(147 days)
Bactisure Wound Lavage is to be used with the Zimmer Pulsavac Plus AC lavage systems and is indicated for use in cleansing and removal of debris, including micro-organisms, from wounds.
Bactisure Wound Lavage is an aqueous solution for irrigation and debridement of wounds. The solution is a clear, colorless, low-odor aqueous solution that is used to remove debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganisms, from wounds. Bactisure Wound Lavage is provided in a 1000mL polypropylene plastic container with a single port and will be labeled "not for IV use". The container will be provided in a polyethylene overwrap and packaged. The formulation for Bactisure Wound Lavage is composed of ethanol, acetic acid, sodium acetate, benzalkonium chloride, and water.
This document describes K192349, a 510(k) premarket notification for the "Bactisure Wound Lavage" device. The acceptance criteria described here refer to the performance testing used to demonstrate substantial equivalence to a predicate device, rather than specific performance metrics for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Meets the requirements of ISO 10993-1. |
| Sterilization | Meets the requirements of ISO 11737-2, ISO 14937, and ISO 17665-1. |
| Safety related to composition change | Toxicological risk analysis mitigated biocompatibility concerns related to the change in composition. |
| Safety related to ethanol content | Addition of contraindication ("Due to the ethanol content, do not use this product on neonates or infants (children under the age of 2)") and updated warnings in the Instructions for Use supported by literature and risk analyses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study with patients or data points. The performance testing appears to be primarily laboratory-based (biocompatibility, sterilization, toxicological analysis, literature review) rather than a direct evaluation of device performance on a biological test set with a specific sample size. Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the typical sense for this submission type.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This submission relies on established international standards (ISO) for biocompatibility and sterilization, and internal risk analyses and literature reviews for safety related to product composition and use. There is no mention of external experts establishing a "ground truth" for a specific test set of cases.
4. Adjudication Method for the Test Set:
Not applicable, as there is no specific test set requiring adjudication in the context of clinical or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance:
Not applicable. This device is a medical lavage solution, not an AI-assisted diagnostic or assistive technology. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a medical solution and does not involve an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- International Standards: For biocompatibility (ISO 10993-1) and sterilization (ISO 11737-2, ISO 14937, ISO 17665-1).
- Toxicological Risk Analysis: For assessing the safety implications of changes in solution composition.
- Literature Reviews and Risk Analyses: For supporting contraindications and warnings related to specific ingredients (e.g., ethanol content).
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning or AI models, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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.