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510(k) Data Aggregation
(173 days)
BERGEN MEDICAL PRODUCTS, INC.
ACTABOND Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. ACTABOND Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
ACTABOND Topical Skin Adhesive is a skin closure device that is comprised of a 2-octyl cyanoacrylate liquid adhesive formulation containing D & C Violet #2. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. In vitro studies have shown that following application, ACTABOND Adhesive acts as a barrier to prevent bacterial penetration. The barrier properties of ACTABOND Adhesive have not been studied in clinical or animal models.
This document is a 510(k) premarket notification for the ACTABOND Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with strict acceptance criteria and performance metrics for a novel AI or diagnostic device. Therefore, much of the requested information regarding AI-specific assessments (MRMC studies, stand-alone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract information related to the performance testing performed to demonstrate equivalence to the predicate device.
Here's the breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Specific numerical acceptance criteria are not explicitly stated in the provided text as this is a substantial equivalence submission rather than a de novo marketing authorization or a clinical trial report with pre-defined endpoints for efficacy. Instead, the performance studies aimed to demonstrate "equivalence to the predicate device." The "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the listed tests.
| Performance Test | Acceptance Criteria (inferred) | Reported Device Performance |
|---|---|---|
| Wound closure strength | Equivalent to predicate (ASTM F2458-05) | Demonstrated equivalence to the predicate device. |
| Tensile strength | Equivalent to predicate (ASTM F2258-05) | Demonstrated equivalence to the predicate device. |
| Lap shear strength | Equivalent to predicate (ASTM F2255-05) | Demonstrated equivalence to the predicate device. |
| Heat of polymerization | Equivalent to predicate | Demonstrated equivalence to the predicate device. |
| Applicator Functionality | Acceptable and comparable to predicate | Demonstrated equivalence to the predicate device. |
| Viscosity | Met specifications, comparable to predicate | Evaluated. Conclusion: Demonstrated equivalence to the predicate device. |
| Setting time | Met specifications, comparable to predicate | Evaluated. Conclusion: Demonstrated equivalence to the predicate device. |
| Purity | Met specifications, comparable to predicate | Evaluated. Conclusion: Demonstrated equivalence to the predicate device. |
| Moisture | Met specifications, comparable to predicate | Evaluated. Conclusion: Demonstrated equivalence to the predicate device. |
| Hydrolytic degradation | Met specifications, comparable to predicate | Evaluated. Conclusion: Demonstrated equivalence to the predicate device. |
| Bacterial barrier | Met specifications, comparable to predicate | Evaluated. In vitro studies showed it acts as a barrier. Not studied in clinical/animal models. |
| Acute wound closure (Porcine) | No remarkable differences from predicate | No remarkable differences between subject and predicate device groups. |
| Maintenance of wound closure (Porcine) | No remarkable differences from predicate | No remarkable differences between subject and predicate device groups; both maintained wound closure. |
| Support of normal wound healing (Porcine) | No remarkable differences from predicate | No remarkable differences between subject and predicate device groups; both supported normal healing without delay and showed complete epidermal re-epithelialization at 14 days. |
| Histological evaluation (Porcine) | No remarkable differences from predicate | No remarkable differences between subject and predicate device groups. |
| Biocompatibility (Cytotoxicity) | Met ISO 10993-5:2009(R)2014 standards | Demonstrated safe for intended use. |
| Biocompatibility (Irritation/Intracutaneous reactivity) | Met ISO 10993-10:2010 standards | Demonstrated safe for intended use. |
| Biocompatibility (Systemic Injection) | Met ISO 10993-11:2006(R)2010 standards | Demonstrated safe for intended use. |
| Biocompatibility (Sensitization/Kligman Maximization) | Met ISO 10993-10:2010 standards | Demonstrated safe for intended use. |
| Biocompatibility (Intramuscular implantation) | Met ISO 10993-6:2007(R)2010 standards | Demonstrated safe for intended use. |
| Sterility Assurance Level (e-beam & EO) | 10⁻⁶ | Validated to provide a Sterility Assurance Level of 10⁻⁶. |
| Shelf-life | Confirmed through real-time aging studies | Confirmed through real-time aging studies. |
2. Sample size used for the test set and the data provenance
- Bench Studies: Sample sizes for individual bench tests (viscosity, setting time, strength tests, etc.) are not provided.
- Animal Study: The sample size for the porcine study is not explicitly stated. It refers to "a surgically induced, full thickness, linear wound healing model" and "Both groups" (subject and predicate device groups), implying at least two groups of animals, but the number of animals per group is not specified.
- Data Provenance: The studies were conducted by Bergen Medical Products, Inc. (USA) as part of their design control requirements. The porcine study is an animal model, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench Studies: Not applicable. These are objective physical/chemical measurements.
- Animal Study: A "histological evaluation was also performed." This implies expert pathologists were involved, but the number and qualifications are not specified.
4. Adjudication method for the test set
- Bench Studies: Not applicable. These are quantitative measurements.
- Animal Study: Not specified for the histological evaluation.
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
- Not applicable. This submission is for a medical device (topical skin adhesive), not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a physical medical device (topical skin adhesive), not a standalone algorithm.
7. The type of ground truth used
- Bench Studies: Objective physical and chemical measurements (e.g., ASTM standards for strength, measured properties like viscosity, purity).
- Animal Study: Clinical observations of wound healing and histological analysis (microscopic examination of tissue by experts) were used as "ground truth" to compare the wound healing outcomes between the subject and predicate devices.
- Biocompatibility: Standardized ISO methods and biological responses (e.g., cytotoxicity, irritation).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set. The device formulation and performance are based on established material science and empirical testing.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned.
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