(119 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the device, with no mention of AI or ML.
No.
The device's stated intended use is "To filter air between the patient's exhaled air and the testing equipment" for pulmonary function testing. It acts as a barrier to protect equipment and does not directly treat or diagnose a disease or condition for the patient.
No
The device is a filter used with pulmonary function testing equipment. Its purpose is to filter air, not to diagnose or provide diagnostic information itself. It is explicitly described as filtering air between the patient and the testing equipment.
No
The device description explicitly states it is a "filter" with "lightweight, compact housing with electrostatic filter media," indicating it is a physical hardware component. The performance studies also focus on physical characteristics like filtration efficiency and resistance to flow.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "filter air between the patients's exhaled air and the testing equipment" during pulmonary function testing. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on a specimen.
- Device Description: The description focuses on the physical components and function of a filter (housing, electrostatic filter media). It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
The device's function is to protect the testing equipment and potentially reduce the spread of pathogens during a pulmonary function test, which is a physiological measurement, not an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
For use with pulmonary function testing. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, disposable.
Product codes
BZG
Device Description
The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary Page 1 of 2 28-Feb-09
| Pulmonary Filtration Technologies, LLC
755 A Buckley Rd.
San Luis Obispo, CA 93401 | MAR - 2 2005
Tel - 800-837-6751
Fax - 805-763-1303 |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Official Contact: | Richard J. White, President |
| Proprietary or Trade Name: | The PFT Filter |
| Common/Usual Name: | PFT filter |
| Classification Name: | Diagnostic spirometer (accessory) |
| Device: | The PFT Filter |
| Predicate Devices: | Engineered Medical Systems - PFT - K013123
PDS KoKo -- K934475 |
Device Description:
The PFT Filter is filter for use with PFT equipment and testing. It is intended to interface between the equipment and the patient during the test. It has a lightweight, compact housing with electrostatic filter media.
Indications for Use:
| Indications for Use -- | For use with pulmonary function testing. To filter air between
the patient's exhaled air and the testing equipment.
Single patient use, single session, disposable. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories |
| Contraindications -- | None |
1
510(k) Summary Page 2 of 2 28-Feb-09
| Attribute | Proposed | Predicates |
|---|---|---|
| The PFT Filter | ||
| Indications for Use | For use with pulmonary function | |
| testing. To filter air between the | ||
| patients's exhaled air and the | ||
| testing equipment. | For use with pulmonary function | |
| testing. To filter air between the | ||
| patients's exhaled air and the | ||
| testing equipment. | ||
| EMS - PFT - K013123 | ||
| Environments of use | Hospital, Sub-acute Institutions, | |
| Doctor's offices, Laboratories | Hospital, Sub-acute Institutions, | |
| Doctor's offices, Laboratories | ||
| EMS - PFT - K013123 | ||
| Single patient use, single | ||
| session, disposable | Yes | Yes |
| EMS - PFT - K013123 | ||
| May be used on different PFT | ||
| testing machines | Yes | Yes - not specified |
| EMS - PFT - K013123 | ||
| Design and Performance Testing and Results | ||
| Filter media type | Electrostatic | Electrostatic |
| EMS - K013123, | ||
| PDS KoKo - K934475 | ||
| Internal volume | 51 ml | 50 ml |
| PDS KoKo – K934475 | ||
| Resistance to flow | ||
| (Reported as an average) | 0.5 cm H2O @ 60 Lpm | |
| 0.7 cm H2O @ 720 Lpm | 0.5 cm H2O @ 60 Lpm | |
| 0.7 cm H2O @ 720 Lpm | ||
| EMS - K013123 | ||
| Bubble test per ASTM F316-03 | 1.0 cm H2O @ .26 Lpm | 1.2 cm H2O @ 0.26 Lpm |
| Reference only | ||
| Bacterial Filtration Efficiency | 99.9+% | 99.99+% |
| Viral Filtration Efficiency | 99.9+% | 99.99+% |
| PDS - KoKo-K934475 | ||
| Per Nelson Labs (MIL-M-36954 | ||
| -1975) | ||
| Weight | 46 gm | 41 gm |
| PDS-KoKo – K934475 | ||
| Duration of use | Trade/Device Name: The PFT Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 16, 2009 Received: February 18, 2009 |
Dear Mr. Dryden:
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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sultte y. Micham Ons.
Ginette Y, Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
K083233 510(k) Number:
Device Name: The PFT Filter
Indications for Use:
For use with pulmonary function testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zra M. Z-
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KO83233
Page S1.16