QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE

K080680 · Surgical Specialties Corp · NEW · Mar 21, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080680
• Device Name: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
• Applicant: Surgical Specialties Corp
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Mar 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quill™ Self-Retaining System (SRS) comprised of PDO is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

Quill™ Self-Retaining System (SRS) is a synthetic absorbable monofilament suture made of polydioxanone (PDO). Device features bi-directional barbs along the long axis of the monofilament. Surgeon places suture in tissue; barbs imbed into tissue to provide approximation without knots. Provides security of interrupted suture strand; if suture breaks, remaining passes maintain wound edge approximation. Used by surgeons for soft tissue approximation. Modification from predicate involves decreased spacing between barbs to increase number of barbs per linear length, thereby increasing tissue holding strength.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, function, and intended use comparisons.

Technological Characteristics

Synthetic absorbable monofilament suture composed of polydioxanone (PDO). Features bi-directional barbs along the long axis. Available in USP Size 3-0, dyed violet or undyed. Sterilized via ethylene oxide (EO).

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™ Self-Retaining System (SRS) comprised of PDO (K071989)

Submission Summary (Full Text)

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KO 86680
Page 1 of 3

### 1. Applicant Contact:

Trudy Estridge Director, Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA Phone: [phone] Fax: [phone] Email: [e-mail]

MAR 2 1 2008

Date Prepared: 03-07-08

| | Name of Device: | Quill™ Self-Retaining System (SRS) comprised of PDO<br>(Polydioxanone) |
|--|----------------------|-----------------------------------------------------------------------------------------|
| | Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
| | Classification Name: | Absorbable polydioxanone surgical suture<br>Regulation 21 CFR 878.4840 Product Code NEW |

# Identification of device(s) to which the submitted claims equivalence: 3.

The Quill™ Self-Retaining System (SRS) comprised of PDO is substantially equivalent to the following predicate device:

- Quill® Synthetic Absorbable Barbed Suture by Quill Medical Corporation, . 510(k) K051609
- Quill™ Self-Retaining System (SRS) comprised of PDO (Polydioxanone) by ● Surgical Specialties Corporation dba Angiotech, 510(k) K071989

#### 4. Device Description:

The Quill™ Self-Retaining System (SRS) comprised of PDO is a synthetic absorbable monofilament suture comprised of polyester [poly (p-dioxanone)] per 21 CFR 878.4840. It is available sterile, dyed violet (D&C Violet No. 2 per 21 CFR 74.3602) or undyed (beige) in various suture lengths and needle configurations in USP Sizes 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

The Quill™ Self-Retaining System (SRS) comprised of PDO approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Quill™ Self-Retaining System (SRS) comprised of PDO pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the QuillTM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.

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#### ડ. Intended Use of the Device:

QuillTM Self-Retaining System (SRS) comprised of PDO are indicated for soft tissue approximation where use of an absorbable suture is appropriate.

#### Characteristics of the device in comparison to those of the predicate device(s) 6.

The Quill™ Self-Retaining System (SRS) comprised of PDO is equivalent to the predicate devices in its intended use of soft tissue approximation where use of an absorbable suture is appropriate and the technology of using barbs instead of knots to hold the tissue in approximation. The device modification is to decrease the spacing between the barbs on the suture length thereby increasing the number of barbs per linear length to increase tissue holding strength.

The comparison of the new device to the predicate devices is summarized below:

| | Quill TM SRS comprised<br>of PDO<br>510(k) <i>TBD</i> | Quill® Synthetic<br>Absorbable Barbed Suture<br>510(k) K051609 | Quill TM SRS comprised of<br>PDO, 510(k) K071989 |
|---------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| Product Code | NEW | Identical | Identical |
| Suture<br>Characteristic | Synthetic Absorbable<br>Monofilament | Identical | Identical |
| Intended Use | Soft tissue approximation | Identical | Identical |
| Technique of<br>Deployment | Attached needles | Identical | Identical |
| Technological<br>Characteristic | Bi-directional barbs along<br>the long axis of the suture<br>monofilament | Identical | Identical |
| Material | Polydioxanone | Identical | Identical |
| Sterilization | EO | Identical | Identical |
| Packaging | Device wound onto inner<br>support card, within a foil<br>pouch within a poly/tyvek<br>pouch | Identical | Identical |

#### 7. Safety and Performance:

The difference between the Quill™ Self-Retaining System (SRS) comprised of PDO and the above mentioned predicate devices does not raise any questions regarding the safety and effectiveness of the device. The device, as designed, is as safe and effective as its predicate devices.

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## 8. Conclusion

Based on the design, material, function and intended use discussed herein, Angiotech believes the Quill™ Self-Retaining System (SRS) comprised of PDO is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2008

Surgical Specialties Corporation % Angiotech Trudy D. Estridge, Ph.D. 13921 Park Center Road, Suite 100 Herndon, Virginia 21071

Re: K080680

Trade/Device Name: Quill™ Self-Retaining System (SRS) comprised of PDO Regulation Code: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: March 7, 2008 Received: March 10, 2008

Dear Dr. Estridge:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Trudy D. Estridge, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment F - Indications for Use Statement

510k number if known:

K680680

Quill™ Self-Retaining System (SRS) comprised of PDO Device Name:

Indications for Use:

.

Quill™ Self-Retaining System (SRS) comprised of PDO 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkum

Division of General, Restorative. and Neurological Devices

**510(k) Number** K08 0680