(111 days)
Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds.
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.
The provided document is a 510(k) summary for the Irrisept Antimicrobial Wound Lavage, Wound Solution Kit (K240552). It outlines the device's characteristics and compares it to a predicate device (Irrisept Antimicrobial Wound Lavage, K210536) to demonstrate substantial equivalence.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance targets in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance criteria are implicitly defined by demonstrating that the subject device's performance is equivalent to the predicate device in terms of safety and effectiveness, despite a minor modification (inclusion of sterile accessories). The underlying "performance" refers to the functional capabilities and safety profiles as evaluated through various standards and tests.
Here's an attempt to structure this information based on the provided text:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Subject Device - K240552) |
|---|---|---|
| Intended Use | Intended for wound cleansing and removal of wound debris. | Maintains the same intended use as the predicate: "Intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms, from wounds." |
| Indications for Use | Same as predicate. | Irrisept® Antimicrobial Wound Lavage intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. (Identical to predicate) |
| Type of Use | Prescription Use Only. | Prescription Use Only. (Identical to predicate) |
| 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. (Adds clarification about manual or powered irrigation, but the core mechanism is preserved.) |
| Solution Composition | 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP. | 0.05% Chlorhexidine Gluconate in 99.95% Sterile Water for Irrigation, USP. (Identical to predicate) |
| Biocompatibility | Biocompatible per ISO 10993 testing. | Biocompatible per ISO 10993 testing for a surface device with breached or compromised surface contact and a limited duration (≤ 24 hours). (Identical to predicate, confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories) |
| Preservative Effectiveness | Demonstrated per USP <51> testing. | Demonstrated per USP <51> testing. (Identical to predicate, confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories) |
| Aseptic Processing | Conforms to ISO 13408. | Conforms to ISO 13408 Aseptic Processing of Health Care Products. (Leveraged from Predicate K210536). |
| Endotoxins & Pyrogens | Conforms to USP <85>, <151>, <161>. | Conforms to USP <85> Bacterial Endotoxins Test, USP <151> Pyrogen Test (USP Rabbit Test), and USP <161> Medical Devices- Bacterial Endotoxin and Pyrogen Tests. (USP <161> leveraged from Predicate K210536, others confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories.) |
| Sterilization | Conforms to ISO 11135, ISO 10993-7, USP <71>, AAMI TIR 28. | The accessories 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. Conforms to USP <71> Sterility Tests and AAMI TIR 28 Product Adoption and Process Equivalence for Ethylene Oxide Sterilization. (The bottle exterior is now non-sterile, but the accessories are sterilized and solution is aseptically processed. New configuration tested for conformity). |
| Packaging & Shelf-Life | Conforms to ISO 11607, ASTM F1980-16, ASTM F2096-11, ASTM F1929-15. | Conforms to ISO 11607, ASTM F1980-16, ASTM F2096-11, ASTM F1929-15. (Confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories.) |
| Functional Testing | Mechanical removal of wound debris, including microorganisms, is equivalent to the predicate. | 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. (Confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories.) |
| Distribution | Conforms to ASTM D4169-22. | Conforms to ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems. (Confirmed by testing of the 450 mL non-sterile packaged Irrisept device with accessories.) |
The overall acceptance criterion is "Substantial Equivalence" to the predicate device (K210536), meaning the device does not raise new safety or effectiveness questions. The rationale states: "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."
Study Details:
The provided document describes a submission for substantial equivalence for a medical device (Irrisept Antimicrobial Wound Lavage, Wound Solution Kit, K240552), not a study proving device efficacy in a clinical setting in the way one would analyze a new drug or diagnostic algorithm. Rather, it focuses on demonstrating that a modified version of an already cleared device is as safe and effective as the original. This is a common regulatory pathway for devices.
Here's how the other points apply or don't apply to this type of submission:
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Sample size used for the test set and the data provenance:
- This submission relies heavily on bench testing and standard conformity assessments rather than "test sets" of patient data. For example, tests like Biocompatibility (ISO 10993), Preservative Antimicrobial Effectiveness (USP <51>), Endotoxins (USP <85>), Sterility (USP <71>), Packaging, and Functional Testing were performed.
- The "samples" would be units of the device and its accessories subjected to these tests. The document doesn't specify the exact number of units or lot numbers used for each specific test, but implies that adequate samples were tested per the relevant standards.
- Data Provenance: The tests are generally conducted in a laboratory setting. There is no mention of country of origin for any "data set" as might be seen for clinical trials. Some standards (e.g., from USP or ISO) are internationally recognized.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable in this context. There is no "ground truth" to be established by experts in the sense of diagnosing a disease or interpreting an image for a test set. The validation is against established scientific and regulatory standards for device performance and safety (e.g., ISO, USP, ASTM). Experts involved would be those performing or supervising the laboratory tests, and their qualifications would be in areas like microbiology, toxicology, sterilization science, and engineering, demonstrating compliance with the specified standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where subjective human interpretation needs to be standardized or resolved (e.g., multiple radiologists reviewing images). For this device, performance is evaluated against objective, measurable criteria defined by the listed standards.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a wound lavage solution and kit, not an AI-assisted diagnostic or therapeutic tool. Therefore, concepts like "human readers" or "AI assistance" are entirely irrelevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. This device is a physical medical device (a wound lavage solution and kit). It does not involve any algorithms or software that would have a standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is defined by compliance with established international and national standards (ISO, USP, AAMI, ASTM) for safety, materials, manufacturing, sterilization, and functional performance. For example:
- Biocompatibility: Ground truth is defined by the toxicological and biological response criteria specified in ISO 10993.
