QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)

K120827 · Angiotech · NEW · Jul 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120827
• Device Name: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
• Applicant: Angiotech
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Jul 13, 2012
• Decision: SESE
• Submission Type: Traditional
• 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 synthetic absorbable surgical suture composed of polydioxanone (PDO) monofilament, dyed with D&C Violet No. 2. The device features small bi-directional barbs along its length, which anchor into tissue to eliminate the need for manual knot-tying during wound closure. It is available in various lengths and diameters (sizes 2 through 4-0) with attached needles. Used by surgeons in clinical settings for soft tissue approximation, the device provides mechanical tension to hold tissue edges together while the material is absorbed by the body over time. The knotless design simplifies the suturing process and maintains approximation without traditional knots.

Clinical Evidence

Pre-clinical animal performance testing was conducted to support the safety and performance claims. No human clinical trial data was required or provided.

Technological Characteristics

Material: Polydioxanone (PDO) monofilament dyed with D&C Violet No. 2. Design: Bi-directional barbs for knotless tissue approximation. Sizes: 2 through 4-0. Sterilization: Not specified.

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 Synthetic Absorbable Barbed Suture (K051609)
• Quill Synthetic Absorbable Barbed Suture (K080680)
• Quill Synthetic Absorbable Barbed Suture (K080985)

Reference Devices

• Ethicon PDS II™ (Polydioxanone) Sutures (N18331)

Submission Summary (Full Text)

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K120827

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# Section 5 – 510(k) Summary

JUL 1 3 2012

| Date Prepared: | March 16, 2012 | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Company: | Angiotech<br>100 Dennis Dr.<br>Reading, PA 19606 | |
| Contact: | Kirsten Stowell<br>Regulatory Affairs Manager<br>Phone:<br>Fax:<br>Email: | 610-404-3367<br>610-404-3924<br>[e-mail] |
| Device trade name: | Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) | |
| Device Common<br>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>devices to which the<br>device is substantially<br>equivalent: | K051609<br>K080680<br>K080985<br>N18331 | Quill Synthetic Absorbable Barbed Suture<br>Ethicon PDS II™ (Polydioxanone) Sutures |
| Description of the<br>device: | The Quill™ Knotless Tissue-Closure Device comprised of PDO<br>(Polydioxanone) is a synthetic absorbable tissue-closure device<br>that is intended for use in the closure of soft tissue. It is<br>comprised of polyester [poly (p-dioxanone)] monofilament suture<br>material, dyed with D&C Violet No. 2. The device is designed<br>with small bi-directional barbs along the length that eliminate the<br>need to tie knots during approximation. The device is available in<br>various lengths in diameter sizes 2 through 4-0 with various<br>needles attached to each end. | |
| 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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K120827 page 2/2

### Substantial Equivalence:

Performance tests:

The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) has the same design and materials as its predicates, including the same intended use, technological characteristics and size ranges as the predicate devices.

The The intended use is identical to both predicate devices. design, material and chemical composition of the proposed device is identical to the predicate Quill Synthetic Absorbable Barbed Suture (K051609, K080680, K080985).

Pre-clinical animal performance testing was conducted to confirm and support the information provided in the QuillTM Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) Instructions for Use.

The results of this testing demonstrates that the Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is substantially equivalent in safety and performance to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

#### Public Health Service

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

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

JUL 1 3 2012

Re: K120827

Trade/Device Name: Quill™ Knotless Tissue-Closure Device, Polydioxanone Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: July 02, 2012 Received: July 05, 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

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### Page 2 - Ms. 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/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/ReportalProblem/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,

for

Mark N. Mallery

Mark N. Melkerson Director · Division of Surgical, Orthopedic and Restorative 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:

K120827

Device Name: QuillTM PDO Knotless Tissue-Closure Device, Polydioxanone

Indications for Use:

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 _ X (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)

Daniel Kline for mm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120827