(95 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the adhesive and applicator, with no mention of AI or ML.
No
The device is a topical skin adhesive used to hold closed skin edges of wounds, which is a supportive function rather than directly treating a medical condition or restoring a body function.
No
The device is a topical skin adhesive intended to hold closed approximated skin edges. It does not provide information about a patient's health status or diagnose a condition.
No
The device description clearly states it is a liquid topical skin adhesive contained within a plastic ampoule and applicator sleeve, indicating it is a physical product, not software.
Based on the provided information, 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 "liquid topical skin adhesive" that polymerizes on the skin. This is a material applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve any such testing of bodily specimens.
Therefore, SURGISEAL Topical Skin Adhesive is a medical device, but it falls under a different category than In Vitro Diagnostics.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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:
The testing performed on the Stylus product(s) included:
- Cytotoxicity - (SURGISEAL TM Stylus Topical Skin Adhesive Flock Tip (Lot James A)): ISO 10993-Part 5 - Test for In-Vitro Cytotoxicity. Results: No Cytotoxic Effect (PASS).
- Cytotoxicity - SURGISEAL TM Stylus Twist TM Topical Skin Adhesive (Lot x 5923): ISO 10993-Part 5 - Test for In-Vitro Cytotoxicity. Results: No Cytotoxic Effect (PASS).
- ISO Intracutaneous Reactivity Test - SecureSeal TM (Lot 121512i): ISO 10993-10: Test for Irritation and Skin Sensitization. Results: No Dermal Reactions (PASS).
- Primary Skin Irritation SecureSeal TM - (Lot 121512i): ISO 10993-10: Test for Irritation and Skin Sensitization. Results: No Dermal Irritations (Pass).
Based on the results, the proposed devices are considered to be non-cytotoxic and non-irritants.
Performance Testing:
The following testing was performed on the proposed devices: Flexibility, In-vitro wound closure, Viscosity, Set-time, Purity, Surface Coverage, Linear Coverage.
The performance testing 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 are sterilized in accordance with the order of operation of the assembly. First, 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.
The devices do not impact the 24 month (2 year) expiration date. 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 will be labeled with a two (2) year expiration date.
Key Results:
Based on extensive bench performance testing, the proposed devices SURGISEAL Stylus TM and Stylus Twist TM Topical Skin Adhesive, in comparison to predicate device, SURGISEAL (K082993) have demonstrated to be safe and efficacious per the performance studies.
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.
Not Found
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
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 Boulevard |
| Suite 1B02 | |
| Wyomissing, 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 | May 28, 2013 |
| Name of Device(s): | |
| Trade or | |
| proprietary name | SURGISEAL ® Stylus™ and Stylus 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) |
| 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, thoroughly
cleansed, trauma induced lacerations.
SURGISEAL may be used in conjunction with, but not in place of, deep dermal
sutures. |
| Technological
Characteristics | The technological characteristics of SURGISEAL Stylus™ and Stylus Twist™
Topical Skin Adhesive are equivalent in performance to the predicate device
SURGISEAL 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 a
low viscosity formulation to allow for varied layered applications of the adhesive
to the intended area and allow for either a single thick, continuous layer or two
thin layers of the adhesive to the wound area.
SURGISEAL product family is used for topical applications only to hold closed
easily approximated skin edges of wounds.
The differences between the proposed devices SURGISEAL Stylus™ and Stylus
Twist ™ Topical Skin Adhesive; and the predicate devices are the following:
The currently marketed, SURGISEAL® Topical Skin Adhesive, single
use applicator consists of a thermal formed LDPE/PP/Polyacrylonitrile
(Barex 210) foil heated seal on a PET/Aluminum/Polyacrylonitrile backing
with attached Polyurethane foam with a PE Layer, which is supplied at a
volume of about 0.35 mL
The proposed devices SURGISEAL Stylus™ and Stylus Twist ™ Topical
Skin Adhesives, single-use applicator consists of a a thermal formed
LDPE/PP/Polyacrylonitrile
(Barex 210) adhesive
Ampoule 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. |
| Substantial
Equivalence | Biocompatibility:
The biocompatibility testing of the adhesive, that was previously conducted to the
currently marketed device, SURGISEAL (K082993) per the International Standard
ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and
Testing" is deemed supportive of the proposed devices, SURGISEAL Stylus™
and Stylus Twist ™ Topical Skin Adhesive. Based on the lack of changes to the
formulation, there was no additional biocompatibility testing of the adhesive
conducted to support the requirements for biological evaluation of devices for the
prolonged exposure.. The following biocompatibility testing was performed on
the Stylus product(s): |
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
・
:
・
2
| Biocompatibility Test | Test Description | Summary of
Results | Results |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------|---------|
| Cytotoxicity - (SURGISEALTM
Stylus Topical Skin Adhesive
Flock Tip (Lot James A)) | ISO 10993-Part
5 - Test for In-
Vitro
Cytotoxicity | No
Cytotoxic
Effect | PASS |
| Cytotoxicity - SURGISEALTM
Stylus TwistTM Topical Skin
Adhesive (Lot x 5923) | ISO 10993-Part
5 - Test for In-
Vitro
Cytotoxicity | No
Cytotoxic
Effect | PASS |
| ISO Intracutaneous Reactivity
Test - SecureSealTM (Lot
121512i) | ISO 10993-10:
Test for Irritation
and Skin
Sensitization | No Dermal
Reactions | PASS |
| Primary Skin Irritation
SecureSealTM - (Lot 121512i) | ISO 10993-10:
Test for Irritation
and Skin
Sensitization | No Dermal
Irritations | 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
3
| 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
4
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
5
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
6
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 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 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