AIR SAFETY HEPA AND NON-HEPA FILTERS

K033008 · Air Safety, Ltd. · CAH · May 13, 2004 · Anesthesiology

Device Facts

• Record ID: K033008
• Device Name: AIR SAFETY HEPA AND NON-HEPA FILTERS
• Applicant: Air Safety, Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.

Device Story

Air Safety HEPA and non-HEPA filters are single-patient-use devices designed for integration into anesthesia and respiratory breathing circuits. The devices utilize standard 15/22 mm connectors, with optional gas sampling luer ports, to filter inspired and expired gases. HEPA models employ pleated paper fiber media for depth filtration, while non-HEPA models use electrostatic polypropylene media. Used in hospitals, homes, sub-acute institutions, and emergency services, these filters protect patients and equipment by reducing bacterial and viral transmission. Healthcare providers install the filters within the ventilator or circuit exhalation limb to maintain gas sterility. The device provides passive filtration; it does not require active power or electronic processing. Clinical benefit includes the reduction of cross-contamination risks in respiratory support environments.

Clinical Evidence

Bench testing only. Performance validated via bacterial filtration efficiency (BFE) and viral filtration efficiency (VFE) testing conducted by Nelson Laboratories. HEPA models demonstrated up to 99.99999% filtration efficiency; non-HEPA models demonstrated up to 99.99996% BFE. Testing performed in accordance with EN 13328, DOE-3025-99, DOE-3020-97, and ASTM D2986 standards. No clinical trials were conducted.

Technological Characteristics

Housing: Polystyrene. Filter media: Pleated paper fiber (HEPA) or polypropylene (electrostatic non-HEPA). Connectivity: Standard 15/22 mm conical connectors (ISO 5356-1) and luer fittings (ISO 594-2). Resistance to flow: < 3.4 cm H2O at 60 Lpm. Dead space: 45-84 ml. Filtration performance tested per EN 13328, DOE-3025-99, DOE-3020-97, and ASTM D2986.

Indications for Use

Indicated for patients requiring filtration of inspired and/or expired gases during use with ventilators, anesthesia machines, and open flow systems. Applicable for patients with tidal volumes > 150 ml. Single patient use up to 24 hours.

Regulatory Classification

Identification

A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Predicate Devices

• Engineered Medical Systems HEPA (K013089)
• Engineered Medical Systems Non-HEPA (K013122)
• Smiths Filter (K002201)
• NPB D/X7 (K964540)
• NPB D/X7 (K984379)

Submission Summary (Full Text)

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K033008

## MAY 1 3 2004

### Summary of Safety and Effectiveness

### Air Safety Ltd. NFC House, Vickers Industrial Estate Mellishaw Lane Morecambe, Lancaster LA3 3EN England Non-Confidential Summary of Safety and Effectiveness Page 1 of 3 7-May-04

| Official Contact: | Steve Brown – Quality Manager |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Air Safety HEPA and non-HEPA Filters |
| Common/Usual Name: | Bacterial / Viral Filters |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH |
| Predicate Devices: | Engineered Medical Systems –<br>HEPA - K013089<br>Non-HEPA – K013122<br>Smiths Filter – K002201<br>NPB D/X7 - K964540 and K984379 |

### Device Description

The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.

### Indications for Use and Environments

Indications for Use -

### Anesthesia / Respiratory Filters

For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.

Model - HEPA filter 3000/04 - Single patient use for exhalation limb of circuit on NPB 700 series ventilators

Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model - Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.

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## Non-Confidential Summary of Safety and Effectiveness

Page 2 of 3 7-May-04

Environment of Use --

Home, Hospital, Sub-acute Institutions, Emergency services

## General Technical Characteristics

| Attribute | Air Safety |
|----------------------------------------------------------------------------|-------------------------------------------------|
| Indications for use - To filter inlet, inspired<br>and / or expired gases. | Same |
| Intended for extended or single patient use up<br>to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient some with tidal volumes > 150 ml |
| Intended Environment of Use | Home, Hospital, sub-acute, Emergency services |
| Placement in various locations in circuit or<br>ventilator | Yes |
| Design | |
| Gas sampling port | Optional |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 45 to 84 ml<br>209 mm for Model 3000/04 |
| Resistance to flow | < 3.4 cm H2O @ 60 Lpm |
| HEPA - Models - 6500/01, 6888/01,<br>8222/01, 8444/01 | 99.99999%<br>Model 3000/04 - 99.9999% |
| Bacterial filtration - BFE - Nelson | |
| HEPA - Models - 6500/01, 6888/01,<br>8222/01, 8444/01 | 99.99975%<br>Model 3000/04 - 99.9999% |
| Viral filtration - VFE - Nelson | |
| Non- HEPA - Model 4000/01 | 99.99996% |
| Bacterial filtration - BFE – Nelson | |
| Non- HEPA - Model 4000/01 | 99.99925% |
| Viral filtration - VFE - Nelson | |
| Materials | |
| Housing polystyrene | Yes |
| Filter media - HEPA | Paper fiber |
| Filter Media - Electrostatic - non-HЕРА | Polypropylene |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| DOE 3025-99, DOE 3020-97 and ASTM<br>D2986 - DOP | > 99.97% of 0.3 micron DOP particle @<br>60 Lpm |

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### Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 7-May-04

# Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the The data within the backle and effective and substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2004

Air Safety Ltd. C/O Mr. Paul Dryden ProMcdic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055

Re: K033008

Trade/Device Name: Air Safety HEPA and Non-HEPA Filters Regulation Number: 21 CFR 868.5620 Regulation Name: Filter, Bacterial, Breathing-Circuit Regulatory Class: Class II Product Code: CAH Dated: March 12, 2004 Received: March 15, 2004

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 for assession 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.

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

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Page 2 -- Mr. Paul Dryden

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deeting your device as described in your Section 510(k) i his letter will anow you to begin manketing your unce of your device of your device to a legally premarket nothleadon: "The PDA mumg of Gastian 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 If you desire specific acrice for your 201) 594-4646. Also, please note the regulation entitled, Contact the Office of Compraise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Syra Jurn

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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## Indications for Use

| | Page 1 of 1 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K033008 (To be assigned) |
| Device Name: | Air Safety HEPA filters<br>Model 3000/04<br>Models – 6500/01, 6888/01, 8222/01, 8444/01<br>Non-HEPA filters – Model – 4000/01 |

### Indications for Use:

### Ancsthesia / Respiratory Filters

Ancistiesia / Respiratory / Interia machines and open flow systems where filtration of inspired and / or expired gases is desired.

Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators

Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Noder - Non 1121 111111111111111111111111111111111111111111111111111111111111111111111

| Prescription Use XX | |
|---------------------|--|
| (Per CFR 801.109) | |

or

| Over-the-counter use | |
|----------------------|--|
|----------------------|--|

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am

(Division Sion-Off Division of Anesthesiology General Hospital. Infection Control, Dental Devices

510(k) Number: KC33658