Irrisept Antimicrobial Wound Lavage

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY | PREPARATION DATE: | 27 May 2021 | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) NUMBER: | K210536 | | APPLICANT: | Irrimax® Corporation<br>1665 Lakes Parkway, Suite 102<br>Lawrenceville, GA 30043 | | CONTACT PERSON: | Christy Coleman, OD, MPH<br>Vice President, Regulatory Affairs,<br>Irrimax® Corporation<br>Tel: (770) 807-3355 | | DEVICE TRADE NAME: | Irrisept® Antimicrobial Wound Lavage | | CLASSIFICATION NAME: | Jet Lavage | | DEVICE CLASSIFICATION: | Class II (21 CFR 880.5475)<br>Unclassified (Pre-amendment) | | PRODUCT CODE: | FQH; FRO | | PRIMARY PREDICATE DEVICE: | Irrisept® Wound Debridement and Cleansing System<br>Product Code: FQH (Jet Lavage); Class II<br>(21 CFR 880.5475)<br>Product Code FRO (Dressing, Wound,<br>Drug); Unclassified (pre-amendment)<br>Applicant: Irrimax Corporation<br>Cleared under K202222 on December 14,<br>2020 | | SECONDARY PREDICATE DEVICE: | Atteris Antimicrobial Skin and Wound<br>Cleanser<br>Product Code: FRO (Dressing, Wound,<br>Drug); Unclassified (pre-amendment)<br>Applicant: Rochal Industries, LLC<br>Cleared under K160192 on July 28, 2016 | ## 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. {4}------------------------------------------------ #### 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. {5}------------------------------------------------ | 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 of<br>wound debris | Intended for wound cleansing and removal of wound<br>debris | Intended for wound cleansing and removal of wound<br>debris | | | Indications for Use | Irrisept® Antimicrobial Wound Lavage is<br>intended for mechanical cleansing and removal of<br>debris, dirt and foreign materials, including<br>microorganisms from wounds. | Irrisept Wound Debridement and Cleansing System is<br>a wound cleansing and delivery system. The<br>mechanical action effectively loosens and removes<br>wound debris. | (Rx use) Atteris Antimicrobial Skin & Wound<br>Cleanser is intended for mechanical cleansing and<br>removal of debris, dirt and foreign materials,<br>including microorganisms from wounds such as stage<br>I-IV pressure ulcers, diabetic foot ulcers, post-surgical<br>wounds, first and second degree burns, grafted and<br>donor sites.<br>(OTC use) Atteris Antimicrobial Skin & Wound<br>Cleanser is intended for physical cleaning and removal<br>of dirt and debris, from skin scrapes, cuts, lacerations,<br>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 wound<br>removes wound debris. | The mechanical action of fluid across the wound<br>removes wound debris. | The mechanical action of fluid across the wound<br>removes wound debris. | | | Solution | 0.05% Chlorhexidine Gluconate in 99.95% Sterile<br>Water for Irrigation, USP | 0.05% Chlorhexidine Gluconate in 99.95% Sterile<br>Water for Irrigation, USP | Purified Water, Poloxamer 407,<br>Sodium Chloride, Ethylhexylglycerin,<br>Hypromellose, Octane-1,2-diol,<br>Polyaminopropyl Biguanide [PHMB] | | | Solution<br>Antimicrobial<br>Preservative | Chlorhexidine Gluconate | Chlorhexidine Gluconate | Polyaminopropyl Biguanide [PHMB] | | | How Supplied | Provided for single use. A 450 mL bottle of<br>Irrisept is double wrapped in CSR and sealed<br>within an outer Tyvek® pouch. The bottle exterior,<br>CSR wraps, and applicator are sterilized by EO.<br>The bottle contains aseptically processed Irrisept<br>solution. | Provided for single use. A 450 mL bottle of Irrisept is<br>double wrapped in CSR and sealed within an outer<br>Tyvek® pouch. The bottle exterior, CSR wraps, and<br>applicator are sterilized by EO. The bottle contains<br>aseptically processed Irrisept solution. | Provided non-sterile in 8 fluid ounce bottle with sprayer. | | | Applicator | Multiport applicator that threads onto the Irrisept<br>Bottle | Multiport applicator that threads onto the Irrisept Bottle | Sprayer attachment | | | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | | | | Comparison Feature | PROPOSED DEVICE<br>Irrisept Antimicrobial Wound Lavage | PREDICATE DEVICE<br>Irrisept Wound Debridement and Cleansing System | SECONDARY PREDICATE DEVICE<br>Atteris Antimicrobial Skin & Wound Cleanser | | | Sterilization | Bottle exterior, CSR wraps, and outer packaging<br>conforms to ISO 11135-7 for EO sterilization and<br>ISO 10993-7 for EO residuals<br>whereas the solution is aseptically processed | Bottle exterior, CSR wraps, and outer packaging<br>conforms to ISO 11135-7 for EO sterilization and ISO<br>10993-7 for EO residuals<br>whereas the solution is aseptically processed | Provided non-sterile | | | Biocompatibility | Biocompatible per ISO 10993 testing for a surface<br>device with breached or compromised surface<br>contact and a limited duration (≤ 24 hours) | Biocompatible per ISO 10993 testing for a surface<br>device with breached or compromised surface contact<br>and a limited duration (≤ 24 hours) | Biocompatible per ISO 10993 testing | | | Preservative<br>Effectiveness over<br>Shelf-Life | Demonstrated per USP <51> testing | Demonstrated per USP <51> testing | Demonstrated per USP <51> testing | | {6}------------------------------------------------ {7}------------------------------------------------ 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. {8}------------------------------------------------ ## 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.