(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 testing. | Demonstrated per USP 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 , , . | Conforms to USP Bacterial Endotoxins Test, USP Pyrogen Test (USP Rabbit Test), and USP Medical Devices- Bacterial Endotoxin and Pyrogen Tests. (USP 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 , 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 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 ), Endotoxins (USP ), Sterility (USP ), 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 and validated by ISO 11135 for EO sterilization.
- Microbial reduction: Ground truth for preservative effectiveness is defined by USP 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:
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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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