(119 days)
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.
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.
The provided text describes a 510(k) summary for "The PFT Filter," a device intended for use with pulmonary function testing equipment to filter air between the patient and the equipment.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (Predicate Device) | Reported Device Performance (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. |
| Environments of use | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories |
| Single patient use, single session, disposable | Yes | Yes |
| May be used on different PFT testing machines | Yes - not specified (for predicate EMS - PFT - K013123) | Yes |
| Filter media type | Electrostatic | Electrostatic |
| Internal volume | 50 ml (for predicate PDS KoKo – K934475) | 51 ml |
| Resistance to flow @ 60 Lpm | 0.5 cm H2O | 0.5 cm H2O |
| Resistance to flow @ 720 Lpm | 0.7 cm H2O | 0.7 cm H2O |
| Bubble test per ASTM F316-03 | 1.2 cm H2O @ 0.26 Lpm (Reference only) | 1.0 cm H2O @ .26 Lpm |
| Bacterial Filtration Efficiency (BFE) | 99.99+% | 99.9+% |
| Viral Filtration Efficiency (VFE) | 99.99+% (for predicate PDS - KoKo-K934475) | 99.9+% |
| Weight | 41 gm (for predicate PDS-KoKo – K934475) | 46 gm |
| Duration of use |
§ 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).