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510(k) Data Aggregation
(538 days)
CENTURY PHARMACEUTICALS, INC.
Dakin's Skin and Wound Cleanser is intended for cleansing of acute, chronic and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second degree burns, and grafted and donor sites.
Dakin's Skin and Wound Cleanser is intended for cleansing of minor lacerations, minor abrasions and minor wounds, and for removal of foreign objects such as dirt and debris.
The Dakin's Skin and Wound Cleanser, Sodium Hypochlorite 0.125% is an aqueous, clear, colorless solution with mild chlorine odor, modified with sodium bicarbonate, used as a solution to cleanse and debride wounds. Sodium hypochlorite is used as a solution preservative, and sodium bicarbonate is used as a pH modifier.
Dakin's Skin and Wound Cleanser is packaged in amber HDPE (High Density PolyEthylene) bottles and induction sealed caps. A permanently affixed label, lot number and expiration date will be on each bottle of the Dakin's Skin and Wound Cleanser.
The provided document is a 510(k) premarket notification decision letter and summary for a medical device called "Dakin's Skin and Wound Cleanser." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with specific acceptance criteria and detailed study results typical for novel devices or significant modifications.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert adjudication, MRMC studies, or standalone algorithm performance.
Here's why and what information is present:
- Lack of Acceptance Criteria and Performance Data: The 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This typically involves performance testing (e.g., biocompatibility, stability, shelf-life, antimicrobial effectiveness) to show the new device performs as intended and is as safe and effective as the predicate, but it doesn't involve establishing and meeting clinical performance acceptance criteria in the same way a PMA (Premarket Approval) submission for a novel device would.
- The "Study" Mentioned: The document mentions a "Preclinical Wound Healing Study in Yucatan miniature swine" (page 6). This is a preclinical animal study, not a human clinical trial. Its purpose was to show that "Daily treatment of the abraded site with either Dakin's Skin and Wound Cleanser or Predicate did not inhibit the healing process when compared with untreated sites." This is a comparative study against the predicate and a control, aimed at showing non-inferiority in terms of healing inhibition in a preclinical model, not establishing clinical effectiveness or meeting specific performance metrics with human data.
- No Information on AI/Algorithm Performance: The device is a "Dakin's Skin and Wound Cleanser," which is a topical solution (sodium hypochlorite). It is not an AI-powered diagnostic or therapeutic device. Therefore, questions regarding MRMC studies, standalone algorithm performance, training/test sets for AI, expert adjudication for ground truth of an AI model, and data provenance related to AI model development are not applicable to this device or document.
Summary of what can be extracted from the document:
- Device Name: Dakin's Skin and Wound Cleanser
- Predicate Device: Patrin Pharma, Inc. – Hy-Chlo Wound Solution (K113312)
- Indications for Use (similar for both proposed and predicate):
- OTC: Cleansing of minor cuts, lacerations, abrasions, minor wounds, and removal of foreign objects.
- Professional Use: Cleansing of acute, chronic, and open wounds such as stage I-IV pressure ulcers, diabetic foot and leg ulcers, surgical wounds, first and second-degree burns, and grafted and donor sites.
- Non-clinical Performance Testing (mentioned on page 6):
- Biocompatibility (Cytotoxicity, Sensitization, Dermal Irritation)
- Preclinical Wound Healing Study in Yucatan miniature swine
- Antimicrobial (preservative testing) - meets USP criteria for antimicrobial effectiveness.
In conclusion, this document is a regulatory approval notice for a topical wound cleanser based on substantial equivalence to an existing product, not a study report for an AI device or a device requiring complex clinical performance acceptance criteria and human clinical trials as per your prompt's questions.
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(136 days)
CENTURY PHARMACEUTICALS, INC.
OTC: Wound Cleanser is intended for mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations.
Professional Use: Wound Cleanser intended for mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post surgical wounds, first and second degree burns, grafted and donor sites.
The Wound Cleanser is an aqueous solution of sodium hypochlorite, modified with sodium bicarbonate, used as a solution to mechanically cleanse and debride open wounds. The sodium hypochlorite concentration 0.0125% weight / volume.
Sodium hypochlorite is a solution preservative.
Here's the analysis of the acceptance criteria and study information for the given device, based on the provided text:
Device: Wound Cleanser (K090791)
This document describes a 510(k) premarket notification for a Wound Cleanser. The submission aims to demonstrate substantial equivalence to predicate devices (Oculus - Dermacyn - K042729 and Anacapa - Anasept Skin and Wound Cleanser - K073547).
