(78 days)
The ComPAS software is intended to operate with the ScreenStar pneumotachograph The Oomr AS sonward to intended to tpon the ScreenStar to display the flow and volume spiromotor: Gomi FD doo hy from patient effort. This information is formatted for use in pulmonary function testing and reports.
ComPAS (computerized Pulmonary Analysis Sysem)
I am sorry, but based on the provided text, the document is a 510(k) clearance letter for the ComPAS (computerized Pulmonary Analysis System) software. It affirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain the detailed study information such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any information about a multi-reader multi-case study, or standalone performance. The letter refers to indications for use but does not delve into the specifics of the testing methodology or results.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Mr. Patrick Morgan Morgan Scientific Inc. 151 Essex Street Haverhill, MA 01832
Re: K013752
ComPAS (computerized Pulmonary Analysis Sysem) Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II (two) Product Code: 73 BZG Dated: November 7, 2001 Received: November 13, 2001
Dear Mr. Morgan:
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. Patrick Morgan
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 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 yours,
Kollath
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):K013752
Device Name: ComPAS Software
Indications For Use:
The ComPAS software is intended to operate with the ScreenStar pneumotachograph The Oomr AS sonward to intended to tpon the ScreenStar to display the flow and volume spiromotor: Gomi FD doo hy from patient effort. This information is formatted for use in pulmonary function testing and reports.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Denla Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K015752
§ 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).