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 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). 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 text describes the Irrisept Antimicrobial Wound Lavage device and its 510(k) submission for clearance. The submission focuses on demonstrating substantial equivalence to a predicate device, particularly by specifying the removal of "microorganisms" through mechanical cleansing.

However, the documentation does not contain information related to an AI/ML medical device, nor does it conduct studies involving human reader performance, expert consensus on images, or training/test set data and ground truth establishment typically associated with such device evaluations.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and the study proving the device meets it, as they pertain to AI/ML device performance metrics which are not discussed in this medical device submission.

The document primarily focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices based on:

Intended Use: Minor modification to explicitly include "microorganisms" in the removal of wound debris.
Technological Characteristics: The proposed device remains largely unchanged from its primary predicate (Irrisept Wound Debridement and Cleansing System, K202222) in terms of solution composition, mechanism of action, how supplied, applicator, sterilization, and biocompatibility.
Performance Testing: Extensive list of standard medical device performance tests (e.g., sterilization, biocompatibility, packaging integrity, shelf-life, endotoxin, pyrogen testing) confirming it performs as safely and effectively as the predicate. The only new specific performance claim for this 510(k) is "mechanical action equivalent to the predicate devices, demonstrating that the fluid dispensed during the use of the device is sufficient to mechanically remove debris, including microorganisms, from wounds." This implies a physical/mechanical study, not an AI/ML performance study.

Given the context, here's what can and cannot be answered:

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

This document does not present acceptance criteria and performance in the format of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by meeting various medical device standards and demonstrating equivalence to a predicate device.

Acceptance Criteria (Implied by Substantial Equivalence Basis) & Reported Performance:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Intended Use	Device is intended for mechanical cleansing and removal of debris, dirt, foreign materials, AND microorganisms from wounds.	Confirmed; specified in Indications for Use. The change to include "microorganisms" is supported by substantial equivalence claim to secondary predicate.
Technological Characteristics	Must be substantially equivalent to predicate device (K202222) in terms of solution, applicator, mechanism, etc.	Confirmed; "unchanged from the legally marketed predicate Irrisept device (K202222) in its intended use, performance, and technological characteristics."
Biocompatibility	Device materials are biocompatible (per ISO 10993).	Confirmed; "Biocompatible per ISO 10993 testing."
Sterilization	Device components (bottle exterior, wraps, applicator) are sterilized (per ISO 11135, ISO 10993-7 for residuals) and solution is aseptically processed.	Confirmed; adherence to ISO standards and USP <71> Sterility Tests.
Preservative Antimicrobial Effectiveness	Solution preservative (CHG) effective over shelf-life (per USP <51>).	Confirmed; "Demonstrated per USP <51> testing."
Endotoxins & Pyrogens	Device/solution meets endotoxin and pyrogen limits (per USP <85>, <151>, <161>).	Confirmed; "Demonstrated per USP testing."
Packaging & Shelf-Life	Packaging maintains sterility and product integrity over shelf-life (per ISO 11607, ASTM F1980, F2096, F1929, D4169).	Confirmed; "Demonstrated per ASTM and ISO standards."
Mechanical Action	Fluid dispensed is sufficient to mechanically remove debris, including microorganisms.	Confirmed; "tested to show mechanical action equivalent to the predicate devices."
Safety & Effectiveness Concerns	No new safety and effectiveness concerns raised by the specified change to indications for use.	Confirmed; "does not raise new safety and effectiveness concerns."

Regarding the other points, they are not applicable to this submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a medical device clearance based on substantial equivalence and standard performance testing, not an AI/ML performance study with a test set of data. The "mechanical action" testing would involve physical samples/models, not digital data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" derived from expert consensus on images is mentioned or required for this type of device (wound lavage).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No AI/ML test set or expert adjudication process is described.

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

Not applicable. This is not an AI/ML device assisting human readers. It's a wound lavage device.

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

Not applicable. This is not an algorithm.

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

Not applicable in the context of AI/ML. The "ground truth" for this device would be its physical/chemical properties and its ability to mechanically remove debris, established through validated laboratory tests and engineering studies, not clinical outcomes or expert image interpretation.

8. The sample size for the training set

Not applicable. There is no AI/ML model or training set.

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

Not applicable. There is no AI/ML model or training set.

