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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the IRRIGO Wound Wash Jet System. This document is a submission to the FDA seeking to demonstrate substantial equivalence to existing legally marketed devices, not a study proving the device meets specific acceptance criteria through clinical or AI-based performance metrics.

The document discusses bench testing conducted to ensure the device meets established specifications and standards related to its composition, sterility, pressure generation (up to 15 psi), biocompatibility, and packaging integrity. However, it does not present a study with the kind of acceptance criteria, test set, ground truth establishment, or human-in-the-loop performance evaluation that would be relevant for an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and study proving device performance, as the document pertains to a medical device for wound irrigation and does not describe an AI/ML-based device or a clinical study with the specified types of performance measures.

Here's why the specific points cannot be extracted from the provided text:

Table of acceptance criteria and reported device performance: The document lists standards and tests (e.g., USP standards for sodium chloride irrigation, sterility, endotoxins, biocompatibility tests). It states that the device "is tested against established specifications and meets Biocompatibility requirements" and "IRRIGO Wound Wash Jet System is tested against established specifications and meets Biocompatibility requirements." It also mentions "IRRIGO PSI Testing/Internal Pressure Curves" and that the device "can generate upto 15 psi of stream pressure." However, these are general statements of compliance with technical standards, not a specific table of acceptance criteria with corresponding performance values that would typically be presented for an AI/ML or a complex clinical effectiveness study. There are no performance metrics like sensitivity, specificity, accuracy, or reader improvement.
Sample size, data provenance: Not applicable. This is not a study involving patient data or an AI model. The "testing" refers to manufacturing and device-specific technical compliance.
Number of experts, qualifications: Not applicable. No ground truth established by experts is mentioned, as this is not a diagnostic device or a study requiring human adjudication of performance.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This device is not an AI algorithm assisting human readers.
Standalone performance (algorithm only): Not applicable. This is not an algorithm.
Type of ground truth: Not applicable.
Sample size for training set: Not applicable. There is no AI model.
How ground truth for training set was established: Not applicable.

In summary, the provided text describes the regulatory filing for a physical medical device (wound wash system) and its bench testing for safety and functional specifications, not a study evaluating an AI/ML device or its clinical performance in the way implied by the request.

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known) K210987

Device Name IRRIGO Wound Wash Jet System

Indications for Use (Describe)

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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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

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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

For Prescription Use Only.

VIII. Substantial Equivalence Comparison Table

Device Name	IRRIGO WoundWash Jet System	Premier SterileSaline WoundWash	Primary CareSolutions SterileWater and SterileSaline	SubstantialEquivalent(SE)
	Subject Device	Primary Predicate	SecondaryPredicate
510(k) #	K210987	K090848	K082330	----------
ClassificationProductCode	FRO, FQH	FRO, FQH	FRO, FQH, JOL	SE
FluidComposition	0.9% sodium chloride(USP) and purifiedwater (USP)	0.9% sodiumchloride (USP) andpurified water (USP)	0.9% sodiumchloride (USP) andsterile water forirrigation (USP)	SE
IndicationsFor Use	Rx:IRRIGO WoundWash Jet System isintended for use by orunder the direction ofprofessionalhealthcare provider inmoistening andlubricating absorbentwound dressings,cleansing, andmaintaining a moistwound environmentfor traumatic woundssuch as pressuresores, leg ulcers ofdiabetic and vascular	Rx:Saline Wound Washis intended for use byor under the directionof a professionalhealthcare providerin moistening andlubricating absorbentwound dressings,cleansing, andmaintaining a moistwound environmentfor traumatic woundssuch as pressuresores, leg ulcers ofdiabetic and vascularorigin cuts	Rx:Moisturizing ofWound Dressings,Device Irrigationand Jet Lavage forTissue Debridement	SE; Subjectdevice -Irrigo is forRx Only.
	origin, cuts, abrasions,and minor burns.	abrasions, and minorburns.		Traditional 510(k)
		OTC:Saline Wound Washis intended for use inmoistening andlubricating absorbentwound dressings andfor cleansing minorwounds, scrapes andminor burns. Ifredness, swelling orbleeding continues,please seek the helpof nurse, nurses aid,doctor, or othermedical professional.
Description	IRRIGO WoundWash Jet System is asterile single patientuse jet lavage medicaldevice that consists of0.9% USP SodiumChloride solubilizedin USP Purified Waterfor Irrigation andpackaged in a foodgrade compressibletranslucent LDPE 2oz(60mL) bottle with aLPDE luer-lock typetip spray insert and anHPDE colored cap.	Saline Wound Washis a multi-use,isotonic, sterilesaline solutionpackaged in a bag-in-can aerosol system.Actuation of thedevice (product can)delivers a consistentflow of sterileisotonic salinesolution at publishedsafe and effectivewound impactpressures of 4 to 15psi (Clinical PracticeGuideline Number15 AHCPR, USHealth and HumanServices).	This device is USPpurified water orsaline sealed in100mL HDPEbottles or 120mLHIPS cups.	SE;Subjectdevice -Irrigo issimilar tobothpredicates.Difference isPrimaryPredicate is abag-in-canaerosolsystem;Subjectdevice is in anon-aerosolbottle.Subject andprimarypredicatecapable ofdeliveringupto 15 psi ofpressure;Unknown forSecondaryPredicate.
Mechanismof Action	The mechanicalaction of isotonicsaline solutionmoving across thewound aids in theremoval of foreignmaterial, such as dirtand debris, as well asany necrotic tissue,wound exudates andother extraneousmatter.	The mechanicalaction of isotonicsaline solutionmoving across thewound aids in theremoval of foreignmaterial, such as dirtand debris, as well asany necrotic tissue,wound exudates andother extraneousmatter.	The mechanicalaction of isotonicsaline solutionmoving across thewound aids in theremoval of foreignmaterial, such as dirtand debris, as well asany necrotic tissue,wound exudates andother extraneousmatter.	SE
Preservative	No preservatives areadded since thefinished device issterilized by gammairradiation.	No preservatives areadded since thefinished device issterilized by gammairradiation.	Unknown	SE; Subjectand PrimaryPredicate;Unknown forSecondaryPredicate
Packaging	IRRIGO WoundWash Jet System is asterile single patientuse jet lavage medicaldevice that consists of0.9% USP SodiumChloride solubilizedin USP Purified Waterfor Irrigation andpackaged in a foodgrade compressibletranslucent LDPE 2oz(60mL) bottle with aLPDE luer-lock typetip spray insert and anHPDE colored cap.	Saline Wound Washis an aerosol bag-in-can system.The propellant,compressed air, ischarged into thecontainer betweenthe bag and the cancreating a means todispense the contentsof the bag, isotonicsterile salinesolution.The bag is a 4-layerlaminate systemincluding asandwichedpolyethylene layerestablishing animpermeable barrierbetween thepropellant(compressed air) andthe bag contents(sterile isotonicsaline).The isotonic salinesolution of is in	100mL HDPEbottles or 120mLHIPS cups	SE;Subject andSecondaryPredicatesimilar,Primarypredicate –aerosol bag-in-can system
		0.9% sodiumchloride solutionprepared fromsodium chloride,USP, and purifiedwater, USP.
SterilizationMethod	Gamma	Gamma	Gamma	SE
SingleUse/Multi-Use	Single Use	Multi Use	Single Use	SE; SubjectDevice is forSingle UseOnly.
Rx or OTC	Rx	Both	Rx	SE; SubjectDevice is forRx Use Only.

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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)

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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".

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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 ●

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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.

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.