(264 days)
The SIMTEC Intelliflow Respiratory Analyzer is intended to acquire and interpret pulmonary function data and for CO analysis.
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This document, a 510(k) clearance letter for the SIMTEC INTELLIFLOW® Respiratory Analyzer, provides limited information regarding acceptance criteria and study details. Based on the provided text, the following can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Conforms to the 24 waveforms recommended by the American Thoracic Society (ATS) Standard of Spirometry (Am. Rev. Respir. Dis. 1987;136, 1285-1298) for acquiring and interpreting pulmonary function data and for CO analysis. | The Intelliflow unit was tested at LDS Hospital to verify it conforms to the 24 waveforms. However, the Intelliflow does NOT meet the ATS guidelines for accuracy. Specifically, the following five waveforms have not been qualified for accuracy according to the LFS simulator: #3FVC, #15MMEF, #21FVC, #23FVC, #24FVC. (The document states "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.") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not explicitly stated. The document refers to "24 waveforms recommended by the American Thoracic Society Standard of Spirometry." It implies the device was tested against these 24 waveforms.
- Data provenance: The testing was performed at "LDS Hospital." The country of origin can be inferred to be the USA, given the FDA clearance. The study appears to be a prospective verification/validation study, as it was conducted to demonstrate conformance to a standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not stated. The "ground truth" for the test appears to be the defined characteristics of the ATS standard waveforms themselves, not observations by human experts. The accuracy against these waveforms was assessed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not stated. The evaluation was against a defined standard (ATS waveforms) using an LFS simulator, not through human adjudication of differing interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a respiratory analyzer for acquiring and interpreting pulmonary function data, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The "Intelliflow unit was tested... to verify that it conforms to the 24 wave forms." This implies an evaluation of the device's output against a standard without direct human intervention in the interpretation during the test. The device itself is designed to "acquire analysis and interpret pulmonary function data," suggesting its primary function is standalone interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth used was the specifications of the "24 waveforms recommended by the American Thoracic Society Standard of Spirometry" as generated by an "LFS simulator." This is an objective, standardized ground truth based on a recognized industry standard for spirometry.
8. The sample size for the training set
- Not applicable/Not stated. The INTELLIFLOW® Respiratory Analyzer described here appears to be a device for data acquisition and interpretation based on established physiological principles and algorithms, not a machine learning or AI-based device that typically requires a large training set in the modern sense.
9. How the ground truth for the training set was established
- Not applicable/Not stated, as there is no indication of a training set in the context of machine learning. The device's operation is based on conformity to a standard.
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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
c-
§ 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).