- Sterility: Ground truth is "sterile" as defined by USP <71> and validated by ISO 11135 for EO sterilization.
- Microbial reduction: Ground truth for preservative effectiveness is defined by USP <51> criteria for inhibiting microbial growth.
- Functional equivalence: "Custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device." The "ground truth" for these custom tests would be the established performance characteristics of the predicate device.
- The "ground truth" here is defined by compliance with established international and national standards (ISO, USP, AAMI, ASTM) for safety, materials, manufacturing, sterilization, and functional performance. For example:
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth for a training set.
In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a modified physical medical device to a previously cleared one, rather than presenting a clinical study with outcome-based performance metrics usually associated with AI or novel diagnostic technologies. The "acceptance criteria" are compliance with relevant safety and performance standards.
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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"
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(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.
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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
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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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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 KitUnclassifiedFRO; FQHIrrisept® Antimicrobial Wound LavageProduct 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 forIrrigation, United States Pharmacopeia (USP) and accessories forirrigation. The solution is aseptically-filled in a Blow-Fill-Seal(BFS) bottle. The CHG acts as a preservative to inhibit microbialgrowth in the solution. |
| Intended Use/Indications for Use: | Irrisept® Antimicrobial Wound Lavage, Wound Solution Kit isintended for mechanical cleansing and removal of debris, dirt andforeign materials, including microorganisms, from wounds. |
| TechnologicalCharacteristics: | This line extension will provide users with the same 450 mL bottleof Irrisept in a shelf box with sterile pouched accessories(spikeable cap and hangers) to facilitate fluid delivery. TheIrrisept® Antimicrobial Wound Lavage, Wound Solution Kitconfiguration does not raise new safety or effectiveness questions.All technological aspects of mechanical cleansing and removal ofwound debris are preserved. |
| Comparison toPredicate: | The Irrisept device use and performance characteristics are notaltered by this modification. |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | PREDICATE DEVICEIrrisept® Antimicrobial Wound Lavage(450 ml) | SUBJECT DEVICEIrrisept® Antimicrobial Wound Lavage,Wound Solution Kit(450 ml) |
| 510(k) Number | K210536 | K240552 |
| Product Code | FQH, Jet LavageFRO, Dressing, Wound, Drug | FRO, Dressing, Wound, DrugFQH, Jet Lavage |
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| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | PREDICATE DEVICEIrrisept® Antimicrobial Wound Lavage(450 ml) | SUBJECT DEVICEIrrisept® 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 removalof wound debris | Intended for wound cleansing and removalof wound debris |
| Indications for Use | Irrisept® Antimicrobial Wound Lavageintended for mechanical cleansing andremoval of debris, dirt and foreignmaterials, including microorganisms fromwounds. | Irrisept® Antimicrobial Wound Lavageintended for mechanical cleansing andremoval of debris, dirt and foreignmaterials, including microorganisms fromwounds. |
| Type of Use | Prescription Use Only | Prescription Use Only |
| Mechanism of Action | The mechanical action of fluid across thewound removes wound debris. | The mechanical action of fluid across thewound removes wound debris.The mechanical action of the irrigation canbe 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 ofIrrisept is double wrapped in CSR andsealed within an outer Tyvek® pouch. Thebottle exterior, CSR wraps, and applicatorare sterilized by EO. The bottle containsaseptically processed Irrisept solution. | Provided for single use. A 450 mL bottle ofIrrisept and pouched accessories(spikeable cap and hangers) containedwithin an outer shelf box. The pouchedaccessories are sterilized by EO. Thebottle contains aseptically processedIrrisept solution. |
| Sterilization | The bottle exterior, CSR wraps, andapplicator are sterilized by EO and conformto ISO 11135-7 for EO sterilization and ISO10993-7 for EO residuals | The bottle exterior is non-sterile and theaccessories are sterilized by EO andconform to ISO 11135-7 for EOsterilization and ISO 10993-7 for EOresiduals |
| Biocompatibility | Biocompatible per ISO 10993 testing for asurface device with breached orcompromised surface contact and a limitedduration (≤ 24 hours) | Biocompatible per ISO 10993 testing for asurface device with breached orcompromised surface contact and alimited duration (≤ 24 hours) |
| Preservative Effectivenessover Shelf-Life | Demonstrated per USP <51> testing | Demonstrated per USP <51> 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 <51> Antimicrobial Effectiveness
Endotoxins and Pyrogens
- USP <85> Bacterial Endotoxins Test .
- . USP <151> Pyrogen Test (USP Rabbit Test)
- USP <161> Medical Devices- Bacterial Endotoxin and . Pyrogen Tests (leveraged from Predicate K210536)
Sterilization
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- ISO 11135 Sterilization of Health-Care Products -. Ethylene Oxide
- ANSI AAMI ISO 10993-7 - Ethylene oxide sterilization residuals
- USP <71> 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 SubstantialEquivalence: | The indication for use, intended use, principles of operation,and performance have not been altered. The minor change toadd the existing Irrisept device (450 mL) with sterileaccessories for use with powered irrigation does not raise anynew or different questions of safety or effectiveness. TheIrrisept device under this Traditional 510(k) has demonstratedthe same level of performance as the predicate device (IrriseptK210536) and is therefore substantially equivalent. |
|---|---|
| Conclusion: | The Irrisept® Antimicrobial Wound Lavage, Wound Solution Kitdevice, as modified by this 510(k) does not raise any newissues 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.
N/A