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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 17, 2015

Adhezion Biomedical, LLC Ms. Tracy Lofgren Authorized Regulatory Consultant One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K150866

Trade/Device Name: SURGISEAL® Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: June 17, 2015 Received: June 18, 2015

Dear Ms. Lofgren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerely yours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150866

Device Name SURGISEAL® Topical Skin Adhesive

Indications for Use (Describe)

SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[In accordance with 21CFR 807.92]

Adhezion Biomedical, LLC SURGISEAL® Topical Skin Adhesive

Submitter / 510(k) Holder 1.

Adhezion Biomedical LLC One Meridian Boulevard, Suite 1B02 Wyomissing, PA 19610 Tel: 970.379.4707 Fax: 610.373.2081

Contact Person:	Tracy LofgrenAuthorized Regulatory ConsultantAdhezion Biomedical, LLC
Date Prepared:	July 15, 2015
2. Device Name
Proprietary Name:	SURGISEAL® Topical Skin Adhesive
Common/Usual Name:	Device, Tissue Adhesive for Topical Approximation
Classification:	Class II
Regulation:	21 CFR 878.4010
Product Code:	MPN

3. Predicate Device

Legally Marketed device to which equivalence is claimed:

Proprietary Name:	SURGISEAL® Topical Skin Adhesive
510(k) Clearance:	K130329

4. Device Description

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.

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5. Intended Use

SURGISEAL 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.

Reason for 510(k) Submission 6.

Device modification to equivalent patient contacting material due to shift of supplier

7. Comparison of Technological Characteristics with Predicate

The technological characteristics of the proposed and predicate devices are similar. SURGISEAL adhesive consists of a monomeric (2-octyl cyanoacrylate) liquid adhesive formulation packaged in a single-use applicator. The device is a low viscosity formulation to allow for varied layered applications of the adhesive to the intended area and allow for either a single consistent intact film thickness, continuous layer or two thin layers of the adhesive to the wound area.

SURGISEAL is used for topical applications only to hold closed, easily approximated skin edges of wounds while maintaining wound approximation.

Performance Testing Summary 8.

Biocompatibility:

Biocompatibility testing was conducted on the new applicator material per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". The tests included cytotoxicity, acute systemic injection, guinea pig maximization sensitization and intracutaneous irritation test.

With regard to the entire device, biocompatibility testing was previously conducted on the currently marketed device, SURGISEAL Teardrop (K130329).

Performance Testing:

Bench tests in this submission include Film Thickness determinations for new material component; as well as an assessment of flexibility, linear and surface coverage, set-time and viscosity and in vitro wound closure strength. Shelf life bench testing was also conducted.

Sterilization and Shelf-Life

SURGISEAL® Topical Skin Adhesive is sterilized by ethylene oxide and gamma irradiation; both in accordance with ISO 11137-2:2006

Stability and shelf life were verified with the same acceptance criteria as the predicate.

9. Conclusion

Based on extensive bench performance testing, the modified device, SURGISEAL Topical Skin Adhesive is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.