INTELLIFLOW RESPIRATORY ANALYZER

K970840 · Simtec, Inc. · BZC · Nov 26, 1997 · Anesthesiology

Device Facts

• Record ID: K970840
• Device Name: INTELLIFLOW RESPIRATORY ANALYZER
• Applicant: Simtec, Inc.
• Product Code: BZC · Anesthesiology
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1880
• Device Class: Class 2

Intended Use

The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO₂ analysis. The Intelliflow unit was tested at LDS Hospital to verify that it conforms to the 24 wave forms recommended by the American Thoracic Society Standard of Spirometry, Am. Rev. Respir. Dis. 1987;136, 1285-1298. The Intelliflow does not meet the ATS guidelines for accuracy. The following five wave forms have not been qualified for accuracy according to the LFS simulator: #3FVC, #15MMEF, #21FVC, #23FVC, #24FVC. A copy of the actual results is enclosed with the operator's manual. Please contact SIMTEC for an explanation of the differences in the LDS simulator results and the method used by SIMTEC to verify the accuracy of all 24 wave forms. This device is not intended for patient monitoring.

Device Story

Intelliflow Respiratory Analyzer acquires and interprets pulmonary function data and CO2 levels. Device processes respiratory signals to generate diagnostic data. Used in clinical settings for pulmonary assessment; not for patient monitoring. Healthcare providers use output to interpret respiratory function. Device performance verified against American Thoracic Society (ATS) spirometry waveforms; specific waveforms (#3FVC, #15MMEF, #21FVC, #23FVC, #24FVC) noted as not qualified for accuracy per LDS simulator.

Clinical Evidence

Bench testing only. Device tested at LDS Hospital against 24 waveforms recommended by American Thoracic Society (ATS) Standard of Spirometry. Results indicate device does not meet ATS guidelines for accuracy; five specific waveforms (#3FVC, #15MMEF, #21FVC, #23FVC, #24FVC) failed qualification on LFS simulator.

Technological Characteristics

Respiratory analyzer for pulmonary function and CO2 analysis. Connectivity and materials not specified. Software-based interpretation of respiratory waveforms.

Indications for Use

Indicated for acquisition and interpretation of pulmonary function data and CO2 analysis. Not intended for patient monitoring.

Regulatory Classification

Identification

A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV 26 1997

Mr. John R. Simpson
SIMTEC, Inc.
P.O. Box 816
217 North Main Street
Marion, South Carolina 29571

Re: K970840
INTELLIFLOW® Respiratory Analyzer
Regulatory Class: II (two)
Product Code: 73 BZC
Dated: November 5, 1997
Received: November 7, 1997

Dear Mr. Simpson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. John R. Simpson

This letter will allow you to begin marketing your device as described in your 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 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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K970840

# INDICATIONS FOR USE

The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO₂ analysis. The Intelliflow unit was tested at LDS Hospital to verify that it conforms to the 24 wave forms recommended by the American Thoracic Society Standard of Spirometry, Am. Rev. Respir. Dis. 1987;136, 1285-1298. The Intelliflow does not meet the ATS guidelines for accuracy. The following five wave forms have not been qualified for accuracy according to the LFS simulator: #3FVC, #15MMEF, #21FVC, #23FVC, #24FVC. A copy of the actual results is enclosed with the operator's manual. Please contact SIMTEC for an explanation of the differences in the LDS simulator results and the method used by SIMTEC to verify the accuracy of all 24 wave forms. This device is not intended for patient monitoring.


John R. Simpson
SIMTEC, INC.

Nov. 26, 1997