QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE

K052373 · Quill Medical, Inc. · GAW · Sep 26, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052373
• Device Name: QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
• Applicant: Quill Medical, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Sep 26, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.

Device Story

Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread made of long-chain polyolefin polymer. It features bidirectional barbs along its long axis. Used by surgeons in clinical settings for soft tissue approximation. The device is placed within tissues; opposing barbs embed into the tissue to secure the wound edges. This mechanism provides the security of an interrupted suture without the bulk of a knot. If the suture breaks, remaining passes maintain wound approximation. The device is supplied sterile with attached needles.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Monofilament polypropylene suture; bidirectional barbs along the long axis; available in various diameters, lengths, and needle configurations; dyed blue [Phthalocyaninato(2-)] copper or undyed; EO sterilized; packaged in Tyvek pouches.

Indications for Use

Indicated for soft tissue approximation in patients requiring surgical closure, excluding closure of the epidermis.

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

• Contour Midface Opposing Unidirectional Threads™ (K050548)
• Quill® Synthetic Absorbable Barbed Suture (K051609)

Submission Summary (Full Text)

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K652373₁/₃

# SEP 2 6 2005

## Section 5 - 510(k) Summary

### Applicant Contact: 1.

Lois Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, NC 27713 Phone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: August 29, 2005

- Name of Device: Quill® Nonabsorbable Polypropylene Barbed Suture 2. Nonabsorbable Polypropylene Surgical Suture Common Name: Nonabsorbable Polypropylene Surgical Suture Classification Name: Regulation 21 CFR 878.5010, Product Code GAW
## Identification of device(s) to which the submitted claims equivalence: 3.

The Quill® Nonabsorbable Polypropylene Barbed Suture is substantially equivalent to the following predicate devices:

- For Material / Technological Characteristics: .
- Contour Midface Opposing Unidirectional Threads™ by Surgical 피 Specialties Corp., 510k K050548
- For Indication for Use based on Technological Characteristics: .
- Ouill® Synthetic Absorbable Barbed Suture by Quill Medical, Inc., 510k ■ K051609

### 4. Device Description:

The Quill® Nonabsorbable Polypropylene Barbed Suture is a monofilament, flexible thread prepared from long chain polyolefin polymer. It is available sterile, dyed blue [Phthalocyaninato(2-)] copper (and also undyed) in various suture diameters, lengths and needle configurations. Each suture has bidirectional barbs along the long axis of the suture monofilament.

The Quill® Nonabsorbable Polypropylene Barbed Sutures approximate tissues 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® Nonabsorbable Polypropylene Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill® Nonabsorbable Polypropylene Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

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K052373²/₃

# Section E - 510(k) Summary (continued)

### ડ. Intended Use of the Device:

Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for use in soft tissue approximation excluding closure of the epidermis.

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

# Indication for Use Comparison:

The Quill® Nonabsorbable Polypropylene Barbed Suture is equivalent in its intended use of soft tissue approximation to the Quill® Synthetic Absorbable Barbed Suture.

# Material and Technology Comparison:

The Quill® Nonabsorbable Polypropylene Barbed Suture is equivalent to the predicate device as shown in the table below:

| | Quill® Nonabsorbable Polypropylene<br>Barbed Suture,<br>510(k) TBD | Contour Midface Opposing<br>Unidirectional Threads™,<br>510(k) K050548 |
|---------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Product Code | GAW | GAW |
| Technique of<br>Deployment | Attached needles. | Attached needles. |
| Technological<br>Characteristic | Bi-directional barbs along the long axis<br>of the suture monofilament. | Bi-directional barbs along the long axis<br>of the suture monofilament. |
| Material | Polypropylene (cleared per K904906) | Polypropylene (cleared per K904906) |
| Sterilization | EO | EO |
| Packaging | Identical (device wound onto cardboard<br>inner support card and packaged in a<br>Tyvek pouch) | Identical (device wound onto cardboard<br>inner support card and packaged in a<br>Tyvek pouch) |

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K052373
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## Section E - 510(k) Summary (continued)

### 7. Safety and Performance:

The difference between the Quill® Nonabsorbable Polypropylene Barbed Suture and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the barbed suture. The Quill® Synthetic Absorbable Barbed Suture employs the same technological characteristics to support the intended use of soft tissue approximation of the nonabsorbable fiber (polypropylene) used in the Contour Midface Opposing Unidirectional Threads™. In addition, polypropylene is commonly used in medical applications and has proven to be biocompatible. 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, Quill Medical believes the Quill® Nonabsorbable Polypropylene Barbed Suture is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

SEP 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lois V. Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, North Carolina 27713

Re: K052373

Trade/Device Name: Quill® Nonabsorbable Polypropylene Barbed Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: August 29, 2005 Received: August 30, 2005

Dear Ms. 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- Ms. Lois V. 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/dsma/dsmamain.html

Sincerely yours

Sincerely yours,

Barbara Pouehund
for

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

Enclosure

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052373

# Section 4 - Indications for Use Statement

510k number if known:

Quill® Nonabsorbable Polypropylene Barbed Suture Device Name:

Indications for Use:

Quill® Nonabsorbable Polypropylene Barbed Sutures are indicated for soft tissue approximation excluding closure of the epidermis.

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)

Chubare Buchus for MXM
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number k052373