(185 days)
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K/DEN number and list them here in a comma separated list exactly as they appear in the text:
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No
The summary describes software that processes and displays data from spirometers and gas analyzers, but there is no mention of AI or ML techniques being used for analysis, interpretation, or prediction.
No
The software is for displaying and formatting pulmonary function test data; it does not provide any treatment or therapy.
Yes
The device "ComPAS" uses measured flow and volume information, as well as gas analyzer readings, directly from patient effort to display data for "pulmonary function testing and reports". Pulmonary function tests are diagnostic tools used to assess lung function and diagnose respiratory conditions.
Yes
The device is described as "ComPAS software" and its intended use is to operate with and utilize data from external hardware devices (spirometers and PFT systems) for display and reporting. There is no mention of any hardware component being part of the ComPAS device itself.
Based on the provided information, it is unlikely that the ComPAS software is an IVD (In Vitro Diagnostic) device. Here's why:
- Focus on Patient Effort and Direct Measurement: The intended use explicitly states that ComPAS uses data measured directly from patient effort (flow, volume, gas analyzer readings). This indicates the software is processing physiological measurements taken from the patient's body, not analyzing samples in vitro (outside the body).
- Pulmonary Function Testing: The information is formatted for use in pulmonary function testing. Pulmonary function tests are typically performed by having the patient breathe into a device, which measures their lung capacity and airflow. This is a direct physiological measurement, not an in vitro test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for the diagnosis, monitoring, or treatment of diseases based on the analysis of biological samples.
In summary, the ComPAS software appears to be a data processing and display tool for physiological measurements obtained directly from a patient during pulmonary function testing, rather than a device that analyzes samples in vitro.
N/A
Intended Use / 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.
Product codes
BZG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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.
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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
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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