IRRIGO Wound Wash Jet System

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May 31, 2022 Inopro Inc Alain Lefebvre President 800 rue Sud Porte A Cowansville, Quebec J2K 2Y3 Canada Re: K210987 Trade/Device Name: IRRIGO Wound Wash Jet System Regulatory Class: Unclassified Product Code: FRO, FQH Dated: March 10, 2021 Received: April 1, 2021 Dear Alain Lefebvre: 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. 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Sincerely, Julie Morabito, Ph.D. Acting 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210987 Device Name IRRIGO Wound Wash Jet System ### Indications for Use (Describe) IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Regulatory Sponsor Inopro, Inc. 800 rue Sud Porte A Cowansville Quebec J2K 2Y3 Canada Contact: Alain Lefebvre Title: President Phone: (514) 438-8481 Email: alefebvre@inopro.ca #### II. Date Prepared March 2, 2022 - III. Type of 510(k) Submission Traditional #### Device Identification IV. | Trade/Proprietary Name: | IRRIGO Wound Wash Jet System | |-------------------------|------------------------------| | Common Name: | Dressing, Wound, Drug | | Classification: | Unclassified | | FDA Product Code: | FRO, FQH | | Review Panel: | General Hospital | #### V. Legally Marketed Predicate Device(s) Primary Predicate K090848 Premier Saline Wound Wash ## Secondary Predicate K082330 Primary Care Solutions Sterile Water and Sterile Saline These predicates have not been subject to a design-related recall. #### VI. Device Description IRRIGO Wound Wash Jet System is a sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water for Irrigation and packaged in a food grade compressible translucent LDPE 2oz (60mL) bottle with a LPDE luer-lock type tip spray insert and an HPDE colored cap. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Inopro Inc. The logo features the word "inopro" in blue, with a red plus sign above the "o". To the right of the logo is the word "inc." in a smaller font. Below the logo is the text "IRRIGO Wound Wash Jet System" in a larger, bold font. The mechanism of action of the solution moving across the wound aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudates, and other extraneous matter. IRRIGO Wound Wash Jet System can generate upto 15 psi of stream pressure. No preservatives are added since the finished device is sterilized by gamma irradiation. #### VII. Indications for Use IRRIGO Wound Wash Jet System is intended for use by or under the direction of a professional healthcare provider in moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts, abrasions, and minor burns. For Prescription Use Only. #### VIII. Substantial Equivalence Comparison Table | Device Name | IRRIGO Wound<br>Wash Jet System | Premier Sterile<br>Saline Wound<br>Wash | Primary Care<br>Solutions Sterile<br>Water and Sterile<br>Saline | Substantial<br>Equivalent<br>(SE) | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate | Secondary<br>Predicate | | | 510(k) # | K210987 | K090848 | K082330 | ---------- | | Classification<br>Product<br>Code | FRO, FQH | FRO, FQH | FRO, FQH, JOL | SE | | Fluid<br>Composition | 0.9% sodium chloride<br>(USP) and purified<br>water (USP) | 0.9% sodium<br>chloride (USP) and<br>purified water (USP) | 0.9% sodium<br>chloride (USP) and<br>sterile water for<br>irrigation (USP) | SE | | Indications<br>For Use | Rx:<br>IRRIGO Wound<br>Wash Jet System is<br>intended for use by or<br>under the direction of<br>professional<br>healthcare provider in<br>moistening and<br>lubricating absorbent<br>wound dressings,<br>cleansing, and<br>maintaining a moist<br>wound environment<br>for traumatic wounds<br>such as pressure<br>sores, leg ulcers of<br>diabetic and vascular | Rx:<br>Saline Wound Wash<br>is intended for use by<br>or under the direction<br>of a professional<br>healthcare provider<br>in moistening and<br>lubricating absorbent<br>wound