Summary

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May 28, 2021

Irrimax Corporation Christy Coleman VP Regulatory 1665 Lakes Parkway, Suite 102 Lawrenceville, Georgia 30043

Re: K210536

Trade/Device Name: Irrisept Antimicrobial Wound Lavage Regulatory Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II, unclassified Product Code: FQH, FRO Dated: February 19, 2021 Received: February 24, 2021

Dear Christy Coleman:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Lixin Liu, Ph.D. Assistant Director (Acting) 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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Indications for Use

510(k) Number (if known) K210536

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

PREPARATION DATE:	27 May 2021
510(K) NUMBER:	K210536
APPLICANT:	Irrimax® Corporation1665 Lakes Parkway, Suite 102Lawrenceville, GA 30043
CONTACT PERSON:	Christy Coleman, OD, MPHVice President, Regulatory Affairs,Irrimax® CorporationTel: (770) 807-3355
DEVICE TRADE NAME:	Irrisept® Antimicrobial Wound Lavage
CLASSIFICATION NAME:	Jet Lavage
DEVICE CLASSIFICATION:	Class II (21 CFR 880.5475)Unclassified (Pre-amendment)
PRODUCT CODE:	FQH; FRO
PRIMARY PREDICATE DEVICE:	Irrisept® Wound Debridement and Cleansing SystemProduct Code: FQH (Jet Lavage); Class II(21 CFR 880.5475)Product Code FRO (Dressing, Wound,Drug); Unclassified (pre-amendment)Applicant: Irrimax CorporationCleared under K202222 on December 14,2020
SECONDARY PREDICATE DEVICE:	Atteris Antimicrobial Skin and WoundCleanserProduct Code: FRO (Dressing, Wound,Drug); Unclassified (pre-amendment)Applicant: Rochal Industries, LLCCleared under K160192 on July 28, 2016

DEVICE DESCRIPTION:

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INTENDED USE/INDICATIONS FOR USE:

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The Irrisept device that is the subject of this 510(k) is substantially equivalent to its predicate, predecessor K202222, Irrisept. The Irrisept solution contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation that acts as a preservative to inhibit microbial growth in the solution. The Irrisept Antimicrobial Wound Lavage is unchanged from the legally marketed predicate Irrisept device (K202222) in its intended use, performance, and technological characteristics. The removal of wound debris, including dirt, foreign materials and microorganisms, is consistent with the secondary predicate device (Atteris Antimicrobial Skin & Wound Cleanser, legally marketed under K160192). Both devices have the same intended use and apply a solution to the wound for removal of wound debris. This 510(k) is to specify the removal of microorganisms through mechanical cleansing action within the indications for use statement of the Irrisept® device, consistent with the Atteris predicate device.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	PROPOSED DEVICE	PREDICATE DEVICE	SECONDARY PREDICATE DEVICE
	Irrisept Antimicrobial Wound Lavage	Irrisept Wound Debridement and Cleansing System	Atteris Antimicrobial Skin & Wound Cleanser
510(k) Number	K210536	K202222	K160192
Product Code	FQH, Jet Lavage	FQH, Jet Lavage	FQH, Jet Lavage
	FRO, Dressing, Wound, Drug	FRO, Dressing, Wound, Drug
Product Classification	Class II (21 CFR 880.5475)	Class II (21 CFR 880.5475)	Unclassified (Pre-amendment)
	Unclassified (Pre-amendment)	Unclassified (Pre-amendment)
Intended Use	Intended for wound cleansing and removal ofwound debris	Intended for wound cleansing and removal of wounddebris	Intended for wound cleansing and removal of wounddebris
Indications for Use	Irrisept® Antimicrobial Wound Lavage isintended for mechanical cleansing and removal ofdebris, dirt and foreign materials, includingmicroorganisms from wounds.	Irrisept Wound Debridement and Cleansing System isa wound cleansing and delivery system. Themechanical action effectively loosens and removeswound debris.	(Rx use) Atteris Antimicrobial Skin & WoundCleanser is intended for mechanical cleansing andremoval of debris, dirt and foreign materials,including microorganisms from wounds such as stageI-IV pressure ulcers, diabetic foot ulcers, post-surgicalwounds, first and second degree burns, grafted anddonor sites.(OTC use) Atteris Antimicrobial Skin & WoundCleanser is intended for physical cleaning and removalof dirt and debris, from skin scrapes, cuts, lacerations,minor irritations, exit sites and unbroken skin.
Type of Use	Prescription use only	Prescription use only	Both prescription use and over-the-counter use
Mechanism of Action	The mechanical action of fluid across the woundremoves wound debris.	The mechanical action of fluid across the woundremoves wound debris.	The mechanical action of fluid across the woundremoves wound debris.
Solution	0.05% Chlorhexidine Gluconate in 99.95% SterileWater for Irrigation, USP	0.05% Chlorhexidine Gluconate in 99.95% SterileWater for Irrigation, USP	Purified Water, Poloxamer 407,Sodium Chloride, Ethylhexylglycerin,Hypromellose, Octane-1,2-diol,Polyaminopropyl Biguanide [PHMB]
SolutionAntimicrobialPreservative	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Polyaminopropyl Biguanide [PHMB]
How Supplied	Provided for single use. A 450 mL bottle ofIrrisept is double wrapped in CSR and sealedwithin an outer Tyvek® pouch. The bottle exterior,CSR wraps, and applicator are sterilized by EO.The bottle contains aseptically processed Irriseptsolution.	Provided for single use. A 450 mL bottle of Irrisept isdouble wrapped in CSR and sealed within an outerTyvek® pouch. The bottle exterior, CSR wraps, andapplicator are sterilized by EO. The bottle containsaseptically processed Irrisept solution.	Provided non-sterile in 8 fluid ounce bottle with sprayer.
Applicator	Multiport applicator that threads onto the IrriseptBottle	Multiport applicator that threads onto the Irrisept Bottle	Sprayer attachment
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	PROPOSED DEVICEIrrisept Antimicrobial Wound Lavage	PREDICATE DEVICEIrrisept Wound Debridement and Cleansing System	SECONDARY PREDICATE DEVICEAtteris Antimicrobial Skin & Wound Cleanser
Sterilization	Bottle exterior, CSR wraps, and outer packagingconforms to ISO 11135-7 for EO sterilization andISO 10993-7 for EO residualswhereas the solution is aseptically processed	Bottle exterior, CSR wraps, and outer packagingconforms to ISO 11135-7 for EO sterilization and ISO10993-7 for EO residualswhereas the solution is aseptically processed	Provided non-sterile
Biocompatibility	Biocompatible per ISO 10993 testing for a surfacedevice with breached or compromised surfacecontact and a limited duration (≤ 24 hours)	Biocompatible per ISO 10993 testing for a surfacedevice with breached or compromised surface contactand a limited duration (≤ 24 hours)	Biocompatible per ISO 10993 testing
PreservativeEffectiveness overShelf-Life	Demonstrated per USP <51> testing	Demonstrated per USP <51> testing	Demonstrated per USP <51> testing

