MEDGEM

K021605 · Healthetech, Inc. · BZL · Jun 14, 2002 · Anesthesiology

Device Facts

• Record ID: K021605
• Device Name: MEDGEM
• Applicant: Healthetech, Inc.
• Product Code: BZL · Anesthesiology
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1730
• Device Class: Class 2

Intended Use

The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Device Story

MedGem measures oxygen uptake (VO2) to assess metabolic rate. Device functions as an oxygen uptake computer; inputs include respiratory gas exchange data. Operates in clinical or research settings; used by healthcare professionals. Output provides quantitative metabolic data to assist clinicians in nutritional assessment or metabolic monitoring. Benefits include objective measurement of energy expenditure to guide patient care.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Oxygen uptake computer; Class II device (21 CFR 868.1730); Product Code BZL. Technical details regarding materials, sensing principles, or software architecture are not specified in the provided text.

Indications for Use

Indicated for clinical and research applications requiring measurement of oxygen uptake in patients.

Regulatory Classification

Identification

An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2002

HealtheTech, Inc. c/o Glenn M. Thibault 523 Park Point Dr. Golden, CO 80401

Re: K021605

MedGem Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: Class II (two) Product Code: BZL Dated: May 15, 2002 Received: May 16, 2002

Dear Mr. Thibault:

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 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.

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

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## Page 2 - Mr. Glenn M. Thibault

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Dakota Tuth

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section D - Statement of Indications for Use

| 510(k) Number: | K021605 |
|----------------|---------|
|----------------|---------|

MedGem Device Name:

Indications for Use: The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Prescription Use
(per 21 CFR 801.109)

or

Over-the -- Counter Use_______________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K021165