(219 days)
Not Found
No
The description focuses on the physical filtering mechanism and does not mention any computational or algorithmic processes.
No
The device is a filter used to prevent infection by trapping bacteria and viruses in respiratory gases. It does not directly treat a disease or condition.
No
The device is described as a filter for respiratory gases, trapping bacteria and viruses. Its purpose is to prevent infection, not to diagnose a medical condition.
No
The device description clearly states it is a physical filter consisting of a membrane and plastic housing, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter respiratory gases to prevent infection from airborne bacteria and viruses. This is a physical filtering process applied to the air being breathed, not a test performed on a biological sample from the patient to diagnose a condition.
- Device Description: The device description details a physical filter membrane and housing that traps bacteria and viruses from respiratory gases. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The device functions as a physical barrier for respiratory gases, which falls under the category of a medical device used in respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / 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 concem.
Product codes
CAH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Identical
Indicated Patient Age Range
all patient populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5260 Breathing circuit bacterial filter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| 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 |
| 845 Aronson Lake Court. Roswell, GA 30075 USA | |
| Tel 678 908 8180. Fax 678 623 3765 | |
| 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.
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| 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
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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:
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