(155 days)
Barle Tissue Adhesive 2 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 and simple, thoroughly cleansed, trauma induced lacerations. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. It is applied to easily approximated skin edges and polymerizes within minutes. Barle Tissue Adhesive 2 is supplied in a single patient use configuration.
The provided text describes a 510(k) summary for a medical device, Barle Tissue Adhesive 2. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the information provided focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving performance against them in the same way one would for a new, non-predicate-based device.
Therefore, the document does not contain the acceptance criteria and study details as typically defined for demonstrating the performance of an AI/ML-based device or a novel medical device against specific performance metrics.
Specifically, the document lacks information regarding:
- A table of acceptance criteria and reported device performance because the submission is for substantial equivalence to predicates, not for meeting new performance thresholds.
- Sample sizes used for a test set and data provenance in the context of a performance study.
- Number of experts and their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- MRMC comparative effectiveness study, effect size, or improvement of human readers with AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on the following:
- Device Description: Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure.
- Indications for Use: Intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions (including punctures from minimally invasive surgery) and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches.
- Technological Characteristics: Substantially equivalent to predicate devices, with changes being modification of the applicator body design to remove actuation "wings" and addition of a microbial barrier claim.
- Substantial Equivalence Justification: Barle Tissue Adhesive 2 is substantially equivalent to Barle Tissue Adhesive (K123133) and LiquiBand® Flow Control Topical Skin Adhesive (K122446) with regard to Indication For Use, target population, intended application, mechanism of action, and performance. It is also substantially equivalent to LiquiBand® Flow Control regarding the microbial barrier claim.
- Conclusion: Based on extensive design verification, functional, and performance testing conducted in accordance with the "Class II Special Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin, May 30 2008," Barle Tissue Adhesive 2 is considered safe, effective, and performs as well as the legally marketed predicate devices.
In summary, this document is a 510(k) submission asserting substantial equivalence based on comparable characteristics and adherence to existing guidance documents, not a detailed report of a performance study with specific acceptance criteria and study results against those criteria.
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Image /page/0/Picture/1 description: The image shows the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo consists of a stylized letter "A" above the company name. The company name is written in a simple, sans-serif font, with "Advanced Medical Solutions" on the first line and "(Plymouth) Ltd." on the second line.
Advanced Medical Solutions (Plymouth) Limited Western Wood Way, Langage Science Park, Flympton, Plymouth, Devon, PL7 5BG UK Tel: +44 (0) 1752-209955 Fax: +44 (0) 1752 209956 Web: www.admedsal.com
DEC 2 0 2013
510(k) Summary
| Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.Western Wood WayLangage Science ParkPlymouth, Devon. PL7 5BGUnited KingdomTel: +44 (0)1752 209955Fax: +44 (0) 1752 209956 |
|---|---|
| Contact Person: | Kay M°GrathSenior Regulatory Affairs AssociateAdvanced Medical Solutions Ltd |
| Date of Summary: | 12 September 2013 |
| Device TradeName: | Barle Tissue Adhesive 2 |
| Common or Usual.Name: | Topical Skin Adhesive |
| ClassificationName: | Tissue Adhesive (21 CFR 878.4010) |
| Product Code: | MPN |
| PredicateDevice(s): | Barle Tissue Adhesive (K123133)LiquiBand® (K122446) |
| DeviceDescription: | Barle Tissue Adhesive 2 is a sterile, topical tissue adhesivecontaining 2-octyl cyanoacrylate for wound closure. It isapplied to easily approximated skin edges and polymerizeswithin minutes.Barle Tissue Adhesive 2 is supplied in a single patient useconfiguration. |
| Indication forUse: | Barle Tissue Adhesive 2 topical skin adhesive is intended fortopical applications only, to hold closed easily approximatedskin edges of wounds from surgical incisions, includingpunctures from minimally invasive surgery and simple,thoroughly cleansed, trauma induced lacerations. Barle TissueAdhesive 2 topical skin adhesive may be used in conjunction |
Image /page/0/Picture/6 description: The image contains two logos. The logo on the left is the BSI (British Standards Institution) logo, which features the letters "BSI" above a heart shape inside of a circle. The logo on the right is the UKAS (United Kingdom Accreditation Service) logo, which features a crown above a check mark, with the words "UKAS QUALITY MANAGEMENT" below the check mark, and the number "003" at the bottom.
Carrencate No. MO 305407
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| TechnologicalCharacteristics | The technological characteristics of Barle Tissue Adhesive 2 aresubstantially equivalent to the predicate devices.The main reasons for the submission of Barle Tissue Adhesive 2,following clearance of the Barle Tissue Adhesive (K123133), isbecause of these changes:Modification of the applicator body design to removeactuation "wings". Addition of a microbial barrier claim. |
|---|---|
| SubstantialEquivalence: | Barle Tissue Adhesive 2 is substantially equivalent to BarleTissue Adhesive (K123133) and LiquiBand® Flow Control TopicalSkin Adhesive (K122446) with regard to Indication For Use, targetpopulation, intended application, mechanism of action andperformance at achieving its intended use; in addition BarleTissue Adhesive 2 is substantially equivalent to LiquiBand® FlowControl with regard to the microbial barrier claim. |
| Conclusion | Extensive design verification, functional and performance testinghave been conducted. Barle Tissue Adhesive 2 was evaluated intests to establish a performance and safety profile in accordancewith the Class II Special Controls Guidance Document: TissueAdhesive for Topical Approximation of Skin, May 30 2008.Based on the non-clinical testing carried out, Barle TissueAdhesive 2 is considered as safe, as effective and performs aswell as the legally marketed predicate devices - Barle TissueAdhesive (K123133) and LiquiBand® Flow Control (K122446). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
December 20, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Medical Solutions (Plymouth) Limited Ms. Kay McGrath Senior Regulatory Affairs Associate Western Wood Way Langage Science Park Plympton, Devon United Kingdom PL7 5BG
Re: K132243
Trade/Device Name: Barle Tissue Adhesive 2 Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: December 5, 2013 Received: December 9, 2013
Dear Ms. McGrath:
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
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Page 2 - Ms. Kay McGrath
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.goy/MedicalDevices/ResourcesforYou/Industry/default,htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix 4-2
INDICATIONS FOR USE STATEMENT
K132243 510(k) Number:
Barle Tissue Adhesive 2 Device Name:
000-869 Model Number:
Barle Tissue Adhesive 2 topical skin adhesive is intended for Indications For Use: topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: NO (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)
Jiyoung Dang -S
§ 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.