(185 days)
The ComPAS software is intended to operate with the ScreenStar pneumotachograph spirometer, Morgan Transflow Test PFT System and the Morgan Transfer Test Benchmark PFT System. ComPAS uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS also utilizes gas analyzer readings from the Transflow Test and Transfer Test Benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.
Not Found
This document is an FDA 510(k) clearance letter for the ComPAS Software, a diagnostic spirometer. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain the detailed study information requested in the prompt.
Therefore, I cannot provide the specific answers to your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based solely on the provided text. The letter only indicates that a premarket notification was reviewed and found to be substantially equivalent.
To answer your questions, I would need access to the actual 510(k) premarket notification submission for K021200, which would typically include the performance testing and validation data.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 00 Corporate Boulevard ckville MD 20850
Mr. Patrick F. Morgan President Morgan Scientific, Incorporated 151 Essex Street Haverhill, Massachusetts 01832
Re: K021200
Trade/Device Name: ComPAS Software Regulation Number: 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: July 22, 2002 Received: August 2, 2002
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.
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.
{1}------------------------------------------------
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.
Tim A. Ulatowski
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
{2}------------------------------------------------
Morgan Scientific, Inc. 151 Essex Street Haverhill, MA 01832
Establishment Registration Number: 8020734
July 18th 2002
510(k) Number: K021200
Device Name: ComPAS Software
Indications For Use:
The ComPAS software is intended to operate with the ScreenStar pneumotachograph spirometer, Morgan Transflow Test PFT System and the Morgan Transfer Test Benchmark PFT System. ComPAS uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS also utilizes gas analyzer readings from the Transflow Test and Transfer Test Benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devi 510(k) Number:_
Confidential Appendix B
§ 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).