(111 days)
No
The document describes a wound lavage solution and delivery system, focusing on its chemical composition, packaging, and mechanical cleansing function. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for mechanical cleansing and removal of debris, dirt, and foreign materials from wounds. It is not designed to treat a disease or condition, but rather to clean wounds.
No
The device is described as an irrigation device for mechanical cleansing and removal of debris from wounds, and the active ingredient is a preservative. Its purpose is to clean wounds, not to diagnose a condition.
No
The device description clearly states it is a "single-use, self-contained irrigation device comprised of a 450 mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation." This indicates a physical device with a liquid component, not a software-only device.
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 accessories for irrigation. It's applied directly to the wound.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- No Mention of Diagnostic Testing: The performance studies focus on the mechanical removal of debris and the properties of the solution and device itself, not on the accuracy of a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (on the body) for wound cleansing.
N/A
Intended Use / Indications for Use
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds.
Product codes
FRO; FQH
Device Description
Irrisept® Antimicrobial Wound Lavage is a single-use, self-contained irrigation device comprised of a 450 mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds
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
Testing of the 450 mL non-sterile packaged Irrisept device with accessories was completed, including:
Biocompatibility: ISO 10993-1 Biological Evaluation of Medical Devices.
Aseptic Processing: ISO 13408 Aseptic Processing of Health Care Products. (leveraged from Predicate K210536)
Preservative Antimicrobial Effectiveness: USP Antimicrobial Effectiveness.
Endotoxins and Pyrogens: USP Bacterial Endotoxins Test. USP Pyrogen Test (USP Rabbit Test), USP Medical Devices- Bacterial Endotoxin and. Pyrogen Tests (leveraged from Predicate K210536).
Sterilization: ISO 11135 Sterilization of Health-Care Products -. Ethylene Oxide, ANSI AAMI ISO 10993-7 - Ethylene oxide sterilization residuals, USP Sterility Tests. AAMI TIR 28 Product Adoption and Process Equivalence - for Ethylene Oxide Sterilization.
Packaging and Shelf-Life: ISO 11607 - Packaging for Terminally Sterilized Medical Devices, ASTM F1980-16 Standard Guide for Accelerated Aging of. Sterile Barrier Systems for Medical Devices, ASTM F2096-11 Standard Test Method for Detecting. Gross Leaks in Packaging by Internal Pressurization (Bubble Test), ASTM F1929-15 Standard Test Method for Detecting. Seal Leaks in Porous Medical Packaging by Dye Penetration.
Functional Testing: ISO 1135-4 Transfusion Equipment for Medical Use. The subject device was assessed for performance through custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device.
Distribution: ASTM D4169-22 Standard Practice for Performance. Testing of Shipping Containers and Systems.
Key Results: The Irrisept device under this Traditional 510(k) has demonstrated the same level of performance as the predicate device (Irrisept K210536) and is therefore substantially equivalent.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 18, 2024
Irrimax Corporation Tanya Eberle VP, Regulatory Affairs 1665 Lakes Parkway Suite 102 Lawrenceville, Georgia 30043
Re: K240552
Trade/Device Name: Irrisept Antimicrobial Wound Lavage Regulatory Class: Unclassified Product Code: FRO Dated: February 27, 2024 Received: February 28, 2024
Dear Tanya Eberle:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
3
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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240552
Device Name
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit
Indications for Use (Describe)
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
SUBMITTER'S INFORMATION
| Owner: | Irrimax® Corporation |
|---|---|
| Address: | 1665 Lakes Parkway, Suite 102, Lawrenceville, GA 30043 |
| Phone: | 770-807-3355 |
| Contact Person: | Tanya Eberle, VP, Regulatory Affairs |
| Date Summary Prepared: | February 28, 2022 |
DEVICE INFORMATION
| Name of Device:
Regulatory Class:
Product Code:
Predicate Device: | Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit
Unclassified
FRO; FQH
Irrisept® Antimicrobial Wound Lavage
Product Code: FQH (Jet Lavage); Class II (21 CFR 880.5475)
Product Code: FRO (Dressing, Wound, Drug); Unclassified (pre-
amendment) cleared under K210536 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | Irrisept® Antimicrobial Wound Lavage is a single-use, self-
contained irrigation device comprised of a 450 mL bottle of 0.05%
Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for
Irrigation, United States Pharmacopeia (USP) and accessories for
irrigation. 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. |
| Intended Use/
Indications for Use: | Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit is
intended for mechanical cleansing and removal of debris, dirt and
foreign materials, including microorganisms, from wounds. |
| Technological
Characteristics: | This line extension will provide users with the same 450 mL bottle
of Irrisept in a shelf box with sterile pouched accessories
(spikeable cap and hangers) to facilitate fluid delivery. The
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit
configuration does not raise new safety or effectiveness questions.
