SPIRO'AIR

K042595 · Morgan Scientific, Inc. · BZG · May 4, 2005 · Anesthesiology

Device Facts

• Record ID: K042595
• Device Name: SPIRO'AIR
• Applicant: Morgan Scientific, Inc.
• Product Code: BZG · Anesthesiology
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended 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 analyzers to display single breath diffusion data on the SpiroAir to display the reports.

Device Story

SpiroAir PFT System functions as a diagnostic spirometer; integrates with ComPAS pulmonary function software. Device captures flow and volume signals; utilizes gas analyzers to compute single breath diffusion data. System displays respiratory metrics and generates reports for clinical review. Used in clinical settings by healthcare professionals to assess patient lung function and support diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Diagnostic spirometer; operates with ComPAS software for data processing and display; includes gas analysis capability for diffusion testing; classified as Class II, Product Code BZG.

Indications for Use

Indicated for use in pulmonary function testing to measure and display flow, volume, and gas analysis data for clinical assessment of respiratory function.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use

510(k) K042595

Device Name: SpiroAir PFT System

Indications for use:

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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