(259 days)
SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.
SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures
SURGISEAL Twist Topical Skin Adhesives are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip. This Twist applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
The provided text describes the 510(k) premarket notification for the SURGISEAL Twist™ Topical Skin Adhesive. The submission is for a device modification (dimensional specification change to the tip) and claims substantial equivalence to the predicate device, SURGISEAL Stylus Twist™ Topical Skin Adhesive (K130474).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative table format with corresponding "reported device performance." Instead, it states that the modified device "met specifications and demonstrated equivalence" to the currently marketed device. The performance claims are qualitative comparisons to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent Performance to Predicate Device | "The technological characteristics of SURGISEAL Stylus Twist and SURGISEAL Twist Topical Skin Adhesives are equivalent in performance." "In all cases, the dimensional tip specification modification SURGISEAL Twist Topical Skin Adhesive met specifications and demonstrated equivalence to the currently marketed device." |
| Sufficient Flexibility (Device specific) | Bench tests included "Flexibility". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device." |
| Adequate Linear and Surface Coverage (Device specific) | Bench tests included "Linear and Surface Coverage". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device." |
| Equivalent Wound Closure Strength (Device specific) | Bench tests included "Wound Closure Strength". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device." |
| Sufficient Force Expression (Device specific) | Bench tests included "Force Expression". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device." |
| Biocompatibility | "The biocompatibility testing that was previously conducted to the currently marketed devices, SURGISEAL Stylus Twist (K130474) per the International Standard ISO-10993... The existing testing is deemed supportive of the modified device... the subject device is considered to be non-toxic, non-irritating, non-sensitizing and biocompatible and no additional biocompatibility testing was necessary." |
| Sterilization Efficacy | "The sterilization process of the dimensional tip specification modification device remains unchanged." The sterilization methods (gamma irradiation per ISO 11137-2:2006 and ethylene oxide per ISO 11135-1 and 2:2008) are stated to be in accordance with relevant standards. |
| Shelf-life Maintenance (24 months / 2 years) | "The proposed dimensional tip specification modification of SURGISEAL Twist™ Topical Skin Adhesives does not impact the 24 month (2 year) expiration date (shelf-life) of the currently marketing predicated devices." |
| Maintains Approximation of Wound Edges (Primary function) | "...has demonstrated that a dimensional tip modification to the product maintains approximation of wound edges." (This is a summary statement based on the bench performance testing.) |
| Microbial Barrier Properties (Qualified statement, not criteria) | "In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." (This is noted as a characteristic but not a proven clinical acceptance criterion for the current submission.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes for the bench tests (Flexibility, Linear and Surface Coverage, Wound Closure Strength, and Force Expression). It merely states that "Additional bench testing was performed."
- Data Provenance: The document implies that the bench testing was conducted by Adhezion Biomedical, LLC or a contracted lab to support the 510(k) submission. There is no information about the country of origin of the data. The studies are described as "bench testing," meaning they are laboratory-based, not patient-based, and thus are not retrospective or prospective clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable (N/A) as the described studies are physical bench tests on a medical device, not a diagnostic algorithm that requires expert ground truth.
4. Adjudication Method for the Test Set:
This section is N/A for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This section is N/A. The device is a topical skin adhesive, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This section is N/A. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests would be the established engineering and material science specifications and performance metrics of the predicate device (SURGISEAL Stylus Twist™) and the relevant industry standards for medical adhesives and device performance. The goal was to demonstrate that the modified device's performance aligns with these established benchmarks.
8. The Sample Size for the Training Set:
This section is N/A. The device is a physical medical device; there is no "training set" in the context of an algorithm or AI model development.
9. How the Ground Truth for the Training Set Was Established:
This section is N/A for the same reason as point 8.
Summary of the Study:
The study described is not a clinical study involving patients or a diagnostic study involving human interpretation. It is a set of bench performance tests designed to demonstrate that a specific dimensional modification to the tip of the SURGISEAL Twist™ Topical Skin Adhesive does not negatively impact its existing physical and performance characteristics compared to its legally marketed predicate device (SURGISEAL Stylus Twist™ Topical Skin Adhesive).
The key findings are that the modified device:
- Maintains equivalent performance characteristics (Flexibility, Linear and Surface Coverage, Wound Closure Strength, Force Expression) compared to the predicate device.
- Retains the established biocompatibility profile of the predicate device.
- Uses the same validated sterilization process.
- Does not impact the predicate device's 24-month shelf-life.
- Overall, it "maintains approximation of wound edges," which is its primary functional purpose.
§ 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.