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. The SURGISEAL Twist applicator contains the identical adhesive formula as the predicate devices, SURGISEAL® Topical Skin Adhesive and SURGISEAL StylusTM Topical Skin Adhesive, but 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 with either Applicator, 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called SURGISEAL Twist™ Topical Skin Adhesive. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical characteristics and bench testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study aimed at proving efficacy. Instead, it describes general claims based on "extensive bench performance testing" and focuses on substantial equivalence to predicate devices. The primary purpose of this 510(k) submission is a "Labeling Change to include Microbial Barrier description," which is based on in vitro studies.

However, from the "Performance Testing" section, we can infer some criteria related to the physical properties of the adhesive application:

Acceptance Criteria (Inferred)	Reported Device Performance
Consistent and controlled film thickness during application	"Film Thickness determinations for each of the SURGISEAL Teardrop, Stylus and Twist applicators" were performed. (Specific results are not provided but are implied to be acceptable for substantial equivalence)
Effective dispensing of adhesive (for different applicator designs)	"The technological characteristics of each applicator design are geometrically unique but have similar capabilities for adhesive deployment and film coverage." (Implies effective and comparable deployment)
Maintenance of an intact adhesive film for microbial barrier	"In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "in vitro studies" and "bench tests" for performance testing.

Sample Size for Test Set: Not explicitly stated. The phrase "Film Thickness determinations for each of the SURGISEAL Teardrop, Stylus and Twist applicators" suggests multiple samples were tested for each applicator type, but the exact number is not provided.
Data Provenance: The tests are "in vitro" (laboratory-based) and "bench tests," meaning they were conducted in a controlled lab environment. The document is silent on the country of origin of the data beyond the submitter's address in Wyomissing, Pennsylvania, USA. The studies are retrospective in the sense that they are presented as part of a 510(k) submission which often relies on pre-market testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. For in vitro and bench tests, "ground truth" often refers to a defined standard or measurement method, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to bench or in vitro performance testing where results are typically data-driven rather than subject to expert interpretation and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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 indicates that human-in-the-loop assessments or clinical outcome studies involving human readers/evaluators were not part of this submission's evidence for the labeling change.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical product (topical skin adhesive), not an algorithm or AI. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance described is inherent to the physical properties and application of the adhesive.

7. The Type of Ground Truth Used

For the microbial barrier claim, the ground truth was established through in vitro studies demonstrating the physical barrier property. For film thickness and adhesive deployment, the ground truth would be based on physical measurements and technical specifications (e.g., thickness gauges, visual inspection, or other analytical methods). It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI/ML algorithm.

Summary

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

August 21, 2014

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

Re: K141215

Trade/Device Name: SURGISEAL Twist™ Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulatory Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: May 28, 2014 Received: May 29, 2014

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/Resourcesfor You/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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K141215

Device Name SURGISEAL Twist™ 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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Image /page/3/Picture/0 description: The image contains the logo for Adhezion Biomedical. The logo consists of a stylized blue symbol on the left, resembling interconnected curves. To the right of the symbol is the word "Adhezion" in a bold, sans-serif font, with the word "BIOMEDICAL" in a smaller font size underneath. The overall design is clean and modern.

Section 7: 510(k) Summary

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

Requirements of 21 CFR 807.92 is below.
Submitter Information:
Name	Adhezion Biomedical, LLC
Address	One Meridian BoulevardSuite 1B02Wyomissing, PA 19610
Phone Number	(610) 241-7191
Fax Number	(610) 373-2081
EstablishmentRegistration	3006385287
Name of contactperson(s)	Richard Jones, Regulatory and Quality Assurance ConsultantTracy Lofgren, Regulatory Consultant
Date prepared	August 1, 2014
Name of Device:
Trade or proprietaryname	SURGISEAL TwistTM Topical Skin Adhesive
Common or usualname	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 Marketeddevice(s) to whichequivalence isclaimed	SURGISEAL® Topical Skin Adhesive (K082993, K123936, K130329, K140517)SURGISEAL StylusTM Topical Skin Adhesive (K130474, K140517)SURGISEAL TwistTM Topical Skin Adhesive (K130474)
Reason for 510(k)submission	Labeling Change to include Microbial Barrier description
Device Description	SURGISEAL® Topical Skin Adhesive is a sterile, professional liquidskin adhesive containing a monomeric (2-octyl cyanoacrylate)formulation and the colorant D&C Violet #2. The SURGISEAL Twistapplicator contains the identical adhesive formula as the predicatedevices, SURGISEAL® Topical Skin Adhesive and SURGISEALStylusTM Topical Skin Adhesive, but is comprised of a plastic ampoulecontainer contained within an applicator sleeve with the applicator tip.This Twist applicator tray is contained in an outer Tyvek pouch. WhenSURGISEAL is applied to the skin with either Applicator, itpolymerizes in minutes.In vitro studies have shown that SURGISEAL acts as a physical barrier
Indications for 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. 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.
TechnologicalCharacteristics	The technological characteristics of each applicator design are geometrically unique but have similar capabilities for adhesive deployment and film coverage. The predicate Teardrop applicator shape is flat with a small specific depth incorporating a smooth, wide foam surface tip for larger area coverage; whereas, the subject Twist applicator shape is tubular with a smaller width angled tip for a more precision deployment with less peripheral coverage. Each has a unique distinctive design for releasing the identical SurgiSeal formula to the tip for patient skin contact.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.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.
SubstantialEquivalence	Biocompatibility:Biocompatibility testing was previously conducted on the currently marketed device, SURGISEAL Twist (K130474), per the International Standard ISO-10993, “Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing”. The existing testing is deemed supportive of the proposed labeled devices. Based on the results from those studies, both proposed labeled devices are considered to be non-toxic,
biocompatibility testing was necessary as the subject device is identicalto the device identified in K130474.
Performance Testing:
Bench tests in this submission include Film Thickness determinationsfor each of the SURGISEAL Teardrop, Stylus and Twist applicators.
Sterilization and Shelf-Life
SURGISEAL Twist™ Topical Skin Adhesive is sterilized inaccordance with the order of operation of the assembly. The filledampoule containing the adhesive is sterilized by gamma irradiation inaccordance with ISO 11137-2:2006. Then the finished bulk applicatorin the secondary packaging is sterilized by ethylene oxide in accordancewith ISO 11135-1:2008 and ISO 11135-2:2008.
The proposed labeling modification sterilization does not impact the 24month (2 year) expiration date (shelf-life) proposed for these productsand will therefore remain to be labeled with a two (2) year expirationdate.

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The labeling change clarifies 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 Twist Topical Skin Adhesive, has demonstrated to be safe & efficacious.

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.