CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18

K983610 · Intersurgical, Inc. · CAH · Apr 30, 1999 · Anesthesiology

Device Facts

• Record ID: K983610
• Device Name: CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
• Applicant: Intersurgical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Apr 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. 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; 1831 & 1831-T: 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. 1644, 1644-T, 1831, 1831-T: 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

Breathing filters (1644, 1644T, 1831, 1831T) function as mechanical barriers in respiratory circuits. 1644 series placed at equipment connection to reduce bacterial transmission; 1831 series placed at patient connection to reduce bacterial/viral transmission and conserve heat/humidity. Single-patient use; non-sterile; non-conductive. Operated by clinicians in hospital settings. Requires manual connection via ISO fittings. Output is filtered air/gas flow. Benefits include reduced cross-contamination and maintenance of patient airway moisture/temperature. Cautions include avoiding use with nebulized drugs, avoiding placement downstream of water bath humidifiers, and mandatory replacement every 24 hours.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical breathing filters with ISO connections. Non-conductive materials. Non-sterile. Single-patient use. No electronic components, software, or energy source.

Indications for Use

Indicated for use in patients requiring respiratory support to reduce bacterial/viral transmission and/or conserve heat and humidity. 1644/1644-T used at equipment connection; 1831/1831-T used at patient connection. Contraindicated for patients with thick or copious secretions.

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

APR 30 999

Mr. Thomas R. Gunerman Intersurqical Incorporated 417 Electronics Parkway Liverpool, NY 13088

Re: K983610 Breathing Filters Models 1644, 1644T, 1831 and 1831T Requlatory Class: II (two) Product Code: 73 CAH February 1, 1999 Dated: February 4, 1999 Received:

Dear Mr. Gunerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Thomas R. Gunerman

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix I. Indication For Use

510(k) Number (if known): K983610

Device Name: 1644 Clear-Guard Midi 1644-T Clear-Guard Midi with Flextube 1831 Clear-Therm Mini 1831-T Clear-Therm Mini with Flextube

Indications For Use:

1644 & 1644-T: For use at the equipment connection. Designed to reduce bacterial transmission to and from patient, equipment and environment. 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; 1831 & 1831-T: 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. 1644, 1644-T, 1831, 1831-T: 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)

or

Concurrence of CDRH. Office of Device Evaluation (ODE)

Ath. A. Giarlow, L.

5100k) Numb

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)