BARLE TISSUE ADHESIVE 2

K132243 · Advanced Medical Solutions (Plymouth), Ltd. · MPN · Dec 20, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132243
• Device Name: BARLE TISSUE ADHESIVE 2
• Applicant: Advanced Medical Solutions (Plymouth), Ltd.
• Product Code: MPN · General, Plastic Surgery
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate; used for wound closure by holding approximated skin edges together. Device polymerizes within minutes upon application. Supplied in single-patient-use configuration; features modified applicator body design without actuation wings. Used in clinical settings for surgical incisions and trauma-induced lacerations. Provides a microbial barrier. Healthcare providers apply the adhesive topically to skin edges; acts as a wound closure agent to facilitate healing and protect the wound site.

Clinical Evidence

Bench testing only. No clinical data presented. Performance and safety profile established via extensive design verification, functional, and performance testing in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin (May 30, 2008).

Technological Characteristics

Topical tissue adhesive containing 2-octyl cyanoacrylate. Single-patient-use applicator. Modified design (no actuation wings). Provides microbial barrier. Sterilized device.

Indications for Use

Indicated for topical closure of easily approximated skin edges of surgical incisions (including minimally invasive surgery) and simple, cleansed, trauma-induced lacerations. May be used with deep dermal stitches. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Barle Tissue Adhesive (K123133)
• LiquiBand® (K122446)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Web: www.admedsal.com

DEC 2 0 2013

## 510(k) Summary

| Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.<br>Western Wood Way<br>Langage Science Park<br>Plymouth, Devon. PL7 5BG<br>United Kingdom<br><br>Tel: [phone]<br>Fax: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kay M°Grath<br>Senior Regulatory Affairs Associate<br>Advanced Medical Solutions Ltd |
| Date of Summary: | 12 September 2013 |
| Device Trade<br>Name: | Barle Tissue Adhesive 2 |
| Common or Usual.<br>Name: | Topical Skin Adhesive |
| Classification<br>Name: | Tissue Adhesive (21 CFR 878.4010) |
| Product Code: | MPN |
| Predicate<br>Device(s): | Barle Tissue Adhesive (K123133)<br>LiquiBand® (K122446) |
| Device<br>Description: | Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive<br>containing 2-octyl cyanoacrylate for wound closure. It is<br>applied to easily approximated skin edges and polymerizes<br>within minutes.<br>Barle Tissue Adhesive 2 is supplied in a single patient use<br>configuration. |
| Indication for<br>Use: | Barle Tissue Adhesive 2 topical skin adhesive is intended for<br>topical applications only, to hold closed easily approximated<br>skin edges of wounds from surgical incisions, including<br>punctures from minimally invasive surgery and simple,<br>thoroughly cleansed, trauma induced lacerations. Barle Tissue<br>Adhesive 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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| Technological<br>Characteristics | The technological characteristics of Barle Tissue Adhesive 2 are<br>substantially equivalent to the predicate devices.<br>The main reasons for the submission of Barle Tissue Adhesive 2,<br>following clearance of the Barle Tissue Adhesive (K123133), is<br>because of these changes:<br>Modification of the applicator body design to remove<br>actuation "wings". Addition of a microbial barrier claim. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | Barle Tissue Adhesive 2 is substantially equivalent to Barle<br>Tissue Adhesive (K123133) and LiquiBand® Flow Control Topical<br>Skin Adhesive (K122446) with regard to Indication For Use, target<br>population, intended application, mechanism of action and<br>performance at achieving its intended use; in addition Barle<br>Tissue Adhesive 2 is substantially equivalent to LiquiBand® Flow<br>Control with regard to the microbial barrier claim. |
| Conclusion | Extensive design verification, functional and performance testing<br>have been conducted. Barle Tissue Adhesive 2 was evaluated in<br>tests to establish a performance and safety profile in accordance<br>with the Class II Special Controls Guidance Document: Tissue<br>Adhesive for Topical Approximation of Skin, May 30 2008.<br><br>Based on the non-clinical testing carried out, Barle Tissue<br>Adhesive 2 is considered as safe, as effective and performs as<br>well as the legally marketed predicate devices - Barle Tissue<br>Adhesive (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 [phone] or [phone] 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 [phone] or [phone] 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