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

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%).

AI/ML Overview

This document is a 510(k) summary for the IRRISEPT™ Wound Debridement and Cleansing System. It focuses on establishing substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study data in the way one might expect for a novel device requiring extensive clinical trials.

Therefore, the requested information cannot be fully extracted as defined in the prompt, particularly for elements related to detailed performance metrics against acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance. This type of submission relies on demonstrating that the new device operates similarly to and is as safe and effective as devices already on the market.

However, based on the provided text, I can infer and extract some relevant points about how the device's acceptable performance is implied and referenced, even if not explicitly presented as a formal acceptance criteria table.

Here's a breakdown of what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criterion is implicitly tied to substantial equivalence to predicate devices, particularly regarding its ability to generate sufficient pressure for wound cleansing.

Acceptance Criterion (Implied)	Reported Device Performance
Ability to produce effective wound cleansing/irrigation pressure.	7-8 psi of pressure: "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."
Effective loosening and removal of wound debris (mechanical action).	"The mechanical action effectively loosens and removes wound debris." This is stated as a functional capability and is central to its intended use and similarity to predicates.
Preservative efficacy (due to CHG).	"The CHG acts as a preservative to help inhibit microbial growth in the solution." and "Chlorhexidine Gluconate, a proven effective preservative, already premixed and packaged for ease of use on wounds."
Substantial Equivalence to Predicate Devices.	The entire 510(k) submission aims to prove this. The device is stated to have "the same intended use, principles of operation, and technological characteristics as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. This type of 510(k) submission generally does not involve a specific "test set" of patient data in the clinical trial sense for performance metrics like sensitivity/specificity. The evaluation relies on comparing technical characteristics and intended use to existing devices.
Data Provenance: Not applicable in the context of a clinical test set. The claim of 7-8 psi pressure references recommendations from the American College of Emergency Physicians (A.C.E.P), indicating a reliance on established clinical guidelines for appropriate pressure levels in wound irrigation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. There is no mention of a "test set" requiring expert ground truth for performance evaluation. The substantial equivalence argument rests on engineering specifications and comparison to predicate devices, not subjective expert assessment of device performance on a dataset.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no test set requiring multi-expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, this type of study was not done. The device is a wound cleansing system, not an imaging diagnostic tool that would typically involve MRMC studies.
Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance: Not applicable. This device is a manual, human-operated medical device, not an algorithm.

7. The type of ground truth used:

Ground Truth: For the pressure claim, the "ground truth" is established clinical guidelines from the American College of Emergency Physicians (A.C.E.P) regarding effective wound irrigation pressure (7-8 psi). For the general function, the ground truth is the established performance and safety profile of the predicate devices.

8. The sample size for the training set:

Sample Size: Not applicable. There is no concept of a "training set" for this type of medical device submission. The device's design and features are based on established engineering principles and comparison to predicate devices, not machine learning or AI models.

9. How the ground truth for the training set was established:

Ground Truth Establishment: Not applicable, as there is no training set.

Summary

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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: (404) 317-9335 Fax: (678) 225-5877

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:

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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

Page 1 of 1

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
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.(b)
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.