(91 days)
Not Found
No
The description focuses on densiometric measurements and scientifically derived algorithms, with no mention of AI or ML terms or concepts.
No
The device measures body composition and energy expenditure but does not treat any condition.
No
The device is used for measuring body mass and estimating body composition, resting metabolic rate (RMR), and total energy expenditure (TEE) in generally healthy individuals. It is not indicated for diagnosing any disease or condition.
No
The device description explicitly mentions a "weighing apparatus" and "air displacement plethysmography," which are hardware components used to measure mass and volume, respectively. The software component processes this data, but the device is not solely software.
Based on the provided information, the BOD POD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- BOD POD Function: The BOD POD measures body mass and estimates body composition, RMR, and TEE by directly interacting with the human body (air displacement plethysmography and weighing). It does not analyze specimens taken from the body.
Therefore, the BOD POD falls outside the scope of an IVD device.
N/A
Intended Use / Indications for Use
The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.
Product codes (comma separated list FDA assigned to the subject device)
MNW, OAC
Device Description
The Sonamet Body Composition System is designed to measure the mass and estimate the body composition of individuals. Once an individual's body composition has been determined, the BOD POD is able to accurately estimate Resting Metabolic Rate (RMR) and total Energy Expenditure (TEE).
The BOD POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The subject's body composition is then estimated using several algorithms derived from scientific research.
An individual's RMR and TEE can also be estimated accurately using values for Fat Mass and Fat Free Mass. Scientifically derived algorithms utilize the Fat Mass and Fat Free mass values determined by the BOD POD to calculate RMR and TEE.
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
18 years or older
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)
The results of verification testing demonstrate that the RMR and TEE results generated by the BOD POD Body Composition Analyzer are accurate when compared with expected results based on published scientific research, and is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated.
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.
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
JUN 27 2006
Section 5 – 510(k) Summary
The following is the 510(K) summary in accordance with 21CFR807.87(h)
SUBMITTER INFORMATION
| Company Name: | Life Measurement, Inc. |
|---|---|
| Establishment Registration Number: | 3003873943 |
| Company Address: | 1850 Bates Avenue |
| Concord, CA 94520 | |
| Company Phone: | (925) 676-6002 |
| Company Facsimile: | (925) 676-6005 |
| Contact Person: | Michael Sullivan |
| Vice President of Operations |
DEVICE IDENTIFICATION
| Device Trade Name: | Sonamet Body Composition Analyzer
Note : The trade name for the original Sonamet Body Composition
analyzer is currently the “BOD POD”. This will remain unchanged. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Generic Name: | Body Composition Analyzer |
| Device Classification: | Classification code: 21 CFR 870.2770
Code MNW |
| Classification Panel | Cardiovascular |
1
IDENTIFICATION OF PREDICATE DEVICES
The Sonamet Body Composition System is substantially equivalent to the following devices, which have received FDA clearance:
| Device Name | Manufacturer | K Number |
|---|---|---|
| Sonamet Body | ||
| Composition Analyzer | Life Measurement, | |
| Inc. | K924972 | |
| TANITA Segmental | ||
| Body Composition | ||
| Analyzer Model BC-418 | TANITA Corporation | |
| of America | K033157 |
The technological characteristics of the Sonamet Body Composition System have not been changed. The method of calculating RMR using values of Fat Free Mass is similar to the methods used by the TANITA Model BC-418 unit to calculate Basal Metabolic Rate.
DEVICE DESCRIPTION
The Sonamet Body Composition System is designed to measure the mass and estimate the body composition of individuals. Once an individual's body composition has been determined, the BOD POD is able to accurately estimate Resting Metabolic Rate (RMR) and total Energy Expenditure (TEE).
The BOD POD estimates body composition using a densiometric approach (i.e. by determining the density of the entire body). A weighing apparatus is used to measure the subject's mass. Air displacement plethysmography is used to measure the subject's volume. Using this data, the subject's density is calculated. The subject's body composition is then estimated using several algorithms derived from scientific research.
An individual's RMR and TEE can also be estimated accurately using values for Fat Mass and Fat Free Mass. Scientifically derived algorithms utilize the Fat Mass and Fat Free mass values determined by the BOD POD to calculate RMR and TEE.
INTENDED USE
The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.
CONCLUSIONS DRAWN FROM STUDIES
The results of verification testing demonstrate that the RMR and TEE results generated by the BOD POD Body Composition Analyzer are accurate when compared with expected results based on published scientific research, and is substantially equivalent to the predicate devices. Test results indicate that the device satisfies functional performance requirements safely and accurately when used as indicated.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alex Urlando Vice President, Operations Life Measurement, Inc. 1850 Bates Avenue CONCORD, CA 94520
MAY - 1 2007
Re: K060848 Trade/Device Name: BOD POD® Sonamet Body Composition Analyzer [modified indications] Regulation Number: 21 CFR§870.2770 Regulation Name: Air Displacement Plethysmograph for Body Composition Analysis Regulatory Class: Class II Product Code: OAC Dated: March 23, 2006 Received: March 31, 2006
Dear Mr. Urlando:
This letter corrects our substantially equivalent letter of June 27, 2006.
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 (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
3
Page 2 - Mr. Alex Urlando
CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section Fins loter will and it your of the FDA finding of substantial equivalence of your device s rotty premazine ted 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 10 gatable of the may obtain other general information on your responsibilities under the Act 601.97). Touring of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K060848
Device Name: Sonamet Body Composition Analyzer (BOD POD)
Indications For Use:
The BOD POD® is indicated for measuring the body mass and estimation the beste composition (i.e. percent and absolute amounts of fat and lean body on the more and any and Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Have 1 (21 CFR 8: , . .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON FRIENDE ACCLE P NEEDED)
Concurrence of CDRH, Office of Device Evaluation = 140 €
Nancy C. Gordon
(Division Sign-Off)
Division of Reprodu live, Abdo and Radiological Devices 510(k) Number
Page 1 of
(vers 6/25/05)