All technological aspects of mechanical cleansing and removal of
wound debris are preserved. |
| Comparison to
Predicate: | The Irrisept device use and performance characteristics are not
altered by this modification. |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | PREDICATE DEVICE | |
| Irrisept® Antimicrobial Wound Lavage | ||
| (450 ml) | SUBJECT DEVICE | |
| Irrisept® Antimicrobial Wound Lavage, | ||
| Wound Solution Kit | ||
| (450 ml) | ||
| 510(k) Number | K210536 | K240552 |
| Product Code | FQH, Jet Lavage | |
| FRO, Dressing, Wound, Drug | FRO, Dressing, Wound, Drug | |
| FQH, Jet Lavage |
5
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | PREDICATE DEVICE | |
| Irrisept® Antimicrobial Wound Lavage | ||
| (450 ml) | SUBJECT DEVICE | |
| Irrisept® Antimicrobial Wound Lavage, | ||
| Wound Solution Kit | ||
| (450 ml) | ||
| Product Classification | Class II (21 CFR 880.5475) | |
| Unclassified (Pre-Amendment) | Class II (21 CFR 880.5475) | |
| Unclassified (Pre-Amendment) | ||
| Intended Use | 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 | |
| intended for mechanical cleansing and | ||
| removal of debris, dirt and foreign | ||
| materials, including microorganisms from | ||
| wounds. | Irrisept® Antimicrobial Wound Lavage | |
| intended for mechanical cleansing and | ||
| removal of debris, dirt and foreign | ||
| materials, including microorganisms from | ||
| wounds. | ||
| Type of Use | Prescription Use Only | Prescription Use Only |
| 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 the irrigation can | ||
| be by manual or powered irrigation. | ||
| 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 | ||
| 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 and pouched accessories | ||
| (spikeable cap and hangers) contained | ||
| within an outer shelf box. The pouched | ||
| accessories are sterilized by EO. The | ||
| bottle contains aseptically processed | ||
| Irrisept solution. | ||
| Sterilization | The bottle exterior, CSR wraps, and | |
| applicator are sterilized by EO and conform | ||
| to ISO 11135-7 for EO sterilization and ISO | ||
| 10993-7 for EO residuals | The bottle exterior is non-sterile and the | |
| accessories are sterilized by EO and | ||
| conform to ISO 11135-7 for EO | ||
| sterilization and ISO 10993-7 for EO | ||
| residuals | ||
| 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) | ||
| Preservative Effectiveness | ||
| over Shelf-Life | Demonstrated per USP testing | Demonstrated per USP testing |
Performance Data: Testing of the 450 mL non-sterile packaged Irrisept device with accessories was completed, including:
Biocompatibility
- ISO 10993-1 Biological Evaluation of Medical Devices .
Aseptic Processing
- ISO 13408 Aseptic Processing of Health Care Products . (leveraged from Predicate K210536)
Preservative Antimicrobial Effectiveness
- . USP Antimicrobial Effectiveness
Endotoxins and Pyrogens
- USP Bacterial Endotoxins Test .
- . USP Pyrogen Test (USP Rabbit Test)
- USP Medical Devices- Bacterial Endotoxin and . Pyrogen Tests (leveraged from Predicate K210536)
Sterilization
6
- ISO 11135 Sterilization of Health-Care Products -. Ethylene Oxide
- ANSI AAMI ISO 10993-7 - Ethylene oxide sterilization residuals
- USP Sterility Tests .
- AAMI TIR 28 Product Adoption and Process Equivalence ● for Ethylene Oxide Sterilization
Packaging and Shelf-Life
- ISO 11607 - Packaging for Terminally Sterilized Medical Devices
- ASTM F1980-16 Standard Guide for Accelerated Aging of . Sterile Barrier Systems for Medical Devices
- ASTM F2096-11 Standard Test Method for Detecting . Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F1929-15 Standard Test Method for Detecting . Seal Leaks in Porous Medical Packaging by Dye Penetration
Functional Testing
- . ISO 1135-4 Transfusion Equipment for Medical Use
- The subject device was assessed for performance through . custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device.
Distribution
- ASTM D4169-22 Standard Practice for Performance . Testing of Shipping Containers and Systems
| Rationale for Substantial
Equivalence: | The indication for use, intended use, principles of operation,
and performance have not been altered. The minor change to
add the existing Irrisept device (450 mL) with sterile
accessories for use with powered irrigation does not raise any
new or different questions of safety or effectiveness. The
Irrisept device under this Traditional 510(k) has demonstrated
the same level of performance as the predicate device (Irrisept
K210536) and is therefore substantially equivalent. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit
device, as modified by this 510(k) does not raise any new
issues regarding safety or effectiveness. The Irrisept Wound |
Solution Kit (450 mL Irrisept solution and sterile-pouched accessories) is suitable for commercial sale and is substantially equivalent to the predicate Irrisept® Antimicrobial Wound Lavage device.