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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the Quill™ Self-Retaining System (SRS) comprised of PDO. It asserts substantial equivalence to predicate devices but does not describe a study proving the device meets acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text. The document primarily focuses on demonstrating that the new device is substantially equivalent to existing, legally marketed predicate devices, rather than presenting a performance study with acceptance criteria.

Here's a breakdown of what can and cannot be provided based on the input:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify performance acceptance criteria or report performance statistics from a study. It states that the device modification (decreased barb spacing) is intended "to increase tissue holding strength," but no quantitative data or specific acceptance criteria are presented to demonstrate this improvement or equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or an associated study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No test set or ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This document is for a surgical suture, not an AI-assisted diagnostic device. Therefore, an MRMC study is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This document is for a surgical suture, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is described as no study demonstrating performance against specific criteria is presented.
The sample size for the training set:
- Cannot be provided. No training set is described.
How the ground truth for the training set was established:
- Cannot be provided. No training set or ground truth establishment process is described.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The document's primary argument for acceptance is substantial equivalence to predicate devices, not the fulfillment of specific performance acceptance criteria from a new study.

Implied Acceptance Criteria (Substantial Equivalence): The "acceptance criteria" in this context are implicitly that the new device (Quill™ Self-Retaining System (SRS) comprised of PDO with decreased barb spacing) is as safe and effective as the predicate devices, despite a modification. The document asserts this equivalence through a comparison table (Characteristics of the device in comparison to those of the predicate device(s) 6.).
"Study" (Comparison and Assertion): The "study" here is essentially the comparison presented in the table, demonstrating that all key characteristics (product code, suture characteristic, intended use, technique of deployment, technological characteristic, material, sterilization, packaging) are "Identical" to the predicate devices, with the only specified modification being the decreased spacing between barbs to "increase tissue holding strength" (a functional claim, but not backed by a performance study in this document). The conclusion is a statement of belief in substantial equivalence rather than a report of study results against quantifiable acceptance criteria.

Key takeaway: This document represents a 510(k) submission where substantial equivalence is demonstrated through comparison to predicates, not through detailed performance studies against defined acceptance criteria.

Summary

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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: 703-796-8927 Fax: 703-673-0061 Email: testridge@angio.com

MAR 2 1 2008

Date Prepared: 03-07-08

	Name of Device:	Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone)
	Common Name:	Suture, Surgical, Absorbable, Polydioxanone
	Classification Name:	Absorbable polydioxanone surgical sutureRegulation 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:

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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 comprisedof PDO510(k) TBD	Quill® SyntheticAbsorbable Barbed Suture510(k) K051609	Quill TM SRS comprised ofPDO, 510(k) K071989
Product Code	NEW	Identical	Identical
SutureCharacteristic	Synthetic AbsorbableMonofilament	Identical	Identical
Intended Use	Soft tissue approximation	Identical	Identical
Technique ofDeployment	Attached needles	Identical	Identical
TechnologicalCharacteristic	Bi-directional barbs alongthe long axis of the suturemonofilament	Identical	Identical
Material	Polydioxanone	Identical	Identical
Sterilization	EO	Identical	Identical
Packaging	Device wound onto innersupport card, within a foilpouch within a poly/tyvekpouch	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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 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

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.