Who is the manufacturer of IRRIGO Wound Wash Jet System?

Inopro, Inc. filed the 510(k) submission for IRRIGO Wound Wash Jet System (K210987).

What is the FDA product code for IRRIGO Wound Wash Jet System?

FQH. It is classified under 21 CFR 880.5475 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for IRRIGO Wound Wash Jet System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IRRIGO Wound Wash Jet System?

Premier Saline Wound Wash (K090848); Primary Care Solutions Sterile Water and Sterile Saline (K082330).

Who can help prepare an FDA 510(k) submission like IRRIGO Wound Wash Jet System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IRRIGO Wound Wash Jet System

K210987 · Inopro, Inc. · FQH · May 31, 2022 · General Hospital

Device Facts

Record ID	K210987
Device Name	IRRIGO Wound Wash Jet System
Applicant	Inopro, Inc.
Product Code	FQH · General Hospital
Decision Date	May 31, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5475
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

IRRIGO Wound Wash Jet System is a sterile, single-patient-use jet lavage device. It consists of 0.9% USP Sodium Chloride in USP Purified Water, packaged in a 60mL compressible LDPE bottle with a luer-lock tip spray insert. Operated by a healthcare provider, the device is manually compressed to generate a pulsatile stream of saline solution (up to 15 psi) directed at the wound. This mechanical action removes foreign material, dirt, debris, necrotic tissue, and wound exudates. The device is used in clinical settings to facilitate wound cleansing and maintain a moist environment, aiding in patient healing. It is sterilized via gamma irradiation and contains no preservatives.

Clinical Evidence

Bench testing only. Testing included USP 43-NF38:2020 standards for sodium chloride irrigation, sterility, bacterial endotoxins, and purified water. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous reactivity, skin sensitization), ISO 10993-11 (acute systemic toxicity), and USP 151 (material-mediated pyrogenicity). Performance testing included internal pressure curves (up to 15 psi) and packaging integrity leak tests.

Technological Characteristics

Materials: LDPE (bottle/tip), HDPE (cap). Principle: Manual compression for pulsatile jet lavage. Energy: Manual. Dimensions: 60mL bottle. Connectivity: None. Sterilization: Gamma irradiation (ISO 11137). Standards: USP 43-NF38:2020, ISO 10993, ANSI AAMI ST67:2019.

Indications for Use

Indicated for professional healthcare provider use in moistening/lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds including pressure sores, diabetic/vascular leg ulcers, cuts, abrasions, and minor burns.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Premier Saline Wound Wash (K090848)
Primary Care Solutions Sterile Water and Sterile Saline (K082330)

Related Devices

K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP · Medline Industries, Inc. · Jul 2, 2018
K083042 — WOUND FLUSH, STERILE WATER & NORMAL SALINE · Nurse Assist, Inc. · Dec 18, 2008
K243001 — Sterile Water USP and Sterile 0.9% Normal Saline USP · Laboratorios Biogalenic S.A. DE C.V. · Mar 6, 2025
K082330 — PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION · Primary Care Solutions, Inc. · Oct 9, 2008
K161658 — Anexa Wound Flush, Sterile Water & Sterile Normal Saline · Anexa Biomedical, Inc. · Sep 14, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. 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, 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. 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}------------------------------------------------ Image /page/3/Picture/1 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". # Section 5: 510(k) Summarv [K210987] #### I. 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 Wash Jet System | Premier Sterile Saline Wound Wash | Primary Care Solutions Sterile Water and Sterile Saline | Substantial Equivalent (SE) | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Primary Predicate | Secondary Predicate | | | 510(k) # | K210987 | K090848 | K082330 | ---------- | | Classification Product Code | FRO, FQH | FRO, FQH | FRO, FQH, JOL | SE | | Fluid Composition | 0.9% sodium chloride (USP) and purified water (USP) | 0.9% sodium chloride (USP) and purified water (USP) | 0.9% sodium chloride (USP) and sterile water for irrigation (USP) | SE | | Indications For Use | Rx: IRRIGO Wound Wash Jet System is intended for use by or under the direction of 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 | Rx: Saline Wound Wash 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 | Rx: Moisturizing of Wound Dressings, Device Irrigation and Jet Lavage for Tissue Debridement | SE; Subject device - Irrigo is for Rx Only. | | | origin, cuts, abrasions, and minor burns. | abrasions, and minor burns. | | Traditional 510(k) | | | | OTC: Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor burns. If redness, swelling or bleeding continues, please seek the help of nurse, nurses aid, doctor, or other medical professional. | | | | 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. | Saline Wound Wash is a multi-use, isotonic, sterile saline solution packaged in a bag-in- can aerosol system. Actuation of the device (product can) delivers a consistent flow of sterile isotonic saline solution at published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15 AHCPR, US Health and Human Services). | This device is USP purified water or saline sealed in 100mL HDPE bottles or 120mL HIPS cups. | SE; Subject device - Irrigo is similar to both predicates. Difference is Primary Predicate is a bag-in-can aerosol system; Subject device is in a non-aerosol bottle. Subject and primary predicate capable of delivering upto 15 psi of pressure; Unknown for Secondary Predicate. | | Mechanism of Action | The mechanical action of isotonic saline 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. | The mechanical action of isotonic saline 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. | The mechanical action of isotonic saline 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. | SE | | Preservative | No preservatives are added since the finished device is sterilized by gamma irradiation. | No preservatives are added since the finished device is sterilized by gamma irradiation. | Unknown | SE; Subject and Primary Predicate; Unknown for Secondary Predicate | | Packaging | 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. | Saline Wound Wash is an aerosol bag-in- can system. The propellant, compressed air, is charged into the container between the bag and the can creating a means to dispense the contents of the bag, isotonic sterile saline solution. The bag is a 4-layer laminate system including a sandwiched polyethylene layer establishing an impermeable barrier between the propellant (compressed air) and the bag contents (sterile isotonic saline). The isotonic saline solution of is in | 100mL HDPE bottles or 120mL HIPS cups | SE; Subject and Secondary Predicate similar, Primary predicate – aerosol bag- in-can system | | | | 0.9% sodium chloride solution prepared from sodium chloride, USP, and purified water, USP. | | | | Sterilization Method | Gamma | Gamma | Gamma | SE | | Single Use/Multi- Use | Single Use | Multi Use | Single Use | SE; Subject Device is for Single Use Only. | | Rx or OTC | Rx | Both | Rx | SE; Subject Device is for 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.