(264 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with these technologies in the context of medical devices. The performance testing focuses on conformance to established standards and waveforms, not on the evaluation of an AI/ML model.
No
The device is described as an analyzer intended to acquire and interpret pulmonary function data and CO analysis, indicating a diagnostic or monitoring purpose rather than a therapeutic one.
Yes
Explanation: The device is intended to "acquire and interpret pulmonary function data," and "interpret" implies providing information that can be used for diagnosis. The testing against ATS guidelines for spirometry further supports its diagnostic intent, even if it does not meet accuracy guidelines.
Unknown
The provided text does not contain a device description, which is crucial for determining if the device is software-only. The testing description mentions an "Intelliflow unit" and a "LFS simulator," suggesting potential hardware components, but this is not definitive without a device description.
Based on the provided information, the SIMTEC Intelliflow Respiratory Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "acquire and interpret pulmonary function data and for CO analysis." This describes a device that measures physiological parameters directly from a patient's respiratory system, not a device that analyzes samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: While the description is "Not Found," the intended use strongly suggests a non-IVD device.
- No mention of analyzing samples: The description of the device's function focuses on acquiring and interpreting pulmonary function data, which is done by interacting with the patient's breathing. There is no mention of analyzing biological samples.
Therefore, the SIMTEC Intelliflow Respiratory Analyzer falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO 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.
Product codes
73 BZC
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
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1880 Pulmonary-function data calculator.
(a)
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.(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 image of three human profiles facing right, with flowing lines extending from the bottom of the profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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 Requlatory Class: II (two) Product Code: 73 BZC November 5, 1997 Dated: November 7, 1997 Received:
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 You provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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 analysis. The and interpret pulmonary function data and for CO 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 Kitzhaber
John R. Simpson SIMTEC, INC.
Nov. 26, 1997
A.L. A. Coth.
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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 970840 510(k) Number
CTC
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