(211 days)
No
The device description and intended use focus on a chemical adhesive and its application method, with no mention of AI/ML technologies or data processing.
No.
The device is a topical adhesive used to close skin edges and is not intended for the treatment or prevention of disease.
No.
The device is a topical skin adhesive intended to hold closed skin edges, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a liquid skin adhesive with physical applicators (Teardrop, Stylus, Twist), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions... simple, thoroughly cleansed, trauma induced lacerations." This describes a device used directly on the body for a physical purpose (holding skin edges together).
- Device Description: The description details a "sterile, professional liquid skin adhesive" that polymerizes on the skin. This is a physical adhesive applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not involve the analysis of biological specimens outside the body.
The information provided clearly indicates a topical adhesive for wound closure, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
MPN
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin edges of wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was previously conducted on the currently marketed devices, SURGISEAL Teardrop (K082993), SURGISEAL Stylus (K130474) and 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, non-irritating, non-sensitizing and biocompatible. No additional biocompatibility testing is necessary as the subject devices are identical those identified in K082993 and K130474.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K123936, K130329, K140517, K130474, K133963, K141215
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K161011 |
|---|---|
| Device Name | SURGISEAL® Topical Skin Adhesive |
| SURGISEAL Stylus™ Topical Skin Adhesive | |
| SURGISEAL Twist™ Topical Skin Adhesive | |
| Indications for Use (Describe) | 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 |
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 Boulevard |
| Suite 1B02 | |
| Wyomissing, PA 19610 | |
| Phone Number | (610) 241-7191 |
| Fax Number | (610) 373-2081 |
| Establishment | |
| Registration | 3006385287 |
| Name of contact | |
| person | Richard Jones, Regulatory and Quality Assurance Consultant |
| Date prepared | November 3, 2016 |
| Name of Device(s): | |
| Trade or proprietary | |
| names | SURGISEAL® Topical Skin Adhesive |
| SURGISEAL Stylus™ Topical Skin Adhesive | |
| 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® Topical Skin Adhesive - K082993 |
| Reason for 510(k) | |
| submission | Labeling change |
| 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. 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. | |
| 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. | |
| Technological | The technological characteristics of SURGISEAL Topical Skin Adhesive |
| Characteristics | (K082993, K123936, K130329 & K140517), SURGISEAL Stylus Topical |
| Skin Adhesive (K130474 & K140517) and SURGISEAL Twist Skin | |
| Adhesive (K130474, K133963, K141215) are identical. 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. | |
| Due to the anhydrous property of the SurgiSeal adhesive, gram + and | |
| gram - bacteria which become incorporated within the adhesive upon | |
| application, are not expected to grow within the adhesive. | |
| 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. |
4
5
| Substantial
| Equivalence | Biocompatibility: |
|---|---|
| Biocompatibility testing was previously conducted on the currently | |
| marketed devices, SURGISEAL Teardrop (K082993), SURGISEAL | |
| Stylus (K130474) and 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, non-irritating, non-sensitizing and biocompatible. No additional | |
| biocompatibility testing is necessary as the subject devices are identical | |
| those identified in K082993 and K130474. | |
| Sterilization and Shelf-Life | |
| SURGISEAL® Topical Skin Adhesive is terminally sterilized by electron | |
| beam irradiation as well as by gamma irradiation; both in accordance with | |
| ISO 11137-2:2006 | |
| SURGISEAL Stylus™ and SURGISEAL Twist™ Topical Skin Adhesives | |
| are sterilized in accordance with the order of operation of the assembly. | |
| The filled ampoule containing the adhesive is sterilized 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 11135-1:2008 and ISO 11135-2:2008. | |
| SURGISEAL has a 2 year shelf life. |