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 Twist Topical Skin Adhesives are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator 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, 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 text describes the 510(k) premarket notification for the SURGISEAL Twist™ Topical Skin Adhesive. The submission is for a device modification (dimensional specification change to the tip) and claims substantial equivalence to the predicate device, SURGISEAL Stylus Twist™ Topical Skin Adhesive (K130474).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative table format with corresponding "reported device performance." Instead, it states that the modified device "met specifications and demonstrated equivalence" to the currently marketed device. The performance claims are qualitative comparisons to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent Performance to Predicate Device	"The technological characteristics of SURGISEAL Stylus Twist and SURGISEAL Twist Topical Skin Adhesives are equivalent in performance." "In all cases, the dimensional tip specification modification SURGISEAL Twist Topical Skin Adhesive met specifications and demonstrated equivalence to the currently marketed device."
Sufficient Flexibility (Device specific)	Bench tests included "Flexibility". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device."
Adequate Linear and Surface Coverage (Device specific)	Bench tests included "Linear and Surface Coverage". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device."
Equivalent Wound Closure Strength (Device specific)	Bench tests included "Wound Closure Strength". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device."
Sufficient Force Expression (Device specific)	Bench tests included "Force Expression". The claim is that the modified device "met specifications and demonstrated equivalence to the currently marketed device."
Biocompatibility	"The biocompatibility testing that was previously conducted to the currently marketed devices, SURGISEAL Stylus Twist (K130474) per the International Standard ISO-10993... The existing testing is deemed supportive of the modified device... the subject device is considered to be non-toxic, non-irritating, non-sensitizing and biocompatible and no additional biocompatibility testing was necessary."
Sterilization Efficacy	"The sterilization process of the dimensional tip specification modification device remains unchanged." The sterilization methods (gamma irradiation per ISO 11137-2:2006 and ethylene oxide per ISO 11135-1 and 2:2008) are stated to be in accordance with relevant standards.
Shelf-life Maintenance (24 months / 2 years)	"The proposed dimensional tip specification modification of SURGISEAL Twist™ Topical Skin Adhesives does not impact the 24 month (2 year) expiration date (shelf-life) of the currently marketing predicated devices."
Maintains Approximation of Wound Edges (Primary function)	"...has demonstrated that a dimensional tip modification to the product maintains approximation of wound edges." (This is a summary statement based on the bench performance testing.)
Microbial Barrier Properties (Qualified statement, not criteria)	"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." (This is noted as a characteristic but not a proven clinical acceptance criterion for the current submission.)

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

Sample Size: The document does not specify the exact sample sizes for the bench tests (Flexibility, Linear and Surface Coverage, Wound Closure Strength, and Force Expression). It merely states that "Additional bench testing was performed."
Data Provenance: The document implies that the bench testing was conducted by Adhezion Biomedical, LLC or a contracted lab to support the 510(k) submission. There is no information about the country of origin of the data. The studies are described as "bench testing," meaning they are laboratory-based, not patient-based, and thus are not retrospective or prospective clinical studies.

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

This section is not applicable (N/A) as the described studies are physical bench tests on a medical device, not a diagnostic algorithm that requires expert ground truth.

4. Adjudication Method for the Test Set:

This section is N/A for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This section is N/A. The device is a topical skin adhesive, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This section is N/A. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the bench tests would be the established engineering and material science specifications and performance metrics of the predicate device (SURGISEAL Stylus Twist™) and the relevant industry standards for medical adhesives and device performance. The goal was to demonstrate that the modified device's performance aligns with these established benchmarks.

8. The Sample Size for the Training Set:

This section is N/A. The device is a physical medical device; there is no "training set" in the context of an algorithm or AI model development.

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

This section is N/A for the same reason as point 8.

Summary of the Study:

The study described is not a clinical study involving patients or a diagnostic study involving human interpretation. It is a set of bench performance tests designed to demonstrate that a specific dimensional modification to the tip of the SURGISEAL Twist™ Topical Skin Adhesive does not negatively impact its existing physical and performance characteristics compared to its legally marketed predicate device (SURGISEAL Stylus Twist™ Topical Skin Adhesive).

The key findings are that the modified device:

Maintains equivalent performance characteristics (Flexibility, Linear and Surface Coverage, Wound Closure Strength, Force Expression) compared to the predicate device.
Retains the established biocompatibility profile of the predicate device.
Uses the same validated sterilization process.
Does not impact the predicate device's 24-month shelf-life.
Overall, it "maintains approximation of wound edges," which is its primary functional purpose.

Summary

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

September 9, 2014

Adhezion Biomedical, LLC Ms. Caridad Smith Director of Regulatory Affairs and Quality Assurance One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K133963

Trade/Device Name: SURGISEAL Twist" Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: August 13, 2014 Received: August 14, 2014

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 (reporting of medical

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

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Indications for Use

510(k) Number (if known) K133963

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)

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Image /page/3/Picture/0 description: The image shows the logo for Adhezion BIOMEDICAL. The logo consists of a blue abstract design on the left, resembling curved lines or waves. To the right of the design is the word "Adhezion" in a dark blue, sans-serif font. Below "Adhezion" is the word "BIOMEDICAL" in a smaller, lighter blue font.

