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 Stylus and Stylus Twist Topical Skin Adhesive 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 Stylus applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the SURGISEAL Stylus™ and Stylus Twist™ Topical Skin Adhesives, based on the provided text:

Acceptance Criteria and Device Performance

The submission discusses performance criteria generally, stating that the new applicator designs "demonstrated that the applicator design modification to the currently marketed product does not impact the performance specification criteria identified for the SURGISEAL product family." Specific numerical acceptance criteria are not provided in the excerpt.

The general performance attributes tested and the qualitative results are:

Acceptance Criteria Category	Specific Test	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-Part 5)	No Cytotoxic Effect (PASS)
	ISO Intracutaneous Reactivity (ISO 10993-10)	No Dermal Reactions (PASS)
	Primary Skin Irritation (ISO 10993-10)	No Dermal Irritations (Pass)
Device Performance	Flexibility	Does not impact performance specification criteria
	In-vitro wound closure	Does not impact performance specification criteria
	Viscosity	Does not impact performance specification criteria
	Set-time	Does not impact performance specification criteria
	Purity	Does not impact performance specification criteria
	Surface Coverage	Does not impact performance specification criteria
	Linear Coverage	Does not impact performance specification criteria
Sterilization	Sterilization by gamma irradiation (ISO 11137-2:2006)	Achieves 10^-6^ SAL
	Sterilization by ethylene oxide (ISO 11135-1:2008 & 11135-2:2008)	Achieves 10^-6^ SAL
Shelf-Life	Real-time and accelerated aging studies	Same performance characteristics as predicate (2-year expiration)

Study Details

Here's the breakdown of the study details based on the provided text:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of units or measurements for each performance test. The biocompatibility tests mention specific "Lots" (e.g., Lot James A, Lot x 5923, Lot 121512i), implying multiple samples were tested from these production batches.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be bench testing ("In-vitro," "bench performance testing") and animal studies (implied by "Intracutaneous Reactivity," "Primary Skin Irritation"), rather than clinical studies on human subjects, based on the descriptive nature of the provided summary. All data appears to be retrospective as it compares to an already marketed device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these performance and biocompatibility tests is based on objective, standardized test methods (e.g., ISO standards) and measurable outcomes, rather than expert interpretation of images or clinical cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As the tests are objective and based on standardized protocols with pass/fail criteria or measurements, there's no mention of an adjudication process by human experts.
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: Not applicable. This device is a topical skin adhesive, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a product for wound closure, not an algorithm. The performance tests are for the physical and biological characteristics of the adhesive and its applicator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the biocompatibility tests is defined by the objective results of the ISO 10993 standards (e.g., absence of cytotoxic effect, dermal reactions, or irritations). For the performance tests, the ground truth is against pre-established "performance specification criteria identified for the SURGISEAL product family" (presumably internal quantitative targets for flexibility, viscosity, set-time, etc.).
The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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K130474

Section 8: 510(k) Summary

MAY 3 1 2013

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	(484) 334-2929
Fax Number	(610) 373-2081
EstablishmentRegistration	3006385287
Name of contactperson	Caridad Smith, Sr. Manager of Regulatory Affairs and Quality Assurance
Date prepared	May 28, 2013
Name of Device(s):
Trade orproprietary name	SURGISEAL ® Stylus™ and Stylus Twist™ Topical Skin Adhesive
Common or usualname	Device, Tissue Adhesive for Topical Approximation
Classificationname	Class II
ClassificationPanel	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)DERMABOND NX (DERMABOND Advanced ® - (K100423)Derma+Flex QS (K101276)
Reason for 510(k)submission	Modification to Currently Marketed Device
Device Description	SURGISEAL Stylus and Stylus Twist Topical Skin Adhesive 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 Stylus applicator tray 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 only to
	hold closed easily approximated skin edges of wounds from surgical incisions,including punctures from minimally invasive surgery, simple, thoroughlycleansed, trauma induced lacerations.SURGISEAL may be used in conjunction with, but not in place of, deep dermalsutures.
TechnologicalCharacteristics	The technological characteristics of SURGISEAL Stylus™ and Stylus Twist™Topical Skin Adhesive are equivalent in performance to the predicate deviceSURGISEAL Topical Skin Adhesive.SURGISEAL product family consists of a monomeric (2-octyl cyanoacrylate)liquid adhesive formulation packaged in a single-use applicator. The device is alow viscosity formulation to allow for varied layered applications of the adhesiveto the intended area and allow for either a single thick, continuous layer or twothin layers of the adhesive to the wound area.SURGISEAL product family is used for topical applications only to hold closedeasily approximated skin edges of wounds.The differences between the proposed devices SURGISEAL Stylus™ and StylusTwist ™ Topical Skin Adhesive; and the predicate devices are the following:The currently marketed, SURGISEAL® Topical Skin Adhesive, singleuse applicator consists of a thermal formed LDPE/PP/Polyacrylonitrile(Barex 210) foil heated seal on a PET/Aluminum/Polyacrylonitrile backingwith attached Polyurethane foam with a PE Layer, which is supplied at avolume of about 0.35 mLThe proposed devices SURGISEAL Stylus™ and Stylus Twist ™ TopicalSkin Adhesives, single-use applicator consists of a a thermal formedLDPE/PP/Polyacrylonitrile(Barex 210) adhesiveAmpoule with an Aluminum ampoule lid including a plastic inner layer(seal). The applicator sleeve is MDPE, which are supplied at a volume of ≥0.5mL.The SURGISEAL Stylus has a Nylon fiber foam tip. The SURGISEAL Stylus Twist has a HDPE composition foam tip.
SubstantialEquivalence	Biocompatibility:The biocompatibility testing of the adhesive, that was previously conducted to thecurrently marketed device, SURGISEAL (K082993) per the International StandardISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation andTesting" is deemed supportive of the proposed devices, SURGISEAL Stylus™and Stylus Twist ™ Topical Skin Adhesive. Based on the lack of changes to theformulation, there was no additional biocompatibility testing of the adhesiveconducted to support the requirements for biological evaluation of devices for theprolonged exposure.. The following biocompatibility testing was performed onthe Stylus product(s):

