(212 days)
Not Found
Not Found
No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) and an accelerometer/gyroscope for body composition and activity tracking. There are no mentions of AI, ML, deep learning, or any related concepts in the provided text.
No
The device is a body fat analyzer and calorie tracker, intended for use by healthy subjects to estimate body composition and track calorie expenditure. It does not provide treatment or alleviate symptoms of a disease, which are characteristics of a therapeutic device.
No
Explanation: The device is described as a "body fat analyzer" used to estimate body composition metrics like percent body fat, lean body mass, and total body water. It is intended for "healthy subjects" and is not mentioned to diagnose or treat any medical condition.
No
The device description explicitly mentions the use of Bioelectrical Impedance Analysis (BIA) and a "Stayhealthy Activity Monitor" which is described as a triaxial accelerometer and gyroscope. These are hardware components, indicating the device is 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 BCM and SAM devices described here measure body composition (fat, lean mass, water) and track activity/calories. They do this through bioelectrical impedance analysis and accelerometry/gyroscopy, which are physical measurements taken on the body itself, not on samples taken from the body.
Therefore, the device's function and the methods it uses fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.
Product codes
MNW
Device Description
The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client.
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
ages 8-92
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 and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jesus T. Farinas Consultant Stayhealthy, Inc. 742 E. Huntington Drive. MONROVIA CA 91016
CAN. 2 6 201
Re: K101807
Trade/Device Name: Stayhealthy Body Composition Monitor-BCM Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: January 15, 2011 Received: January 20, 2011
Dear Mr. Farinas:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
1
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOIffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default:htm.
Sincerely yours,
Hubert Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(K) NUMBER (IF KNOWN):
DEVICE NAME:
Stayhealthy Body Composition Monitor-BCM
INDICATIONS FOR USE:
The BCM is used as body fat analyzer that estimate the percent body fat (%BF), percent lean body mass(%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis). The SAM or Stayhealthy Activity Monitor [ a triaxial accelerometer and 3axis, gyroscope equipped calorie tracker- (CT2)], is a device that is sold as companion device with the BCM and is used to track the number of calories used by the client. The device is intended for use by healthy subjects ages 8-92.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
losun Whang
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101807
Page 1 of
ల్లా