(210 days)
Histoacryl and Histoacryl Blue topical skin adhesives are 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. They may be used in conjunction with, but not in place of, dermal sutures.
Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives composed of n-butyl-2-cyanoacrylate monomer. The two products are different in only one respect: Histoacryl is provided as a colorless liquid, and Histoacryl Blue is colored with a royal blue dye D&C Violet #2 with intent to ease visualization of the extent of the device during application. Both tissue adhesives are supplied in 0.5 ml single patient use plastic ampoules. Each ampoule can remain sterile. Both tissue adhesives remain liquid until exposed to water or water-containing substances, after which it cures (polymerizes) and forms a strong, flexible bond.
The provided text describes the 510(k) premarket notification for the Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial or algorithm performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Skin Approximation of Skin) | Reported Device Performance |
|---|---|
| Tensile strength (ASTM F2458-05) | Performed (details not provided) |
| Set (polymerization) time | Performed (details not provided) |
| Viscosity | Performed (details not provided) |
| GC Chemical Analysis | Performed (details not provided) |
Note: The document states that testing was "performed in accordance to FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Skin Approximation of Skin to demonstrate that the Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive is substantially [equivalent]". However, the actual acceptance values (e.g., minimum tensile strength, acceptable range for set time or viscosity) and the numerical results obtained are not provided in this summary. The summary only confirms that these tests were conducted.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on the sample size used for the mechanical and chemical tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). These tests would typically use material samples rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of testing described (mechanical and chemical property testing for a tissue adhesive). Ground truth for such tests is typically established by standardized laboratory measurements according to specified ASTM or other recognized standards.
4. Adjudication Method
This information is not applicable as the described tests are laboratory-based and do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or mentioned. This type of study is more relevant for diagnostic or image-based AI devices where human reader performance is a key metric. The device here is a topical skin adhesive.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not performed within the context of an algorithm. The device itself is a physical product (a topical skin adhesive), and its performance data relates to its physical and chemical properties.
7. Type of Ground Truth Used
The ground truth for the performance testing described (tensile strength, set time, viscosity, chemical analysis) would be based on standardized test methods and measurements. For example, the "Tensile strength (ASTM F2458-05)" refers to an established standard for measuring tensile strength, which defines how the 'true' tensile strength is determined.
8. Sample Size for the Training Set
This information is not applicable. The device is a chemical product, not an AI algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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FEB - 6 2012
arket Notification
Page 1 of 2
KIII 459
Histoacryl and Histoacryl Blue
Image /page/0/Picture/3 description: The image shows a close-up of a document with some text. The text "510" is visible at the top of the image. The letter "B" is also visible in the image.
510(k) SUMMARY (as required by 21 CFR 807.92)
(K) SChildren - Propical Skin Adhesive Topical Skin Adhesive
Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive
Topical Skin Address July 7, 2011 July 7, 2011
MPANY:
Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Center Valley, PA 16654
Establishment Registration Number: 2916714
CONTACT:
Kathy A. Racosky 610-984-9291 (phone) 610-791-6882 (fax) 610-731-055xy@aesculap.com
Aesculap Histoacryl and Histoacryl Blue TRADE NAME:
Topical Skin Adhesive COMMON NAME:
CLASSIFICATION NAME: Tissue adhesive
Regulation Number: 878.4010
MPN PRODUCT CODE:
DEVICE DESCRIPTION
DEVICE DESCRIPTION
Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives composed of n-Histoacryl and Histoacryl Blue are sterile liquid toplaars are different in only one respect:
butyl-2-cyanoacrylate monomer. The two products are different in only one respe Histoachy and History of the two products are different in only one the dye
Histoacryl is provided as a ooloress liquid, and Histoacry Blue is colored with a bith a oyal as a colorless liquid, and filstoachyr black on the device during application.
Histoacryl is provided as a colorless liqualization of the device during and Fistoachy is provised in athesives are supplied in 0.5 ml single patient
D&C Violet #2 with intent to ease visualization of the extent of the D&C Tiber in This Market of the Supplied in ols of supplied in one of the extern of the extern of the extern of the extern of the extern of the extent of the lead History and Richard Justices remain liquid until exposed to water
use plastic ampoules . Each tissue adhesives remain liquid until exposed to water
ampoule can remain steries use, passes ampediation in the . Both tissue, after which it cures (polyments)
ampoule can remain sterile, Both tissue, after which it cures (polymerizes) and
or water-cont or water-containing substantees into
INDICATIONS FOR USE
INDICATIONS FOR USE
Histoacryl and Histoacryl Blue topical skin adhesives are intended for topicalion Histoacryl and Histoacryl Blue topical skin edges of minimum-tension wounds from clean
to hold closed easily approximated skin edges of minimum-induced lacerations. to hold closed easily approximated skin edges of trauma-induced lacerations.
surgical incisions and simple, thoroughly cleansed, trauma-induced in place to her besting and simple, thoroughly cleansed, trauna industrial with, but not in place of, dermal sutures.
0003
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KIII959
Histoacryl and Histoacryl Blue
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ANTIAL EQUIVALENCE
SUBSINANIA Believes that the Histoacryl and Histoacryl Blue Topical Skin Adhesive is
Aliana Mather Maddiet Medictions of and Histocoryl Blue Topical Skin Adhesive, Tissue ുട്ടേയ്മ്മ, lnc. believes that the Histoacryl and Histoachyl Blue Topical Skin Adhesive, Tissue
reubstantially equivalent to Histoacryl and Histoacryl Blue Topical Skin Adhe ally equivalent (0 ... The only difference is the packaging.
R
PUPPOSE FOR PREMARKET NOTIFICATION
and if
The purpose of this submission is to gain marketing clearance for Histoacryl and The purpose of Topical Skin Adhesive.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive is equivalent in The Aesculap Histoacryl and Filstoacryl and Histoacryl Blue Topical Skin Adhesive,
performance to the predicate device Histoacryl and Histoaryl ond Histoary/ Blue performance to the predicate Gevice Pinstoury and Histoacyl and Histoacyl Blue
Tissue Seal LLC (P050013). The main difference between Histoacryl Blue I Issue Seal LLO (r 0500 10). The main amore within an aluminum pouch.
PERFORMANCE DATA
Testing was performed in accordance to FDA's Class II Special Control Cuidance Testing was penomied in accordance to T brical Approximation of Skin to demonstrally Document for Tissue Adnesive for the Topical Skin Adhesive is substantially that the Aesoulap I hotodory. and inst. The following testing was performed:
- Tensile strength (ASTM F2458-05) .
- Set (polymerization) time .
- Viscositv .
- GC Chemical Analysis ●
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 6 2012
Aesculap, Inc. % Ms. Kathy A. Racosky 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K111959
Trade/Device Name: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: February 02, 2012 Received: February 03, 2012
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
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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KIII959
Histoacryl and Histoacryl Blue
Page 1 of 1
INDICATIONS FOR USE STATEMENT
KIII959 510(k) Number:_
harket Notification
Defice Name: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive
Histoacryl and Histoacryl Blue topical skin adhesives are intended for topical application Histoacryi and filefoury. Dias toploskin edges of minimum-tension wounds from clean to nota olders only of thoroughly cleansed, trauma-induced lacerations. surglour including to the may be used in conjunction with, but not in place of, dermal sutures.
X Prescription Use
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane In Nixon
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111959
§ 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.