(329 days)
The Polytech filter is a disposable, single-patient session filter for spirometric and pulmonary function testing. The Polytech filter is designed to reduce cross contamination in pulmonary function equipment. The filter is to be used with children and adult subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician.
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This document is a 510(k) summary for the Polytech Pulmonary Function Filter, a disposable filter for spirometric and pulmonary function testing. As such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and study particulars for a device using an AI algorithm.
The questions you've asked are typically relevant for AI/ML-based medical devices that require extensive validation studies to demonstrate their performance against defined acceptance criteria. This document is for a physical, disposable filter, not an AI diagnostic or predictive tool.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This document does not define performance metrics in terms of sensitivity, specificity, accuracy, etc., as would be expected for an AI algorithm. Its performance relates to its physical function as a filter.
- Sample size used for the test set and the data provenance: Not applicable to a physical filter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document indicates that the device is a "Polytech Pulmonary Function Filter" and that it is "designed to reduce cross-contamination in pulmonary function equipment." The FDA deemed it "substantially equivalent" to legally marketed predicate devices. This equivalence is typically based on comparing the new device's technological characteristics and performance to those of a legally marketed predicate device, ensuring it's as safe and effective. The performance of such a filter would be assessed based on its filtration efficiency (e.g., bacterial/viral filtration efficiency), pressure drop, and absence of shedding, rather than diagnostic precision metrics.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines representing its wings.
AUG 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard
Public Health Service
Rockville MD 20850
Mr. Timothy Byrd President Polytechnic Resources Incorporated 1107 Middle River Road, Suite B-1 Baltimore, Maryland 21220
Re: K042758
Trade/Device Name: Polytech Pulmonary Function Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: August 23, 2005 Received: August 25, 2005
Dear Mr. Byrd:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosale) to tegans and ment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosmette Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to sueri additional connovous , Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of reants concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 lossantes or our device complies with other requirements of the Act that I DA has made a acteriminations administered by other Federal agencies. You must of any I cuttar statutes and regarations and limited to: registration and listing (21 comply with an the Ace 31equirements)01); good manufacturing practice requirements as set CFK Fatt 607), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control pro holors (Seeting your device as described in your Section 510(k) I his letter will anow you to obgin manieming of substantial equivalence of your device to a legally premits tourication. The PDF Imaling of ending of 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), please If you desire specific advice in 1940 (276-0120. Also, please note the regulation entitled, conlact the Office of Compullier and (2 + notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Sufette Y. Michie Oms.
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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1107 Middle River Road Baltimore, Maryland 21220
Image /page/2/Picture/1 description: The image shows the logo for Polytechnic Resources LLC. The logo features a stylized "PR" monogram on the left, with the words "polytechnic resources" in a bold, sans-serif font to the right of the monogram. The letters "LLC" are in a smaller font size and are located to the right of the word "resources".
410.391.4700 Fax 410.391.0507 Cell 443.570.3196
SECTION B
510 (k) NUMBER: K042758 DEVICE NAME: POLYTECH FILTER
INDICATIONS FOR USE
The Polytech filter is a disposable, single-patient session filter for spirometric and pulmonary function testing. The Polytech filter is designed to reduce cross pantionial in pulmonary function equipment. The filter is to be used with children and adult subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician.
Prescription Use __ X (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number
§ 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).