K Number
K013752
Device Name
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
Date Cleared
2002-01-30

(78 days)

Product Code
Regulation Number
868.1840
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
ComPAS (computerized Pulmonary Analysis Sysem)
More Information

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Not Found

No
The document does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with AI/ML in medical devices (like image processing, training/test sets, or performance metrics related to algorithmic accuracy).

No.
The device is a software for displaying flow and volume spirometry data for pulmonary function testing and reports, not directly treating a disease or condition.

Yes
The device is intended to display flow and volume spirometry data from patient effort for use in pulmonary function testing and reports, which are diagnostic activities.

No

The intended use explicitly states the software operates with a pneumotachograph, indicating a hardware component is required for the device's function.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the software operating with a pneumotachograph to display flow and volume data from patient effort for pulmonary function testing. This is a measurement of physiological function in vivo (within the living body), not an analysis of samples in vitro (outside the living body).
  • Device Description: The description "computerized Pulmonary Analysis System" further supports its role in analyzing pulmonary function directly from the patient.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD.

Therefore, the ComPAS software, as described, is a medical device used for pulmonary function testing, but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes

73 BZG

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

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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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Page 1 of 1

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