(115 days)
Not Found
No
The summary describes a metabolic monitor that measures oxygen uptake and metabolic rate. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The device appears to rely on direct physiological measurements rather than algorithmic interpretation of complex data.
No.
The device measures oxygen uptake and metabolic rate for assessment, but it is not intended for treatment or therapy. It acts as a diagnostic or monitoring tool rather than a therapeutic one.
Yes
The device measures oxygen uptake (RMR and VO2max) to assess basic pulmonary function, which are diagnostic indicators.
No
The device description explicitly states it is a "metabolic monitor" designed for measuring oxygen uptake, implying it includes hardware components for measurement, not just software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for use in "clinical and research application to measure oxygen uptake." While oxygen uptake itself isn't directly measured in vitro (outside the body), the measurement of metabolic rate and VO2max involves analyzing gases exhaled by the patient. This analysis of biological samples (exhaled breath) for clinical purposes falls under the scope of IVDs.
- Device Description: The device is described as a "metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake)." These measurements are used for assessing physiological function and can be used in clinical diagnosis or monitoring.
- Predicate Devices: The listed predicate devices, "Reevue Indirect Calorimeter" and "Quark pulmonary function testing system," are also devices that measure metabolic and pulmonary function by analyzing exhaled gases, which are typically classified as IVDs.
While the device doesn't process images or use AI/ML, and the anatomical site isn't explicitly stated (though it's related to respiration), the core function of analyzing biological samples (exhaled breath) for clinical and research purposes strongly indicates that it is an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZL
Device 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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
clinical and research application
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)
Not Found
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.
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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).
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§ 868.1730 Oxygen uptake computer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
37 Via dei Piani di Monte Savello Pavona di Albano Laziale (Rome) 00040 Italy Tel: +39-06-9315492, Fax: +39-06-9314580 http://www.cosmed.it, e-mail: info@cosmed.it
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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