IRRISEPT WOUND CLEANSING SYSTEM

K080779 · Irrimax Corporation · FQH · Feb 4, 2009 · General Hospital

Device Facts

• Record ID: K080779
• Device Name: IRRISEPT WOUND CLEANSING SYSTEM
• Applicant: Irrimax Corporation
• Product Code: FQH · General Hospital
• Decision Date: Feb 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IRRISEPT™ Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

Device Story

IRRISEPT™ is a manual, self-contained wound irrigation system; consists of a bottle containing 0.05% Chlorhexidine Gluconate (CHG) in sterile water and a patented multi-port splashguard. User twists off bottle cap, attaches splashguard, and manually applies pressure to irrigate wound. Device generates 7-8 psi of pressure; mechanical action agitates, loosens, and removes wound debris. CHG acts as preservative to inhibit microbial growth in solution. Used in clinical settings; operated by healthcare providers. Provides effective wound cleansing/irrigation; benefits patient by facilitating debris removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual irrigation system; 0.05% Chlorhexidine Gluconate in sterile water (USP); multi-port splashguard; 7-8 psi pressure output; non-powered; single-use.

Indications for Use

Indicated for use as a wound cleansing delivery system to loosen and remove wound debris.

Regulatory Classification

Identification

A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• MicroKlenz™ Antimicrobial, Deodorizing Wound Cleanser (K022670)
• DermaGran® Wound Cleanser (K970660)
• DermaGran® Wound Cleanser (K954743)
• DermaGran® Wound Cleanser (K945802)
• BioPatch® CHG Dressing (K003229)

Submission Summary (Full Text)

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K080779 page 1/2

# 510(k) SUMMARY - Revised

FEB - 4 2009

Owner's Information:

IRRIMAX Corporation 1792 Bell Tower Lane Weston, FL 33326 Tel: [phone] Fax: [phone]

Contact Person:

Julie Stephens, President/Consultant Regulatory Resources Group, Inc.

K080779 510(k) Number:

Date Prepared: August 2008

Trade/Proprietary Name: IRRISEPT™ Wound Debridement and Cleansing System

Common Name: Wound Cleanser

Jet Lavage, Class II, 21 CFR 880.5475 Classification Name:

FQH

Product Code:

Legally Marketed Predicate Devices: MicroKlenz™ Antimicrobial, Deodorizing Wound Cleanser, 510(k) #: K022670; DermaGran® Wound Cleanser, 510(k) #s: K970660; K954743, K945802; BioPatch® CHG Dressing, 510(k) #: K003229

### Device Description:

IRRISEPT™ Wound Debridement and Cleansing System is a manual, self-contained irrigation device with 0.05% Chlorhexidine Gluconate (CHG) solution. The mechanical action effectively loosens and removes wound debris. The CHG acts as a preservative to help inhibit microbial growth in the solution.

The IRRISEPT™ Wound Debridement and Cleansing System is straightforward and uncomplicated to use. The User opens a prepackaged box, which contains one bottle and one splashquard. The bottle is opened by twisting off its "T" cap seal. The splashguard is then removed from its pouch and screwed directly onto the bottle. The IRRISEPT™ Wound Debridement and Cleansing System is now ready for use. The IRRISEPT™ Wound Debridement and Cleansing System can produce 7-8 psi of pressure as recommended by College of Emergency Physician's (A.C.E.P) for effective wound American cleansing/irrigation. This pressure is sufficient to agitate, loosen and remove debris from wounds.

The incredients of the solution are 0.05% Chlorhexidine Gluconate (CHG) in Sterile Water for Irrigation, USP (99.95%).

#### Intended Use:

The IRRISEPT™ Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

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### 510(k) SUMMARY - Revised

## Similarities and Differences of the Proposed Devices to the Predicate Devices:

#### Similarities

The IRRISEPT™ Wound Debridement and Cleansing System is substantially equivalent in intended use and method of use to the predicate devices. The preservative present in the IRRISEPT™ solution, Chlorhexidine Gluconate (CHG), is equivalent to Johnson & Johnson's predicate device, BioPatch® CHG Dressing, and has been utilized extensively in the marketplace.

#### Differences

The IRRISEPT™ Wound Debridement and Cleansing System differs in its mechanical action because it utilizes a patented multi-port splashguard that screws onto the bottle to irrigate the wound while the predicate devices use either a pump-spray bottle or they directly pour the fluid onto the wound site.

### Conclusion:

The IRRISEPT™ Wound Debridement and Cleansing System has the same intended use, principles of operation, and technological characteristics as the predicate devices. The IRRISEPT™ Wound Debridement and Cleansing System was developed with Chlorhexidine Gluconate, a proven effective preservative, already premixed and packaged for ease of use on wounds.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

### Public Health Service

FEB - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IRRIMAX Corporation % Regulatory Resource Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 3004

Re: K080779

Trade/Device Name: IRRISEPT™ Wound Debridement and Cleansing System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FOH Dated: January 12, 2009 Received: January 13, 2009

### Dear Ms. Stephens:

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.

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 (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.

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## Page 2 - Ms. Julie Stephens

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use - Revised

510(k) Number (if known): K080779

Device Name: IRRISEPT™ Wound Debridement and Cleansing System IRRIMAX Corporation

Indications For Use:

The IRRISEPT™ Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

Prescription Use __ X (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)

**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

510/11

Longong

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