GARD FILTER, COMBIGARD FILTE / HME

K014281 · Munktell Filter AB · CAH · Jun 26, 2002 · Anesthesiology

Device Facts

• Record ID: K014281
• Device Name: GARD FILTER, COMBIGARD FILTE / HME
• Applicant: Munktell Filter AB
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Intended for single patient use up to 24 hours.

Device Story

Gard Filter is a machine-side breathing circuit filter; utilizes pleated paper microfiber media for bacterial and viral filtration. Device features standard 15/22 mm connectors and a gas sampling port. Intended for single-patient use up to 24 hours in hospital, home, or sub-acute settings. Operates by filtering inspired/expired gases to reduce particulate/pathogen transmission. Healthcare providers install the filter at the machine-side of the circuit; output is filtered gas flow. Benefits include protection of patients and equipment from cross-contamination.

Clinical Evidence

Bench testing only. Performance data includes bacterial and viral filtration efficiency (BFE/VFE) of 99.9999% tested by Nelson Labs, and resistance to flow of ≤ 1.6 cm H2O at 60 lpm. No clinical data provided.

Technological Characteristics

Housing: Polystyrene. Filter media: Paper microfiber. Connectivity: Standard 15/22 mm conical connectors (ISO 5356-1). Form factor: 60 gm weight, 124 ml dead space. Gas sampling port included. Mechanical filtration principle. No software or electronic components.

Indications for Use

Indicated for adult patients requiring filtration of inspired and/or expired gases during use with ventilators, anesthesia machines, or open flow systems in hospital, home, or sub-acute institutional 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

• Mallinckrodt Sterivent (HEPA) (K941676)
• ARC Filter (K011212)
• Porous Media – DBF 23 (K964979)

Submission Summary (Full Text)

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1014281

## Munktell Filter AB Box 300 S 790 20, Grycksbo, Sweden

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 15, 2002

| Munktell Filter AB<br>Box 300<br>S 790 20 Grycksbo, Sweden | Tel - 011 (46) 23-683-80<br>Fax - 011 (46) 23-401-15 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Official Contact: | Gustav Kyrk - Managing Director |
| Proprietary or Trade Name: | Gard Filter |
| Common/Usual Name: | Bacterial / Viral Filter |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Mallinckrodt Sterivent (HEPA) – K941676<br>ARC Filter – K011212<br>Porous Media – DBF 23 – K964979 |

Device Description: July 2017 11:43 11:00 11:00 10:00 10:00

The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.

| Intended Use: | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indicated Use -- | For use with ventilators, anesthesia machines, and open flow<br>systems where filtration of inspired and / or expired gases is<br>desired. Tobe placed at the machine-side of the circuit only.<br>Intended for single patient use up to 24 hours. | |
| Environment of Use -- | Home. Hospital. Sub-acute Institutions | |

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# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 15, 2002

#### General Technical Characteristics

1

| Attribute | Munktell - Proposed devices |
|--------------------------------------------------------------------|----------------------------------------|
| Indications for use - To filter inspired and / or<br>expired gases | Same |
| Intended for single patient use, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient (adult) |
| Intended Environment of Use | Home, Hospital, Sub-acute institutions |
| Placement at machine side of circuit only | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 124 ml |
| Resistance to flow | $≤$ 1.6 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| Weight (gm) | 60 gm |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Paper microfiber |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |

## 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 to the predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Munktell Filter AB c/o Mr. Paul Dryden ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055

Re: K014281 Gard Filter, Model # 321 111 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: April 2, 2002 Received: April 3, 2002

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,

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Page 2 - Mr. Paul Dryden

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | Indications for Use . Me . Mar . 1988 . 1998 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K014281 |
| Device Name: | Gard Filter |
| Intended Use: | For use with ventilators, anesthesia machines, and open flow<br>systems where filtration of inspired and / or expired gases is<br>desired. To be placed at the machine -side of the circuit only.<br>Single patient use. Duration of use up to 24 hours. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiqyascular & Resoir- to ... "Bevices 510(k) Number LO

Prescription Use (Per CFR 801.109)

or

Over-the-counter use __