(125 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-ocylt 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.
This document describes the regulatory submission for SURGISEAL® Topical Skin Adhesive, specifically focusing on a labeling change rather than a new device or a new AI/Machine Learning (AI/ML) device. Therefore, many of the requested criteria related to AI/ML or direct performance studies are not explicitly stated or applicable in this context.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable for this particular submission type:
1. Table of acceptance criteria and the reported device performance:
The document describes performance testing relative to a predicate device and specifications, rather than detailing specific acceptance criteria with numerical targets.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Wound Closure Strength | Met specifications and demonstrated equivalence to predicate device(s). |
| Set-time | Met specifications and demonstrated equivalence to predicate device(s). |
| Linear Coverage | Met specifications and demonstrated equivalence to predicate device(s). |
| Film Thickness | Met specifications and demonstrated equivalence to predicate device(s). |
| Tissue Approximation Time | Met specifications and demonstrated equivalence to predicate device(s). |
| Biocompatibility | Considered non-toxic, non-irritating, non-sensitizing, and biocompatible, based on previous testing of the identical predicate device (K082993) per ISO-10993. |
| Sterilization | Maintained and identical to predicate device (electron beam irradiation per ISO 11137-2:2006). |
| Shelf-Life | Maintained and identical to predicate device (2 years), with no impact from labeling change. |
2. Sample size used for the test set and the data provenance:
The document mentions "Additional bench testing was performed to support the modification to the currently marketed product," but it does not specify the sample size for this bench testing. Similarly, data provenance (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided as this submission is for a labeling change to a medical device (topical skin adhesive), not an AI/ML device requiring expert ground truth for interpretation of images or clinical data. The performance is assessed through bench tests.
4. Adjudication method for the test set:
This is not applicable or provided as the evaluation relies on physical bench tests, not expert interpretation requiring adjudication.
5. 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:
This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.
7. The type of ground truth used:
For the performance testing mentioned, the "ground truth" would be defined by the specifications and established performance benchmarks of the predicate device and industry standards for wound closure products. For biocompatibility, the ground truth was established by adherence to ISO-10993 standards.
8. The sample size for the training set:
This is not applicable as this is not an AI/ML device and therefore does not involve a training set.
9. How the ground truth for the training set was established:
This is not applicable as this is not an AI/ML device and therefore does not involve a training set.
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "extensive bench performance testing" and biocompatibility testing.
- Biocompatibility Testing: Previously conducted on the currently marketed device, SURGISEAL (K082993), per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The results considered the device non-toxic, non-irritating, non-sensitizing, and biocompatible. No additional biocompatibility testing was deemed necessary for this K123936 submission as the subject device is identical to K082993.
- Performance Testing: "Additional bench testing was performed to support the modification to the currently marketed product." These tests included:
- Wound closure strength
- Set-time
- Linear coverage
- Film thickness
- Tissue approximation time
The document states: "In all cases, the modified labeled SURGISEAL Topical Skin Adhesive met specifications and demonstrated equivalence to the predicate device(s)."
The overall conclusion is: "Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges."
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Section 8: 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 | (484) 334-2929 |
| Fax Number | (610) 373-2081 |
| Establishment Registration | 3006385287 |
| Name of contact person | Caridad Smith, Sr. Manager of Regulatory Affairs and Quality Assurance |
| Date prepared | April 23, 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 (K082993)Sure + Close and DERMA+FLEX QS ( K101276)Dermabond Advanced (K100423) |
| Reason for 510(k) submission | Labeling Change |
| Device Description | SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skinadhesive containing a monomeric (2-ocylt cyanoacrylate) formulation and thecolorant D&C Violet #2. Each applicator consists of a thermoformed blistertray with a heat sealed lid with an attached applicator sponge tip. Thisapplicator tray with sponge tip is contained in an outer Tyvek pouch. |
| Indications for use | SURGISEAL Topical Skin Adhesive is intended for topical applications onlyto 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. |
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:
| K123936 p | |
|---|---|
| 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) liquid adhesiveformulation packaged in a single-use applicator. The device is a low viscosityformulation to allow for varied layered applications of the adhesive to theintended area and allow for either a single thick, continuous layer or two thinlayers of the adhesive to the wound area. | |
| The main difference between proposed labeled SURGISEAL and currentlymarketed SURGISEAL is to allow a single layer application. The proposedlabeled SURGISEAL will contain similar application language to thefollowing legally marketed predicate device(s): | |
| Sure + Close and DERMA+FLEX QS ( K101276)Dermabond Advanced (K100423) | |
| SubstantialEquivalence | Biocompatibility: |
| Biocompatibility testing was previously conducted on the currently marketeddevice, SURGISEAL (K082993) 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 device,SURGISEAL. Based on the results from those studies, the proposed labeleddevice is considered to be non-toxic, non-irritating, non-sensitizing andbiocompatible. No additional biocompatibility testing was necessary asthe subject device is identical to K082993. | |
| 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 Notification K082993 isidentical. Additional bench testing was performed to support the modificationto the currently marketed product. Bench tests included: wound closurestrength, set-time, linear coverage, film thickness and tissue approximationtime. | |
| In all cases, the modified labeled SURGISEAL Topical Skin Adhesive metspecifications and demonstrated equivalence to the predicate device(s). | |
| Sterilization and Shelf-Life | |
| The modified labeled device is terminally sterilized by electron beamirradiation in accordance with ISO 11137-2:2006, which is identical to thepredicate device (K082993). | |
| There is no impact on the labeling change from two light layer applications ofthe topical skin adhesive to a single "thick, continuous" layer application 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. The proposed device, SURGISEAL Topical Skin Adhesive will be | |
| labeled with a two (2) year expiration date. | |
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Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges.
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Image /page/3/Picture/0 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol. The caduceus is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Adhezion Biomedical, LLC % Ms. Caridad Smith Sr. Manager of Regulatory Affairs and Quality Assurance One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610
Letter dated: April 24, 2013
Re: K123936
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: March 22, 2013 Received: March 25, 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
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Page 2 - Ms. Caridad Smith
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/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.
Mark Nijelkerson -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
510(k) Number (if known): K123936
Device Name:
SURGISEAL® Topical Skin Adhesive
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, thoroughly cleansed, trauma induced lacerations.
SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
Prescription Use X
AND/OR
(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)
JiyoungDang -S
Page 1 of
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123936
K123936/S001 SURGISEAL Topical Skin Adhesive Page 78 of 166
§ 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.