MODEL 2800 PFT FILTER

K051712 · Air Safety, Ltd. · BZG · Sep 1, 2005 · Anesthesiology

Device Facts

• Record ID: K051712
• Device Name: MODEL 2800 PFT FILTER
• Applicant: Air Safety, Ltd.
• Product Code: BZG · Anesthesiology
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1840
• Device Class: Class 2

Intended Use

Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use

Device Story

Compact, single-patient-use electrostatic filter for pulmonary function testing (PFT) circuits; housing made of polystyrene with electrostatic polypropylene filter media. Device connects between patient and PFT equipment to filter exhaled air; prevents cross-contamination. Used in hospitals, sub-acute institutions, and physician offices. Operates as a passive mechanical barrier; no active components. Benefits patient by reducing risk of pathogen transmission during respiratory diagnostic procedures.

Clinical Evidence

Bench testing only. Bacterial and viral filtration efficiency (BFE/VFE) testing performed by Nelson Laboratories demonstrated 99.9999% bacterial filtration and 99.999+% viral filtration, matching the predicate device.

Technological Characteristics

Compact housing; polystyrene housing; electrostatic polypropylene filter media; 75 ml deadspace; flow resistance 0.7 cm H2O at 720 lpm and 0.5 cm H2O at 60 lpm; single-patient use; various end-fittings for PFT equipment compatibility.

Indications for Use

Indicated for use with pulmonary function testing equipment for any patient requiring air filtration between exhaled air and testing equipment.

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 (K013123)

Submission Summary (Full Text)

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SEP - 1 2005 Air Safety Model 2800 PFT Filter

## Section 4 - Certifications and Summaries

#### Summary of Safety and Effectiveness 4.1

### Air Safety Ltd. NFC House, Vickers Industrial Estate Mellishaw Lane Morecambe, Lancs LA3 3EN England

#### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 23-June-05

| Official Contact: | Steve Brown - Quality Manager |
|----------------------------|--------------------------------------|
| Proprietary or Trade Name: | Air Safety Model 2800 PFT Filters |
| Common/Usual Name: | PFT Filter |
| Classification Name: | Diagnostic Spirometer Accessory, BZG |
| Predicate Devices: | Engineered medical Systems - K013123 |
| Device Description: | |

The EMS PFT Filter is acompact, electrostatic filter with various end-fitting adaptable to various pulmonary function testing circuits. It has 75 ml deadspace of 0.7 cm H2O at 720 lpm per ATS spirometry guidelines or 0.5 cm H2O @ 60 lpm. There are various connectors to allow connection to various PFT equipment. Single patient use.

BFE and VFE testing has been performed by Nelson Laboratories to demonstrate substantial equivalence to the predicate device.

| Intended Use and Environments |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Indications for Use -- Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment.

Environment of Use -- Hospital, Sub-acute Institutions, Physician Offices

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Section 4 - Certifications and Summaries

## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 23-June-05

# General Technical Characteristics

| | Proposed device<br>Filter – Model 2800 | Predicate EMS K013123 |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | | |
| Intended use | For use with pulmonary function<br>testing equipment, to filter air<br>between the patient's exhaled air<br>and the testing<br>equipment | For use with pulmonary<br>function testing equipment, to<br>filter air between the patient's<br>exhaled air and the testing<br>equipment |
| Intended for single patient | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population | Any patient | Same |
| Intended Environment of Use | Hospital, sub-acute, physician<br>office | Hospital, sub-acute |
| Can be used with several<br>different PFT machines | Yes | Yes |
| Design Features | | |
| Compact housing | Yes | Yes |
| Various end-fittings | Yes | Yes |
| Dead Space (ml) | 75 ml | 75 ml |
| Resistance to flow at 720 lpm<br>per ATS standard for<br>spirometry | $0.7 cm H_2O$ | $0.7 cm H_2O$ |
| Resistance to flow at 60 lpm | $0.5 cm H_2O$ | $0.5 cm H_2O$ |
| Bacterial filtration | 99.9999% | 99.9999% |
| Viral filtration | 99.999+% | 99.999+% |
| Weight | 40 gm | 40 gm |
| Materials | | |
| Housing polystyrene | Yes | Yes |
| Filter media | Electrostatic polypropylene | Electrostatic polypropylene |
| Performance | | |
| None under Section 514 | Yes | Yes |

# Differences between Other Legally Marketed Predicate Devices

The proposed device, Model 2800, is identical to the predicate. Air Safety manufactures the predicate for EMS, therefore there are no significant differences.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2005

Air Safety Limited C/O Mr. Paul Dryden Regulatory Consultant Promedic, Incorporated 6329 W. Waterview Ct. McCordsville, Indiana 46055-9501

Re: K051712

Trade/Device Name: Model 2800 PFT Filter Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: II Product Code: BZG Dated: June 23, 2005 Received: June 27, 2005

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Suette H. Michael D.M.D

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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| 4.3 | Indications for Use |
|-----|---------------------|
|-----|---------------------|

| | Page 1 of 1 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K051712 |
| Device Name: | Air Safety Model 2800 PFT filter |
| Intended Use: | Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. |
| | Single patient use |
| Environment of Use: | Hospital, Sub-acute Institutions, Physician offices |
| Prescription Use XX (Per CFR 801.109) | or Over-the-counter use |

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number.