Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Device Description

Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.

AI/ML Overview

The provided document is a 510(k) summary for the Irrisept® Antimicrobial Wound Lavage (150 mL), which is a modified version of a previously cleared device (450 mL Irrisept® Antimicrobial Wound Lavage, K210536). This submission asserts substantial equivalence to the predicate device, meaning the new device generally adheres to the same performance standards established for the predicate.

The document does not detail specific acceptance criteria values or a standalone study demonstrating the device's meeting of these criteria in the context of a new clinical or performance trial for effectiveness in all aspects. Instead, it relies on demonstrating that the modified device performs equivalently to the predicate device through various tests and that the modifications do not raise new safety or effectiveness concerns.

Here's an analysis based on the provided text, addressing your specific questions to the extent the document allows:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with corresponding reported performance values for each functional aspect. Instead, it lists various tests performed and asserts that the device (150 mL version) demonstrated the "same level of performance as the predicate device" or was "equivalent to the predicate device" in functional testing.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meets ISO 10993-1	Biocompatible per ISO 10993 Testing (Identical to predicate)
Aseptic Processing: Meets ISO 13408	Confirmed for aseptic processing
Preservative Antimicrobial Effectiveness: Meets USP <51>	Demonstrated per USP <51> testing (Identical to predicate)
Endotoxins and Pyrogens: Meets USP <85>, <151>, <161>	Confirmed to meet USP <85> Bacterial Endotoxins Test, USP <151> Pyrogen Test, and USP <161> Medical Devices- Bacterial Endotoxin and Pyrogen Tests (Implied to be compliant with predicate's performance, although "identical" is not explicitly stated for all these specific tests in the comparison table, it is for Biocompatibility).
Shelf-Life: Meets USP <51> (Antimicrobial Effectiveness) and USP <71> (Sterility) and chemistry	Demonstrated per USP <51> Antimicrobial Effectiveness, Sterility USP <71> and chemistry
Functional Testing (Mechanical removal of wound debris): Equivalent to predicate device	Assessed for performance through custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device.
Distribution Testing: Meets ASTM D4169-22	Confirmed to meet ASTM D4169-22 - Standard Practice for Performance Testing of Shipping Containers and Systems

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for any of the tests mentioned (e.g., number of units tested for functional performance, biocompatibility, etc.).
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given that this is a 510(k) summary for a modified device, the testing would be conducted prospectively for the new iteration to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this document. The document describes a medical device (wound lavage) and its physical and chemical properties and functional equivalence to a predicate device, not a diagnostic or AI-driven decision support system that requires expert ground truth establishment for a test set.

4. Adjudication method for the test set

This is not applicable for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a wound lavage, not an AI or imaging diagnostic tool that would be part of a MRMC study.

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

This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance testing, the "ground truth" would be established by the validated methods described (e.g., ISO standards for biocompatibility, USP methods for antimicrobial effectiveness and sterility, custom tests for functional equivalence to the predicate). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. For the functional testing, "custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device" implies a controlled experimental setup to measure the efficacy of removing debris, with the predicate device's performance serving as the benchmark.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set.

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

This is not applicable for the same reasons as point 8.

Summary

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September 22, 2022

Irrimax Corporation Tanya Eberle VP Regulatory Affairs 1665 Lakes Parkway, Suite 102 Lawrenceville, Georgia 30043

Re: K222804

Trade/Device Name: Irrisept® Antimicrobial Wound Lavage Regulatory Class: Unclassified Product Code: FRO. FOH Dated: September 15, 2022 Received: September 16, 2022

Dear Tanya Eberle:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K222804

Device Name

Irrisept® Antimicrobial Wound Lavage

Indications for Use (Describe)

Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

SUBMITTER'S INFORMATION

Owner:	Irrimax® Corporation
Address:	1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043
Phone:	770-807-3355
Contact Person:	Tanya Eberle, VP, Regulatory Affairs
Date Summary Prepared:	September 15, 2022

