(295 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® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
The provided text describes a 510(k) submission for the SURGISEAL® Topical Skin Adhesive, focusing on labeling changes and sterilization methods. However, it does not include specific quantitative acceptance criteria or a study detailing device performance against such criteria in the manner requested by the prompt for an AI-related device.
The information primarily discusses:
- Device Identification and Classification: Name, type, class, regulatory information.
- Predicate Devices: SURGISEAL® Topical Skin Adhesive (K082993) and Dermabond Advanced (K100423).
- Reason for Submission: Labeling change and inclusion of gamma sterilization.
- Device Description: 2-octyl cyanoacrylate formulation with D&C Violet #2.
- Indications for Use: Topical application to hold closed easily approximated skin edges of wounds (surgical incisions, punctures from minimally invasive surgery, simple trauma-induced lacerations), potentially with deep dermal sutures.
- Technological Characteristics & Substantial Equivalence: Claims equivalence to the predicate SURGISEAL® device. Discusses biocompatibility (referencing previous testing for K082993) and performance testing (stated that performance testing from K082993 is the same, with additional bench testing to support modifications, but no details are provided). Mentions terminal sterilization by electron beam identical to the predicate, and new gamma irradiation.
- Shelf-Life: Adoption of the current predicate's two-year shelf-life.
- FDA Correspondence: A letter from the FDA determining substantial equivalence for K130329.
Based on the provided text, the following information cannot be extracted or is not applicable in the context of an AI device performance study:
- Table of Acceptance Criteria and Reported Device Performance: This document does not present quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or specific performance metrics of the device in a clinical study. It states that "extensive bench performance testing" was done but provides no data.
- Sample Size used for the test set and data provenance: Not applicable. No clinical test set data is provided. The biocompatibility and performance testing refer to previous submissions (K082993) or unspecified "additional bench testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This is a medical device (topical skin adhesive), not an AI diagnostic/imaging device that would typically involve MRMC studies.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the AI sense. The "ground truth" for a skin adhesive would typically relate to wound closure efficacy, tensile strength, infection rates, cosmetic outcome, etc., which are not detailed in this summary.
- The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of available information relevant to "acceptance criteria" and "study":
- Acceptance Criteria (Implied): The device is considered to meet "acceptance criteria" by demonstrating substantial equivalence to legally marketed predicate devices (SURGISEAL® Topical Skin Adhesive K082993 and Dermabond Advanced K100423) in terms of Indications for Use, technological characteristics, biocompatibility, performance, and sterilization methods. The specific performance data supporting this equivalence is referenced as originating from the predicate device's submission (K082993) and "additional bench testing" for the current modification, but no raw data or numerical targets are given in this summary.
- Study Proving Acceptance Criteria:
- Biocompatibility: Testing was previously conducted on the predicate device (SURGISEAL K082993) per ISO-10993. The results from those studies (non-toxic, non-irritating, non-sensitizing, biocompatible) are deemed supportive for the proposed device due to lack of changes to surface-contacting materials.
- Performance Testing: "The performance testing provided in the Premarket Notification K082993 is the same." Additionally, "Additional bench testing was performed to support the modification to the currently marketed product." No details of this additional bench testing (e.g., type of tests, results, sample sizes) are provided in this summary.
- Sterilization and Shelf-Life: The modified device uses electron beam (identical to predicate K082993) and new gamma irradiation, both in accordance with ISO 11137-2:2006. Shelf-life is adopted from the predicate as 2 years, based on no impact from labeling changes on expiration date.
In conclusion, this document primarily asserts substantial equivalence through reference to prior studies and unspecified bench testing, rather than presenting a detailed independent study with specific performance metrics and acceptance criteria for the current submission.
§ 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.