HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER

K092409 · Intersurgical, Inc. · CAH · Mar 10, 2010 · Anesthesiology

Device Facts

• Record ID: K092409
• Device Name: HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER
• Applicant: Intersurgical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity. The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment. Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.

Device Story

Devices are breathing filters and heat/moisture exchangers (HME) for use in ventilation circuits. Hydro-Guard Mini connects between patient and equipment to filter pathogens and retain heat/humidity; Air-Guard Clear connects to equipment to protect oxygen concentrators/respiratory devices from contamination. Single-patient use; 24-hour duration. Operated by clinicians or patients in healthcare/home settings. Filters act as physical barriers to airborne/aerosolized particles. Benefits include reduced cross-contamination risk and maintenance of airway moisture/temperature for ventilated patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design characteristics.

Technological Characteristics

Breathing circuit bacterial filters and HME. Single-patient use. Designed for integration into standard ventilation breathing systems. Mechanical filtration principle. 24-hour operational limit.

Indications for Use

Indicated for adult patients requiring ventilation in healthcare or home environments. Used in breathing systems to reduce bacterial/viral transmission between patient and equipment, and to conserve heat and humidity (Hydro-Guard Mini). Maximum duration of use is 24 hours.

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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Michael Zalewski Regulatory Affairs/ Quality Assurance Specialist Intersurgical, Incorporated 417 Electronics Parkway Liverpool, New York 13088

MAR 1 0 2010

Re: K092409

Trade/Device Name: 1745 Hydro-Guard Mini Breathing filter and Heat and Moisture Exchanger 1790 Air-Guard Clear Breathing Filter Regulation Number: 21CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: March 1, 2010 Received: March 5, 2010

Dear 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Zalewski

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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): K092409

### Device Name:

. - --------------------------------------------------------------------------------------------------------------------------------------------------------------------------

1745 Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger 1790 Air-Guard Clear Breathing Filter

### Indications For Use:

The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity.

The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment.

Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.

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or

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

ision of Anesthesiology, General Hospital tion Control, Dental Devices

4092409 J (k) Number: ________________________________________________________________________________________________________________________________________________________________

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