(425 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a saline wound wash system, with no mention of AI or ML capabilities.
Yes.
The device is intended for "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," which are therapeutic applications.
No
The device is described as a wound wash system used for cleansing and maintaining a moist wound environment, not for diagnosing a condition.
No
The device description clearly outlines physical components (bottle, tip, cap) and a liquid solution, indicating it is a hardware device with a physical delivery mechanism, not software-only.
Based on the provided information, the IRRIGO Wound Wash Jet System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "moistening and lubricating absorbent wound dressings, cleansing, and maintaining a moist wound environment for traumatic wounds". This is a direct application to the wound for therapeutic and cleansing purposes.
- Device Description: The device is a "sterile single patient use jet lavage medical device that consists of 0.9% USP Sodium Chloride solubilized in USP Purified Water". This is a solution for external application and irrigation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or determine the status of a disease or condition based on in vitro examination of specimens derived from the human body.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide information for diagnosis, monitoring, or screening. The IRRIGO Wound Wash Jet System is used directly on the wound for cleansing and maintaining a suitable environment, which is a therapeutic and supportive function, not a diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO, FQH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IRRIGO Wound Wash is tested against the following established specifications and standards:
- USP 43-NF38:2020 Sodium Chloride Irrigation
- USP 43-NF38:2020 Sterility Tests
- USP 43-NF38:2020 Bacterial Endotoxins Test
- USP 43-NF38:2020 Purified Water
- USP 43 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
- Material-Mediated Pyrogenicity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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)
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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
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. |
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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".
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 Sterility Tests ●
- USP 43-NF38:2020 Bacterial Endotoxins Test
- USP 43-NF38:2020 Purified Water
- USP 43 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 ●
- 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.