A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER

K063526 · A-M Systems, Inc. · CAH · Jun 29, 2007 · Anesthesiology

Device Facts

• Record ID: K063526
• Device Name: A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
• Applicant: A-M Systems, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Indications for Use

This device is intended for use on all patient populations, in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Device Story

A-M SYSTEMS VIROMAX is a non-sterile, single-patient-use breathing filter; consists of gas-permeable, electrostatically-charged hydrophobic filter membrane enclosed in transparent plastic housing. Device integrates into standard 15mm/22mm breathing circuits. Respiratory gases pass through membrane, which traps bacteria and viruses. Used in clinical settings to protect patients and equipment from airborne pathogens.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing comparisons to the predicate device.

Technological Characteristics

Non-sterile, single-patient-use breathing filter. Components: electrostatically-charged hydrophobic filter membrane, transparent plastic housing. Interface: standard 15mm and 22mm fittings for breathing circuits. Passive filtration mechanism.

Indications for Use

Indicated for all patient populations requiring filtration of respiratory gases in breathing circuits to reduce risk of airborne bacterial and viral infection.

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

• K961914

Submission Summary (Full Text)

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

K063526

# JUN 2 9 7007 510(k) Summary As Required by 21 section 807.92 ( c )

| 1-Submitter Name: | A-M SYSTEMS, INC |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 2-Address: | 131 Business Park Loop<br>Carlsborg, WA 98324 USA |
| 3-Phone: | 360 683 8300 |
| 4-Fax: | 360 683 3525 |
| 5-Contact Person: | Arthur B Green III |
| 6- Submission Correspondent: | Jay Mansour of Mansour Consulting LLC<br>845 Aronson Lake Court. Roswell, GA 30075 USA<br>Tel [phone]. Fax [phone] |
| 7-Date summary prepared: | October 14th, 2006 |
| 8-Device Trade or Proprietary Name: | A-M SYSTEMS VIROMAX Viral and Bacterial Filter |
| 9-Device Common or usual name: | Breathing Filter |
| 10-Device Classification Name: | Breathing Circuit Bacterial Filter |
| 11-Substantial Equivalency is claimed against | K961914 |

### 12-Description of the Device:

The A-M SYSTEMS VIROMAX Viral and Bacterial Filter is a non-sterile, single patient use breathing filter consisting of a gas permeable filter membrane enclosed in a transparent plastic housing. When the A-M SYSTEMS Viral and Bacterial Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter membrane, thus trapping bacteria and viruses.

### 13-Intended use of the device: (refer to FDA forms attached)

This device is intended for use on all patient populations, in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concem.

### 14-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

### 15-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Refer to the explanations within the main submission.

PAGE 8

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

| FDA file reference number | 510k # K961914 |
|--------------------------------------------------|-----------------------------|
| Attachments inside notification submission file | 510k FDA website print outs |
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | |
| Design | Similar |
| Materials | |
| Performance | |
| Sterility | |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Not applicable |
| Anatomical sites | Identical |
| Human factors | |
| Energy used and/or delivered | Not applicable |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Not applicable |
| Thermal safety | |
| Radiation safety | |

And Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children

PAGE 9

i !

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

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 9 2007

A-M Systems, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K063526

Trade/Device Name: A-M SYSTEMS VIROMAX Viral and Bacterial Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filer Regulatory Class: II Product Code: CAH Dated: June 16, 2007 Received: June 19, 2007

Dear Mr. Job:

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.

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

Page 2 - Mr. Job

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,

Suste y. Michie 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

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

## Indications for Use

1463526 510(k) Number (if known):

Device Name: A-M SYSTEMS VIROMAX Viral and Bacterial Filter

Indications For Use:

This device is indicated for use on all patient populations, in conjunction with other respirations devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21. CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 1

KOG3SZL 510(k) Number:

PAGE 13