It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo performance criteria through rigorous clinical trials. Therefore, the "acceptance criteria" here are largely defined by the characteristics and performance of the predicate devices, and the "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to show alignment with these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (Wound Cleanser - K090791) |
|---|---|---|
| Indications for Use (OTC) | Mechanical cleansing of dirt and debris from skin, abrasions, minor irritations, cuts, exit sites, and intact skin. (Similar to Anacapa Anasept and Oculus Dermacyn) | Mechanical cleansing of dirt and debris from skin, abrasions, cuts, and minor irritations. (Identical to predicate Anacapa Anasept and similar to Oculus Dermacyn) |
| Indications for Use (Professional) | Mechanical cleansing and removal of foreign materials including microorganisms 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. (Similar to Anacapa Anasept and Oculus Dermacyn) | Mechanical cleansing and debriding acute and chronic wounds; such as stage I-IV pressure ulcers, diabetic foot ulcers, pre and post-surgical wounds, first and second-degree burns, grafted and donor sites. (Identical to predicate Anacapa Anasept and similar to Oculus Dermacyn) |
| Formulation/Technology | Similar formulation/technology to Oculus – Dermacyn and Anacapa - Anasept. | Similar formulation/technology to Oculus – Dermacyn and Anacapa - Anasept. (Specifics: Purified Water, Sodium bicarbonate, Sodium Hydroxide, Sodium Hypochlorite) |
| Sodium Hypochlorite Concentration | Approximately 85 ppm (0.0085%) for Oculus Dermacyn; Isotonic solution for Anacapa Anasept. | 0.0125% Weight / volume (This is noted as a difference from the predicate, but stated as not introducing new patient safety issues). |
| Materials in Patient Contact | Identical to predicate device Oculus – Dermacyn - K042729. | Identical to predicate device Oculus – Dermacyn - K042729. (Implies same materials used in patient contact for the proposed Wound Cleanser as in Oculus Dermacyn). |
| Biocompatibility | Tested as stated in 510(k) Summary for predicate devices. | Cytotoxicity, Sensitization, Dermal Irritation (Results are not explicitly provided in the summary but it's stated these tests were performed, implying they met acceptable safety profiles for a wound cleanser). |
| Stability/Shelf-life | Tested as stated in 510(k) Summary for predicate devices. | Shelf-life: 2 years; Time-to-use: 3 months (Once opened/prepared, not explicitly stated how this compares but implies testing was done to support these claims, similar to how predicate devices would have established theirs). |
| Environment of Use | Hospitals, nursing homes, wound clinics, and pre and post hospitals. (Identical to Anacapa Anasept.) | Hospitals, nursing homes, wound clinics, and pre and post hospitals. (Identical to predicate Anacapa Anasept.) |
| Contraindications/Warnings | None specified for predicate devices. | Warnings: For external use only, Not for injection, Not for use in or near the eyes, Stop use if redness/irritation/swelling/pain persists, Do not use if sensitive to compounds, Keep out of reach of children. (These are standard for OTC products and wound cleansers, developed to mitigate potential risks.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This document does not describe a clinical study with a "test set" in the traditional sense of patient data used to evaluate AI performance. Instead, it relies on non-clinical performance testing (biocompatibility, stability) and a comparison of the device's characteristics to its predicate devices. Therefore, the concept of a "test set" from a data provenance perspective (country, retrospective/prospective) is not applicable here.
- The tests mentioned (Cytotoxicity, Sensitization, Dermal Irritation) would have used in vitro or in vivo animal models, or potentially human volunteer patch tests for irritation/sensitization, but specific numbers and provenance are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the submission primarily focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing, rather than an expert-adjudicated test set. The "ground truth" for the device's safety and efficacy is implicitly derived from the established safety and efficacy of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the reasons stated above.
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 an AI-powered device. Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- This is not an AI-powered device. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests (biocompatibility, stability, shelf-life), the "ground truth" would be established by validated laboratory assays and protocols for assessing endpoints like cell viability (cytotoxicity), inflammatory responses (sensitization, irritation), and chemical degradation over time (stability).
- For the overall device, the "ground truth" for its safety and effectiveness is primarily established by the long-standing regulatory approval and clinical use of its predicate devices. The substantial equivalence pathway relies on the understanding that if a new device is sufficiently similar to a legally marketed predicate, it can be presumed safe and effective.
8. The sample size for the training set
- This is not an AI-powered device, so there is no concept of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI-powered device.
Summary of the 510(k) Basis:
The provided document, a 510(k) summary, demonstrates that the Wound Cleanser product achieves substantial equivalence to its predicate devices (Oculus - Dermacyn - K042729 and Anacapa - Anasept Skin and Wound Cleanser - K073547). This is achieved by showing:
- Identical/Similar Indications for Use: Both OTC and Professional Use indications are aligned with the predicates.
- Similar Formulation/Technology: The core components, while having a slightly different concentration of sodium hypochlorite (0.0125% vs. ~0.0085% for one predicate), are considered similar and the difference is deemed not to introduce new safety issues.
- Identical Materials in Patient Contact: Stated as identical to one predicate (Oculus Dermacyn).
- Identical Environment of Use: Aligned with one predicate (Anacapa Anasept).
- Non-Clinical Performance: Biocompatibility (cytotoxicity, sensitization, dermal irritation) and stability/shelf-life testing were conducted, implicitly meeting acceptable standards as they support the 2-year shelf-life and 3-month use-after-opening claims without raising new safety concerns.
The FDA's review led to a determination of substantial equivalence, meaning the device can be legally marketed based on its similarity to existing cleared devices, rather than requiring a full de novo clinical trial demonstrating independent efficacy and safety.
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