CLEAR-THERM MICRO HME, MODEL 1441

K032322 · Intersurgical, Inc. · CAH · May 13, 2004 · Anesthesiology

Device Facts

• Record ID: K032322
• Device Name: CLEAR-THERM MICRO HME, MODEL 1441
• Applicant: Intersurgical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The Intersurgical Clear-Therm Micro Filter is for use at the patient connection on the breathing circuit and is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Device Story

Clear-Therm Micro Filter (Model 1441) is a breathing circuit accessory; functions as a heat and moisture exchanger (HME) with bacterial/viral filtration capabilities. Device placed at patient connection point in breathing circuit; captures exhaled heat and moisture to return to patient during inspiration; filters pathogens to protect equipment and patient. Used in clinical settings; operated by healthcare professionals. Benefits include reduced risk of cross-contamination and maintenance of airway humidity/temperature.

Clinical Evidence

Bench testing only.

Technological Characteristics

Breathing circuit filter with integrated CO2 monitoring port. Functions as a heat and moisture exchanger (HME) and bacterial/viral filter. Class II device (21 CFR 868.5620, Product Code CAH).

Indications for Use

Indicated for use in breathing circuits to reduce bacterial/viral transmission between patient and equipment and to conserve patient heat and humidity. 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2004

Mr. Michacl Zalewski RA/QA Specialist Intersurgical Incorporated 417 Electronics Parkway Liverpool, NY 13088

Re: K032322

Trade/Device Name: Clear-Therm Micro HME, Model 1441 Regulation Number: 21 CFR 868.5620 Regulation Name: Filter, Bacterial, Breathing-Circuit Regulatory Class: Class II Product Code: CAH Dated: March 31, 2004 Received: April 5, 2004

Dcar Mr. Zalewski:

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 cnactment date of the Medical Device Amendthents, 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 gencral approvisions 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 (1 WI ), It hay no cash 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.

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

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## Page 2 - Mr. Michael Zalewski

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 067), acems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of the entrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1030.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough finding of substantial equivalence of your device to a premarket nother on. - The PDF matts 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), If you desire specific at 100 to pliance 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 may obtain 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,

Susan Runny

4

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

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## Indications for Use

510(k) Number (if known): KO32322

Device Name: 1441 Clear-Therm Micro Filter with CO2 Monitoring Port Indications For Use:

The Intersurgical Clear-Therm Micro Filter is for use at the the intersurgious ont is designed to reduce bacterial/viral patient connection on the patient and equipment and to reduce the loss of patient heat and humidity. It is for use in the the 10ss of patient neat and hamestricts this device to sale by or on the order of a physician.

Prescription Use_xxxxx (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)

Quesh

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510(k) Number