(127 days)
OTC: Anasept™ Antimicrobial Skin and Wound Gel is intended for OTC use for management of skin abrasions, lacerations, minor irritations, cuts, exit sites and intact skin. of being as a long and the Antimicrobial Skin and Wound Gel is intended to be used under the supervision of a healthcare professional in the management of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
OTC: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for OTC use for mechanical cleansing of dirt and debris form skin abrasions, minor irritations, cuts, exit sites and intact skin.
Professional Use: Anasept™ Antimicrobial Skin and Wound Cleanser is intended for professional use for cleansing and removal of foreign material including micro-organisms and debris from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Anasept™ Antimicrobial Skin and Wound Gel is a clear, amorphous, isotonic hydrogel wound I thatept - - Intimerooms in a moist wound environment that is conducive to healing, by either absorbing wound exudate or donating moisture while delivering antimicrobial sodium hypochlorite. This antimicrobial agent inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heat-sealed, coextruded tubes fitted with a "flip top" dispenser closure.
Anasept™ Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in the mechanical removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are mechanically removed by the action of the fluid (Wound Cleanser) moving across the wound bed or application site. The device also contains an antimicrobial agent that inhibits the growth of microorganisms. Anasept™ Antimicrobial Skin and Wound Cleanser will be supplied in High Density Polyethylene bottles in various packaging configuration: 15 oz in HDPE bottle with dispensing caps and 8, & 12 oz with Trigger sprayer and 8 oz with Finger pump sprayer.
The provided text describes two devices: Anasept™ Antimicrobial Skin and Wound Gel and Anasept™ Antimicrobial Skin and Wound Cleanser. Both are being submitted for 510(k) clearance and claim substantial equivalence to existing predicate devices. The performance testing is focused on demonstrating the antimicrobial efficacy of the active ingredient (sodium hypochlorite) within the respective formulations.
Here's a breakdown of the requested information for both devices based on the provided text, as they underwent very similar testing based on the summaries:
Anasept™ Antimicrobial Skin and Wound Gel & Anasept™ Antimicrobial Skin and Wound Cleanser
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: Inhibition/Reduction of common wound pathogens (bacteria and fungi) | Gel: "All test results indicate that product is very capable of inhibiting the growth of bacteria and reducing high level concentrations (10^7 /gram of product) of microorganisms to undetectable levels." |
| Cleanser: "All test results indicate that product is very capable of inhibiting the growth of bacteria and reducing high level concentrations of microorganisms (10^7 organisms /gram of product) to undetectable levels." (Further specified as "Reduction by Log 7" within fifteen minutes for the Cleanser). | |
| Biocompatibility: Safety for intended use/contact with tissue | Gel: "Anasept™ Antimicrobial Skin and Wound Gel has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use." |
| Cleanser: "Anasept™ Antimicrobial Skin and Wound Cleanser has been subjected to in-vitro and in-vivo biocompatibility studies to demonstrate that the device is safe for the indications for use." | |
| Stability: Product remains stable and effective for its shelf life | Gel: "Stability studies have been performed on the product to demonstrate the product is stable and effective for the entire shelf life." |
| Cleanser: "The results of the stability studies support the two years shelf life of the product." | |
| Manufacturing Quality: Meets established specifications for safety and effectiveness | Gel: "All established GMPs will assure that the device manufactured at Anacapa™ Technologies, Inc meets all the established specifications prior to release and is safe and effective for its intended use." |
| Cleanser: "All established GMPs will assure that the device manufactured at Anacapa™ Technologies, Inc meets all the established specifications prior to release and is safe and effective for its intended use." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "Time/Kill studies" or "biocompatibility studies." It refers to "test organisms prescribed in the USP Antimicrobial Effectiveness Testing " and "additional bacterial strains."
- Data Provenance: The studies are described as "in-vitro and in-vivo biocompatibility studies" and "Time/Kill studies" performed "in accordance with the procedure provided with the original submission." There is no mention of country of origin for the data or if it's retrospective or prospective. Given the nature of these tests, they are likely prospective laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the text. The antimicrobial efficacy testing is based on established microbiological testing methods (USP ) against known organism concentrations. Biocompatibility studies also follow standard protocols. These types of tests do not typically rely on expert consensus for "ground truth" in the same way clinical diagnostic studies might.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The performance tests described (Time/Kill, biocompatibility, stability) are objective laboratory measurements, not subjective evaluations requiring adjudication.
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 information is not applicable/provided. The devices are antimicrobial gels and cleansers, not AI-powered diagnostic tools or image analysis devices. Therefore, MRMC studies involving human readers and AI assistance are not relevant to these products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided. The devices are physical products, not algorithms. The "standalone" performance here refers to the product's inherent antimicrobial and physiochemical properties as tested in the laboratory.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the antimicrobial efficacy testing is defined by quantifiable reduction of specified microorganisms (e.g., "reducing high level concentrations (10^7 /gram of product) of microorganisms to undetectable levels" or "Reduction by Log 7"). The specific microorganisms are listed (e.g., Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, MRSA, VRE, etc.).
- For biocompatibility, the ground truth would be the absence of adverse biological reactions in accordance with established safety standards for in-vitro and in-vivo tests.
- For stability, the ground truth is the maintenance of product specifications (e.g., antimicrobial efficacy, physical properties) over time.
8. The Sample Size for the Training Set
- This information is not applicable/provided. These are not machine learning models requiring training sets. The studies involve testing the product against panels of microorganisms or in biocompatibility models.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable/provided for the reasons stated in point 8.
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