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There are no technological differences between the two versions of Irrisept. The change to the Irrisept labeled indication for use to include removal of "microorganisms" as a type of wound debris does not change the intended use of the device and does not raise new safety and effectiveness concerns. Substantial equivalence has been confirmed through performance testing.

PERFORMANCE TESTING:

Performance testing is unchanged between Irrisept Antimicrobial Wound Lavage and the predicate Irrisept device for biocompatibility, aseptic processing, sterility, preservative antimicrobial effectiveness, endotoxin and pyrogen testing, EO sterilization, packaging integrity, and shelf-life validation. Performance testing demonstrates that the subject Irrisept is as safe and as effective as the predicate, predecessor Irrisept product. These tests include:

Preservative Antimicrobial Effectiveness .
- o USP <51> Antimicrobial Effectiveness Testing
Aseptic Processing ●
- o ISO 13408 Aseptic Processing of Health Care Products
Sterilization ●
- o ISO 11135 Sterilization of Health-Care Products Ethylene Oxide
- ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals O
- o USP <71> Sterility Tests
- AAMI TIR 28 Product adoption and process equivalence for ethylene o oxide sterilization
Endotoxins and Pyrogens ●
- o USP <85> Bacterial Endotoxins Test
- o USP <151> Pyrogen Test (USP Rabbit Test)
- o USP <161> Medical Devices- Bacterial Endotoxin and Pyrogen Tests
. Packaging and Shelf-Life
- ISO 11607 Packaging for Terminally Sterilized Medical Devices O
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile o Barrier Systems for Medical Devices
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in O Packaging by Internal Pressurization (Bubble Test)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in o Porous Medical Packaging by Dye Penetration
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping o Containers and Systems
. Biocompatibility
- o ISO 10993- Biological Evaluation of Medical Devices

In addition, the subject device was also tested to show mechanical action equivalent to the predicate devices, demonstrating that the fluid dispensed during the use of the device is sufficient to mechanically remove debris, including microorganisms, from wounds.

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SUBSTANTIAL EQUIVALENCE CONCLUSION:

The performance testing conducted demonstrates that the Irrisept Antimicrobial Wound Lavage is substantially equivalent to the predicate Irrisept device in intended use and technological characteristics and this premarket notification supports the addition of "microorganisms" as a type of wound debris removed by the device in the labeled indications for use.

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.