(107 days)
No
The document describes a topical skin adhesive and its applicator, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
This device is a topical skin adhesive used to hold closed skin edges of wounds. It helps in wound closure but does not treat disease or restore function, which are characteristics of a therapeutic device.
No
The device is a topical skin adhesive intended to hold closed approximated skin edges. It does not provide any diagnostic information or assessment of a medical condition.
No
The device description clearly indicates it is a topical skin adhesive, a physical substance applied to the skin, and includes details about its chemical composition and applicator. This is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "topical applications only to hold closed easily approximated skin edges of wounds". This is a direct application to the body for a physical purpose (wound closure).
- Device Description: The description details a topical adhesive that polymerizes on the skin.
- Lack of In Vitro Testing: The description and performance studies focus on biocompatibility and bench tests related to the physical properties of the adhesive and applicator. There is no mention of testing biological samples (blood, urine, tissue, etc.) outside of the body to diagnose or monitor a condition.
- Anatomical Site: The anatomical site is the "skin edges of wounds", which is a direct application to the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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
MPN
Device Description
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. When SURGISEAL is applied to the skin with the applicator, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin edges
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 conducted on the new applicator material per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". The tests included cytotoxicity, acute systemic injection, guinea pig maximization sensitization and intracutaneous irritation test.
With regard to the entire device, biocompatibility testing was previously conducted on the currently marketed device, SURGISEAL Teardrop (K130329).
Bench tests in this submission include Film Thickness determinations for new material component; as well as an assessment of flexibility, linear and surface coverage, set-time and viscosity and in vitro wound closure strength. Shelf life bench testing was also conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2015
Adhezion Biomedical, LLC Ms. Tracy Lofgren Authorized Regulatory Consultant One Meridian Boulevard, Suite 1B02 Wyomissing, Pennsylvania 19610
Re: K150866
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: June 17, 2015 Received: June 18, 2015
Dear Ms. Lofgren:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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.
For
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K150866
Device Name SURGISEAL® 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) |
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510(k) Summary
[In accordance with 21CFR 807.92]
Adhezion Biomedical, LLC SURGISEAL® Topical Skin Adhesive
Submitter / 510(k) Holder 1.
Adhezion Biomedical LLC One Meridian Boulevard, Suite 1B02 Wyomissing, PA 19610 Tel: 970.379.4707 Fax: 610.373.2081
| Contact Person: | Tracy Lofgren
Authorized Regulatory Consultant
Adhezion Biomedical, LLC |
|--------------------|-------------------------------------------------------------------------------|
| Date Prepared: | July 15, 2015 |
| 2. Device Name | |
| Proprietary Name: | SURGISEAL® Topical Skin Adhesive |
| Common/Usual Name: | Device, Tissue Adhesive for Topical Approximation |
| Classification: | Class II |
| Regulation: | 21 CFR 878.4010 |
| Product Code: | MPN |
3. Predicate Device
Legally Marketed device to which equivalence is claimed:
| Proprietary Name: | SURGISEAL® Topical Skin Adhesive |
|---|---|
| 510(k) Clearance: | K130329 |
4. Device Description
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. When SURGISEAL is applied to the skin with the applicator, 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.
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5. Intended 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.
Reason for 510(k) Submission 6.
Device modification to equivalent patient contacting material due to shift of supplier
7. Comparison of Technological Characteristics with Predicate
The technological characteristics of the proposed and predicate devices are similar. 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.
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.
Performance Testing Summary 8.
Biocompatibility:
Biocompatibility testing was conducted on the new applicator material per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing". The tests included cytotoxicity, acute systemic injection, guinea pig maximization sensitization and intracutaneous irritation test.
With regard to the entire device, biocompatibility testing was previously conducted on the currently marketed device, SURGISEAL Teardrop (K130329).
Performance Testing:
Bench tests in this submission include Film Thickness determinations for new material component; as well as an assessment of flexibility, linear and surface coverage, set-time and viscosity and in vitro wound closure strength. Shelf life bench testing was also conducted.
Sterilization and Shelf-Life
SURGISEAL® Topical Skin Adhesive is sterilized by ethylene oxide and gamma irradiation; both in accordance with ISO 11137-2:2006
Stability and shelf life were verified with the same acceptance criteria as the predicate.
9. Conclusion
Based on extensive bench performance testing, the modified device, SURGISEAL Topical Skin Adhesive is substantially equivalent to the predicate.