QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

K132268 · Surgical Specialties Corporation Dba Angiotech · NEW · Aug 23, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132268
• Device Name: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
• Applicant: Surgical Specialties Corporation Dba Angiotech
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quill™ PDO Knotless Tissue-Closure Device comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

Quill™ PDO Knotless Tissue-Closure Device is a sterile, synthetic, absorbable surgical suture; composed of polydioxanone dyed with D&C Violet No. 2. Features uni-directional barbs along the monofilament axis; includes welded primary and secondary loops at the distal end. Available in sizes 2 through 3-0 with various needle types. Used by surgeons for soft tissue approximation; eliminates need for manual knot tying. Device provides mechanical tissue closure; absorbs over time. Benefits include simplified closure procedure and secure tissue approximation.

Clinical Evidence

No clinical data. Bench testing only. Testing included USP monograph compliance for absorbable sutures (tensile strength, needle attachment) and in vitro post-hydrolysis tensile testing per FDA Class II Special Controls Guidance Document: Surgical Sutures (2003).

Technological Characteristics

Material: Polydioxanone (polyester) dyed with D&C Violet No. 2. Design: Monofilament with uni-directional barbs and distal welded primary/secondary loops. Sizes: 2 through 3-0. Sterilization: Sterile. Compliance: USP monograph for absorbable sutures; FDA Class II Special Controls Guidance Document: Surgical Sutures.

Indications for Use

Indicated for soft tissue approximation in patients where 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™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size -0- (K113744)
• Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size 2-0 and 3-0 (K123877)

Submission Summary (Full Text)

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## 510(k) Summary

| Date Prepared: | July 19, 2013 | | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--|
| Company: | Surgical Specialties Corporation, dba Angiotech<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] | AUG 2 3 2013 | |
| Device trade name: | Quill™ PDO Knotless-Tissue Closure Device, Variable Loop<br>Design (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<br>device to which the<br>device is substantially<br>equivalent: | K113744 | Quill™ PDO Knotless Tissue-Closure Device,<br>Variable Loop Design, Size -0- | |
| | K123877 | Quill™ PDO Knotless Tissue-Closure Device,<br>Variable Loop Design, Size 2-0 and 3-0 | |
| Description of the<br>device: | The Quill™ PDO Knotless Tissue-Closure Device, Variable Loop<br>Design (Polydioxanone) is a sterile, synthetic absorbable tissue-<br>closure device that is intended for use in the closure of soft tissue.<br>It is comprised of polyester [poly (p-dioxanone)], dyed with D&C<br>Violet No. 2. The instrument is designed with small uni-<br>directional barbs along the long axis of the suture monofilament<br>which contains a welded primary loop and secondary loop design<br>at the distal end. It is available in diameter Size 2 through 3-0 in<br>various lengths affixed to various needle types. | | |
| Indications for Use: | Quill™ PDO Knotless Tissue-Closure Device comprised of<br>Polydioxanone is indicated for soft tissue approximation where<br>use of an absorbable suture is appropriate. | | |

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### K132268 p. 2 of 2

Substantial Equivalence: The QuillTM Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) has the same design and materials as the Ouill™ PDO Knotless Tissue-Closure Device 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 suture diameter.

Non-clinical laboratory performance testing was conducted to Performance tests: confirm that the Quill™ PDO Knotless Tissue-Closure device, Variable Loop Design (Polydioxanone), conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and needle attachment. 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 QuillTM PDO Knotless Tissue-Closure device, Variable Loop Design (Polydioxanone), is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

August 23, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Kirsten Stowell Regulatory Affairs Manager Surgical Specialties Corporation, dba Angiotech 100 Dennis Drive Reading, Pennsylvania 19606

Re: K132268

Trade/Device Name: Ouill PDO Knotless-Tissue Closure Device, Variable Loop Design (Polydioxanone) Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: July 26, 2013 Received: July 29, 2013

Dear Ms. Stowell:

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

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Page 2 - Kirsten Stowell

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 (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/ucm 1 1 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 [phone] or [phone] 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

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### Section 4 - Indications for Use Statement

K132268 510k number if known:

QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design

Polydioxanone

Indications for Use:

Device Name:

Quill™ PDO Knotless Tissue-Closure Device comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132268

Quill™ PDO Device Special 510(k)

CONFIDENTIAL