and body impedance which are used to calculate an estimated value for fat mass and lean mass.
Product codes
74 MNW
Device Description
Not Found
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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 a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2003
Mr. Mike Cosco Product Manager Rowenta Inc. 196 Boston Avenue MEDFORD MA 02155
Re: K023429
Trade/Device Name: BODYPARTNER VISION Model BM 210 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: June 23, 2003 Received: June 25, 2003
Dear Mr. Cosco:
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. Ilsting 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.
1
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 the 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" (21CFR Part 807.97) you may obtain. 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 C. Brogdon
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
l'age 2
2
INDICATIONS FOR USE
510 (k) Number: K023429
| Device name: | ROWENTA BODYPARTNER VISION Model BM-210 |
|---|---|
| Indications for use: | The Rowenta Bodypartner VISION/SCALE is intended to measure weight |
| and body impedance which are used to calculate an estimated value for fat | |
| mass and lean mass. | |
| Company name: | Rowenta Inc. 196 Boston Avenue, Medford, MA 02155 USA |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
David A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use