(107 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.
Adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. When SURGISEAL is applied to the skin with the applicator, it polymerizes in minutes.
This document describes the 510(k) premarket notification for the SURGISEAL® Topical Skin Adhesive. The submission primarily addresses a device modification due to a shift in supplier for an equivalent patient-contacting material. Therefore, the "study" mainly focuses on demonstrating that the new material does not negatively impact the device's performance or safety compared to the predicate device.
Here's an analysis based on the provided text, focusing on acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993, Part 5) | Non-cytotoxic | New applicator material tested per ISO-10993, Part 5. Results are implicitly acceptable as the conclusion states substantial equivalence. |
| Acute Systemic Injection (ISO 10993, Part 11) | No adverse systemic reactions | New applicator material tested per ISO-10993, Part 11. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Guinea Pig Maximization Sensitization (ISO 10993) | Not a sensitizer | New applicator material tested per ISO-10993. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Intracutaneous Irritation Test (ISO 10993, Part 10) | Non-irritating | New applicator material tested per ISO-10993, Part 10. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Performance Testing | Film Thickness determinations | Consistent film thickness with the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted for the new material component. Results are implicitly acceptable as the conclusion states substantial equivalence. |
| Flexibility | Equivalent flexibility to the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Linear and Surface Coverage | Equivalent linear and surface coverage to the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Set-Time | Equivalent set-time to the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Viscosity | Equivalent viscosity to the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| In vitro Wound Closure Strength | Equivalent wound closure strength to the predicate device (implied, as the modification is for an "equivalent patient contacting material") | Conducted. Results are implicitly acceptable as the conclusion states substantial equivalence. | |
| Sterilization & Shelf-Life | Sterilization validation | Sterilized in accordance with ISO 11137-2:2006 (EO and gamma irradiation validated) | Sterilized by ethylene oxide and gamma irradiation in accordance with ISO 11137-2:2006. Results are implicitly acceptable as the conclusion states substantial equivalence. |
| Stability and Shelf Life | Same acceptance criteria as the predicate device (implies no significant degradation or loss of function over the stated shelf life) | Verified with the same acceptance criteria as the predicate. Results are implicitly acceptable as the conclusion states substantial equivalence. |
Note: The document states that the new material is "equivalent" and that the modified device is "substantially equivalent to the predicate." Therefore, the acceptance criteria for most tests are implicitly that the performance of the modified device (with the new material) must be comparable to or within acceptable limits of the predicate device. Specific numerical targets are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for the various biocompatibility and performance bench tests.
The data provenance is from bench testing (in vitro) rather than clinical studies, and the location of this testing is not specified, though it would typically be conducted by the manufacturer or a contract research organization. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are typically considerations for clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the studies described are bench tests (biocompatibility and performance) and not studies requiring expert interpretation or ground truth establishment based on medical assessment. The "ground truth" for these types of tests is generally defined by standardized methods and analytical measurements.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are bench tests and do not involve human interpretation or adjudication in the medical sense.
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
An MRMC comparative effectiveness study was not performed. This submission is for a medical device (topical skin adhesive), not an AI/imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable as the device is a topical skin adhesive, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to clinical or diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applicable here. For the bench tests described:
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and accepted biological responses in specific in vitro and in vivo models.
- Performance Testing: Ground truth is established by standardized material testing methods and measurements (e.g., precise measurement of film thickness, set-time, viscosity, wound closure strength).
- Sterilization and Shelf-Life: Ground truth is established by adherence to ISO 11137-2:2006 and established stability testing protocols.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is not an AI/machine learning system.
§ 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.