QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM

K072028 · Surgical Specialties Corp · GAM · Aug 3, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072028
• Device Name: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
• Applicant: Surgical Specialties Corp
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quill™ Self-Retaining System (SRS) comprised of MONODERM™ are 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 composed of a glycolide and e-caprolactone copolymer. The device features bi-directional barbs along its long axis, allowing for tissue approximation without the need for surgical knots. During surgery, the clinician places the suture within tissues; the barbs embed into the tissue to hold wound edges in approximation. This design provides the security of an interrupted suture strand while eliminating knot bulk. If the suture breaks, the remaining passes maintain wound approximation. The device is intended for use by surgeons in clinical settings for soft tissue approximation.

Clinical Evidence

Animal studies were conducted to compare the capability of the barbed suture to maintain wound approximation versus traditional knotted sutures (MONOCRYL). No human clinical trial data was required or presented.

Technological Characteristics

Synthetic absorbable monofilament suture made of glycolide and e-caprolactone copolymer. Features bi-directional barbs along the long axis. Available in USP sizes 0, 2-0, and 3-0. Sterilized via ethylene oxide (EO). Packaged in foil pouch within poly/tyvek pouch.

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

• Quill® Synthetic Absorbable Polydioxanone Barbed Suture (K051609)
• MONODERM™ Synthetic Absorbable Surgical Suture (K052437)
• MONOCRYL (Poliglecaprone 25) suture, undyed (K964072)
• MONOCRYL (Poliglecaprone 25) suture, dyed (K960653)

Submission Summary (Full Text)

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### 1. Applicant Contact:

Lois Smart Senior Manager Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA Phone: [phone] Fax: [phone] Email: [e-mail]

K07 2028
Page 1 of 3

AUG - 3 2007

Date Prepared: 07-23-07

| 2. | Name of Device: | Quill™ Self-Retaining System (SRS) comprised of MONODERM™ |
|----|----------------------|------------------------------------------------------------------------------------------------------|
| | Common Name: | Suture, absorbable, synthetic, polyglycolic acid |
| | Classification Name: | Absorbable poly(glycolide/l-lactide) surgical suture<br>Regulation 21 CFR 878.4493, Product Code GAM |

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

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

- Quill® Synthetic Absorbable Polydioxanone Barbed Suture by Quill Medical, . Inc., 510(k) K051609
- MONODERM™ Synthetic Absorbable Surgical Suture by Surgical . Specialties Corp., 510(k) K052437
- MONOCRYL (Poliglecaprone 25) suture, undyed by ETHICON, Inc., 510(k) . K964072
- MONOCRYL (Poliglecaprone 25) suture, dyed by ETHICON, Inc., 510(k) . K960653

### Device Description: 4.

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). 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 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

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K 072028
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The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM 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 QuillTM Self-Retaining System (SRS) comprised of MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ breaks, the remaining suture passes will hold the wound edges in approximation.

### ડ. Intended Use of the Device:

QuillTM Self-Retaining System (SRS) comprised of MONODERM™ 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.

# Indication for Use and Technologv Comparison:

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is equivalent to the Quill® Synthetic Absorbable Polydioxanone Barbed Suture 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 Quill™ Self-Retaining System (SRS) comprised of MONODERM™ was compared to MONOCRYL in animal studies to assess the capabilities of barbs to knots in order to maintain wound approximation.

### Material Comparison:

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is equivalent to the MONODERM™ Synthetic Absorbable Surgical Suture manufactured by Surgical Specialties Corp. as identical materials (fiber-needles & packaging materials) and sterilization method/sterilization cycle is utilized. In addition, the MONODERM™ Synthetic Absorbable Surgical Suture has an intended use of soft tissue approximation

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| | Quill™ SRS<br>comprised of<br>MONODERM<br>510(k) TBD | Synthetic<br>Absorbable<br>PDO Barbed<br>Sutures,<br>K051609 | MONODERM<br>K052437 | MONOCRYL<br>undyed,<br>K964072 | MONOCRYL<br>dyed,<br>K960653 |
|---------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Product Code | GAM | Different - NEW | Identical | Identical | Identical |
| Suture<br>Characteristic | Synthetic Absorbable<br>Monofilament | Identical | Identical | Identical | Identical |
| Intended Use | Soft tissue<br>approximation | Identical | Identical | Identical | Identical |
| Technique of<br>Deployment | Attached needles | Identical | Identical | Identical | Identical |
| Technological<br>Characteristic | Bi-directional barbs<br>along the long axis of<br>the suture<br>monofilament | Identical | Different -Utilizes<br>knots to secure the<br>suture | Different -<br>Utilizes knots to<br>secure the suture | Different -<br>Utilizes knots to<br>secure the suture |
| Material | PGA-PCL | Different -<br>Polydioxanone | Identical | Similar -<br>Poliglecaprone<br>25 | Similar -<br>Poliglecaprone<br>25 |
| Sterilization | EO | Identical | Identical | Identical | Identical |
| Packaging | Device wound onto<br>inner support card,<br>within a foil pouch<br>within a poly/tyvek<br>pouch | Identical | Identical | Identical | Identical |

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

### 7. Safety and Performance:

The difference between the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ and the above mentioned predicate devices do 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.

#### Conclusion 8.

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -3 2007

Angiotech % Lois Smart Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

Re: K072028

Trade/Device Name: Quill" Self-Retaining System (SRS) comprised of MONODERM™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/Llactide) surgical suture Regulatory Class: II Product Code: GAM Dated: July 23, 2007 Received: July 24, 2007

Dear Lois Smart:

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 - Lois Smart

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Sincerelv vo 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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# Section 4 - Indications for Use Statement

510k number if known:

K0720

Device Name: QuillTM Self-Retaining System (SRS) comprised of MONODERMTM

Indications for Use:

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

Prescription Use V (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number