THE PFT FILTER

K083233 · Pulmonary Filtration Technologies, LLC · BZG · Mar 2, 2009 · Anesthesiology

Device Facts

• Record ID: K083233
• Device Name: THE PFT FILTER
• Applicant: Pulmonary Filtration Technologies, LLC
• Product Code: BZG · Anesthesiology
• Decision Date: Mar 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended 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.

Device Story

The PFT Filter is a disposable, single-use accessory for pulmonary function testing (PFT) equipment. It consists of a lightweight polystyrene housing containing electrostatic spun polypropylene filter media. During PFT procedures, the device is placed in-line between the patient and the testing equipment to filter exhaled air. It is operated by healthcare professionals in clinical settings such as hospitals, sub-acute institutions, and doctor's offices. By capturing particulates in the exhaled air, the filter protects the testing equipment from contamination and reduces the risk of cross-contamination between patients. The device is designed to be compatible with various PFT testing machines.

Clinical Evidence

Bench testing only. Performance data includes resistance to flow (0.5 cm H2O @ 60 Lpm; 0.7 cm H2O @ 720 Lpm), bubble test per ASTM F316-03 (1.0 cm H2O @ 0.26 Lpm), and bacterial/viral filtration efficiency (99.9+%).

Technological Characteristics

Housing: polystyrene; Filter media: electrostatic spun polypropylene. Dimensions: 51 ml internal volume, 46 gm weight. Resistance to flow: 0.5 cm H2O @ 60 Lpm, 0.7 cm H2O @ 720 Lpm. Filtration efficiency: 99.9+% bacterial/viral. Mechanical interface for PFT equipment.

Indications for Use

Indicated for use during pulmonary function testing to filter exhaled air between the patient and testing equipment. Intended for single patient, single session, disposable use in hospitals, sub-acute institutions, doctor's offices, and laboratories.

Regulatory Classification

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.

Predicate Devices

• Engineered Medical Systems - PFT - K013123
• PDS KoKo - K934475

Submission Summary (Full Text)

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# 510(k) Summary Page 1 of 2 28-Feb-09

| Pulmonary Filtration Technologies, LLC<br>755 A Buckley Rd.<br>San Luis Obispo, CA 93401 | MAR - 2 2005<br>Tel - 800-837-6751<br>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<br>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<br>the patient's exhaled air and the testing equipment.<br>Single patient use, single session, disposable. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Sub-acute Institutions, Doctor's offices, Laboratories |
| Contraindications -- | None |

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## 510(k) Summary Page 2 of 2 28-Feb-09

| Attribute | Proposed | Predicates |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PFT Filter | |
| Indications for Use | For use with pulmonary function<br>testing. To filter air between the<br>patients's exhaled air and the<br>testing equipment. | For use with pulmonary function<br>testing. To filter air between the<br>patients's exhaled air and the<br>testing equipment.<br>EMS - PFT - K013123 |
| Environments of use | Hospital, Sub-acute Institutions,<br>Doctor's offices, Laboratories | Hospital, Sub-acute Institutions,<br>Doctor's offices, Laboratories<br>EMS - PFT - K013123 |
| Single patient use, single<br>session, disposable | Yes | Yes<br>EMS - PFT - K013123 |
| May be used on different PFT<br>testing machines | Yes | Yes - not specified<br>EMS - PFT - K013123 |
| Design and Performance Testing and Results | | |
| Filter media type | Electrostatic | Electrostatic<br>EMS - K013123,<br>PDS KoKo - K934475 |
| Internal volume | 51 ml | 50 ml<br>PDS KoKo – K934475 |
| Resistance to flow<br>(Reported as an average) | 0.5 cm H2O @ 60 Lpm<br>0.7 cm H2O @ 720 Lpm | 0.5 cm H2O @ 60 Lpm<br>0.7 cm H2O @ 720 Lpm<br>EMS - K013123 |
| Bubble test per ASTM F316-03 | 1.0 cm H2O @ .26 Lpm | 1.2 cm H2O @ 0.26 Lpm<br>Reference only |
| Bacterial Filtration Efficiency | 99.9+% | 99.99+% |
| Viral Filtration Efficiency | 99.9+% | 99.99+%<br>PDS - KoKo-K934475 |
| Per Nelson Labs (MIL-M-36954<br>-1975) | | |
| Weight | 46 gm | 41 gm<br>PDS-KoKo – K934475 |
| Duration of use | < 24 hours | <24 hours or not specified<br>EMS PFT K013123 |
| Materials | Housing – polystyrene<br>Media - spun polypropylene | Identical – EMS – Filter–<br>K013122<br>Identical - AM Systems –<br>K063526 |
| Performance under Section 514 | None | None |

## Differences Between Other Legally Marketed Predicate Devices

The is viewed as substantially equivalent to the following predicate devices – K934475 - PDS - KoKo and K013123 - Engineered Medical Systems - PFT Filter

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is a common symbol of the United States, and its presence on the seal signifies the department's role in protecting the health and well-being of the nation. The text around the eagle clearly identifies the organization.

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Pulmonary Filtration Technologies, LLC C/o Mr. Paul Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

MAR - 2 2009

K083233 Re:

> 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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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### 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

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