dressings,<br>cleansing, and<br>maintaining a moist<br>wound environment<br>for traumatic wounds<br>such as pressure<br>sores, leg ulcers of<br>diabetic and vascular<br>origin cuts | Rx:<br>Moisturizing of<br>Wound Dressings,<br>Device Irrigation<br>and Jet Lavage for<br>Tissue Debridement | SE; Subject<br>device -<br>Irrigo is for<br>Rx Only. | | | origin, cuts, abrasions,<br>and minor burns. | abrasions, and minor<br>burns. | | Traditional 510(k) | | | | <b>OTC:</b><br>Saline Wound Wash<br>is intended for use in<br>moistening and<br>lubricating absorbent<br>wound dressings and<br>for cleansing minor<br>wounds, scrapes and<br>minor burns. If<br>redness, swelling or<br>bleeding continues,<br>please seek the help<br>of nurse, nurses aid,<br>doctor, or other<br>medical professional. | | | | Description | IRRIGO Wound<br>Wash Jet System is a<br>sterile single patient<br>use jet lavage medical<br>device that consists of<br>0.9% USP Sodium<br>Chloride solubilized<br>in USP Purified Water<br>for Irrigation and<br>packaged in a food<br>grade compressible<br>translucent LDPE 2oz<br>(60mL) bottle with a<br>LPDE luer-lock type<br>tip spray insert and an<br>HPDE colored cap. | Saline Wound Wash<br>is a multi-use,<br>isotonic, sterile<br>saline solution<br>packaged in a bag-in-<br>can aerosol system.<br><br>Actuation of the<br>device (product can)<br>delivers a consistent<br>flow of sterile<br>isotonic saline<br>solution at published<br>safe and effective<br>wound impact<br>pressures of 4 to 15<br>psi (Clinical Practice<br>Guideline Number<br>15 AHCPR, US<br>Health and Human<br>Services). | This device is USP<br>purified water or<br>saline sealed in<br>100mL HDPE<br>bottles or 120mL<br>HIPS cups. | SE;<br>Subject<br>device -<br>Irrigo is<br>similar to<br>both<br>predicates.<br>Difference is<br>Primary<br>Predicate is a<br>bag-in-can<br>aerosol<br>system;<br>Subject<br>device is in a<br>non-aerosol<br>bottle.<br><br>Subject and<br>primary<br>predicate<br>capable of<br>delivering<br>upto 15 psi of<br>pressure;<br>Unknown for<br>Secondary<br>Predicate. | | Mechanism<br>of Action | The mechanical<br>action of isotonic<br>saline solution<br>moving across the<br>wound aids in the<br>removal of foreign<br>material, such as dirt<br>and debris, as well as<br>any necrotic tissue,<br>wound exudates and<br>other extraneous<br>matter. | The mechanical<br>action of isotonic<br>saline solution<br>moving across the<br>wound aids in the<br>removal of foreign<br>material, such as dirt<br>and debris, as well as<br>any necrotic tissue,<br>wound exudates and<br>other extraneous<br>matter. | The mechanical<br>action of isotonic<br>saline solution<br>moving across the<br>wound aids in the<br>removal of foreign<br>material, such as dirt<br>and debris, as well as<br>any necrotic tissue,<br>wound exudates and<br>other extraneous<br>matter. | SE | | Preservative | No preservatives are<br>added since the<br>finished device is<br>sterilized by gamma<br>irradiation. | No preservatives are<br>added since the<br>finished device is<br>sterilized by gamma<br>irradiation. | Unknown | SE; Subject<br>and Primary<br>Predicate;<br>Unknown for<br>Secondary<br>Predicate | | Packaging | IRRIGO Wound<br>Wash Jet System is a<br>sterile single patient<br>use jet lavage medical<br>device that consists of<br>0.9% USP Sodium<br>Chloride solubilized<br>in USP Purified Water<br>for Irrigation and<br>packaged in a food<br>grade compressible<br>translucent LDPE 2oz<br>(60mL) bottle with a<br>LPDE luer-lock type<br>tip spray insert and an<br>HPDE colored cap. | Saline Wound Wash<br>is an aerosol bag-in-<br>can system.<br><br>The propellant,<br>compressed air, is<br>charged into the<br>container between<br>the bag and the can<br>creating a means to<br>dispense the contents<br>of the bag, isotonic<br>sterile saline<br>solution.