(69 days)
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.
The provided document describes the safety and effectiveness of Carrington's Carrasyn® wound dressings. It primarily focuses on demonstrating biocompatibility and some clinical observations. However, it does not include detailed acceptance criteria or a study designed to rigorously prove that the device meets specific performance metrics in the way that would typically be expected for a diagnostic or AI-based device's acceptance criteria.
The information provided is more akin to a 510(k) premarket notification summary for a medical device, which generally focuses on demonstrating substantial equivalence to a predicate device and outlining safety and efficacy through biocompatibility and some clinical experience.
Given this, I will interpret "acceptance criteria" as the overall goal of demonstrating safety and effectiveness as outlined in the summary, and "reported device performance" as the outcomes of the studies described.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Safety: Device is not a primary dermal or eye irritant. | Biocompatibility Studies:- Primary Dermal Irritation testing: Demonstrated not to be a primary dermal irritant.- Primary Eye Irritation testing: Demonstrated not to be a primary eye irritant. |
| Safety: Device does not cause adverse events. | Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): No mention of adverse events.Clinical Trial (Aphthous Ulcers - Carrington Patch™):- Randomized, double-blind study: No adverse events reported.- Open-label study: No adverse events reported. |
| Effectiveness: Improves wound healing/manages wounds as intended. | Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Evaluated "acceptability... to clinicians, to wound and skin appearance, and to the wound healing environment." Concluded to be "safe and effective for their intended use." |
| Effectiveness: Reduces discomfort (specifically for aphthous ulcers). | Clinical Trial (Aphthous Ulcers - Carrington Patch™):- Randomized, double-blind study: Found to "reduce discomfort."- Open-label study: Found to "significantly reduce discomfort within 2 minutes." |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of the device (wound dressing, not AI/diagnostic), the concept of a "test set" in the context of an AI model doesn't directly apply. The document describes clinical studies that serve as evidence of safety and effectiveness.
- Clinical Experience (Radiation Dermatitis & Diabetic Ulcers):
- Sample Size: 4 patients with radiation dermatitis, 30 patients with diabetic ulcers.
- Data Provenance: Not specified, but generally implies a prospective clinical observation.
- The Carrington™ Patch - Randomized, Double-Blind Study (Aphthous Ulcers):
- Sample Size: 60 healthy volunteer patients (30 in treatment group, 30 in control group).
- Data Provenance: Not specified, but implies a prospective clinical trial.
- The Carrington™ Patch - Open-Label Study (Aphthous Ulcers):
- Sample Size: 30 healthy volunteer patients.
- Data Provenance: Not specified, but implies a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Biocompatibility Studies: These were laboratory tests conforming to GLP regulations using animal models. The "ground truth" (i.e., irritation levels) would be established by trained technicians/toxicologists following standard protocols. Specific numbers or qualifications are not provided but are inherent in GLP compliance.
- Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): "Clinicians" were involved in evaluating acceptability and wound healing. The number and specific qualifications (e.g., dermatologists, wound care specialists) are not specified.
- Clinical Trials (Aphthous Ulcers): Patients themselves provided input on discomfort via diaries and adverse event reports. Clinicians would have conducted assessments but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Biocompatibility Studies: Not applicable in the sense of expert adjudication. Results were objectively measured based on irritation scores.
- Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Adjudication method not described. It appears to be clinician observation without a formal multi-reader adjudication process.
- Clinical Trials (Aphthous Ulcers): Patient diaries and adverse event reports were primary data sources. Clinicians would have overseen the study, but a specific adjudication method for their observations is not detailed. The randomized double-blind nature of one study partially addresses bias for the discomfort assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document does not describe human readers interpreting images or data with and without AI assistance. This device is a wound dressing, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical wound dressing, not an algorithm.
7. The Type of Ground Truth Used
- Biocompatibility Studies: Objective measurements of dermal and ocular irritation in animal models.
- Clinical Experience (Radiation Dermatitis & Diabetic Ulcers): Clinician observations and assessments of wound/skin appearance and healing environment. Patient acceptability. This is a form of expert clinical assessment.
