(240 days)
OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept WC 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, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
ExSept WC 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 WC Skin and Wound Cleanser has a 30 month shelf life.
The provided text describes a medical device, the "ExSept WC Skin and Wound Cleanser," and its regulatory clearance process (510(k) submission). However, it does not include the detailed information requested regarding specific acceptance criteria, a structured study with a test set, ground truth establishment, or performance metrics in the format of the questions provided.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, mechanism of action (mechanical cleansing), and general safety/efficacy. It mentions "numerous in-vitro and in-vivo studies" and "stability studies" but does not provide details about their methodology, specific acceptance criteria, or quantitative results.
Therefore, I cannot populate most of the requested fields. Here's a breakdown of what can be extracted and what is missing:
Information NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or performance metrics are detailed.
- Sample size used for the test set and the data provenance: No information on a specific test set, its size, or origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of ground truth experts.
- Adjudication method for the test set: Not applicable as no test set data is provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI/imaging device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable as this is a wound cleanser, not an algorithm.
- The type of ground truth used: Not explicitly stated beyond general "efficacy, safety and biocompatibility."
- The sample size for the training set: No information on a training set.
- How the ground truth for the training set was established: Not applicable.
Information that can be inferred or directly stated:
| Category | Information from the Text |
|---|---|
| Acceptance Criteria & Performance | Acceptance Criteria (Inferred from 510(k) Context): The device must demonstrate substantial equivalence to legally marketed predicate devices (ExSept WC, SilvaKlenz, Dermacyn, Anasept) in terms of: |
- Intended Use: Cleansing and removal of dirt, debris, and foreign material from various wound types and skin.
- Mechanism of Action: Mechanical cleansing.
- Safety: Biocompatibility and lack of adverse effects compared to predicates.
- Efficacy: Ability to perform cleaning functions as intended.
- Shelf Life: 30 months (explicitly stated).
Reported Device Performance: The submission states:
- "Numerous in-vitro and in-vivo studies have been performed to demonstrate the efficacy, safety and biocompatibility of the ExSept WC Skin and Wound Cleanser for the indications for use."
- "Stability studies show a shelf life of 30 months for the ExSept WC Skin and Wound Cleanser, when stored at room temperature."
- Conclusion: "ExSept WC Skin and Wound Cleanser will perform as intended as a wound cleanser. ExSept WC Skin and Wound Cleanser is substantially equivalent in its actions and functions as the marketed devices ExSept WC, SilvaKlenz, Dermacyn and Anasept." |
| Sample Size (Test Set) | Not specified. The document refers to "numerous in-vitro and in-vivo studies" generally, not a specific test set. |
| Data Provenance (Test Set) | Not specified. |
| Number & Qualifications of Experts for Ground Truth (Test Set) | Not applicable/specified. The document does not detail expert involvement in establishing ground truth for a specific test set. |
| Adjudication Method (Test Set) | Not applicable/specified. |
| MRMC Comparative Effectiveness Study | No. This is a wound cleanser, not an AI-assisted diagnostic device. |
| Standalone Performance (Algorithm Only) | No. This is a wound cleanser, not an algorithm. |
| Type of Ground Truth Used | The document vaguely refers to "efficacy, safety and biocompatibility" studies. For equivalence, the "ground truth" is that the device performs comparably to established predicate devices based on these characteristics. Specific markers for "efficacy" and "safety" (e.g., wound healing rates, infection rates, skin irritation scores) are implied but not detailed as "ground truth." |
| Sample Size (Training Set) | Not applicable/specified. This is not an AI/machine learning device that uses a "training set." |
| How Ground Truth for Training Set was Established | Not applicable/specified. |
§ 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.