(239 days)
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
Based on 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
The Morgan EX 671 exercise test system is intended as a configurable, non-invasive exercise testing system.
This document is a 510(k) premarket notification letter from the FDA regarding the "Pulmolab EX671 Exercise Testing System." It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain any information about acceptance criteria, a study that proves the device meets those criteria, or any details about device performance or testing methodologies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is an approval letter, not a study report or a summary of performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
X Prescription
use
- or - Over-the-
Counter use
§ 868.1840 Diagnostic spirometer.
(a)
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.(b)
Classification. Class II (performance standards).