(223 days)
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No
The summary describes a standard pulmonary function testing system and software, with no mention of AI or ML capabilities.
No
The device is used to measure and display flow, volume, and gas analysis for pulmonary function testing and reporting, which are diagnostic functions, not therapeutic.
Yes
The device is described as a "PFT System" which "uses flow and volume... to display the flow and volume information and to generate reports" and "utilizes gas analysis... to display single breath diffusion data and to generate reports." This indicates it gathers and processes physiological data for assessment and reporting, which is a diagnostic function for pulmonary health.
No
The summary explicitly states the device is a "SpiroAir PFT System" which operates with software (ComPAS). It also mentions utilizing "flow and volume from the SpiroAir" and "gas analysis from the SpiroAir," indicating a hardware component (the SpiroAir) is integral to the system.
Based on the provided information, it is unlikely that the SpiroAir PFT System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as operating with software to display and report on flow, volume, and gas analysis data for pulmonary function testing. This is related to measuring physiological parameters from a patient, not analyzing samples in vitro (outside the body).
- Lack of IVD Indicators: 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 specific substances or markers in those samples
- Providing diagnostic information based on the analysis of samples
Pulmonary function tests (PFTs) are generally considered in vivo diagnostic procedures, as they involve the patient directly interacting with the device to measure their lung function.
Therefore, based solely on the provided text, the SpiroAir PFT System appears to be a device used for in vivo pulmonary function testing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SpiroAir PFT System is intended to operate with the ComPAS pulmonary function software. ComPAS uses flow and volume from the SpiroAir to display the flow and volume information. ComPAS utilizes gas analysis to display the single breath diffusion data. ComPAS uses flow and volumes from the SpiroAir to display single breath diffusion data.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2005
Mr. Patrick F. Morgan President Morgan Scientific, Incorporated 151 Essex Street Haverhill, Massachusetts 01832
Re: K042595
Trade/Device Name: SpiroAir PFT System Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: April 20, 2005 Received: April 28, 2005
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 approvisions 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 (1 Writ), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Morgan
Please be advised that FDA's issuance of a substantial equivalence determination does not reast be auvrsed that i Dr o lessains on that your device complies with other requirements modifine Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal business requirements, including, but not limited to: registration Tod Intist comply with and are are any labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CFR Part 807), Mosility systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quadion 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) I mis letter will and in Jorder FDA finding of substantial equivalence of your device to a premarket notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you desire spieering and Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain 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/industry/support/index.html.
Sincerely yours,
Carl, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) K042595
Device Name: SpiroAir PFT System
Indications for use:
inclions in the PFT System is intended to operate with the ComPAS pulmonary function
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Prescription Use_ FTeSchption of Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mihard Wihard fo:
Page 1 of 1
510(k) Number.
(Division Sign-Off) Olvision of Anesthesiology, General Hospital, intection Control, Dental Devices