<br><br>The bag is a 4-layer<br>laminate system<br>including a<br>sandwiched<br>polyethylene layer<br>establishing an<br>impermeable barrier<br>between the<br>propellant<br>(compressed air) and<br>the bag contents<br>(sterile isotonic<br>saline).<br><br>The isotonic saline<br>solution of is in | 100mL HDPE<br>bottles or 120mL<br>HIPS cups | SE;<br>Subject and<br>Secondary<br>Predicate<br>similar,<br>Primary<br>predicate –<br>aerosol bag-<br>in-can system | | | | 0.9% sodium<br>chloride solution<br>prepared from<br>sodium chloride,<br>USP, and purified<br>water, USP. | | | | Sterilization<br>Method | Gamma | Gamma | Gamma | SE | | Single<br>Use/Multi-<br>Use | Single Use | Multi Use | Single Use | SE; Subject<br>Device is for<br>Single Use<br>Only. | | Rx or OTC | Rx | Both | Rx | SE; Subject<br>Device is for<br>Rx Use Only. | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Inopro Inc. The logo features the word "inopro" in blue, followed by a red plus sign and a blue water droplet. The word "inc." is written in small, black letters to the right of the water droplet. # IRRIGO Wound Wash Jet System Traditional 510(k) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Inopro Inc. The logo features the word "inopro" in blue, with a red plus sign above the "o". To the right of the name is a blue water droplet and the word "Inc." Below the logo is the text "IRRIGO Wound Wash Jet System". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Inopro Inc. The word "inopro" is written in blue, with a red plus sign above the "o". To the right of the plus sign is a blue water droplet. The word "inc." is written in small blue letters to the right of the water droplet. IRRIGO Wound Wash Jet System #### IX. Summary of Bench Testing IRRIGO Wound Wash is tested against the following established specifications and standards: - USP 43-NF38:2020 Sodium Chloride Irrigation ● - USP 43-NF38:2020 <71> Sterility Tests ● - USP 43-NF38:2020 <85> Bacterial Endotoxins Test - USP 43-NF38:2020 Purified Water - USP 43<541> Titrimetry Sodium Chloride Assay ● - ANSI AAMI ISO 11137-1 Sterilization of healthcare products -Radiation Part 1 ● Requirements for development, validation, and routine control of a sterilization process for medical devices - ANSI AAMI ISO 11137-2 Sterilization of healthcare products -Radiation - Part 2 Establishing the sterilization dose. - ANSI AAMI ST67:2019 Sterilization of healthcare products Requirements and ● guidance for selecting a sterility assurance level (SAL) - IRRIGO PSI Testing/Internal Pressure Curves - Packaging integrity leak test ● IRRIGO Wound Wash Jet System is tested against established specifications and meets Biocompatibility requirements: - ISO 10993-5 Cytotoxicity - ISO 10993-10 Intracutaneous Reactivity ● - ISO 10993-10 Skin Sensitization ● - ISO 10993-11 Acute Systemic Toxicity ● - <USP 151> Material-Mediated Pyrogenicity ● {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Inopro Inc. The logo features the word "inopro" in blue, with a red cross and blue water droplet symbol next to it. Below the logo, the text "IRRIGO Wound Wash Jet System" is written in a larger, bold font. #### X. Statement of Substantial Equivalence The subject device and predicate devices are jet lavage devices used to clean a wound by a pulsatile jet of sterile fluid. These devices have intended use and similar technological characteristics. IRRIGO Wound Wash Jet System has the same intended use and indications for use as the primary and secondary predicate devices. Any minor differences in the technological features of the subject device when compared to the predicate devices have been evaluated through safety and performance testing and other verification and validation testing activities such that the information demonstrates that the subject device, when compared to the predicted devices, does not raise any new questions of safety and effectiveness. IRRIGO Wound Wash Jet System has been determined to be substantially equivalent to the predicate devices.