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 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 a 510(k) submission for the Irrisept Wound Debridement and Cleansing System (K202222), claiming substantial equivalence to its predicate device (K080779). This is a "catch-up 510(k)" primarily addressing updates responsive to user feedback, longer-term shelf-life data, and supplier/contractor changes.

The document does not provide acceptance criteria or a study that specifically proves the device meets distinct acceptance criteria in the context of comparative effectiveness or standalone performance of an AI/algorithm-based device as requested in the prompt. The testing described is focused on demonstrating that the changes made to the device do not raise new questions of safety and effectiveness compared to the predicate device, rather than establishing performance against new, explicit acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a different type of device evaluation (e.g., AI/algorithm performance).

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state "acceptance criteria" in the traditional sense for a new AI/algorithm device (e.g., minimum sensitivity, specificity, or AUC). Instead, the performance testing focuses on demonstrating that the modified device is as safe and effective as the predicate.

The table below outlines the performance testing conducted, which implicitly serves to "meet acceptance criteria" by confirming the safety and effectiveness of the updated device is maintained compared to the cleared predicate. The reported "performance" is that the tests were successfully passed, indicating equivalence to the predicate.

Acceptance Criteria Category (Implicit)	Specific Test Conducted	Reported Device Performance
Antimicrobial Effectiveness	USP <51> Antimicrobial Effectiveness Testing	Demonstrated to be effective (implies comparable to predicate)
Aseptic Processing	ISO 13408 Aseptic Processing of Health Care Products	Compliant (implies comparable to predicate)
Sterilization	ISO 11135 Sterilization of Health-Care Products Ethylene Oxide	Compliant (implies comparable to predicate)
	ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals	Compliant (implies comparable to predicate)
	USP <71> Sterility Tests	Compliant (implies comparable to predicate)
	AAMI TIR 28 Product adoption and process equivalence for ethylene oxide sterilization	Compliant (implies comparable to predicate)
Endotoxins and Pyrogens	USP <85> Bacterial Endotoxins Test	Compliant (Endotoxin Limit ≤ 20 EU/device)
	USP <151> Pyrogen Test (USP Rabbit Test)	Compliant (implies comparable to predicate)
	USP <161> Medical Devices Bacterial Endotoxin and Pyrogen Tests	Compliant (implies comparable to predicate)
Packaging and Shelf-Life	ISO 11607 Packaging for Terminally Sterilized Medical Devices	Compliant, now 2-year shelf-life (vs. 6 months for predicate)
	ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	Compliant (supports 2-year shelf-life)
	ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)	Compliant
	ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration	Compliant
	ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems	Compliant
Biocompatibility	ISO 10993- Biological Evaluation of Medical Devices	Conforms for a surface device with breached/compromised contact (≤ 24 hours)

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

The document does not specify sample sizes for any of the performance tests, nor does it mention data provenance (country of origin, retrospective/prospective). The tests listed are primarily bench/laboratory tests on the device itself or its components (e.g., solution, packaging). This is not a clinical study involving patient data.

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. This is not an AI/algorithm or diagnostic device that requires expert-established ground truth from clinical cases. The tests are laboratory and engineering-based.

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

Not applicable. No clinical test set or adjudication is mentioned.

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 a medical device for wound cleansing (Jet Lavage), not an AI-assisted diagnostic or imaging system.

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

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

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

Not applicable in the context of clinical "ground truth." The "truth" for the performance tests is based on adherence to established international and USP standards (e.g., sterility, endotoxin limits, packaging integrity, biocompatibility).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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December 14, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

Re: K202222

Trade/Device Name: Irrisept Wound Debridement and Cleansing System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II, unclassified Product Code: FOH, FRO Dated: November 12, 2020 Received: November 13, 2020

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 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

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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 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,

For Kimberly Ferlin, 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) K202222

Device Name

Irrisept Wound Debridement and Cleansing System

Indications for Use (Describe)

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

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

510(K) NUMBER:	K202222
PREPARATION DATE:	December 11, 2020
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® Wound Debridement andCleansing System
CLASSIFICATION NAME:	Jet Lavage
DEVICE CLASSIFICATION:	Class II (21 CFR 880.5475)Unclassified (Pre-amendment)
PRODUCT CODE:	FQH; FRO
PREDICATE DEVICE:	Irrisept® Wound Debridement and Cleansing System(K080779)• Product Code FQH (Jet Lavage);Class II (21 CFR 880.5475)• Product Code FRO (Dressing, Wound,Drug); Unclassified (pre-amendment)Applicant: Irrimax Corporation

