The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.
Device Story
COSMED Pony FX is a standalone, modular pulmonary function testing system. It measures lung function parameters (FVC, SVC, MVV) and pulse oximetry. Operated by clinicians in laboratory or clinical settings, the device processes respiratory and oxygen saturation signals to provide diagnostic data. Output is displayed for healthcare providers to assess lung function and oxygenation status, aiding in the diagnosis and management of respiratory conditions.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Standalone, modular pulmonary function testing system. Performs spirometry (FVC, SVC, MVV) and pulse oximetry. Class II device under 21 CFR 868.1890 (Product Codes BTY, DQA).
Indications for Use
Indicated for patients requiring basic pulmonary function testing, including Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), and Maximum Voluntary Ventilation (MVV), as well as pulse oximetry monitoring. Intended for prescription use in a laboratory or clinical setting.
Regulatory Classification
Identification
A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
Submission Summary (Full Text)
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SEP 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cosmed S.R.L. C/O Mr. Robert Schiff Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re: K040549
Trade/Device Name: COSMED Pony FX Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-function Value Calculator Regulatory Class: II Product Code: BTY, DQA Dated: September 20, 2004 Received: September 21, 2004
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 releveloca above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do roometic Act (Act) that do not require approval of a premarket the Federal F 000, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided 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 If your doviee in clabition (such additional controls. Existing major regulations affecting (1 NIT), it may be such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther 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 and insing (2) 300 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), rl you 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/dsma/dsmamain.html
Sincerely vours,
Clu Lin, Ph.D.
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 (if known): Not assigned yet
Device Name: COSMED Pony FX
Indications for Use:
The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.
Prescription Use
(Part 21 CFR 801 Subpart D) X
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
luu Naleum
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K040549
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