- Clinical Trials (Aphthous Ulcers):
- Discomfort: Patient-reported outcome (via diary), which is a subjective but direct measure of a patient's experience.
- Adverse Events: Patient-reported and clinically observed events.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set" in the conventional sense. The "training" for the device's formulation likely involved laboratory research and development, but not data-driven machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model for this device. The development process for the dressing would have involved standard chemical and material science techniques, preclinical testing, and potentially iterative formulation based on performance in those settings.
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JU 11 1996
CARRINGTON
Device Name:
| Classification Name: | Dressings, wound and burns, hydrogel |
|---|---|
| Common Name: | Hydrogel Wound Dressings |
| Proprietary Names: | Carrasyn® Hydrogel Wound DressingCarraGauze® PadsCarraGauze® StripsThe Carrington™ PatchCarraSorb™ M Freeze-Dried Wound Dressing |
| Device Sponsor: | Carrington Laboratories, Inc.2001 Walnut Hill LaneIrving, TX 75038-4404Registration No: 162544 |
Regulatory Classification: Unclassified, (Product code MGO)
Summary of Safety and Effectiveness:
This 510 (k) Premarket Notification provides for the standardization and clarification of previously cleared indications for the labeling of Carrasyn® wound dressings. Carrasyn® Hydrogel Wound Dressing was originally marketed pursuant to 510 (k) Number K902345. The additional wound dressings that are included in this labeling standardization and clarification include CarraGauze® pads (K915001), CarraGauze® strips (K925002), The Carrington™ Patch (K933741) and CarraSorb™ M Freeze-Dried Wound Dressing (K944427).
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are intended for the management of wounds.
Since the products are for use in wounds, the safety of these wound gels was established through standard biocompatibility tests. These biocompatibility tests were conducted in standard animal models with preparations of the Carrasyn® wound dressings. These tests included Primary Dermal Irritation testing and Primary Eye Irritation testing. These studies demonstrated that Carrasyn® wound dressings are not primary dermal irritants or primary eye irritants. These studies were conducted in conformance with Good Laboratory Practices (GLP) regulations of the United States Food and Drug Administration (21 CFR, Part 58).
Carrington Laboratories, Inc. Corporate Office & Manufacturing: 2001 Walnut Hill Lane Irving. Texas 75038 (214) 518-1300 (214) 518-1020 Fax
· Post Office Box 168128
Distribution Center& AccCE
1909 Hereford Drive
Irving, Texas 75038
(214) 518-1300
(214) 756-0108 Fax
Sulte SJO-2632 - Unit C-101 1601 N.W. 97th Avenue Mlaml, Florida 33102-5216 011-506-666-0100
· Irving. TX 75016-8128 · (800) 527-5216
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Clinical experience to date has been gained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV diabetic ulcers of the foot were treated with Carrasyn® Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with Carrasyn® Hydrogel Wound Dressing. These studies evaluated the acceptability of Carrasyn® Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that Carrasyn®wound dressings are safe and effective for their intended use.
Two clinical trials have been conducted to date using The Carrington Patch™ . The first clinical trial was a randomized, double-blind, active-controlled study involved 60 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. The patients were randomly assigned to two groups where one group of 30 patients were treated with The Carrington™ Patch and one group of 30 patients treated with a control. The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to reduce discomfort and no adverse events were reported in association with its use.
The second clinical study was an open-label, uncontrolled study involving 30 healthy volunteer patients with at least one aphthous ulcer less than 48 hours duration. All patients were treated The Carrington™. Patch The patients were asked to apply the dressings topically four times per day and keep a diary as to the overall degree of discomfort and complete an adverse report form. Treatment was continued until the ulcers were healed. The Carrington Patch™ was found to significantly reduce discomfort within 2 minutes and no adverse events were reported in association with its use.
The above studies demonstrate that Carrasyn® wound dressings are safe for their intended use and have not been associated with adverse events. These products are concluded to be a safe and effective dressings in the management of wounds.
N/A