QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

K123836 · Surgical Specialties Corp. Dba Angiotech · GAM · Dec 21, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K123836
• Device Name: QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
• Applicant: Surgical Specialties Corp. Dba Angiotech
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

QuillTM Knotless Tissue-Closure Device comprised of MonodermTM is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

Sterile, synthetic, absorbable tissue-closure device; copolymer of glycolide and e-caprolactone; undyed or dyed with D&C Violet No. 2. Features uni-directional barbs along monofilament axis; welded primary and secondary loop design at distal end. Available in sizes 1 to 3-0 with various needle types. Used by surgeons for soft tissue approximation; eliminates need for manual knots. Benefits include secure tissue closure and simplified surgical technique.

Clinical Evidence

Bench testing only. Testing confirmed conformance to USP monograph for absorbable sutures (tensile strength, needle attachment) per FDA Class II Special Controls Guidance Document: Surgical Sutures. Additional in vitro posthydrolysis tensile testing performed to demonstrate equivalence.

Technological Characteristics

Synthetic absorbable copolymer of glycolide and e-caprolactone. Monofilament design with uni-directional barbs and welded distal loops. Sizes 1 to 3-0. Sterilized. Conforms to USP monograph for absorbable sutures.

Indications for Use

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

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this 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

• QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design, Size -0- (K123409)
• QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design, Size 2-0 (K122898)

Submission Summary (Full Text)

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K123836 Page 1/2

## 510(k) Summary

# DEC 2 1 2012

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| Date Prepared: | December 12, 2012 |
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| Company: | 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] |
| Device trade name: | QuillTM MonodermTM Knotless-Tissue Closure Device, Variable<br>Loop Design |
| Device Common<br>Name: | Absorbable poly(glycolide/l-lactide) Surgical Suture |
| Device classification: | Absorbable poly(glycolide/l-lactide) Surgical Suture<br>Product code, GAM<br>21 CFR 878.4493<br>Class II |
| Legally marketed<br>devices to which the<br>device is substantially<br>equivalent: | K123409 QuillTM MonodermTM Knotless Tissue-Closure<br>Device, Variable Loop Design, Size -0-<br>K122898 QuillTM MonodermTM Knotless Tissue-Closure<br>Device, Variable Loop Design, Size 2-0 |
| Description of the<br>device: | The QuillTM MonodermTM Knotless Tissue-Closure Device,<br>Variable Loop Design 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 a copolymer of glycolide and e-caprolactone,<br>undyed, or dyed with D&C Violet No. 2. The device is designed<br>with small uni-directional barbs along the long axis of the suture<br>monofilament which contains a welded primary loop and<br>secondary loop design at the distal end. It is available in diameter<br>Sizes 1 to 3-0, in various lengths affixed to various needle types. |
| Indications for Use: | QuillTM Knotless Tissue-Closure Device comprised of<br>MonodermTM is indicated for soft tissue approximation where use<br>of an absorbable suture is appropriate. |

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K123836 Page 2/2

Substantial Equivalence: The QuillTM Monoderm™ Knotless Tissue-Closure device. Variable Loop Design is identical in material composition and size range as the Quill™ Monoderm™ predicates. The proposed device is identical in design to the Quill™ Monoderm™ Knotless Tissue-Closure Device predicate devices. In addition, the proposed device has the same intended use as both predicate devices.

Performance tests:

Non-clinical laboratory performance testing was conducted to confirm that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, 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 devices including in vitro posthydrolysis tensile testing.

The results of this testing demonstrates that the QuillTM Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

December 21, 2012

Re: K123836

Trade/Device Name: Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design

Regulation Number: 21 CFR 878.4493

Regulation Name: Absorbable poly (glycolide/l-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: December 12, 2012 Received: December 13, 2012

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 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

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### Page 2 - Ms. Kirsten Stowell

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/CDRH0ffices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm -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

510k number if known: K123836

Device Name: Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design

Indications for Use;

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123836