(125 days)
Spectricept Skin and Wound Cleanser for Professional Use:
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
Spectricept Skin and Wound Cleanser for OTC Use:
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.
Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).
Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.
This document is a 510(k) clearance letter for a medical device called "Spectricept Skin and Wound Cleanser." It states that the device is substantially equivalent to a previously cleared predicate device (K213514). It is a chemical product, not an AI/ML powered device, so many of the requested categories related to AI performance are not applicable.
Here's the summary of the information provided for the Spectricept Skin and Wound Cleanser:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a chemical product clearance, the "acceptance criteria" are related to safety and performance through non-clinical testing, rather than performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device. The "reported device performance" indicates that the device met these criteria.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | ISO 10993-3 | Passed (Genotoxicity, Carcinogenicity and Reproductive Toxicity) |
| ISO 10993-5 | Passed (In Vitro Cytotoxicity) | |
| ISO 10993-10 | Passed (Irritation and Skin Sensitization, Direct Intracutaneous Injection Test) | |
| ASTM F756 | Passed (Assessment of Hemolytic Properties) | |
| Microbiological Purity | USP | Passed (Bacterial Endotoxins Test) |
| USP | Product demonstrated acceptable performance (Antimicrobial Effectiveness Testing) | |
| Local Effects After Implantation | ISO 10993-6 | Passed (Tests for local effects after implantation) - New test for prolonged contact |
| Systemic Toxicity | ISO 10993-11 | Passed (Systemic Toxicity, Direct Systemic Injection Test) - New test for prolonged contact |
| Shelf Life | Not specified | 12 months (Identical to predicate) |
| Formulation | Not specified | Water (99.94%), Hypochlorous Acid (0.036%), Copper Chloride (0.008%), Zinc Chloride (0.008%), Ferric Chloride (0.008%) (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a chemical cleanser and the evaluation is based on non-clinical laboratory testing, not a dataset of patient cases. The testing involves standardized laboratory procedures and materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant here. The "ground truth" for the non-clinical tests is adherence to established international standards and laboratory protocols performed by trained laboratory personnel.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in AI/ML performance studies. Here, the "truth" is determined by the outcome of a standardized laboratory test against a defined pass/fail criterion.
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
This is not applicable. The device is a wound cleanser, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a liquid chemical cleanser, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device's clearance is based on:
- Established International Standards: Such as ISO 10993 series and ASTM F756 for biocompatibility.
- Pharmacopoeial Standards: Such as USP and USP for microbiological evaluation.
- Chemical Composition Analysis: Assuring the formulation is as specified.
- The comparison to the predicate device (K213514) relies on the fact that the two devices are identical in formulation, mechanism of action, and intended use, and the additional biocompatibility testing supported an extended contact time.
8. The Sample Size for the Training Set
This is not applicable. There is no concept of a "training set" for this type of device clearance. The device is a chemical product, not an AI/ML model trained on data.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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