(189 days)
Not Found
No
The description mentions "several algorithms derived from scientific research" for estimating body composition, but there is no mention of AI, ML, or any related concepts like neural networks, training data, or performance metrics typically associated with AI/ML models. The approach described is densiometric, relying on physical measurements and established algorithms.
No
The device measures body composition but does not treat, cure, mitigate, or prevent any disease or condition. Its purpose is diagnostic/measurement.
No
The device measures body mass and estimates body composition (body fat and lean body mass), which is a measurement function, not a diagnostic one. It provides objective data about the infant's physical state rather than identifying a disease or condition.
No
The device description explicitly details hardware components such as a weighing apparatus, air displacement plethysmography system, reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer, and CPU, all housed in a movable cart. This indicates it is a hardware-based medical device with integrated software for calculations.
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 PEA POD measures body mass and estimates body composition (fat and lean mass) using physical methods (weighing and air displacement plethysmography). It does not analyze biological samples taken from the infant.
- Intended Use: The intended use is to measure and estimate physical characteristics of the infant's body, not to diagnose a disease or condition based on biological markers.
Therefore, the PEA POD falls under the category of a medical device but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
The modified Sonamet Body Composition System ("The PEA POD") is designed to measure the mass and estimate the body composition of infants with body weights ranging between 1 and 8 kilograms, who do not require life support. The PEA 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. The device components are housed in a movable cart, which contains the reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer and CPU.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Infants
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 PEA POD Body Composition Analyzer 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
MAR - 1. 2004
K032610
page 1 of 2
Section 6 – 510(k) Summary
SUBMITTER INFORMATION
Company Name:
Establishment Registration Number:
Company Address:
Company Phone:
Company Facsimile:
Contact Person:
Life Measurement, Inc.
3003873943
1850 Bates Avenue Concord, CA 94520
(925) 676-6002
(925) 676-6005
Michael Sullivan Vice President of Operations
DEVICE IDENTIFICATION
| Device Trade Name: | - Modified Sonamet Body Composition Analyzer
Note : The trade name for the original Sonamet Body
Composition analyzer is currently the “BOD POD”. The
modified version will be referred to as the “PEA POD -
Infant Body Composition System” when it is introduced into
the market. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Generic Name: | Body Composition Analyzer |
| Device Classification: | Classification code: 21 CFR 870.2770
Code MNW |
| Classification Panel | Cardiovascular |
1
K032610
page 2 of 2
IDENTIFICATION OF PREDICATE DEVICES
The modified 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 | |
| EM-SCAN HP-2 | ||
| Pediatric Body | ||
| Composition Analyzer | EM-SCAN, Inc. | K902042 |
The intended use and technological characteristics of the modified Sonamet Body Composition System are the same as the above predicate devices. Modifications for the pediatric use indication do not raise additional questions regarding safety and efficacy,
DEVICE DESCRIPTION
The modified Sonamet Body Composition System ("The PEA POD") is designed to measure the mass and estimate the body composition of infants with body weights ranging between 1 and 8 kilograms, who do not require life support. The PEA 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. The device components are housed in a movable cart, which contains the reference chamber, calibration volume, air circulation system, Air Temperature Control System, electronic components, printer and CPU.
INTENDED USE
The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.
CONCLUSIONS DRAWN FROM STUDIES
The results of verification testing demonstrate that the PEA POD Body Composition Analyzer 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
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
MAR - 1. 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Measurement, Inc. c/o Dr. Sheila Pickering 2081 Longden Circle LOS ALTOS CA 94024
Re: K032610
Trade/Device Name: Modified Sonamet Body Composition Analyzer (PEA POD) Regulation Number: 21 CFR $870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 78 MNW Dated: January 5, 2004 Received: January 9, 2004
Dear Dr. Pickering:
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins leter will anow you to begin maining of substantial equivalence of your device to a legally premarket notheadon: "The PPP intenty since of the more 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 If you desire specific advice to: your 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 Additionally, 10. questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by releveloc to promance nonities under the Act may be obtained from the Division of Strail mornation on your responsibility on the 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 Director, Division of Reproductive, Abdoninal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
ATTACHMENT 14
FDA Submission Cover Sheet
510(k) Number: K032610
Device Name: Modified Sonamet Body Composition Analyzer
Indication For Use:
The modified Sonamet Body Composition Analyzer, also known as the PEA POD® Infant Body Composition System (the PEA POD), is indicated for measuring body mass and estimating the body composition (i.e., the body fat and lean body mass) of infants between 1 and 8 kilograms. It is not intended for use with infants requiring life support.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office Of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Per 21CFR
Nancy C. Broadon
(Division Sign-Off Division of Reproductive. Abde and Radiological Devices 510(k) Number.
143