(52 days)
Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.
Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
The provided document is an FDA 510(k) summary for the Exofin® Precision Pen, a topical skin adhesive. It claims substantial equivalence to a predicate device (Exofin® High Viscosity Topical Skin Adhesive, K200264). This means the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel technology.
Therefore, the information required to fully answer your request regarding acceptance criteria, study details, and specific performance metrics for a new device's clinical efficacy, as one might find for an AI medical device, is not present in this document. This document primarily addresses the substantial equivalence of modifications to a previously cleared device.
However, I can extract the available information related to performance testing that was conducted to support this Special 510(k).
Here's a breakdown of what can be gathered from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a specific table of quantitative acceptance criteria for clinical performance (e.g., wound closure rates, dehiscence rates) or quantitative performance metrics for the Exofin Precision Pen in the context of human studies. The performance testing section discusses "Mechanical Applicator Testing" and states it "met all performance criteria," but these criteria are not detailed.
| Acceptance Criteria Category | Reported Device Performance (Exofin® Precision Pen) | Notes from Document |
|---|---|---|
| Mechanical Applicator Testing | Met all performance criteria. | "In these studies, Exofin® Precision Pen met all performance criteria." The specific quantitative criteria (e.g., force required for dispense, flow rate) are not detailed in this summary. This testing relates to the ergonomic "pen" component, not the adhesive's clinical efficacy itself. |
| Adhesive Performance (Indirect) | No change from predicate device (K200264). | "Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done." The performance of the adhesive formulation itself is presumed to be equivalent to the predicate, as it is the same formulation. |
| Biocompatibility | Not required for the pen component; unchanged for adhesive. | "The pen of subject device does not come into direct contact with the patient or adhesive, therefore, biocompatibility is not required. Because the adhesive is unchanged, no additional biocompatibility tests were performed." |
| Sterility Assurance Level (SAL) | 10⁻⁶ | "Exofin® Precision Pen is sterilized in a two-step process by dry heat and ethylene oxide gas at a sterility assurance level (SAL) of 10⁻⁶." |
| Shelf-Life | 12 months | "The data from these studies support a 12-month shelf-life." |
| Microbial Barrier Properties | Acts as a barrier when intact (in-vitro). | "In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact." |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any human clinical trials. The performance testing mentioned ("Mechanical Applicator Testing") would involve device units, not human subjects.
- Data Provenance: Not applicable for human clinical data, as no new clinical studies were conducted for this Special 510(k). The "in-vitro studies" for microbial barrier properties suggest lab-based testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable as no human clinical test set requiring expert ground truth establishment for a novel device was conducted for this Special 510(k).
4. Adjudication Method for the Test Set
- Not applicable as no human clinical test set requiring adjudication was conducted for this Special 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, whereas the Exofin Precision Pen is a therapeutic device (tissue adhesive).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The Exofin Precision Pen is a physical medical device (a topical skin adhesive with an applicator), not an algorithm or AI system.
7. Type of Ground Truth Used
- Not applicable in the context of human clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the mechanical applicator testing would be the engineering specifications and functional requirements for the pen. For the microbial barrier, it would be laboratory culture results.
8. Sample Size for the Training Set
- Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above.
Summary of Device Rationale for this 510(k):
The Exofin® Precision Pen is presented as a modification to an already cleared device (Exofin® High Viscosity Topical Skin Adhesive, K200264). The changes are specifically:
- Addition of a pen (silicone bulb and pen body) for improved ergonomics.
- An increase in blister size to accommodate the pen body.
- An increase in the number of device units per tray from 10 to 12.
The key claim for substantial equivalence is that the adhesive formulation, aluminum tube, and applicator tip remain unchanged from the predicate device. Therefore, clinical performance related to wound closure, strength, etc., is considered unchanged and relies on the predicate's clearance. The new testing conducted was primarily "Mechanical Applicator Testing" to ensure the new pen component functions as intended, and it reportedly "met all performance criteria." Biocompatibility was deemed unnecessary for the non-patient-contacting pen component, and the adhesive's biocompatibility was already established. Sterilization validation and shelf-life studies were also conducted for the new configuration.
§ 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.