(218 days)
OTC: ExSept Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor skin and nail irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, ingrown toe nails, post surgical wounds, first and second degree burns, grafted and donor sites, and exit sites.
ExSept Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept Skin and Wound Cleanser contains a preservative permitting a 30 month shelf life.
The provided text is a 510(k) summary for a wound cleanser and does not contain the type of study information requested. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on the cleansing function.
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Device Performance: The document states that the device "will perform as intended as a wound cleanser" and is "substantially equivalent" to predicate devices. It also mentions "Numerous in-vitro and in-vivo studies have been performed to demonstrate the efficacy, safety and biocompatibility," but it does not provide any specific acceptance criteria (e.g., a specific percentage reduction in bacteria, a quantified debris removal efficiency) or actual performance metrics (e.g., "device achieved X% debris removal") from these studies.
- Sample Sizes, Data Provenance, Expert Information, Adjudication Methods, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Information: These are all details typically found in a detailed clinical or performance study report. The 510(k) summary is a high-level document that omits these particulars. It does not describe how ground truth was established, the qualifications of any experts involved, or how data was adjudicated.
Therefore, I cannot populate the table or answer the specific questions below the table, as the necessary information is simply not present in the provided text.
§ 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.