CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT

K990949 · Intersurgical, Inc. · CAH · Jun 15, 1999 · Anesthesiology

Device Facts

• Record ID: K990949
• Device Name: CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
• Applicant: Intersurgical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Jun 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

1844 & 1844-P: For use at the equipment connection. Designed to reduce bacterial/viral 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; 1841 & 1841-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of pattent 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. 1844, 1844-P, 1841, 1841-T: ISO connections: When assembling any comnections 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; Pederal law restricts this device to sale by or on the order of a physician.

Device Story

Clear-Therm and Clear-Guard devices are respiratory filters and heat/moisture exchangers (HMEF). Devices connect to breathing circuits to filter bacteria/viruses and, for HMEF models, retain patient heat and humidity. 1844/1844-P models connect at equipment side; 1841/1841-T models connect at patient side. 1844-P and 1841-T include ports for CO2 monitoring or tubing connections. Used in clinical settings by healthcare professionals. Devices are single-patient use, non-sterile, and non-conductive. Healthcare providers monitor resistance and replace every 24 hours or upon visible deterioration. Benefits include reduced cross-contamination risk and maintenance of airway humidity/temperature.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Respiratory filters and heat/moisture exchangers. ISO standard connections. Non-conductive materials. Non-sterile. Single-patient use. No electronic components or software.

Indications for Use

Indicated for patients requiring mechanical ventilation or respiratory support. 1844/1844-P used at equipment connection for bacterial/viral filtration. 1841/1841-T used at patient connection for bacterial/viral filtration and heat/moisture exchange. 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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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. 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 15 1999

Mr. Thomas R. Gunerman Mr. Thomas R. Incorporated Intersurgical 417 Electronion 13088-6098

K990949
Clear-Therm HMEF - PN 1841, Clear-Therm HME W/Flextube - PN
Clear-Therm Clard II Filter PN - 1844, and Clear-Guard I Re: ear-Therm HMEF - PN 1841, Clear-Therm RMBF W/FFCheard ------------------------------------------------------------------------------------------------------------------------1841-T, Clear-Guard II Friece Co.
Filter w/CO2 Monitoring Port - PN 1844-P Regulatory Class: II (two) Product Code: _ САН Product Sarch 16, 1999 Dated. March 22, 1999

Dear Mr. Gunerman:

Dear Mr. Guneralians We have reviewed above and we have determined see device is the davice referenced above and we have determined with the series.
substantially equivalent (for the indications for use stated in the substantially equivalent (for the indicated devices marketed in
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment received the states of the interstate comments, or to devices that have been reclassified in accorded with the provisions of the Federal Food, Drug, and in accordance with the provisions of the device, market the devices, subject to
Cosmetic Act (actuals provisions of the Act. The general complex Cosmetic Act (Act) . You may, the Act. The general controls the general controls provisions of the Act. Inc general comments.
the general controls provisements for annual registion,
provisions of the Act manufacturing practice, labeli one of the Act include requirements ros- Manner of the listing of devices, good manufaccuration.
prohibitions against mishranding and adulteration.

proniblem is classified (see above) into either class II (Special If your device is class III (Premarket Approval), it may be and ject to such Controls) or class III (Premarket Approvations affecting your device
Controls, or class III (Premarket regulations, affecting your device can be found in the Code of Federal Regulations, Title 21 Parts 800
can be found in the Code of Federal Regulations, Title 21 Parts 800 can be found in the Code of Federal Regulation assumes complance
to 895. For substantially equivalent determination assumes as set to 895. A substantially equivalent (decolinares) as set
with the Current Good Manufacturing Practice requirements, as set with the Current Good Manufacturing Fraceroor sognitudical Devices:
forth in the Quality System Regulation (QS) for Medical Devices: forth in the Quality System Regulation (Q5) 102 hosting of the OS
General regulation (21 CFR Part 820) and that, through perify su General regulation (2) CER Part 820) and that, through portugular such assumptions. Failure to comply with the GMP regulation may result in assumptions. Failure to comply with the Gut iegatest any
regulatory action, In addition, FDA may publish further announcements: this concerning your device in the Federal Register. Please note:
concerning your device in the Federal Register. Please not affe concerning your device in the Eederal Register. Boes not affect any
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
obligation you might have under sections 531 through 542 of the Act 20 provide you might have under sections 351 chrough \$22.
for dovices under the Electronic Product Radiation Control provisions,
for dovices and Java as requlations, for devices andar one or regulations.

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Page 2 - Mr. Thomas R. Gunerman

sign letter will allow you to begin marketing your device as described.
The substablish are morker notification. The FDA finding of substantial This letter will allow you to begin marketing your association of substantial
in your 510(k) premarket notification. The Finding of substantial in your 510(k) premarket notification. The bur beted predicate device equivalence of your device to a regarly markets provide and thus, permits your
results in a classification for your device and thus, permits your results in a crabbility. The market.

If you desire specific advice for your device on our labeling If you desire specific advice for your device on on for in vitro
regulation (21 cer Part 801 and additionally 809.10 for in vitro regulation (21 CFR Part 801 and additionally of Compliance at diagnostic devices), please contact the origes on the promotion and (301) 594–4648. Additionally, for questions on Eff promobile, and Compliance at
advortising of your device, please contact the Office of Compliation entitled, advertising of your device, prease the regulation entitled, [phone]. Also, please note the regulacion" (2) CFR 807.97) .
"Misbranding by reference to premarket notification" (2) . CFR 807.97) . "Misbranding by reference to premation on tesponsibilities under the Act may
Other general information of Small Manufacturers assistance at i Other general information on your responsibilities and states at its
be obtained from the Division of Small Manufacturers Assistance at its be obtained from the Division of Small Mandractarers worder.
toll-free number [phone] or [phone], or at its internet ( toll-free number [phone] of (802) 600 - 1000
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan,

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

Enclosure

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## Appendix I. Indication For Use

2990949 510(k) Number (if known):

Device Name: 1844 Clear-Guard II Filter 1844-P Clear-Guard II with CO2 Monitoring Port 1841 Clear-Thern HMEF 1841-T Clear-Therm HMEF with Flextube

Indications For Use:

1844 & 1844-P: For use at the equipment connection. Designed to reduce bacterial/viral 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; 1841 & 1841-T: For use at the patient connection. Designed to reduce bacterial/viral transmission and to reduce the loss of pattent 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. 1844, 1844-P, 1841, 1841-T: ISO connections: When assembling any comnections 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; Pederal 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)

M. f

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

Or

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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