AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE

K050953 · Air Safety, Ltd. · CAH · Jun 29, 2005 · Anesthesiology

Device Facts

• Record ID: K050953
• Device Name: AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
• Applicant: Air Safety, Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

Filtration of exhaled gases in the ventilator circuit. Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators. Cleaning method - autoclaved - 30 minutes with 3 minutes at 134°C. Environment of Use -- Hospital, Sub-acute Institutions

Device Story

Air Safety Model 3000/06 is a reusable HEPA filter for ventilator exhalation pathways; designed for Series 700 and 7200 NPB ventilators. Device features clear polycarbonate housing and Multipleat paper fiber media. Filter captures bacteria and viruses from exhaled gases; performance validated via BFE/VFE testing and DOP particle testing. Reusable up to 100 times; sterilization via autoclave (134°C). Clinicians monitor filter status via ventilator self-testing (SST) mode, which detects increased airflow resistance to determine when replacement is necessary. Benefits include protection of equipment and environment from exhaled pathogens.

Clinical Evidence

Bench testing only. Performance validated against BS 3928 Sodium Flame, DOE 3202-97, and ASTM D2986 standards. BFE and VFE testing demonstrated 99.999% filtration efficiency. Flow resistance verified < 1.5 cm H2O at 60 lpm and < 2.5 cm H2O at 100 lpm.

Technological Characteristics

Polycarbonate housing; paper fiber HEPA filter media. Standard 15/22 mm conical connectors (ISO 5356-1). Filtration efficiency > 99.97% for 0.3 micron DOP particles (ASTM D2986). Sterilization: Autoclave (134°C).

Indications for Use

Indicated for filtration of expired gases in patients on Series 700 and 7200 NPB ventilators in hospital or sub-acute settings.

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

• Air Safety – Model 3000/04 – K033008
• PB Omniflow Filter – K890362

Submission Summary (Full Text)

{0}------------------------------------------------

C 050955

Air Safety Model 3000/06 Filter

Premarket Notification 510(k) Section 4 - Certifications and Summaries

JUN 2 9 2005

#### 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 14-Apr-05

| Official Contact: | Steve Brown – Quality Manager |
|----------------------------|----------------------------------------------------------------------|
| Proprietary or Trade Name: | Air Safety Model 3000/06 HEPA Filters |
| Common/Usual Name: | Bacterial / Viral Filters |
| Classification Name: | Filter, Bacterial, Breathing Circuit, CAH |
| Predicate Devices: | Air Safety – Model 3000/04 – K033008<br>PB Omniflow Filter – K890362 |
| Device Description | |

The Air Safety Model 3000/06 HEPA filter is a multi-use, reusable ventilator in-line filter which The An Bareey Indust side of the PB 700 series and 7200 ventilators. It can be cleaned by steam ecomeets in the ennation are 1 year service life. It has standard 22 mm tubing connectors and it has a clear housing. It contains the Air Safety standard Multipleat media which has been HEPA tested for enting performance according to BS 3928 Sodium Flame for Air filters and in accordance to DOE 3202-97 and ASTM D2986 - DOP. In addition BFE and VFE testing has been performed by 1902 5202 77 and in the substantial equivalence to the predicate devices.

#### Intended Use and Environments

Filtration of exhaled gases in the ventilator circuit.

Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the riousl 3000 to to be played. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.

Cleaning method - autoclaved - 30 minutes with 3 minutes at 134°C.

Environment of Use -- Hospital, Sub-acute Institutions

{1}------------------------------------------------

Section 4 - Certifications and Summaries

## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2

14-Apr-05

| Attribute | Air Safety Model 3000/04 - K033008<br>PB - Omniflow - K890362 |
|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for use - To filter expired gases. | Same |
| Intended for extended use up to 15 days<br>continuous, reusable up to 100 times via<br>autoclave or 1 year service life | Yes |
| Prescription | Yes |
| Intended population | Any patient on a ventilator - PB 700 series and<br>7200 |
| Intended Environment of Use | Hospital, sub-acute institution |
| Placement in exhalation limb of circuit | Yes |
| Design | |
| Reusable housing and materials | Yes |
| Clean by autoclave | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | ~ 350 ml |
| Resistance to flow | < 1.5 cm H₂O at 60 lpm and<br>< 2.5 cm H₂O at 100 lpm |
| HEPA - Bacterial filtration - BFE - Nelson<br>Lab. | 99.999% |
| HEPA - Viral filtration - VFE - Nelson Lab. | 99.999% |
| Materials | |
| Housing polycarbonate | Yes |
| Filter media - HEPA | Paper fiber |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| DOE 3202-97 and ASTM D2986 - DOP | Yes > 99.97% of 0.3 micron DOP particle |

# General Technical Characteristics

# Differences between Other Legally Marketed Predicate Devices

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged around the seal's perimeter. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2005

Mr. Paul Dryden President Air Safety Ltd. c/o ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501

Re: K050953

Trade/Device Name: Air Safety Model 3000/06 HEPA Filters Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: April 14, 2005 Received: April 18, 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.

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

{3}------------------------------------------------

### Mr. Paul Dryden

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,

Jenia y. Michieoms

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

{4}------------------------------------------------

#### Indications for Use 4.3

Page 1 of 1

| 510(k) Number: | K050953 (To be assigned) |
|----------------|-----------------------------------------------|
| Device Name: | Air Safety Model 3000/06 HEPA Reusable filter |

### Intended Use:

Filtration of exhaled gases in the ventilator circuit.

Model 3000/06 to be placed in the exhalation pathway of the ventilator circuit where filtration of the expired gases is desired. Filter is reusable up to 100 times, extended use as determined by the increase in airflow resistance, which is determined during self testing (SST) mode of the ventilator. For use with the Series 700 and 7200 NPB ventilators.

Cleaning method -- autoclaved -- 30 minutes with 3 minutes at 134°C.

Environment of Use --Hospital, Sub-acute Institutions

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|-------------------|----------------------|
| (Per CFR 801.109) | |
| | or |
| | Over-the-counter use |

(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K0S0953 |
|----------------|---------|
|----------------|---------|