(6 days)
Not Found
No
The device description and performance studies focus on the chemical composition, sterility, and mechanical function of a wound lavage solution and delivery system. There is no mention of any computational analysis, image processing, or learning algorithms.
No.
The device is intended for mechanical cleansing and removal of debris, dirt, and foreign materials from wounds. It does not state that it treats or prevents disease, nor restores, modifies, or corrects body function.
No.
The device is described as an irrigation device for mechanical cleansing and removal of debris, dirt, and foreign materials from wounds. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it is a "single-use, manual, self-contained irrigation device comprised of a bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation." This describes 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 "single-use, manual, self-contained irrigation device" containing a solution for wound lavage. This aligns with a device used for cleaning, not for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information about a patient's health status.
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's function is to physically cleanse a wound in vivo (on the body).
N/A
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
Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the 150 mL non-sterile packaged Irrisept® Antimicrobial Wound Lavage was completed, including: Biocompatibility - ISO 10993-1 Biological Evaluation of Medical Devices. Aseptic Processing - ISO 13408 Aseptic Processing of Health Care Products. 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. Shelf-Life - USP Antimicrobial Effectiveness. Sterility USP and chemistry. Functional Testing - 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.
The 150 mL Irrisept® Antimicrobial Wound Lavage device has demonstrated the same level of performance as the predicate device (Irrisept® Antimicrobial Wound Lavage, K210536).
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).
This modification falls within the FDA requlations for Special 510(k) review. The indication for use. intended use, principles of operation, and performance have not been altered. The minor change to add the new size to the existing Irrisept® Antimicrobial Wound Lavage (150 mL) in a non-sterile packaged configuration does not raise any new questions of safety or effectiveness.
§ 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.
0
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September 22, 2022
Irrimax Corporation Tanya Eberle VP Regulatory Affairs 1665 Lakes Parkway, Suite 102 Lawrenceville, Georgia 30043
Re: K222804
Trade/Device Name: Irrisept® Antimicrobial Wound Lavage Regulatory Class: Unclassified Product Code: FRO. FOH Dated: September 15, 2022 Received: September 16, 2022
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 (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
1
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 (QS) 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 medical devices and radiation-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. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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
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: | September 15, 2022 |
DEVICE INFORMATION
| Name of Device: | Irrisept® Antimicrobial Wound Lavage |
|---|---|
| Classification Name: | Jet Lavage |
| Product Code: | FQH; FRO |
| Predicate Device: | 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, manual, |
| self-contained irrigation device comprised of a 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 is intended for mechanical |
| cleansing and removal of debris, dirt and foreign materials, | |
| including microorganisms from wounds. | |
| Comparison of the | |
| Technological | |
| Characteristics: | The 150 mL and 450 mL Irrisept® Antimicrobial Wound Lavage |
| devices provide the same aseptically-filled solution of 0.05% | |
| Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for | |
| Irrigation, United States Pharmacopeia (USP) in a Blow-Fill-Seal | |
| bottle. The 150 mL Irrisept® Antimicrobial Wound Lavage device | |
| is provided in a non-sterile packaged configuration where the 450 | |
| mL Irrisept® Antimicrobial Wound Lavage device is sterile | |
| packaged. The 150 mL Irrisept® Antimicrobial Wound Lavage | |
| device includes a solution-filled bottle with integrated applicator | |
| where the 450 mL Irrisept® Antimicrobial Wound Lavage device | |
| includes a separate sterile applicator that is threaded onto the | |
| solution-filled bottle at the time of use. |
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| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | CLEARED IRRISEPT DEVICE | |
| Irrisept® Antimicrobial Wound Lavage | ||
| (450 ml) | SUBJECT IRRISEPT DEVICE | |
| Irrisept® Antimicrobial Wound Lavage | ||
| (150 ml) | ||
| 510(k) Number | K210536 | K222804 |
| Product Code | FQH, Jet Lavage | |
| FRO, Dressing, Wound, Drug | FQH, Jet Lavage | |
| FRO, Dressing, Wound, Drug | ||
| Product Classification | Class II (21 CFR 880.5474) | |
| Unclassified (Pre-amendment) | Class II (21 CFR 880.5474) | |
| Unclassified (Pre-amendment) | ||
| Intended Use | Intended for wound cleansing and removal of wound | |
| debris | Identical | |
| Indications for Use | Irrisept Antimicrobial Wound Lavage intended for | |
| mechanical cleansing and removal of debris, dirt and | ||
| foreign materials, including microorganisms from | ||
| wounds. | Identical | |
| Type of Use | Prescription Use Only | Identical |
| Mechanism of Action | The mechanical action of fluid across the wound | |
| removes wound debris. | Identical | |
| Solution | 0.05% Chlorhexidine Gluconate in 99.95% Sterile | |
| Water for Irrigation, USP | Identical | |
| Solution Antimicrobial | ||
| Preservative | Chlorhexidine Gluconate | Identical |
| Total Volume | 450 mL | 150 mL |
| How Supplied | Provided for single use | Provided for single use |
| Bottle of Irrisept and applicator are double wrapped | ||
| in CSR wrap and sealed within an outer Tyvek® | ||
| pouch. | Bottle of Irrisept with integrated applicator | |
| provided within a shelf box. | ||
| The bottle contains aseptically processed Irrisept | ||
| solution. | 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 and optional splash | |
| accessory are non-sterile. | ||
| Biocompatibility | Biocompatible per ISO 10993 Testing | Identical |
| Preservative Effectiveness over | ||
| Shelf-Life | Demonstrated per USP testing | Identical |
Performance Data:
Testing of the 150 mL non-sterile packaged Irrisept® Antimicrobial Wound Lavage was completed, including: Biocompatibility
- ISO 10993-1 Biological Evaluation of Medical Devices .
Aseptic Processing
- . ISO 13408 Aseptic Processing of Health Care Products
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
Shelf-Life
- USP Antimicrobial Effectiveness .
- . Sterility USP and chemistry
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Functional Testing
- . 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 This modification falls within the FDA requlations for Special Equivalence: 510(k) review. The indication for use. intended use, principles of operation, and performance have not been altered. The minor change to add the new size to the existing Irrisept® Antimicrobial Wound Lavage (150 mL) in a non-sterile packaged configuration does not raise any new questions of safety or effectiveness. The 150 mL Irrisept® Antimicrobial Wound Lavage device has demonstrated the same level of performance as the predicate device (Irrisept® Antimicrobial Wound Lavage, K210536). Therefore, the 150 mL Irrisept® Antimicrobial Wound Lavage device is substantially equivalent to the predicate Irrisept® Antimicrobial Wound Lavage device. The Irrisept® Antimicrobial Wound Lavage device, as modified Conclusion: by this 510(k) does not raise any new issues regarding safety or effectiveness. The 150 mL non-sterile packaged Irrisept® Antimicrobial Wound Lavage is suitable for commercial sale and is substantially equivalent to the predicate Irrisept®
Antimicrobial Wound Lavage device.