BREATHING CIRCUIT FILTER

K012958 · Emergency Filtration Products, Inc. · CAH · Feb 22, 2002 · Anesthesiology

Device Facts

• Record ID: K012958
• Device Name: BREATHING CIRCUIT FILTER
• Applicant: Emergency Filtration Products, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The Series 1 Breathing Circuit Filter is a filter device designed for use with all ISO compliant airway management systems including ventilators, respirators and anesthesia circuitry.

Device Story

Series 1 Breathing Circuit Filter is a passive filtration and humidification device for airway management. It utilizes hydrophobic and hydrophilic filter media within a sonic-welded, ISO-compliant housing. The device is placed in-line within the patient breathing circuit of ventilators, respirators, or anesthesia systems. It functions by filtering microbiological and particulate matter from inspired or expired gases while providing passive humidification. It is intended for use in clinical settings such as hospitals and surgical centers, operated by healthcare professionals. The device benefits patients by reducing the risk of contamination and maintaining moisture levels in the breathing circuit.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing for filtration and humidity control performance.

Technological Characteristics

Hydrophobic and hydrophilic filter media; sonic-welded housing; ISO-compliant dimensions/form factor. Passive filtration and humidification principle. No electronic components or software.

Indications for Use

Indicated for heat and passive humidification with filtration between patient and circuit in hospitals, surgical centers, and long-term healthcare facilities. Used with anesthesiology or respiratory equipment for inspired or expired gas filtration. For use on the inspiratory and/or expiratory side of the patient circuit. Prescription use only.

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

• SIMS Portex, Inc. Breathing Filter and Filtered HME

Submission Summary (Full Text)

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K012958

FEB 2 2 2002

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#### 510 (K) Summary

### Emergency Filtration Products, Inc. 4335 S. Industrial Road Suite 440 Las Vegas, NV 89103 702-798-4541 Telephone [phone] Fax Douglas K. Beplate, President & Chief Technology Officer 8/27/01 Date Prepared

| Trade Name: | Series 1 Breathing Circuit Filter |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Breathing Circuit Filter |
| Classification Name: | Breathing circuit bacterial filter device<br>CAH, Class II<br>21CFR868.5260 |

Emergency Filtration Products, Inc. wishes to introduce to the market the Series 1 Breathing Circuit Filter, a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME.

The Series 1 Breathing Circuit Filter features include the following:

- . Hydrophobic filter media
- . Hydrophilic filter media
- Sonic welded housing .
- ISO compliant .

Intended Use:

The Series 1 Breathing Circuit Filter is a filter device designed for use with all ISO compliant airway management systems including ventilators, respirators and anesthesia circuitry.

Technological Characteristics: None

- Substantial Equivalence: Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards.
Clinical Data: Not available.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 2 2 2002

Mr. Douglas Beplate Emergency Filtration Products, Inc. 4335 South Industrial Road, Suite 440 Las Vegas, NV 89103

Re: K012958

Series 1 Breathing Circuit Filter Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: CAH Dated: November 27, 2001 Received: January 10, 2002

Dear Mr. Beplate:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) in the enactment date of the Medical Device Amendments, or to commerce proc to Hile) 20, 2017 11:15 pm accordance with the provisions of the Federal Food, Drug, de noos that have been 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 I ou may, dicrororo, mainer 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 rr your device is exassinon (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. Douglas Beplate

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 form in the quind by of every of ovisions (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 promatics noticated 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,

Bram D. Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K012958

Device Name: Breathing Circuit Filter

Indications For Use:

Heat and passive humidification with filtration between patient and circuit. Designed for Fical and passive namidines, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term mispirod or expired gasses to required utilizing anesthesiology or respiratory equipment. neathireare tacintros and the inspiratory and/or expiratory side of the patient circuit. Flace at hiacmine one on the mopinatese only. For sale by or on the order of a physician.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012458

OR

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use __________

(Optional Format 1-2-96)