FITMATE SERIES

K071533 · Cosmed Srl · BZL · Sep 28, 2007 · Anesthesiology

Device Facts

• Record ID: K071533
• Device Name: FITMATE SERIES
• Applicant: Cosmed Srl
• Product Code: BZL · Anesthesiology
• Decision Date: Sep 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1730
• Device Class: Class 2

Intended Use

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Device Story

Fitmate series (Fitmate/Fitmate Pro) are portable metabolic monitors; measure oxygen uptake to determine Resting Metabolic Rate (RMR) and maximal oxygen uptake (VO2max). Input: gas exchange data during rest or exercise protocols. Operation: device processes flow and volume signals to calculate metabolic parameters; output displayed for clinician review. Used in clinical and research settings; operated by healthcare professionals. Output assists in assessing pulmonary function and metabolic status; informs clinical decision-making regarding patient fitness and metabolic health. Prescription-only device.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices. Systems meet EMC standard EN60601-1-2 for accuracy of flow and volume measurements.

Technological Characteristics

Portable metabolic cart; measures oxygen uptake via flow/volume sensing. Complies with EN60601-1-2 EMC standards. Includes integrated computer for data processing. Intended for clinical/research use.

Indications for Use

Indicated for clinical and research applications requiring measurement of oxygen uptake, specifically Resting Metabolic Rate (RMR) in all patients, and maximal oxygen uptake (VO2max) for basic pulmonary function assessment in patients undergoing sub-maximal or maximal exercise protocols. Restricted to prescription use.

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.

Predicate Devices

• Reevue Indirect Calorimeter, Model # 8100 (K021490)
• Quark pulmonary function testing system (K001174)

Submission Summary (Full Text)

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COSMED SRL.. ITALY COSMAD, Fitmate

KO71533

## Summary

# SEP 2 8 2007

This device - Fitmate and Fitmate Pro both are is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

#### DESCRIPTION

Fitmate series Trade or proprietary name:

Common or usual name:

Classification name:

Detailed Description:

Fitmate is designed for measuring oxygen uptake at rest and during exercise (VO2max). The device is a metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake), during a sub-maximal or maximal exercise protocol

Portable metabolic cart

Computer, Oxygen Uptake

Intended Use: and

Fitmate series family includes Fitmate

Fitmate Pro. Fitmate is specifically designed for the measurement of Resting Metabolic Rate only, Fitmate Pro includes also the measurement of

maximal oxygen uptake (VO2max).

#### ESTABLISHMENT:

Registration Number:

8021084

Address:

COSMED SRL

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37 Via dei Piani di Monte Savello Pavona di Albano Laziale (Rome) 00040 Italy Tel: [phone], Fax: [phone] http://www.cosmed.it, e-mail: [e-mail]

#### DEVICE CLASS UNDER SECTION 513:

| Class: | II |
|-----------------------|-----|
| Product Code: | BZL |
| Classification Panel: | AN |

#### SUBSTANTIAL EQUIVALENT:

The COSMED Fitmate is similar to the Reevue Indirect Calorimeter, Model # 8100 (K021490) manufactured by Korr Medical Technologies, Inc., 3090 East 3300 South, Suite 100, Salt Lake City, UT 84109, USA and the Quark pulmonary function testing system (K001174) manufactured by COSMED srl, 37 Via dei Piani di Monte Savello Pavona di Albano Laziale (Rome) 00040 Italy.

All three systems are designed for the same intended use and to carry out the same tests. All devices are restricted to be sold by or on the order of a physician. These systems have substantially the same characteristics. The predicate device comparison table is attached.

All systems meet the EMC standard EN60601-1-2 for accuracy of the measurement of flows and volumes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2007

COSMED S.R.L. C/O Mr. Robert Schiff President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006

Re: K071533

Trade/Device Name: Fitmate Series COSMED SRL COSMED FITMATE Regulation Number: 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: II Product Code: BZL Dated: September 6, 2007 Received: September 7, 2007

Dear Mr. Schiff:

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.

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Page 2 - Mr. Schiff

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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Clare

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number: K071533 Fitmate Series

Device Name: COSMED SRL COSMED FITMATE

Indications For Use:

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Prescription Use X (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)

Clues

Page 1 of 1

Sion Sign-Off) Chision of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K071533