(211 days)
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
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. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus and Twist applicators contain the identical adhesive formula and incorporate a plastic ampoule, which houses the adhesive, contained within the double longer plastic sleeves with an attached applicator tip. When SURGISEAL is applied to the skin with these applicators, it polymerizes in minutes.
The provided document is a 510(k) premarket notification for topical skin adhesives (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or performance study.
Therefore, the information required to populate most of the sections of your request (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document. This document is related to a medical device approval and not a software or AI algorithm approval.
However, I can provide information on acceptance criteria that are implicitly or explicitly mentioned for the biocompatibility and sterilization aspects of the device, which are part of its overall safety and effectiveness.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing, and biocompatible as per ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". | Previously conducted testing on predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) deemed supportive. Both proposed labeled devices are considered to be non-toxic, non-irritating, non-sensitizing, and biocompatible. No additional biocompatibility testing was necessary as the subject devices are identical to those identified in K082993 and K130474. |
| Sterilization | Sterilization by electron beam or gamma irradiation in accordance with ISO 11137-2:2006 (for Surgiseal Topical Skin Adhesive). Sterilization by gamma irradiation for the filled ampoule and ethylene oxide for the finished bulk applicator in accordance with ISO 11137-2:2006, ISO 11135-1:2008, and ISO 11135-2:2008 (for Surgiseal Stylus and Surgiseal Twist). | Surgiseal Topical Skin Adhesive is terminally sterilized by electron beam irradiation as well as by gamma irradiation in accordance with ISO 11137-2:2006. Surgiseal Stylus and Surgiseal Twist Topical Skin Adhesives are sterilized with the filled ampoule by gamma irradiation (ISO 11137-2:2006) and the finished bulk applicator by ethylene oxide (ISO 11135-1:2008 and ISO 11135-2:2008). |
| Shelf-Life | Not explicitly stated as a numerical criterion in this document, but a typical acceptance criterion would be to maintain product integrity and sterility over the declared shelf life. | SURGISEAL has a 2-year shelf life. |
Missing Information (Not provided in the document):
- Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI/ML algorithm evaluation; for biocompatibility, sample sizes for in vitro or in vivo tests are part of the ISO standards but not detailed here. The studies were previously conducted on predicate devices. Data provenance would be related to the lab conducting the biocompatibility tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biocompatibility and sterilization is based on established scientific methods and standards.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- The type of ground truth used:
- For Biocompatibility: The "ground truth" is defined by the biological response of cells/tissues to the material, as assessed by standardized tests (e.g., cytotoxicity, irritation, sensitization assays) according to ISO-10993.
- For Sterilization: The "ground truth" is the sterility assurance level (SAL) achieved, verified by validated sterilization cycles and appropriate microbiological testing, according to ISO 11137 and ISO 11135.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The document describes a 510(k) submission for new topical skin adhesive products (Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive). The "study" or rather, the evidence presented to ensure safety and effectiveness and demonstrate substantial equivalence, relies primarily on:
- Identity of Technological Characteristics: The device's formulation (monomeric 2-octyl cyanoacrylate) and mode of action are identical to previously cleared predicate devices.
- Biocompatibility Testing: Prior biocompatibility testing conducted on the predicate devices (SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474), and SURGISEAL Twist (K130474)) in accordance with ISO-10993 was leveraged. This testing confirmed the materials were non-toxic, non-irritating, non-sensitizing, and biocompatible. No new biocompatibility testing was required because the subject devices are identical to the predicates in terms of materials.
- Sterilization Validation: Validation of sterilization methods (electron beam and gamma irradiation for Surgiseal, and gamma followed by ethylene oxide for Stylus and Twist) was conducted according to international standards (ISO 11137-2:2006, ISO 11135-1:2008, ISO 11135-2:2008). This ensures the devices are supplied sterile.
- Shelf-Life Determination: A 2-year shelf life was established, implying stability testing was performed, though details of this testing are not provided in this specific document snippet.
- Microbial Barrier Properties (In vitro): In vitro studies showed SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. However, the document explicitly states that clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between microbial barrier properties and a reduction in infection has not been established.
