TRANQUILL BARBED DEVICE

K133420 · Surgical Specialties Corp. Dba Angiotech · NEW · Nov 29, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K133420
• Device Name: TRANQUILL BARBED DEVICE
• Applicant: Surgical Specialties Corp. Dba Angiotech
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Nov 29, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TranQuill barbed device comprised of dyed PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Device Story

TranQuill barbed device is a sterile, synthetic, absorbable surgical suture; composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Features bi-directional barbs along the monofilament axis to facilitate tissue approximation without knots. Available in sizes 0 through 2-0 with various needle attachments. Used by surgeons for soft tissue approximation; functions as a self-retaining suture system. Benefits include simplified wound closure and secure tissue approximation. Device is a mechanical implant; no electronic or software components.

Clinical Evidence

Bench testing only. Testing included USP monograph compliance for absorbable sutures (tensile strength) and in vitro barb holding strength per FDA Class II Special Controls Guidance Document: Surgical Sutures (2003). Additional in vitro post-hydrolysis tensile testing was performed to demonstrate equivalence to predicate devices.

Technological Characteristics

Material: Polydioxanone (PDO) dyed with D&C Violet No. 2. Design: Monofilament with bi-directional barbs. Sizes: 0 to 2-0. Sterilization: Sterile. Mechanical principle: Self-retaining tissue approximation via barbs. No software, electronics, or connectivity.

Indications for Use

Indicated for soft tissue approximation in patients where the use of an absorbable suture is appropriate.

Regulatory Classification

Identification

An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Quill Synthetic Absorbable Barbed Suture (K051609)
• Quill Self-Retaining System (SRS) comprised of PDO (K080680)
• Quill Self-Retaining System (SRS) comprised of PDO (K080985)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

| Date Prepared: | November 27, 2013 |
|----------------|------------------------------------------------------------------------------------------------------------------------|
| Company: | Surgical Specialties Corporation<br>100 Dennis Dr.<br>Reading, PA 19606 |
| Contact: | Kirsten Stowell<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

NOV 29 2013

| Device trade name: | TranQuill barbed device, comprised of Polydioxanone |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Polydioxanone Absorbable Surgical Suture |
| Device classification: | Absorbable polydioxanone surgical suture<br>Product code, NEW<br>21 CFR 878.4840<br>Class II |
| Legally marketed device to which the device is substantially equivalent: | K051609:<br>K080680<br>K080985 |
| | Quill Synthetic Absorbable Barbed Suture<br>Quill ^TM Self-Retaining System (SRS) comprised of PDO<br>Quill ^TM Self-Retaining System (SRS) comprised of PDO |
| Description of the device: | The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types. |
| Indications for Use: | The TranQuill barbed device comprised of dyed PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. |

.

.

{1}------------------------------------------------

K133420 Page 2/2

Substantial The TranQuill barbed device comprised of polydioxanone has the Equivalence: same design and materials as the QuillTM Synthetic Absorbable Barbed Suture predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the decrease in spacing between barbs. Performance tests: Non-clinical laboratory performance testing was conducted to confirm that the TranQuill barbed device comprised of polydioxanone, conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and in vitro barb holding strength. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing. The results of this testing demonstrates that the TranQuill barbed

device comprised of polydioxanone, is substantially equivalent to the predicate device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Surgical Specialties Corporation Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

January 23, 2014

Re: K133420

Trade/Device Name: TranQuill Barbed Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: November 6, 2013 Received: November 8, 2013

Dear Ms. Stowell:

This letter corrects our substantially equivalent letter of November 29, 2013.

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

{3}------------------------------------------------

Page 2 - Ms. Kirsten Stowell

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 toll-free 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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

{4}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

### 510(k) Number (if known) K133420

### Device Name

TranQuill Barbed Device, comprised of Polydioxanone

#### Indications for Use (Describe)

The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)