BACSTOP FILTER,BACSTOP FILTER/HME

K014282 · Munktell Filter AB · CAH · Jun 26, 2002 · Anesthesiology

Device Facts

• Record ID: K014282
• Device Name: BACSTOP FILTER,BACSTOP FILTER/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
• Attributes: Pediatric

Intended Use

For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required. For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults). Single patient use. Duration of use up to 24 hours.

Device Story

Bacstop Filter and Filter/HME are breathing circuit accessories; incorporate 15/22 mm connectors and gas sampling luer port. Device utilizes electrostatic polypropylene media for bacterial/viral filtration and foam media for heat and moisture exchange (HME). Used in hospitals, homes, sub-acute institutions, and emergency services. Placed in ventilator or anesthesia breathing circuits to filter inspired/expired gases and provide humidification. Single patient use; maximum 24-hour duration. Benefits include reduced risk of cross-contamination and maintenance of airway moisture for patients on mechanical ventilation.

Clinical Evidence

Bench testing only. Performance validated via Nelson Laboratories for bacterial filtration efficiency (99.999%) and viral filtration efficiency (99.99+%). Humidification output tested per ISO 9360 (31 mg H2O/L for adults; 32 mg H2O/L for pediatrics). Flow resistance and dead space measurements provided.

Technological Characteristics

Housing: Polystyrene. Filter media: Electrostatic polypropylene. HME media: Foam. Connectors: Standard 15/22 mm (ISO 5356-1). Luer port: ISO 594-2. Dead space: 23-85 ml. Resistance: <2.1 cm H2O (adult) / <0.82 cm H2O (pediatric).

Indications for Use

Indicated for pediatric patients with tidal volumes 150-500 ml and adult patients with tidal volumes >250 ml requiring gas filtration and moisture retention in breathing circuits. For use with ventilators, anesthesia machines, and open flow systems. Single patient use, up to 24 hours.

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

• Gibeck - Humid-Vent Filter - K881657
• Hudson RCI (Artema) Aqua +FH - K945359
• Mallinckrodt - Hygroboy and Hygrobac - K941381
• Mallinckrodt - Barrierbac and Barrierbac "S" - K941536

Submission Summary (Full Text)

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K0142f2

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

# Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 April 18, 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: | Bacstop, Bacstop Mini, Bacstop Humini |
| Common/Usual Name: | Bacterial / Viral Filter and Heat and Moisture Exchanger |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Gibeck - Humid-Vent Filter - K881657<br>Hudson RCI (Artema) Aqua +FH - K945359<br>Mallinckrodt - Hygroboy and Hygrobac - K941381<br>Mallinckrodt - Barrierbac and Barrierbac "S" - K941536 |

Device Description: 100 100 100 100 11 11 11 11 11 11 11 11 11 11 13 13 13

The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

| Intended Use: | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Indicated Use -- | For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.<br>For pediatric patients with tidal volumes 150-500 ml and adult patients with tidal volumes >250 ml. Duration of use up to 24 hours. Single patient use. | | |
| Environment of Use -- | Home, Hospital, Sub-acute Institutions, Emergency Services | | |

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### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 18, 2002

# General Technical Characteristics

| Attribute | Munktell - Proposed devices |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications for use - To filter inspired and / or<br>expired gases and add and retain moisture | Same |
| Intended for single patient, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient, including adults and pediatrics |
| Intended Environment of Use | Home, Hospital, Sub-acute Institutions,<br>Emergency Services |
| Placement in various locations in circuit | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 23 to 85 ml |
| Resistance to flow | <2.1 cm H2O @ 60 lpm - Adult<br><0.82 cm H2O @ 15 Ipm - Pediatric |
| Bacterial filtration - BFE - Nelson Lab. | 99.999% |
| Viral filtration - VFE - Nelson Lab. | 99.99+% |
| Weight (gm) | 13 to 40 gm |
| Humidification output (mg H2O/l) | 31 mg H2O /L at TV of 1000 ml - adult<br>32 mg H2O /L at TV of 250 ml - pediatric |
| Tidal volume ranges | 150 - 500 ml - pediatric<br>> 250 ml - adult |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Electrostatic polypropylene |
| HME media | Foam |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 594-2 Luer Fittings | Yes |
| ISO 9360- HME moisture output | 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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized image of an eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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 46055-9501

Re: K014282

Munktell Bacstop Filter and Filter/HME, Model # 321 201, 321 202, 321 203, 321 204 Adults, Model # 321 209, 321 210 Pediatric Regulation Number: 868.5260 Regulation Name: Breathing Circuit Filter Regulatory Class: II (two) Product Code: 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. Iisting 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 (OS) 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 | Page 1 of 1 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K014282 |
| Device Name: | Bacstop Filter and Filter / HME |
| Intended Use: | For use with ventilators, anesthesia machines, and open flow<br>systems where filtration of inspired and / or expired gases is<br>desired and to add and retain moisture in the circuit as required.<br><br>For patients with a tidal volume 150-500 ml (pediatrics) and<br>>250 ml (adults).<br><br>Single patient use. Duration of use up to 24 hours. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01428

Prescription Use (Per CFR 801.109)

or

Over-the-counter use _________________________________________________________________________________________________________________________________________________________