AIR SAFETY HEPA, MODEL 3500

K040712 · Air Safety, Ltd. · MOD · Jun 3, 2004 · Anesthesiology

Device Facts

• Record ID: K040712
• Device Name: AIR SAFETY HEPA, MODEL 3500
• Applicant: Air Safety, Ltd.
• Product Code: MOD · Anesthesiology
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2

Intended Use

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway.

Device Story

Air Safety HEPA Model 3500/01 is a disposable, screw-in cartridge inlet filter for NPB Achieva or LP 10 ventilators. Device functions as a mechanical barrier in the gas flow pathway to remove particles ≥ 0.3 microns from air entering the ventilator. Operated by clinicians or patients in home, hospital, or emergency settings during routine preventive maintenance. Output is filtered air; benefits patient by preventing particulate contamination of ventilator gas supply.

Clinical Evidence

Bench testing only. HEPA particulate filtration efficiency verified via DOP aerosol testing methods (DOE 3025-99, DOE 3020-97, ASTM D2986). Results: ≥ 99.97% retention of 0.3 micron particles at 60 Lpm and 100 Lpm. Flow resistance: ≤ 0.9 cm H2O @ 40 Lpm and ≤ 1.25 cm H2O @ 60 Lpm.

Technological Characteristics

HEPA particulate filter; K-resin housing; paper fiber filter media. Screw-in cartridge form factor. Filtration efficiency ≥ 99.97% for 0.3 micron DOP particles per ASTM D2986, DOE 3025-99, and DOE 3020-97. Flow resistance ≤ 0.9 cm H2O @ 40 Lpm; ≤ 1.25 cm H2O @ 60 Lpm.

Indications for Use

Indicated for use as a HEPA particulate filter for the inlet air supplied to patients from NPB Achieva or LP 10 ventilators. Used in home, hospital, sub-acute institutions, and emergency services settings. Prescription use only.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• NPB Achieva ventilator (K990177)
• EMS filter (K013089)

Submission Summary (Full Text)

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Premarket Notification - K040712

### 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 2 1-June-04

| Official Contact: | Steve Brown - Quality Manager |
|----------------------------|----------------------------------------------------------|
| Proprietary or Trade Name: | Air Safety HEPA Model 3500 Filter |
| Common/Usual Name: | Inlet filter |
| Classification Name: | Accessory to a Continuous Ventilator (Respirator), MOD |
| Predicate Devices: | NPB Achieva ventilator - K990177<br>EMS filter - K013089 |
| Device Description | |

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator.

It is a HEPA grade particulate filter for the NPB Achieva or LP 10 ventilators, which is in the gas flow pathway.

HEPA particulate filtration testing was performed via standard DOP aerosol testing methods. There are no Bacterial or Viral filtration efficiency (BFE / VFE) claims made or required for this filter.

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter Intended Use -removes particles of 0.3 micron size (or larger) from entering the ventilator. It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway. It is changed during periodic maintenance of the ventilator.

Environment of Use -- Where the NPB Achieva and LP 10 ventilators are used, i.e., Home, Hospital, Sub-acute Institutions, Emergency services

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 1-June-04

| General Technical Characteristics | |
|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Attribute | Air Safety |
| Indications for use – As a HEPA particulate<br>filter for the inlet air to be supplied to the<br>patient from the ventilator. | Same |
| Intended for disposable, extended use –<br>preventive maintenance | Yes |
| Prescription | Yes |
| Specific equipment | Only for use with the NPB Achieva and LP 10<br>ventilators |
| Intended Environment of Use | As specified by the ventilator |
| Design | |
| Screw-in cartridge to fit the inlet air filter port<br>of the ventilator housing | Yes |
| Dead Space (ml) | Not applicable as it is not in the patient circuit |
| Resistance to flow | ≤ 0.9 cm H2O @ 40 Lpm<br>≤ 1.25 cm H2O @ 60 Lpm |
| HEPA – particulate filtration efficiency<br>(retention) | ≥ 99.97%of 0.3 micron DOP particle at 60 Lpm<br>> 99.97%of 0.3 micron DOP particle at 100 Lpm |
| Materials | |
| Housing K-resin | Yes |
| Filter media - HEPA | Paper fiber |
| Performance Standards | |
| None under Section 514 | Yes |
| DOE 3025- 99, DOE 3020-97 and<br>ASTM D2986 - DOP | Yes ≥ 99.97% of 0.3 micron DOP particle<br>at 60 Lpm and 100 Lpm |

# Differences between Other Legally Marketed Predicate Devices

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines above two wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2004-

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

Rc: K040712

Trade/Device Name: Air Safety HEPA Model 3500 Regulation Number: 21 CFR 868.5895 Regulation Name: Accessory to Continuous Ventilator (Respirator) Regulatory Class: Class II Product Code: MOD Dated: March 17, 2004 Received: March 18, 2004

Dcar Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to re would your end 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, of to do research Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provide for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh 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 mean that 127 may and statutes and regulations administered by other Federal agencies. or the Act of arry I business on the Act's requirements, including, but not limited to: registration

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Page 2 - Mr. Paul Dryden

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 607), laceling systems-(QS) regulation (21 CFR Part 820); and if requirences as set form in the quarty of the 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) This letter will anon you to begin made 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), If you desire specific at 100 for your as 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chris Liu, Ph.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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## Indications for Use

Page 1 of 1

| 510(k) Number: | K040712 (To be assigned) |
|----------------|-----------------------------------------|
| Device Name: | Air Safety HEPA filters - Model 3500/01 |

## Intended Use:

Model 3500/01 is a replacement part for the ventilator. The Inlet Filter removes particles of 0.3 micron size (or larger) from entering the ventilator.

It is a HEPA grade particulate filter for use with the NPB Achieva or LP 10 ventilators. The filter is in the gas flow pathway.

Prescription Use XX (Per CFR 801.109)

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Amy Siliom

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: k040712