(1) BodyMetrix BX2000 is indicated for the measurement of localized fat layer thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition.

(2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The Body View Software is indicated for estimating Basal Metabolic Rate (BMR). The Body View software can track changes in the measurements, and generate body composition reports.

Device Description

BodyMetrix BX2000™ is a portable, hand-held device that uses A-mode ultrasound to measure tissue thickness. The device is powered and communicates with a portable or desktop computer through a USB interface. A piezoelectric transducer is used to generate and transmit ultrasound. sound waves into tissue. The reflected sound waves are detected by a second and separate piezoelectric transducer and digitized before the data is transferred through a USB cable to the computer.

AI/ML Overview

The BodyMetrix BX2000™ measures localized fat and muscle thickness and, with BodyView Software, estimates total body fat percentage (%BF), Waist-to-Hip Ratio (WHR), Body Mass Index (BMI), and Basal Metabolic Rate (BMR) for generally healthy adults and children (6 or older).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details the device's preclinical acoustic output limits, but it does not explicitly state specific acceptance criteria (e.g., accuracy thresholds, precision targets) for its ability to measure tissue thickness or estimate body fat percentage. It only states that "Clinical testing was conducted and submitted as part of the 510(k) application to confirm that BodyMetrix BX2000™ is as safe and effective device for measuring tissue thickness and estimating percentage body fat."

The reported device performance, in terms of clinical accuracy or comparison to a gold standard, is not provided in a quantifiable manner within this summary.

Metric (Implied)	Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Not explicitly stated in the document)
Tissue Thickness Measurement	Likely accuracy against a gold standard	The document states clinical testing was done to confirm safety and effectiveness, but results are not quantified.
Estimated Total Body Fat (%BF)	Likely accuracy against a gold standard	The document states clinical testing was done to confirm safety and effectiveness, but results are not quantified.
Acoustic Output (ISPPA.3)	≤ 60 mW/cm²	60 mW/cm² (Maximum)
Acoustic Output (ISPTA.3)	≤ 0.02 mW/cm²	0.02 mW/cm² (Maximum)
Mechanical Index (MI)	≤ 0.02	0.02 (Maximum)

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that "Clinical testing was conducted and submitted as part of the 510(k) application," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size regarding human reader improvement with or without AI assistance. The device is described as an ultrasonic device for body composition, not explicitly an AI-assisted diagnostic tool that would typically involve such a study with human readers interpreting output.

6. Standalone Performance Study:

The document indicates that clinical testing was conducted to confirm the device's safety and effectiveness for measuring tissue thickness and estimating body fat. This implies a standalone performance evaluation of the algorithm's output, as the device is intended to provide these measurements directly. However, detailed results of this standalone performance are not provided.

7. Type of Ground Truth Used:

The document states that the BodyMetrix BX2000™ "uses the same measurement points and formulas that are used for skinfold calipers." This implies that the ground truth for comparison in the clinical testing likely involved measurements obtained through traditional skinfold calipers or another established body composition assessment method. However, it does not explicitly state the specific "gold standard" or type of ground truth used (e.g., DEXA, hydrodensitometry, pathology, outcomes data).

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for any training set. Given that the device "uses the same measurement points and formulas that are used for skinfold calipers," it's possible that the "algorithm" is based on established formulas rather than a machine learning model requiring a distinct training set. If machine learning was involved, this information is not disclosed.

9. How the Ground Truth for the Training Set Was Established:

As no training set is explicitly mentioned, the document does not describe how ground truth for a training set was established.

Summary

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<082147 PAGE 1: OF 2

MAR 2 0 2009

510(k) Summary

IntelaMetrix, Incorporated - BodyMetrix BX2000™

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

Owner's Name and Address:	IntelaMetrix, Inc.6246 Preston AvenueLivermore, CA 94551(925) 606-7044 - Telephone(925) 371-3903 - Fax
Contact Information:	Heidi StarkIntelaMetrix, Inc.6246 Preston AvenueLivermore, CA 94551(925) 606-7044 - Telephone(925) 371-3903 — Fax
Date Prepared:	March 9, 2009
Device Trade Name:	BodyMetrix BX2000TM
Common Name:	Ultrasound Body Composition Device
Classification Name:	Class II - Analyzer, Body Composition, Ultrasonic(21 CFR 870.2770)
Predicate Devices:	K810116Isorobic Skinfold Caliper

Description of the Device:

K051334

TERASON T2000 Ultrasound System

INTELAMETRIX INC. 510(k) BodyMetrix BX2000

3/9/09

CONFIDENTIAL Page 27 of 29

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K082147
PAGE 2 OF 2

piezoelectric transducer and digitized before the data is transferred through a USB cable to the computer.

Indications for Use:

Performance Data:

Preclinical Testing

BX-2000 acoustic output limits are: ISPPA.3 60 mW/cm2 (Maximum)

company concern and control and and annual and sense	Comments of the comments of the comments of
ISPTA.3	0.02 mW/cm² (Maximum)
MI	· 0.02	(Maximum)

Clinical Testing

Clinical testing was conducted and submitted as part of the 510(k) application to confirm that BodyMetrix BX2000™ is as safe and effective device for measuring tissue thickness and estimating percentage body fat.

Substantial Equivalence:

BodyMetrix BX2000 and its predicate devices are all devices that use low frequency, ultrasound, and are safe for this application. The BodyMetrix BX2000™ uses the same measurement points and formulas that are used for skinfold calipers. The differences in the technological characteristics of BodyMetrix BX2000 and its predicate devices do not raise any new issues of safety or efficacy. Thus, the BodyMetrix BX2000 is substantially equivalent to the predicate device for measurement of human tissue thickness.

Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.

INTELAMETRIX INC. 510(k) BodyMetrix BX2000

3/9/09

CONFIDENTIAL Page 28 of 29

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Heidi Stark VP and CFO IntelaMetrix® 6246 Preston Avenue LIVERMORE CA 94551

Re: K082147

Trade/Device Name: BodyMetrix BX 2000 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OMV Dated: March 9, 2009 Received: March 10, 2009

Dear Ms. Stark:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAR 2 0 2009

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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/cdrb/industry.suppot/index.html,

Sincerely yours,

Janine M. Morris

anine M. M. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082147

Device Name: - BodyMetrix BX 2000

Indications For Use:

(1) BodyMetrix BX2000 is indicated for the measurement of localized fat laver thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition.

(2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The Body/iew Software is indicated for estimating Basal Metabolic Rate (BMR). The BodyView software can track changes in the measurements, and generate body composition reports.

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)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

Page 1 of

Regulation Number and Section

§ 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.