510(k) Summary

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

Submitter Information:
Name	Adhezion Biomedical, LLC
Address	One Meridian BoulevardSuite 1B02Wyomissing, PA 19610
Phone Number	(828) 572-4201
Fax Number	(828) 726-7117
Establishment Registration	3006385287
Name of contact person(s)	Caridad Smith – Director of Regulatory Affairs/Quality AssuranceTracy Lofgren – Regulatory Consultant
Date prepared	August 27, 2014
Name of Device:
Trade or proprietary names	SURGISEAL Twist™ 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 Stylus Twist™ Topical Skin Adhesive (K130474)
Reason for 510(k) submission	Device Modification – Dimensional Specification Change to Tip
Device Description	SURGISEAL Twist Topical Skin Adhesives are sterile, professional liquidtopical skin adhesives containing a monomeric (2-octyl cyanoacrylate)formulation and the colorant D & C Violet #2. Each applicator is comprised ofa plastic ampoule container contained within an applicator sleeve with theapplicator tip. This Twist applicator tray is contained in an outer Tyvek pouch.When SURGISEAL is applied to the skin, it polymerizes in minutes.In vitro studies have shown that SURGISEAL acts as a physical barrier tomicrobial penetration as long as the adhesive film remains intact. Clinicalstudies were not conducted to demonstrate microbial barrier properties and acorrelation between microbial barrier properties and a reduction in infectionhave not been established.
Indications for use	SURGISEAL Twist Topical Skin Adhesive is intended for topical applicationsonly to hold closed easily approximated skin edges of wounds from surgicalincisions, 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 Stylus Twist andSURGISEAL Twist Topical Skin Adhesives are equivalent in performance.SURGISEAL Twist consists of a monomeric (2-octyl cyanoacrylate) liquidadhesive formulation packaged in a single-use applicator. The device is a lowviscosity formulation to allow for varied layered applications of the adhesive tothe intended area and allow for either a single thick, continuous layer or twothin layers of the adhesive to the wound area.The smaller tip dimensions of the SURGISEAL Twist applicator is the onlydifference between the subject and predicate devices.
SubstantialEquivalence	Biocompatibility:The biocompatibility testing that was previously conducted to the currentlymarketed devices, SURGISEAL Stylus Twist (K130474) per the InternationalStandard ISO-10993, “Biological Evaluation of Medical Devices, Part 1:Evaluation and Testing”. The existing testing is deemed supportive of themodified device. Based on the results from those studies, the subject device isconsidered to be non-toxic, non-irritating, non-sensitizing and biocompatibleand no additional biocompatibility testing was necessary.Performance Testing:The performance testing of SURGISEAL Twist Topical Skin Adhesivemodified product is identical to the currently marketed product; therefore theperformance testing provided in the Premarket Notification K130474 is thesame. Additional bench testing was performed to support the dimensional tipspecification modification to the currently marketed product. Bench testsincluded: Flexibility, Linear and Surface Coverage, Wound Closure Strengthand Force Expression.In all cases, the dimensional tip specification modification SURGISEAL TwistTopical Skin Adhesive met specifications and demonstrated equivalence to thecurrently marketed device.Sterilization and Shelf-LifeThe sterilization process of the dimensional tip specification modification
device remains unchanged. All products within the SURGISEAL Twist
Topical Skin Adhesive product family are sterilized in accordance with the
order of operation of the assembly. First to be sterilized is the filled ampoule
containing the adhesive, by gamma irradiation in accordance with ISO 11137-
2:2006. Then the finished bulk applicator in the secondary packaging is
sterilized by ethylene oxide in accordance with ISO 11135-1and 2:2008.
The proposed dimensional tip specification modification of SURGISEALTwist™ Topical Skin Adhesives does not impact the 24 month (2 year)expiration date (shelf-life) of the currently marketing predicated devices.

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Image /page/4/Picture/0 description: The image shows the logo for Adhezion Biomedical. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of several curved lines in a light blue color. The company name is written in a dark blue font, with the word "Adhezion" on top and the word "BIOMEDICAL" underneath.

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Image /page/5/Picture/0 description: The image shows the logo for Adhezion Biomedical. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of several curved lines in shades of blue. The company name "Adhezion" is in a dark blue sans-serif font, with the word "BIOMEDICAL" in a smaller, lighter blue font underneath.

Based on bench performance testing, the specification of the device, SURGISEAL Twist has demonstrated to be substantially equivalent to its currently marketed device from a safety and performance perspective, and has demonstrated that a dimensional tip modification to the product maintains approximation of wound edges.

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.