(128 days)
BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.
The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.
The provided text describes a 510(k) premarket notification for the "BD Surgiphor Antimicrobial Irrigation System." It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of "microorganisms" to the device's indications for use.
Based on the provided text, the device is a medical irrigation system, not an AI/ML device. Therefore, the questions about acceptance criteria, study design, and performance related to AI/ML (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.
The document primarily addresses the substantial equivalence of a physical medical device. The "performance testing" section refers to standard medical device testing (e.g., sterility, biocompatibility, packaging, stability, fluid pressure testing for mechanical action), not AI/ML model performance.
Here's a summary of what is provided regarding acceptance criteria and performance, as applicable to this medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one would for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that "Substantial equivalence has been confirmed through performance testing." The performance testing described is primarily focused on demonstrating the physical and chemical properties and safety of the device, rather than a diagnostic or predictive performance metric.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Preservative Antimicrobial Effectiveness | Compliance with USP | Demonstrated per USP testing. (Implies compliance) |
| Endotoxins and Pyrogens | Compliance with USP , , | Demonstrated per specified USP tests. (Implies compliance) |
| Biocompatibility | Compliance with ISO 10993-1 | Biocompatible per ISO 10993-1. (Implies compliance) |
| Fluid Pressure Testing | Adequate pressure for mechanical action to remove debris (implied) | Demonstrated by testing provided in this 510(k). (Implies adequate performance for its intended mechanical action) |
| Sterilization | SAL of 10^-6, compliance with ISO standards | Provided terminally sterile to a SAL of 10^-6 by gamma irradiation, validated in accordance with specified ANSI/AAMI/ISO standards. (Implies compliance) |
| Packaging and Shelf-Life | Compliance with ISO 11607, ASTM F1980, F2096, D4169 | Demonstrated compliance with specified ISO and ASTM standards for packaging and accelerated aging. (Implies integrity and stability over shelf-life) |
| Stability Testing | Compliance with ICH Q1A(R2), USP , and specific chemical assays | Demonstrated compliance with specified standards and successful determination of Free Iodine, % Available Iodine, Osmolality, and pH (Implies chemical and physical stability over time). |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML context. The tests are for the physical device, not an algorithm processing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth in the context of an AI/ML study does not apply to this physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to expert review of data for AI/ML model ground truth.
5. 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:
- Not applicable. This study type is for evaluating AI assistance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm being evaluated in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML sense. The "ground truth" for this device's effectiveness relies on the mechanical action of fluid physically removing debris, which is demonstrated through fluid pressure testing and comparison to predicate devices, rather than a diagnostic 'truth'. The claim for "microorganism removal" is based on its mechanical action, not a specific antimicrobial kill claim.
8. The sample size for the training set:
- Not applicable. There is no training set for an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI/ML model.
In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, questions 1 (in the AI/ML context), 2, 3, 4, 5, 6, 7 (in the AI/ML context), 8, and 9 are not addressed in the text as they pertain to AI/ML model development and validation. The acceptance criteria and performance discussions are framed within the context of a medical device's physical, chemical, and sterility properties, and its intended mechanical action, demonstrating substantial equivalence to legally marketed predicates.
§ 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.