BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178

K052087 · Ag Industries · CAH · Dec 14, 2005 · Anesthesiology

Device Facts

• Record ID: K052087
• Device Name: BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
• Applicant: Ag Industries
• Product Code: CAH · Anesthesiology
• Decision Date: Dec 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The AG Industries Breathing Filter Bacterial/Viral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical ventilators, IPPB machines and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.

Device Story

Single-use breathing circuit filter; reduces passage of airborne bacteria/viruses in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines. Device consists of plastic top/bottom housings with 22mm ID and 15mm ID/22mm OD ports; electrostatic filter element with bonded scrim secured via sonic weld. Used in hospital, home, or transport settings by clinicians or patients. Acts as a passive barrier to particulate matter; protects equipment and patients from cross-contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Plastic housing (top/bottom) with sonic weld joint; electrostatic filter material with bonded scrim; 22mm ID top port; 15mm ID/22mm OD bottom port. Single-use, passive mechanical filtration.

Indications for Use

Indicated for use as a single-use replacement filter in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce passage of particulate carrying airborne bacteria/viruses. Suitable for hospital, home, or transport 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

• Hudson RCI Bacteria/Viral Filter (K961914)

Submission Summary (Full Text)

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K052087

# 510(k) SUMMARY

DEC 1 4 2005

| Submission Correspondent: | Emergo Group, Inc. |
|---------------------------|---------------------------------------------------------------|
| Address: | 2454 McMullen Booth Road<br>Suite 427<br>Clearwater, FL 33759 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Mr. Ian Gordon |

| Submission Sponsor: | AG Industries<br>239 Seebold Spur<br>Fenton, MO 63026 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | October 17, 2005 |
| Trade Name: | Breathing Filter Bacterial / Viral |
| Common Name: | Bacteria Filter |
| Classification: | CAH, Filter, Bacterial, Breathing-Circuit<br>Regulation # 868.5260 |
| Description: | The Breathing Filter is a replacement filter for use mechanical<br>ventilators, anesthesia machines, manual resuscitation devices,<br>and IPPB machines. The product is composed of 3 main<br>elements. These include a top housing, a bottom housing, and a<br>filter element. The filter material is secured in the top and bottom<br>housing using a sonic weld joint.<br><ul><li>The top housing is made of plastic and has a clear polish finish and has a standard 22mm ID connection port.</li><li>The bottom housing is made of plastic and has a clear polish finish and has a standard 15mm ID/22mm OD connection port for universal usage.</li><li>The filter element is composed of electrostatic material, with a bonded scrim, on one side of the filter element only.</li></ul> |
| Intended Use: | The AG Industries Breathing Filter Bacterial/Viral is a single use<br>replacement filter intended for use in mechanical ventilators,<br>anesthesia machines, manual resuscitation devices, and IPPB<br>machines to reduce the passage of particulate that may carry<br>airborne bacteria and/or viruses. When used with mechanical<br>ventilators, IPPB machines and resuscitation devices, the<br>replacement filter may be used in the hospital, home, or transport<br>applications. |

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Predicate Devices: The predicate device referenced in this submission is:

Hudson Respiratory Care, Inc. – Hudson RCI Bacteria/Viral Filter - 510(k) # K961914

#### Safety and Effectiveness:

Performance testing has been completed on the AG Industries Breathing Filter Bacterial/Viral. The differences between the AG Industries Breathing Filter Bacterial/Viral specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness.

#### Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The differences between the AG Industries Breathing Filter Bacterial/Viral and the predicate device cited do not raise any different questions regarding safety and effectiveness. There are no significant differences in the technological characteristics or in the intended use of these devices.

The device, as designed and tested, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device.

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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 consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circle around the caduceus. The caduceus is depicted as a series of curved lines that resemble a human figure.

Public Health Service

DEC 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AG Industrics C/O Mr. Ian Gordon Emergo Group, Incorporated 2454 McMullen Booth Road Clearwater, Florida 33759

Re: K052087

Trade/Device Name: Breathing Filter Bacterial/Viral Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: December 5, 2005 Received: December 12, 2005

Dear Mr. Gordon:

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 Eederal Register.

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#### Page 2 - Mr. Gordon

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 and instills (s 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 premaired 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), r you accure of the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You onay 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/cdrlv/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known): k052087

### Device Name: Breathing Filter Bacterial / Viral

#### Indications for Use:

The AG Industries Breathing Filter Bacterial/Viral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical that may our and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

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Aun Sulin

General Hospital,
Control, Central Devices
K052587