PULMOLAB EX671 EXERCISE TESTING SYSTEM

K020280 · Morgan Medical , Ltd. · BZG · Sep 24, 2002 · Anesthesiology

Device Facts

• Record ID: K020280
• Device Name: PULMOLAB EX671 EXERCISE TESTING SYSTEM
• Applicant: Morgan Medical , Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Sep 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system, targeted at a population age range of between 5 and 85 and capable of measuring directly the following parameters: a. Tidal volume b. Breathing frequency c. Expired oxygen d. Expired carbon dioxide. From the measured parameters the instrument calculates the following parameters: a. Oxygen uptake b. Carbon dioxide production c. Ventilation d. Respiratory exchange ratio e. Time of inspiration f. Time of expiration g. End tidal oxygen h. End tidal carbon dioxide i. Anaerobic threshold

Device Story

Pulmolab EX671 is a configurable, non-invasive exercise testing system. It measures tidal volume, breathing frequency, expired oxygen, and expired carbon dioxide directly. Using these inputs, the system calculates oxygen uptake, CO2 production, ventilation, respiratory exchange ratio, inspiratory/expiratory time, end-tidal gas concentrations, and anaerobic threshold. Used in clinical settings by healthcare professionals to assess patient respiratory and metabolic function during exercise. Output provides clinicians with physiological data to evaluate exercise performance and metabolic status, aiding in clinical decision-making regarding patient health and fitness.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diagnostic spirometer/exercise testing system. Measures respiratory gas flow and composition. Configurable, non-invasive. Class II device (21 CFR 868.1840).

Indications for Use

Indicated for non-invasive exercise testing in patients aged 5 to 85 years to measure respiratory and metabolic parameters including tidal volume, breathing frequency, oxygen uptake, CO2 production, ventilation, respiratory exchange ratio, and anaerobic threshold.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Morgan Medical Limited C/O Mr. Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street NW Washington DC 20004-1109

Re: K020280

Trade/Device Name: Pulmolab EX671 Exercise Testing System Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: June 26, 2002 Received: June 26, 2002

Dear Mr. Kahan:

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 or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Jonathan S. Kahan. Esq.

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

Susan Runge

Timothy A. Ulatowski 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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The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system, targeted at a population age range of between 5 and 85 and capable of measuring directly the following parameters:

- a. Tidal volume
- b. Breathing frequency -
- Expired oxygen c.
- d. Expired carbon dioxide

a. "Expred varion aron aroned parameters the instrument calculates the following parameters:

- a. Oxygen uptake
- Carbon dioxide production b.
- C. Ventilation
- Respiratory exchange ratio d.
- Time of inspiration e.
- f. Time of expiration
- End tidal oxygen g.
- End tidal carbon dioxide h.
- Anaerobic threshold i.

signature

Wision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K020180

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