DEVICE DESCRIPTION:

INTENDED USE/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.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The Irrisept that is the subject of this 510(k) is substantially equivalent to its predicate, predecessor K080779 Irrisept. This is a catch-up 510(k) submission intended to update the Irrisept record at FDA with the changes that have been implemented in the subject product. As such, the intended use/indications remain identical to that for the cleared product. Further, the implemented changes were primarily to be responsive to user feedback, capture the now available longer-term shelf-life data, or reflect a need to change a supplier or manufacturing contractor. These are captured in the comparison table below.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	Cleared Irrisept Product(K080779)	Subject Irrisept Product(K202222)
Intended Use/Indications for Use	The Irrisept WoundDebridement and CleansingSystem is a wound cleansingdelivery system. Themechanical action effectivelyloosens and removes wounddebris.	Identical
Rx only	Prescription Product	Identical
Single Use	Single Use	Identical
Mechanism of Action	The mechanical action of fluidacross the wound removeswound debris.	Identical.
Components andMaterials	Polypropylene bottleSolutionPolycarbonate applicator	New supplier forChlorhexidine GluconateNew supplier forpolycarbonate
Solution Composition	0.05% Chlorhexidine Gluconatein 99.95% Sterile Water forIrrigation, USP	Identical
Container Design	450 mL BFS bottle delivers fluidby manual compression	Identical
Applicator Design	Multi-port applicator thatthreads onto bottle.	Multi-port applicator thatthreads onto bottle and witha longer tip.Change to a higher capacitymanufacturing mold
Biocompatibility	Conforms to ISO 10993-1 for asurface device with breached orcompromised surface contactand a limited contact duration(≤ 24 hours)	Identical
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	Cleared Irrisept Product(K080779)	Subject Irrisept Product(K202222)
Manufactured usingAseptic Techniques	Solution is manufactured using Blow-Fill-Seal (BFS) aseptic processing. Solution labeled as Sterile.	Identical BFS process New contract manufacturer Changed to a higher capacity BFS manufacturing mold
Non-Pyrogenic	Solution	Solution and applicatorEndotoxin Limit ≤ 20 EU/device(<0.045 EU/mL for 450 mL)
Packaging	1. Packaged applicator in Tyvek® film pouch2. Protective PETG tube added over bottle cap to protect bottle cap during shipment3. Sterilized applicator and bottle-filled solution are then packaged in a shelf box.	Changed manufacturing final step for protective PETG tube Bottle-filled solution and applicator are packaged together in CSR wraps and Tyvek® header pouch for sterilization New contract manufacturer
Sterilization	Packaged applicator conforms to ISO 11135 and ISO 10993-7 for EO sterilization, whereas the solution is aseptically processed	The bottle and applicator are EO-sterilized and conform to ISO 11135 and ISO 10993-7, whereas the solution is aseptically processed
Shelf-Life	Six-month shelf-life.	Two-year shelf-life
Labeling	Labeling consists of: Bottle Label Applicator label Package Label - Shelf Box Label Shipping Box Label	Labeling consists of: Bottle Label Package Label - Front Package Label - Back Shipping Box Label

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The differences between the two versions of Irrisept do not raise different questions of safety and effectiveness and have been confirmed through testing.

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PERFORMANCE TESTING:

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
- ISO 11135 Sterilization of Health-Care Products Ethylene Oxide O
- ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals O
- USP <71> Sterility Tests O
- AAMI TIR 28 Product adoption and process equivalence for ethylene oxide O sterilization
Endotoxins and Pyrogens ●
- USP <85> Bacterial Endotoxins Test O
- USP <151> Pyrogen Test (USP Rabbit Test) O
- USP <161> Medical Devices Bacterial Endotoxin and Pyrogen Tests O

● Packaging and Shelf-Life

ISO 11607 Packaging for Terminally Sterilized Medical Devices O
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier O Systems for Medical Devices
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging о by Internal Pressurization (Bubble Test)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous o 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

CONCLUSIONS:

In conclusion, Irrimax has demonstrated through performance testing that the subject Irrisept is substantially equivalent to its predicate Irrisept product in intended use and technological characteristics.

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.