CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3

K024270 · Intersurgical, Inc. · CAH · Jun 24, 2003 · Anesthesiology

Device Facts

• Record ID: K024270
• Device Name: CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3
• Applicant: Intersurgical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

1544, 1544-T & 1544-F: For use at the equipment or patient connection. Designed to reduce bacterial/viral transmission to and from patient, equipment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient; 1541, 1541-T & 1541-F: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources. 1544, 1544-T, 1544-F, 1541, 1541-T, 1541-F: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier. Do not use this product between the patient and a source of nebulized drugs: When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure: Federal law restricts this device to sale by or on the order of a physician.

Device Story

Clear-Therm 3 HMEF and Clear-Guard 3 filters are single-patient-use, non-sterile, non-conductive breathing circuit accessories. Devices connect to patient or equipment to reduce bacterial/viral transmission; HMEF models additionally conserve heat and moisture. Used in clinical settings (e.g., OR, ICU) by healthcare professionals. Operation involves manual connection to breathing circuits via ISO ports. Devices require replacement every 24 hours or upon visible deterioration. Contraindicated for patients with thick secretions; must not be placed downstream of water bath humidifiers on inspiratory limbs. Output is passive filtration and heat/moisture exchange, protecting patient and equipment from cross-contamination.

Clinical Evidence

Bench testing only.

Technological Characteristics

Breathing circuit bacterial/viral filters and Heat and Moisture Exchanger Filters (HMEF). Non-conductive, non-sterile, single-patient-use plastic housing. Features ISO connections for breathing circuit integration. Includes variants with CO2 monitoring ports and integrated catheter mounts (Superset or flexible). Passive operation; no energy source required.

Indications for Use

Indicated for patients requiring mechanical ventilation or anesthesia. Clear-Guard 3 filters reduce bacterial/viral transmission. Clear-Therm 3 HMEFs reduce bacterial/viral transmission and conserve heat/humidity. Contraindicated for patients with thick or copious secretions; not for use with external humidification sources or between patient and nebulized drug sources.

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

JUN 2 4 2003

Mr. Thomas R. Gunerman President Intersurgical, Inc. 417 Electronics Parkway Liverpool, NY 13088

Re: K024270

Trade/Device Name: Clear-Therm 3 HMEF (PN 1541), Clear-Therm HMEF w/Superset (PN 1541-T), Clear-Therm HMEF w/Flextube (PN 1541-F), Clear-Guard 3 Filter (PN 1544), Clear-Guard 3 w/Superset (PN 1544-T), and Clear-Guard 3 w/Flextube (PN 1544-F) Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: March 24, 2003 Received: March 27, 2003

Dear Mr. Gunerman:

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. Thomas R. Gunerman

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), please contact the Office of Compliance 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 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.

Sinar Rump

Susan Runner, DDS, MA Interim 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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## Appendix J. Indication For Use

510(k) Number (if known): Ko24270

Device Name: 1544 Clear-Guard 3 Filter with CO2 Monitoring Port 1544-T Clear-Guard 3 with Superset catheter mount 1544-F Clear-Guard 3 with flexible catheter mount 1541 Clear-Therm 3 HMEF with CO2 Monitoring Port 1541-T Clear-Therm 3 HMEF with Superset catheter mount 1541-F Clear-Therm 3 HMEF with flexible catheter mount

Indications For Use:

1544, 1544-T & 1544-F: For use at the equipment or patient connection. Designed to reduce bacterial/viral transmission to and from patient, equipment. CAUTIONS: When used in the exhalation limb in conjunction with a water bath humidifier, a water trap should be placed between the filter and the patient;

1541, 1541-T & 1541-F: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of patient heat and humidity. CAUTIONS: This product is not suitable for patients with thick or copious secretions; Do not use this product in conjunction with other humidification sources.

1544, 1544-T, 1544-F, 1541, 1541-T, 1541-F: ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. Single patient use. Non conductive. Non sterile. Do not autoclave. CAUTIONS: Never position any filter on the inspiratory limb downstream of a water bath humidifier. Do not use this product between the patient and a source of nebulized drugs: When nebulized drugs are administered, resistance should be monitored and the product should be exchanged following standard hospital procedure; All ports should remain capped when not in use; Replace every 24 hours or more frequently if visible deterioration is observed, following standard hospital procedure: Federal law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

HWath

sthesiology, General Hospital,

510(k) Number: K02427

Prescription Use (Per 21 CFR 801.109)

Or

Over-The-Counter Use

(Optional Format 1-2-96)