In essence, the "study" for this 510(k) submission is a demonstration that the new devices are substantially equivalent to already approved predicate devices regarding their materials, design, intended use, and performance characteristics, supported by prior testing data and adherence to recognized standards for biocompatibility and sterilization.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 8, 2016
Adhezion Biomedical, LLC Richard Jones Regulatroy And Quality Assurance Consultant One Meridian Boulevard, Suite 1b02 Wyomissing, Pennsylvania 19610
Re: K161011
Trade/Device Name: Surgiseal Topical Skin Adhesive, Surgiseal Stylus Topical Skin Adhesive, Surgiseal Twist Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: April 7, 2016 Received: April 11, 2016
Dear Mr. Richard Jones:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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 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" (21 CFR 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
{2}------------------------------------------------
Section 6: Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K161011 |
|---|---|
| Device Name | SURGISEAL® Topical Skin AdhesiveSURGISEAL Stylus™ Topical Skin AdhesiveSURGISEAL Twist™ Topical Skin Adhesive |
| Indications for Use (Describe) | SURGISEAL Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skinedges 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 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------- |
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.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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:
| 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 | Richard Jones, Regulatory and Quality Assurance Consultant |
| Date prepared | November 3, 2016 |
| Name of Device(s): | |
| Trade or proprietarynames | SURGISEAL® Topical Skin AdhesiveSURGISEAL Stylus™ Topical Skin AdhesiveSURGISEAL Twist™ 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 |
| Reason for 510(k)submission | Labeling change |
| Device Description | SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skinadhesive containing a monomeric (2-octyl cyanoacrylate) formulation andthe colorant D&C Violet #2. It incorporates the Teardrop applicator thatconsists of a thermoformed blister tray with a heat sealed lid with anattached applicator sponge tip. The Stylus and Twist applicators containthe identical adhesive formula and incorporate a plastic ampoule, whichhouses the adhesive, contained within the double longer plastic sleeveswith an attached applicator tip. When SURGISEAL is applied to the skinwith these applicators, it polymerizes in minutes. |
| Indications for use | SURGISEAL is intended for topical applications only to hold closed easilyapproximated 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, deepdermal sutures. | |
| Technological | The technological characteristics of SURGISEAL Topical Skin Adhesive |
| Characteristics | (K082993, K123936, K130329 & K140517), SURGISEAL Stylus TopicalSkin Adhesive (K130474 & K140517) and SURGISEAL Twist SkinAdhesive (K130474, K133963, K141215) are identical. SURGISEALadhesive consists of a monomeric (2-octyl cyanoacrylate) liquid adhesiveformulation packaged in a single-use applicator. The device is a lowviscosity formulation to allow for varied layered applications of theadhesive to the intended area and allow for either a single consistent intactfilm thickness, continuous layer or two thin layers of the adhesive to thewound area. |
| SURGISEAL is used for topical applications only to hold closed, easilyapproximated skin edges of wounds while maintaining woundapproximation. | |
| Due to the anhydrous property of the SurgiSeal adhesive, gram + andgram - bacteria which become incorporated within the adhesive uponapplication, are not expected to grow within the adhesive. | |
| In vitro studies have shown that SURGISEAL acts as a physical barrier tomicrobial penetration as long as the adhesive film remains intact. | |
| Clinical studies were not conducted to demonstrate microbial barrierproperties and a correlation between microbial barrier properties and areduction in infection have not been established. |
{4}------------------------------------------------
{5}------------------------------------------------
| SubstantialEquivalence | Biocompatibility: |
|---|---|
| Biocompatibility testing was previously conducted on the currentlymarketed devices, SURGISEAL Teardrop (K082993), SURGISEALStylus (K130474) and SURGISEAL Twist (K130474) per theInternational Standard ISO-10993, "Biological Evaluation of MedicalDevices, Part 1: Evaluation and Testing”. The existing testing is deemedsupportive of the proposed labeled devices. Based on the results fromthose studies, both proposed labeled devices are considered to be non-toxic, non-irritating, non-sensitizing and biocompatible. No additionalbiocompatibility testing is necessary as the subject devices are identicalthose identified in K082993 and K130474. | |
| Sterilization and Shelf-Life | |
| SURGISEAL® Topical Skin Adhesive is terminally sterilized by electronbeam irradiation as well as by gamma irradiation; both in accordance withISO 11137-2:2006 | |
| SURGISEAL Stylus™ and SURGISEAL Twist™ Topical Skin Adhesivesare sterilized in accordance with the order of operation of the assembly.The filled ampoule containing the adhesive is sterilized by gammairradiation in accordance with ISO 11137-2:2006. Then the finished bulkapplicator in the secondary packaging is sterilized by ethylene oxide inaccordance with ISO 11135-1:2008 and ISO 11135-2:2008. | |
| SURGISEAL has a 2 year shelf life. |
§ 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.