DEVICE INFORMATION

Name of Device:	Irrisept® Antimicrobial Wound Lavage
Classification Name:	Jet Lavage
Product Code:	FQH; FRO
Predicate Device:	Irrisept® Antimicrobial Wound LavageProduct Code: FQH (Jet Lavage); Class II (21 CFR 880.5475)Product Code: FRO (Dressing, Wound, Drug); Unclassified (pre-amendment) cleared under K210536
Device Description:	Irrisept® Antimicrobial Wound Lavage is a single-use, manual,self-contained irrigation device comprised of a bottle of 0.05%Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water forIrrigation, United States Pharmacopeia (USP) and accessories forirrigation. The solution is aseptically-filled in a Blow-Fill-Seal(BFS) bottle. The CHG acts as a preservative to inhibit microbialgrowth in the solution.
Intended Use/Indications for Use:	Irrisept® Antimicrobial Wound Lavage is intended for mechanicalcleansing and removal of debris, dirt and foreign materials,including microorganisms from wounds.
Comparison of theTechnologicalCharacteristics:	The 150 mL and 450 mL Irrisept® Antimicrobial Wound Lavagedevices provide the same aseptically-filled solution of 0.05%Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water forIrrigation, United States Pharmacopeia (USP) in a Blow-Fill-Sealbottle. The 150 mL Irrisept® Antimicrobial Wound Lavage deviceis provided in a non-sterile packaged configuration where the 450mL Irrisept® Antimicrobial Wound Lavage device is sterilepackaged. The 150 mL Irrisept® Antimicrobial Wound Lavagedevice includes a solution-filled bottle with integrated applicatorwhere the 450 mL Irrisept® Antimicrobial Wound Lavage deviceincludes a separate sterile applicator that is threaded onto thesolution-filled bottle at the time of use.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	CLEARED IRRISEPT DEVICEIrrisept® Antimicrobial Wound Lavage(450 ml)	SUBJECT IRRISEPT DEVICEIrrisept® Antimicrobial Wound Lavage(150 ml)
510(k) Number	K210536	K222804
Product Code	FQH, Jet LavageFRO, Dressing, Wound, Drug	FQH, Jet LavageFRO, Dressing, Wound, Drug
Product Classification	Class II (21 CFR 880.5474)Unclassified (Pre-amendment)	Class II (21 CFR 880.5474)Unclassified (Pre-amendment)
Intended Use	Intended for wound cleansing and removal of wounddebris	Identical
Indications for Use	Irrisept Antimicrobial Wound Lavage intended formechanical cleansing and removal of debris, dirt andforeign materials, including microorganisms fromwounds.	Identical
Type of Use	Prescription Use Only	Identical
Mechanism of Action	The mechanical action of fluid across the woundremoves wound debris.	Identical
Solution	0.05% Chlorhexidine Gluconate in 99.95% SterileWater for Irrigation, USP	Identical
Solution AntimicrobialPreservative	Chlorhexidine Gluconate	Identical
Total Volume	450 mL	150 mL
How Supplied	Provided for single use	Provided for single use
	Bottle of Irrisept and applicator are double wrappedin CSR wrap and sealed within an outer Tyvek®pouch.	Bottle of Irrisept with integrated applicatorprovided within a shelf box.
	The bottle contains aseptically processed Irriseptsolution.	The bottle contains aseptically processed Irriseptsolution.
Sterilization	The bottle exterior, CSR wraps, and applicator aresterilized by EO and conform to ISO 11135-7 for EOsterilization and ISO 10993-7 for EO residuals	The bottle exterior and optional splashaccessory are non-sterile.
Biocompatibility	Biocompatible per ISO 10993 Testing	Identical
Preservative Effectiveness overShelf-Life	Demonstrated per USP <51> testing	Identical

Performance Data:

Testing of the 150 mL non-sterile packaged Irrisept® Antimicrobial Wound Lavage was completed, including: Biocompatibility

ISO 10993-1 Biological Evaluation of Medical Devices .

Aseptic Processing

. ISO 13408 Aseptic Processing of Health Care Products

Preservative Antimicrobial Effectiveness

. USP <51> Antimicrobial Effectiveness

Endotoxins and Pyrogens

USP <85> Bacterial Endotoxins Test .
USP <151> Pyrogen Test (USP Rabbit Test) .
USP <161> Medical Devices- Bacterial Endotoxin and ● Pyrogen Tests

Shelf-Life

USP <51> Antimicrobial Effectiveness .
. Sterility USP <71> and chemistry

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Functional Testing

. The subject device was assessed for performance through custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device.

Distribution

ASTM D4169-22 - Standard Practice for Performance Testing of Shipping Containers and Systems
Rationale for Substantial This modification falls within the FDA requlations for Special Equivalence: 510(k) review. The indication for use. intended use, principles of operation, and performance have not been altered. The minor change to add the new size to the existing Irrisept® Antimicrobial Wound Lavage (150 mL) in a non-sterile packaged configuration does not raise any new questions of safety or effectiveness. The 150 mL Irrisept® Antimicrobial Wound Lavage device has demonstrated the same level of performance as the predicate device (Irrisept® Antimicrobial Wound Lavage, K210536). Therefore, the 150 mL Irrisept® Antimicrobial Wound Lavage device is substantially equivalent to the predicate Irrisept® Antimicrobial Wound Lavage device. The Irrisept® Antimicrobial Wound Lavage device, as modified Conclusion: by this 510(k) does not raise any new issues regarding safety or effectiveness. The 150 mL non-sterile packaged Irrisept® Antimicrobial Wound Lavage is suitable for commercial sale and is substantially equivalent to the predicate Irrisept®

Antimicrobial Wound Lavage device.

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.