The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue.

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

AI/ML Overview

The Quill® Synthetic Absorbable Barbed Suture is indicated for use in soft tissue approximation. The provided text doesn't explicitly define numerical acceptance criteria for a new device's performance (e.g., specific tensile strength thresholds or degradation rates). Instead, it establishes substantial equivalence based on a comparison to predicate devices, supported by various studies.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit numerical acceptance criteria are not stated for a distinct "new device" but rather for equivalence, the table below reflects the types of performance data used to demonstrate safety and effectiveness relative to predicates.

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (Summary from Text)
Biocompatibility: Device material is safe for biological contact.	Biocompatibility data provided.
Functional Performance (Simulated Use): Device performs as intended in simulated surgical conditions.	Simulated use evaluation provided.
Barb Holding & Absorption: Barbs effectively hold tissue, and suture degrades as expected.	Results of in vivo barb holding and absorption assessments provided. Degrades or dissolves over time in tissue. Barbs imbed in tissues.
In Vivo Performance (Animal Studies): Device is safe and effective in living organisms.	Results of in vivo animal studies provided.
Clinical Performance (Human Studies): Device is safe and effective in human use.	Human clinical trial results provided.
Technological Characteristics: Comparable technique of deployment and tissue approximation mechanism.	Subcuticular placement: needle captures a precise bite on each side of the incision. Bi-directional barbs along the long axis of the suture monofilament catch and cinch to approximate the tissue without the need for a knot, similar to an interrupted suture. This is compared to: Contour Midface Opposing Uni-directional Thread (needle placement/introducer, opposing unidirectional cogs) and Insorb™ Absorbable Staple (mechanically placed, cleats of u-shaped staple).
Material Safety: Material is as safe as predicate device.	Equivalent in material to predicate (Quill® Synthetic Absorbable Barbed Suture, K042075). Polydioxanone is well-characterized.

2. Sample Size for Test Set and Data Provenance:

The provided text does not specify the sample sizes or provenance (country of origin, retrospective/prospective) for the test sets in the biocompatibility data, simulated use evaluation, in vivo barb holding and absorption assessments, in vivo animal studies, or human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the text.

4. Adjudication Method for the Test Set:

This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC comparative effectiveness study, or human readers improving with/without AI assistance, is made. This is an absorbable suture, not an AI-based diagnostic device.

6. Standalone (Algorithm Only) Performance Study:

Not applicable, as this is a physical medical device (suture), not an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating safety and effectiveness appears to be based on a combination of:

Biocompatibility standards/testing: Chemical and biological inertness.
Mechanical and functional performance testing: Demonstrating the physical properties and how the suture functions (barb holding, approximation).
In vivo observations (animal studies): Direct biological response and functional outcome in living tissue.
Clinical outcomes (human clinical trials): Safety and efficacy observed in human patients.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device. There is no "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is a physical medical device.

Summary

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K051609

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Section E - 510(k) Summary

1. Applicant Contact:

Lois Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, NC 27713 Phone: 919-806-1961 Fax: 919-806-1953 Email: Ismart@quillmedical.com

Date Prepared: 6-16-05

Name of Device: Quill® Synthetic Absorbable Barbed Suture 2. Common Name: Polydioxanone Absorbable Surgical Sutures Absorbable Polydioxanone Surgical Suture Classification Name: Regulation 21 CFR 878.4840, Product Code NEW

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

The Quill® Synthetic Absorbable Barbed Suture is substantially equivalent to the following predicate devices:

For Material Safety and Technological Characteristics: .
- Quill® Synthetic Absorbable Barbed Suture, 510k K042075 1
- Contour Midface Opposing Uni-directional Thread by Surgical Specialties . Corp., K050548
- Insorb™ Absorbable Staple by Incisive Surgical, Inc., 510k K024117 트
For Indication for Use: .
- Y-Knot Suture Clip by Innovasive Device, Inc., 510k K973313 트
- Insorb™ Absorbable Staple by Incisive Surgical, Inc., 510k K024117 .

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Ko 5160744

Section E - 510(k) Summary (continued)

4. Device Description:

5. Intended Use of the Device:

Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

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51609$_{3/4}$

Section E - 510(k) Summary (continued)

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

Technological Characteristic Comparison:

The Quill® Synthetic Absorbable Barbed Suture is equivalent in technological characteristics to the following predicate devices:

	Quill® SyntheticAbsorbable BarbedSuture	Contour MidfaceOpposing Uni-directionalThread	Insorb™AbsorbableStaple
Technique ofDeployment	Subcuticular placement:Needle captures a precisebite on each side of theincision.	Subcuticular placement:Needle placement (orplaced by introducer).	Subcuticular placement:Mechanically placed bya stapler to capture aprecise bite on each sideof the incision.
TechnologicalCharacteristictoApproximateTissue	Bi-directional barbs alongthe long axis of the suturemonofilament catch andcinch to approximate thetissue as does aninterrupted suture strandbut without the need of aknot.	Opposing unidirectionalcogs along the long axisof the suturemonofilament to fixatethe cheek subdermis in anelevated position.	Cleats of the u-shapedstaple approximatetissue after the stapler isretracted.
Predicate	PDS II Suture:N18331	Contour ExtendedLength ThreadsK041593	Traditional absorbablestaples (two-piecestaple and receiver):K915489 & K915693

Intended Use Comparison:

The Quill® Synthetic Absorbable Barbed Suture is equivalent in intended use to the following predicate devices:

	Y-Knot Suture Clip	Insorb™ Absorbable Staple
Intended Use	For use in general soft tissueapproximation and/or ligationwith #1 and #2 braided polyestersuture.	For use in abdominal, thoracic, gynecologic,orthopedic, plastic and reconstructive surgeryfor the subcuticular closure of skin where anabsorbable tissue fastener is desired fortemporary tissue approximation.
PerformanceData Used forClearance	Mechanical Performance Testing(Y-Knot suture fixationcompared to a knotted suture)	An Animal StudyMechanical Performance TestingPackage Testing
Predicate	Ethibond Extra Polyester Suture	Traditional absorbable staples (two-piecestaple and receiver)

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KOS16094/4

Section E - 510(k) Summary (continued)

Material Safety Comparison:

The Quill® Synthetic Absorbable Barbed Suture is equivalent in material to the predicate device, Quill® Synthetic Absorbable Barbed Suture, cleared by 510k K042075.

7. Safety and Performance:

By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Quill® Synthetic Absorbable Barbed Suture and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the barbed suture. Furthermore, polydioxanone is well-characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.

Biocompatibility data, simulated use evaluation, results of in vivo barb holding and absorption assessments, results of in vivo animal studies and human clinical trial results are provided to support the safety and performance of the Quill® Synthetic Absorbable Barbed Suture.

8. Conclusion

Based on the design, materials, function, intended use and performance evaluations discussed herein, Quill Medical believes the Quill® Synthetic Absorbable Barbed Suture is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the bird's body and head. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

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

Re: K051609

Trade/Device Name: Quill™ Synthetic Absorbable Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: June 16, 2005 Received: June 17, 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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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Section D - Statement of Indications for Use

K051609 510k number if known:

Quill® Synthetic Absorbable Barbed Suture Device Name:

Indications for Use:

. .

Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Prescription Use ﺳﮯ (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)

En Rh
Revision Sign Off

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

Page Number K051609

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
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.(b)
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.