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derma+flex® QS ™ High Viscosity Tissue 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.

derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity.

The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.

The provided text describes a 510(k) premarket notification for a medical device called derma+flex® QS™ High Viscosity Tissue Adhesive. This type of filing aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a traditional clinical study. Therefore, the information you're looking for, such as a table of acceptance criteria and device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or available in this document.

However, I can extract information about the shelf-life study which included performance testing to demonstrate that changes in the sterilization process did not alter the device's performance over time. This is the closest equivalent to a performance study mentioned in the document.

Here's a breakdown of the relevant information from the document regarding the shelf-life study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific quantified acceptance criteria and reported performance values. It only lists the types of tests performed to demonstrate that the minor differences in sterilization did not change the performance of the device over time. The implied acceptance criterion would be that the device's performance on these tests remains within pre-defined acceptable ranges or comparable to the predicate for its stated shelf-life.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document. This was a lab-based, pre-clinical study focusing on material and performance characteristics under different sterilization conditions for shelf-life testing. It is not a clinical study involving human patients or data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Experts: Not applicable. These were laboratory tests against ASTM standards, not expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Lab tests are typically performed according to established protocols and measured objectively, not through human adjudication in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This document describes a 510(k) submission for a tissue adhesive, not an AI or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This is a physical medical device (tissue adhesive), not an algorithm or software.

7. Type of Ground Truth Used:

• Ground Truth: For the shelf-life studies, the "ground truth" would be the established performance characteristics of the predicate device and the specified limits/ranges for each material property and mechanical strength test as defined by industry standards (ASTM), against which the performance of the new device was compared.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The studies described are for shelf-life validation, where samples of the device are tested over time.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not applicable, as there is no training set. The "ground truth" for showing substantial equivalence relies on comparing the device's characteristics and performance to existing, legally marketed predicate devices and established standards.

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DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.

The provided text describes the 510(k) summary for the DERMA+FLEX™ Gel Adhesive and the FDA's clearance letter. It focuses on establishing substantial equivalence to predicate devices and provides details on the device description, indications for use, and a summary of biocompatibility testing. It does not contain information about acceptance criteria for performance, a study to demonstrate device performance in terms of efficacy or effectiveness, or details about sample sizes, expert involvement, or adjudication methods for performance studies.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about performance studies, multi-reader multi-case studies, or standalone algorithm performance.

However, I can extract the information related to the biocompatibility testing that was performed:

1. Table of acceptance criteria and the reported device performance (for biocompatibility testing):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The document describes in vitro and in vivo biocompatibility tests using cell lines (L929 agar overlay test) and animal models (Murine Local Lymph Node Assay and Intracutaneous Inject). Specific sample sizes for these tests are not provided in the document.
• Data provenance is not specified. These are standard laboratory tests typically conducted under controlled conditions and would likely be prospective for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not applicable or not provided for biocompatibility testing. Biocompatibility tests rely on established scientific protocols and quantitative measurements, not expert consensus on qualitative data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable or not provided for biocompatibility testing.

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:

• No MRMC comparative effectiveness study was mentioned or performed. The device is a "Liquid Bandage" and does not involve AI or human image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. The device is a physical product (liquid bandage), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For biocompatibility testing, the "ground truth" is established through:
  • Validated biological assays: such as cell viability assays (L929), immune response assays (LLNA), and irritation potential assays (intracutaneous injection).
  • Interpretation against international standards: (e.g., ISO 10993-5, USP 24) and regulatory guidelines.

8. The sample size for the training set:

• Not applicable. This pertains to algorithm development. For a physical medical device, there isn't a "training set" in the computational sense. The "development" would involve formulation and bench testing.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

In summary, the provided document details biocompatibility testing results to demonstrate the safety of the DERMA+FLEX™ Gel Adhesive, not its performance in terms of efficacy, which is typically established through clinical studies not present in this 510(k) summary. The focus of the 510(k) was on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (biocompatibility).

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