Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design

K151112 · Angiotech · GAW · Sep 10, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151112
• Device Name: Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
• Applicant: Angiotech
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Sep 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quil™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

Device Story

Sterile, synthetic, nonabsorbable tissue-closure device; comprised of high molecular weight, isotactic polypropylene (undyed or blue-dyed). Features uni-directional barbs along suture monofilament; includes welded primary and secondary loop design at distal end. Used by surgeons for soft tissue approximation; eliminates need for traditional knots. Benefits include secure tissue closure without knot-related complications. Available in various lengths and needle types; diameter sizes 0, 1, and 2.

Clinical Evidence

Bench testing only. Non-clinical laboratory performance testing conducted per USP monograph for nonabsorbable sutures and FDA Class II Special Controls Guidance Document: Surgical Sutures (2003).

Technological Characteristics

Material: High molecular weight, isotactic polypropylene (undyed or Phthalocyaninato (2-) Copper dyed). Design: Uni-directional barbs, welded primary/secondary loop. Sizes: 0, 1, 2. Sterilization: Sterile. Non-absorbable.

Indications for Use

Indicated for soft tissue approximation in patients requiring surgical closure, excluding epidermis. Prescription use only.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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

• Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K130078)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted in profile, with its head facing right, and its feathers are represented by a series of curved lines.

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

September 10, 2015

Angiotech Ms. Hilary Wells Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

Re: K15112

Trade/Device Name: Quill" Polypropylene Knotless Tissue-Closure Device, Variable Loop Design Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: August 9, 2015 Received: August 11, 2015

Dear Ms. Wells:

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

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807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K151112

#### Device Name

QuillTM Polypropylene Knotless Tissue-Closure Device, Variable Loop Design

#### Indications for Use (Describe)

Quil™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <span style="font-family:Wingdings;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family:Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Date Prepared: | September 8, 2015 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Angiotech<br>100 Dennis Dr.<br>Reading, PA 19606 |
| Contact: | Hilary Wells<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device trade name: | Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design |
| Device Common Name: | Nonabsorbable Polypropylene Surgical Suture |
| Device classification: | Nonabsorbable Polypropylene Surgical Suture<br>Product code, GAW<br>21 CFR 878.5010<br>Class II |
| Legally marketed device to which the device is substantially equivalent: | K130078: Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design, Size 0- |
| Description of the device: | The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types. |
| Indications for Use: | Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis |
| Substantial | The proposed additional diameter sizes, Size 1 & 2, of the QuillTM |
| Equivalence: | Polypropylene Knotless Tissue-Closure Device, Variable Loop<br>Design product line have the same material, design, intended use<br>and technological characteristics as the predicate device. The<br>only difference between the proposed and predicate device is the<br>suture diameter. |
| Performance tests: | Non-clinical laboratory performance testing was conducted to<br>confirm that the QuillTM Polypropylene Knotless Tissue-Closure<br>Device, Variable Loop Design conforms to the USP monograph |

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for nonabsorbable sutures (as applicable). 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.

The results of this testing demonstrate that the Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device.