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

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.

AI/ML Overview

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.

Summary

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Appendix 3: 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 is below:

ﺗﻘ

Submitter Information:
Name	Adhezion Biomedical, LLC
Address	One Meridian BoulevardSuite 1B02Wyomissing, PA 19610
Phone Number	(484) 334-2929
Fax Number	(610) 373-2081
Establishment Registration	3006385287DEC 03 2013
Name of contact person	Caridad Smith, Director of Regulatory Affairs and Quality Assurance
Date prepared	November 20, 2013
Name of Device:
Trade or proprietary name	SURGISEAL* Topical Skin Adhesive
Common or usual name	Device, Tissue Adhesive for Topical Approximation
Classification name	Class II
Classification Panel	General and Plastic Surgery Devices
Regulation	Class II, under 21 CFR 878.4010
Product Code(s)	MPN
Legally Marketed device(s) to which equivalence is claimed	SURGISEAL* Topical Skin Adhesive (K082993)Dermabond Advanced (also known as DERMABOND NX Topical SkinAdhesive - K100423)
Reason for 510(k) submission	Labeling Change and Sterilization method (Gamma)
Device Description	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.
Indications for use	SURGISEAL Topical Skin Adhesive is intended for topical applications
	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, deepdermal sutures.
TechnologicalCharacteristics	The technological characteristics of SURGISEAL Topical Skin Adhesive areequivalent in performance to the predicate device SURGISEAL Topical SkinAdhesive.
	SURGISEAL consists of a monomeric (2-octyl cyanoacrylate) liquidadhesive formulation packaged in a single-use applicator. The device is alow viscosity formulation to allow for varied layered applications of theadhesive to the intended area and allow for either a single thick, continuouslayer or two thin layers of the adhesive to the wound area.
	SURGISEAL is used for topical applications only to hold closed easilyapproximated skin edges of wounds while maintain wound approximation.
SubstantialEquivalence	Biocompatibility:
	The biocompatibility testing that was previously conducted to the currentlymarketed device, SURGISEAL (K082993) per the International StandardISO-10993, "Biological Evaluation of Medical Devices. Part 1: Evaluationand Testing". The existing testing is deemed supportive of the proposedlabeled device, SURGISEAL. Based on the lack of changes conducted tosupport the requirements for biological evaluation of devices for theprolonged exposure. surface-contacting materials the biocompatibility testmethod of the currently marketed product was the same. Based on theresults from those studies, the proposed labeled device is considered to benon-toxic, non-irritating, non-sensitizing and biocompatible.
	Performance Testing:The biocompatibility of SURGISEAL Topical Skin Adhesive modifiedproposed label product is identical to the currently marketed product;therefore the performance testing provided in the Premarket NotificationK082993 is the same. Additional bench testing was performed to supportthe modification to the currently marketed product.
	Sterilization and Shelf-Life
	The modified labeled device is terminally sterilized by electron beamirradiation, which is identical to the predicate device (K082993), as well asby gamma irradiation; both in accordance with ISO 11137-2:2006.

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There is no impact on the labeling change from SURGISEAL of the
modified labeled device on the expiration date (shelf-life) of the product.
Therefore an adoption of the current shelf-life for the predicate device can be
assumed to have a two (2) year expiration date.

...

The labeling changes attempts to clarify the performance of the device in order to characterize the ease. safety, or effective use of the product. Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be safe, efficacious per the performance studies.

The inclusion of a secondary irradiation sterilization process to terminally sterilize the SURGISEAL product is being included in order to support the labeling of the medical device as "sterile". The documentation presented in Appendices 1-5, of the important properties/specifications of the device SURGISEAL remain unaffected and therefore provides further assurance of substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 3, 2013

Adhezion Biomedical, L.L.C. Caridad Smith Senior Manager of Regulatory Affairs/Quality Assurance One Meridian Parkway, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K130329

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: October 29, 2013 Received: October 31, 2013

Dear Ms. Smith:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Caridad Smith

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Radiological Health

Joshua C. Nipper -S

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

Enclosure

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Appendix 6: Revised Indications for Use Form

Indications for Use

510(k) Number (if known): K130329

Device Name: SURGISEAL(R) Topical Skin Adhesive

Indications For Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D)

ﻠﻢ

AND/OR Over-The-Counter Use

(21 CFR 807 Subpan C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130329

Page 1 of 1

Supplement 01 of K130329 Adhezion Biomedical, LLC Page 33 of 123

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.