(316 days)
K111959, P960052
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the adhesive, with no mention of AI or ML.
No.
The device is a topical skin adhesive intended to hold closed skin edges, which is a supportive function for wound closure, not a therapeutic treatment for a disease or condition itself.
No
The device description and intended use clearly state that Histoacryl Flexible is a topical skin adhesive used to hold approximated skin edges. It does not perform any diagnostic function such as detecting, analyzing, or identifying diseases or conditions.
No
The device description clearly states it is a sterile liquid topical skin adhesive provided in plastic ampoules, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the topical application to hold closed skin edges. This is a direct application to the body for a physical purpose (wound closure).
- Device Description: The description details a sterile liquid adhesive that polymerizes on contact with tissue. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) to provide diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on the physical properties of the adhesive (strength, set time, etc.) and its ability to act as a microbial barrier, which are relevant to its function as a wound closure device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Histoacryl Flexible topical skin adhesive is intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl Flexible 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
Histoacryl Flexible Topical Skin Adhesive is a sterile liquid topical skin adhesive composed of n-butyl-2-cyanoacrylate monomer, softener, stabilizer, and colorant (D&C Violet #2). It is provided in 0:5 ml single patient use plastic ampoules. Each ampoule is sealed within a foil pouch so the exterior of the ampoule can remain sterile. The tissue adhesives remain liquid until exposed to water or water-containing substances including tissue, after which it cures (polymerizes) and forms a film that bonds to the underlying surface.
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)
Performance testing was performed in accordance to FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Approximation of Skin. Comparative testing demonstrated substantially equivalent performance to Histoacryl and Histoacryl Blue Topical Skin Adhesive and Dermabond for:
- Lap shear strength (ASTM F2255-05) .
- Peel adhesion strength (ASTM F 2256-05) .
- Impact strength (ASTM F2458-05) .
- Set (polymerization) time .
- Heat of polymerization .
- Viscosity .
- GC Chemical Analysis
- Hydrolytic degradation
- Ease of expression
Microbial barrier testing was conducted using Histoacryl and Histoacryl Flexible. The method was a strike through test that was conducted with common organisms known to cause infections and represent gram positive, gram negative, motile and non-motile as well as fungi. The challenge was at a minimum concentration of 1 x 10^6 cfu.
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.
K111959, P960052
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
K121976 Page 1 of 3
510(k) SUMMARY (as required by 21 CFR 807.92)
Histoacryl Flexible Topical Skin Adhesive April 15, 2013
COMPANY:
B.
Aesculap®, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
CONTACT:
Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) kathy racosky@aesculap.com
COMMON NAME: Topical Skin Adhesive
CLASSIFICATION NAME: Tissue Adhesive
REGULATION NUMBER: 878.4010
PRODUCT CODE: MPN
DEVICE DESCRIPTION
Histoacryl Flexible Topical Skin Adhesive is a sterile liquid topical skin adhesive composed of n-butyl-2-cyanoacrylate monomer, softener, stabilizer, and colorant (D&C Violet #2). It is provided in 0:5 ml single patient use plastic ampoules. Each ampoule is sealed within a foil pouch so the exterior of the ampoule can remain sterile. The tissue adhesives remain liquid until exposed to water or water-containing substances including tissue, after which it cures (polymerizes) and forms a film that bonds to the underlying surface.
In vitro studies have shown that Histoacryl Flexible acts as a 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.
INDICATIONS FOR USE
Histoacryl Flexible topical skin adhesive is intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl Flexible may be used in conjunction with, but not in place of, deep dermal sutures.
1
SUBSTANTIAL EQUIVALENCE
Aesculap. Inc. believes that the Histoacryl Flexible Topical Skin Adhesive is substantially equivalent to the Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive (K111959) and Dermabond (P960052).
PURPOSE FOR PREMARKET NOTIFICATION
The purpose for this submission is to gain marketing clearance for the new Histoacry Flexible Topical Skin Adhesive.
TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))
The technological characteristics of the Aesculap Histoacryl Flexible Topical Skin Adhesive are equivalent in performance to the predicate devices Histoacryl and Histoacryl Blue Topical Skin Adhesive, Aesculap Inc. (K111959) and Dermabond (P960052). The subject device is shown to be substantially equivalent and has the same performance characteristic to the predicate devices through comparison in technology, Indication For Use, mechanism of action, intended application and performance. Both Histoacryl and Histoacryl Blue Topical Skin Adhesive and Histoacryl Flexible Topical Skin Adhesive devices use n-butyl-2-cyanoacrylate to facilitate wound closure. Histoacryl Flexible is designed to bond to the skin to provide flexible wound closure maintaining wound approximation.
In vitro studies have shown that Histoacryl acts as a 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.
The main differences between Histoacryl Flexible and Histoacryl are
- · a change in formulation to allow flexible wound closure
- · storage conditions at or below 77°F (25°C) versus 72°F (22°C)
Biocompatibility:
The biological evaluation of Histoacryl Flexible Topical Skin Adhesive device has been performed in accordance with ISO 10993, "Biological Evaluation of Medical Devices Part -1: Evaluation and Testing, for breached or compromised surfaces with blood contact for the wound closure and subsequent layer adhesives".
Biocompatibility tests were conducted for a "breached or compromised surface with blood contact device with prolonged contact duration of greater than 24 hours but less than 30 days". Tests include MEM cytotoxicity (ISO 10993-5), intracutaneous reactivity (ISO 10993-10), maximization sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), and muscle implantation (ISO 10993-6).
The results provide evidence that Histoacryl Flexible is safe and biocompatible for its intended use and therefore substantially equivalent to the predicate devices.
2
Performance testing:
Testing was performed in accordance to FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Approximation of Skin to demonstrate that the Aesculap Histoacryl Flexible Topical Skin Adhesive is substantially equivalent to other predicate devices. The following comparative testing demonstrated substantially equivalent performance to Histoacryl and Histoacryl Blue Topical Skin Adhesive and Dermabond:
- Lap shear strength (ASTM F2255-05) .
- Peel adhesion strength (ASTM F 2256-05) .
- Impact strength (ASTM F2458-05) .
- Set (polymerization) time .
- Heat of polymerization .
- Viscosity .
- . GC Chemical Analysis
- · Hydrolytic degradation
- Ease of expression
Microbial barner testing was conducted using Histoacryl and Histoacryl Flexible. The method was a strike through test that was conducted with common organisms known to cause infections and represent gram positive, gram negative, motile and non-motile as well as fungi. The challenge was at a minimum concentration of 1 x 10° cfu.
Sterilization and Shelf-Life:
Sterilization of Histoacryl Flexible Topical Skin Adhesive is the same as the predicate device. Histoacryl and Histoacryl Blue Topical Skin Adhesive. The sterilization process consists of 1) ETO sterilization of the ampoule, 2) gamma radiation sterilization of the aluminum pouch; both are sterilized before 3) the sterility of the liquid topical skin adhesive which is guaranteed by membrane filtration and aseptic filling.
Real-time testing data has been generated to support this submission. Current data supports a 24 month shelf life.
Conclusion:
Based on the nonclinical testing Histoacryl Flexible Topical Skin Adhesive has been demonstrated to be substantially equivalent to Histoacryl and Histoacryl Blue Topical Skin Adhesive and Dermabond.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: May 17, 2013
Aesculap, Inc. % Ms. Kathy A. Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K121976
Trade/Device Name: Aesculap Histoacryl Flexible Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: April 15, 2013 Received: April 18, 2013
Dear Ms. Racosky:
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
4
Page 2 - Ms. Kathy A. Racosky
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number: K121976
Device Name: Aesculap Histoacryl Flexible Topical Skin Adhesive
Indications for Use:
Histoacryl Flexible topical skin adhesive is intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl Flexible may be used in conjunction with, but not in place of, deep dermal sutures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
and/or Over-the-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K121976
178