(88 days)
The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
SURGIPHOR™ Wound 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™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ 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 from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. The povidone iodine 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 is a 510(k) Summary for the SURGIPHOR™ Wound Irrigation System. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It describes non-clinical testing (bench studies, animal studies, biocompatibility) and some clinical testing (Human Repeat Insult Patch Test) to support its claims.
However, the document does not describe an acceptance criteria table related to an AI/ML-based device, nor does it detail a study proving such a device meets specific performance criteria in terms of metrics like sensitivity, specificity, or AUC, established through ground truths and expert consensus for a clinical decision support AI/ML system.
The "device" in this document is a physical wound irrigation system, not a software or AI/ML-driven diagnostic or prognostic tool. Therefore, the questions related to AI/ML device performance (sample size for test/training set, expert involvement, ground truth establishment, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.
In summary, the provided document does not contain the information requested regarding acceptance criteria and performance study details for an AI/ML device. It describes the regulatory submission for a physical medical device (wound irrigation system) based on substantial equivalence to existing products.
§ 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.