(121 days)
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.
| Performance Metric Tested (as per ASTM standards) | Implicit Acceptance Criteria (not explicitly quantified in document) | Reported Device Performance (not explicitly quantified in document) |
|---|---|---|
| Wound Closure Strength (ASTM F2458-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Tensile Strength (ASTM F2258-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| T-Peel Strength (ASTM F2256-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Lap Shear Strength (ASTM F2255-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Viscosity | Maintain specified viscosity range over time. | Performance not altered by sterilization changes. |
| Polymerization Time | Maintain specified polymerization time over time. | Performance not altered by sterilization changes. |
| Purity | Maintain specified purity over time. | Performance not altered by sterilization changes. |
| Water Content | Maintain specified water content over time. | Performance not altered by sterilization changes. |
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.
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.