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Biocompatibility Test	Test Description	Summary ofResults	Results
Cytotoxicity - (SURGISEALTMStylus Topical Skin AdhesiveFlock Tip (Lot James A))	ISO 10993-Part5 - Test for In-VitroCytotoxicity	NoCytotoxicEffect	PASS
Cytotoxicity - SURGISEALTMStylus TwistTM Topical SkinAdhesive (Lot x 5923)	ISO 10993-Part5 - Test for In-VitroCytotoxicity	NoCytotoxicEffect	PASS
ISO Intracutaneous ReactivityTest - SecureSealTM (Lot121512i)	ISO 10993-10:Test for Irritationand SkinSensitization	No DermalReactions	PASS
Primary Skin IrritationSecureSealTM - (Lot 121512i)	ISO 10993-10:Test for Irritationand SkinSensitization	No DermalIrritations	Pass

Based on the results from those studies, the proposed devices are considered to be non-cytotoxic, and non-irritants.

Performance Testing:

The following testing was performed on the proposed devices, SURGISEAL Stylus™ and Stylus Twist™ Topical Skin Adhesive is listed below:

Flexibility �
In-vitro wound closure .
Viscosity
Set-time .
Purity
Surface Coverage
Linear Coverage

The performance testing identified above demonstrated that the applicator design modification to the currently marketed product does not impact the performance specification criteria identified for the SURGISEAL product family.

Sterilization and Shelf-Life

The proposed devices, SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive 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

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with ISO 11135-1:2008 and ISO 11135-2:2008.
The SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive does not
impact the 24 month (2 year) expiration date (shelf-life) proposed for these
products. Real-time and accelerated aging studies were performed using the
STYLUS products and they demonstrated the same performance characteristics as
the currently marketed, predicate device SURGISEAL Topical Skin Adhesive
(K082993). The proposed devices, SURGISEAL Stylus™ and Stylus Twist TM
Topical Skin Adhesive will be labeled with a two (2) year expiration date.

Based on extensive bench performance testing, the proposed devices SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive, in comparison to predicate device, SURGISEAL (K082993) have demonstrated to be safe and efficacious per the performance studies.

The order of operation of a two-part sterilization process of the proposed devices, SURGISEAL Stylus™ and Stylus Twist ™ Topical Skin Adhesive, is necessary in order to sterilize the product and achieve a 10 6 SAL, while supporting the labeling of the medical device as "sterile". In order to maintain the expected performance of the devices, in accordance with the currently marketed SURGISEAL device properties/specifications of the device SURGISEAL remains unaffected and therefore provides further assurance of substantial equivalence, as documented throughout the submission

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Adhezion Biomedical, LLC % Ms. Caridad Smith Sr. Manager of Regulatory Affairs/ Quality Assurance One Meridian Parkway, Suite 1B02 Wyomissing, Pennsylvania 19610

Re: K130474

Trade/Device Name: SURGISEAL Stylus™ Topical Skin Adhesive and SURGISEAL Stylus Twist Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: May 07, 2013 Received: May 08, 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

May 31, 2013

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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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours. FOR Peter D. Rumm -S

	Mark N. Melkerson
	Acting Director
	Division of Surgical Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Section 5: Indications for Use

K130474 510(k) Number (if known): TBD

Device Name(s):

SURGISEAL Stylus™ Topical Skin Adhesive SURGISEAL Stylus Twist™ Topical Skin Adhesive

Indications for Use:

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

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130474

Page 1 of

Abbreviated 510(k) Submission Adhezion Biomedical, LLC SURGISEAL® Topical Skin Adhesive Page 17 of 685

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.