K Number

Device Name

Irrisept Antimicrobial Wound Lavage

Manufacturer

Irrimax Corporation

Date Cleared

2021-05-28

(93 days)

Product Code

FQH FRO

Regulation Number

880.5475

Intended Use

Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202222, K160192

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and mechanical properties of the wound lavage system, with no mention of AI or ML.

Therapeutic

No.
The device is intended for mechanical cleansing and removal of debris from wounds, not for treating a disease or condition. While its function supports wound care, it primarily acts as a cleansing agent rather than a direct therapeutic intervention.

Diagnostic

The device description indicates it is "intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds," and it acts as a preservative. This describes a therapeutic or cleansing device, not one that identifies or diagnoses a condition.

SaMD (Software as a Medical Device)

The device description clearly states it 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... and an applicator". This describes a physical medical device with a solution and applicator, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds." This describes a physical action on a wound, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is a solution and an applicator for wound lavage. It's applied directly to the wound.
Lack of Diagnostic Testing: There is no mention of analyzing a sample (like blood, tissue, or fluid) to provide diagnostic information. The performance studies focus on the physical properties of the solution and device, sterility, biocompatibility, and the effectiveness of the solution as a preservative and for mechanical cleansing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

FQH, FRO

Device Description

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

Not Found

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)

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 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 Sterility Tests
- AAMI TIR 28 Product adoption and process equivalence for ethylene o oxide sterilization
Endotoxins and Pyrogens ●
- o USP Bacterial Endotoxins Test
- o USP Pyrogen Test (USP Rabbit Test)
- o USP 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.

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.

K202222, K160192

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

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.

Summary

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 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

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

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

PREPARATION DATE:	27 May 2021
510(K) NUMBER:	K210536
APPLICANT:	Irrimax® Corporation
1665 Lakes Parkway, Suite 102
Lawrenceville, GA 30043
CONTACT PERSON:	Christy Coleman, OD, MPH
Vice President, Regulatory Affairs,
Irrimax® Corporation
Tel: (770) 807-3355
DEVICE TRADE NAME:	Irrisept® Antimicrobial Wound Lavage
CLASSIFICATION NAME:	Jet Lavage
DEVICE CLASSIFICATION:	Class II (21 CFR 880.5475)
Unclassified (Pre-amendment)
PRODUCT CODE:	FQH; FRO
PRIMARY PREDICATE DEVICE:	Irrisept® Wound Debridement and Cleansing System
Product Code: FQH (Jet Lavage); Class II
(21 CFR 880.5475)
Product Code FRO (Dressing, Wound,
Drug); Unclassified (pre-amendment)
Applicant: Irrimax Corporation
Cleared under K202222 on December 14,
2020
SECONDARY PREDICATE DEVICE:	Atteris Antimicrobial Skin and Wound
Cleanser
Product Code: FRO (Dressing, Wound,
Drug); Unclassified (pre-amendment)
Applicant: Rochal Industries, LLC
Cleared under K160192 on July 28, 2016

DEVICE DESCRIPTION:

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.

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
wound debris	Intended for wound cleansing and removal of wound
debris	Intended for wound cleansing and removal of wound
debris
Indications for Use	Irrisept® Antimicrobial Wound Lavage is
intended for mechanical cleansing and removal of
debris, dirt and foreign materials, including
microorganisms from wounds.	Irrisept Wound Debridement and Cleansing System is
a wound cleansing and delivery system. The
mechanical action effectively loosens and removes
wound debris.	(Rx use) Atteris Antimicrobial Skin & Wound
Cleanser is intended for mechanical cleansing and
removal of debris, dirt and foreign materials,
including microorganisms from wounds such as stage
I-IV pressure ulcers, diabetic foot ulcers, post-surgical
wounds, first and second degree burns, grafted and
donor sites.
(OTC use) Atteris Antimicrobial Skin & Wound
Cleanser is intended for physical cleaning and removal
of dirt and debris, from skin scrapes, cuts, lacerations,
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
removes wound debris.	The mechanical action of fluid across the wound
removes wound debris.	The mechanical action of fluid across the wound
removes wound debris.
Solution	0.05% Chlorhexidine Gluconate in 99.95% Sterile
Water for Irrigation, USP	0.05% Chlorhexidine Gluconate in 99.95% Sterile
Water for Irrigation, USP	Purified Water, Poloxamer 407,
Sodium Chloride, Ethylhexylglycerin,
Hypromellose, Octane-1,2-diol,
Polyaminopropyl Biguanide [PHMB]
Solution
Antimicrobial
Preservative	Chlorhexidine Gluconate	Chlorhexidine Gluconate	Polyaminopropyl Biguanide [PHMB]
How Supplied	Provided for single use. A 450 mL bottle of
Irrisept is double wrapped in CSR and sealed
within an outer Tyvek® pouch. The bottle exterior,
CSR wraps, and applicator are sterilized by EO.
The bottle contains aseptically processed Irrisept
solution.	Provided for single use. A 450 mL bottle of Irrisept is
double wrapped in CSR and sealed within an outer
Tyvek® pouch. The bottle exterior, CSR wraps, and
applicator are sterilized by EO. The bottle contains
aseptically processed Irrisept solution.	Provided non-sterile in 8 fluid ounce bottle with sprayer.
Applicator	Multiport applicator that threads onto the Irrisept
Bottle	Multiport applicator that threads onto the Irrisept Bottle	Sprayer attachment
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison Feature	PROPOSED DEVICE
Irrisept Antimicrobial Wound Lavage	PREDICATE DEVICE
Irrisept Wound Debridement and Cleansing System	SECONDARY PREDICATE DEVICE
Atteris Antimicrobial Skin & Wound Cleanser
Sterilization	Bottle exterior, CSR wraps, and outer packaging
conforms to ISO 11135-7 for EO sterilization and
ISO 10993-7 for EO residuals
whereas the solution is aseptically processed	Bottle exterior, CSR wraps, and outer packaging
conforms to ISO 11135-7 for EO sterilization and ISO
10993-7 for EO residuals
whereas the solution is aseptically processed	Provided non-sterile
Biocompatibility	Biocompatible per ISO 10993 testing for a surface
device with breached or compromised surface
contact and a limited duration (≤ 24 hours)	Biocompatible per ISO 10993 testing for a surface
device with breached or compromised surface contact
and a limited duration (≤ 24 hours)	Biocompatible per ISO 10993 testing
Preservative
Effectiveness over
Shelf-Life	Demonstrated per USP testing	Demonstrated per USP testing	Demonstrated per USP testing

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:

Preservative Antimicrobial Effectiveness .
- o USP 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 Sterility Tests
- AAMI TIR 28 Product adoption and process equivalence for ethylene o oxide sterilization
Endotoxins and Pyrogens ●
- o USP Bacterial Endotoxins Test
- o USP Pyrogen Test (USP Rabbit Test)
- o USP 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

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.