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. 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 QuillTM 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 QuilITM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Quill™ Self-Retaining System (SRS) comprised of PDO, based on the requested information.

Important Note: The provided document is a 510(k) summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and standalone performance studies in the way you might expect for a novel AI device. Therefore, much of the requested information, particularly regarding specific numerical acceptance criteria, detailed study designs for performance, sample sizes for test/training sets, expert qualifications, and AI-specific metrics (like MRMC studies or effect sizes for AI assistance), is not present in this type of regulatory submission.

The device discussed is a surgical suture, not an AI or imaging device. The "study" here refers to the comparisons made to predicate devices to demonstrate substantial equivalence, rather than a clinical trial proving specific performance metrics against a defined standard.

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria (Not Explicitly Stated as Numerical Targets)	Reported Device Performance (as demonstrated by equivalence)
Intended Use	Soft tissue approximation where absorbable suture is appropriate	Meets Predicate: Indicated for soft tissue approximation where use of an absorbable suture is appropriate. (Identical to predicate devices).
Technological Characteristics	Bi-directional barbs for tissue approximation (instead of knots)	Meets Predicate: Utilizes bi-directional barbs along the long axis of the suture monofilament. The primary modification of this specific submission (K080985) is to "decrease the spacing between the barbs... thereby increasing the number of barbs per linear length to increase tissue holding strength." This implies improved performance in this specific aspect compared to previous versions, while still maintaining the fundamental technological characteristic of the predicates.
Material Composition	Polydioxanone (PDO)	Meets Predicate: Comprised of polyester [poly (p-dioxanone)] per 21 CFR 878.4840. (Identical to predicate devices).
Sterilization Method	Ethylene Oxide (EO) Sterilization	Meets Predicate: Uses EO sterilization. (Identical to predicate devices).
Packaging	Device wound onto inner support card, within foil pouch, etc.	Meets Predicate: Packaged with device wound onto inner support card, within a foil pouch within a poly/tyvek pouch. (Identical to predicate devices).
Safety and Effectiveness (Overall)	As safe and effective as predicate devices	Meets Predicate: The document explicitly states: "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." This is the core claim of a 510(k) submission based on substantial equivalence. The specific modification (denser barbing) is presented as an enhancement to "increase tissue holding strength" without compromising overall safety or effectiveness compared to the already approved predicate devices.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The submission relies on a comparison to predicate devices, not an independent test set in the typical sense for performance evaluation in an AI context.
- Data Provenance: Not applicable in the context of an AI device. For this surgical suture, the "data" would be the characteristics and performance data of the predicate devices already approved by the FDA, and possibly internal testing data for the modified barb design, which is not detailed here. It's implicitly retrospective as it compares to existing, approved devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not applicable. Ground truth, in the AI sense, is not established for this device. The regulatory decision is based on assessing the device's design, materials, and intended use against established standards and predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. There is no expert adjudication process described for a "test set" in this context.
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:
- MRMC Study: No, this is not an AI device, so an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical surgical suture, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in the AI sense. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices, and the demonstration that the new device shares fundamental characteristics and performs equivalently or better in its specific modification.
The sample size for the training set:
- Training Set Sample Size: Not applicable.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable.

Summary of 510(k) Approach for K080985:

The K080985 submission for the Quill™ Self-Retaining System (SRS) comprised of PDO is a Special 510(k). This type of submission is typically used when a modification to an existing device (for which the manufacturer already holds a 510(k) clearance) does not raise new questions of safety and effectiveness.

The core of the "study" demonstrating the device meets "acceptance criteria" (which are implicitly the characteristics and performance of the predicate devices) is a comparison to predicate devices. The document highlights that the new device is:

Identical in Product Code, Suture Characteristics, Intended Use, Technique of Deployment, Technological Characteristic (overall barbed design), Material, Sterilization, and Packaging to its predicate devices.
The only described modification is a decrease in spacing between barbs to increase tissue holding strength. The implication is that this modification improves a key performance aspect without altering the fundamental safety or effectiveness profile, thus maintaining substantial equivalence.
The "acceptance criteria" are, therefore, the characteristics and performance standards already established and approved for the predicate Quill SRS devices (K051609, K071989, K080680). The device "meets" these by being substantially equivalent in all critical aspects, and implicitly improving upon one.
No specific clinical trials or studies with explicit numerical performance targets (e.g., tensile strength, degradation rates) are detailed in this summary, as is common for a Special 510(k) where the focus is on demonstrating that the change does not impact safety or effectiveness such that a new predicate comparison is needed.

Summary

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KO80985

Attachment L - 510(k) Summary

1. Applicant Contact:

ﺎﺕ

ﮨﻮ

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

Date Prepared: 04-04-08

2.	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

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

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

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 .
. Quill™ Self-Retaining System (SRS) comprised of PDO (Polydioxanone) by Surgical Specialties Corporation dba Angiotech, 510(k) K080680

4. Device Description:

Attachment L Page 1 of 3

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Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The top line reads "K080985", and the bottom line reads "page 2 of 3". The text appears to be part of a document or page numbering system.

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 QuillTM 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 QuilITM Self-Retaining System (SRS) comprised of PDO breaks, the remaining suture passes will hold the wound edges in approximation.

5. Intended Use of the Device:

Quill™ 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 SRScomprised of PDO510(k) TBD	Quill TM SRScomprised ofPDO, 510(k)K080680	Quill TM SRScomprised ofPDO, 510(k)K071989	Quill® SyntheticAbsorbable BarbedSuture 510(k)K051609
Product Code	NEW	Identical	Identical	Identical
SutureCharacteristic	Synthetic AbsorbableMonofilament	Identical	Identical	Identical
Intended Use	Soft tissue approximation	Identical	Identical	Identical
Technique ofDeployment	Attached needles	Identical	Identical	Identical
TechnologicalCharacteristic	Bi-directional barbs alongthe long axis of the suturemonofilament	Identical	Identical	Identical
Material	Polydioxanone	Identical	Identical	Identical
Sterilization	EO	Identical	Identical	Identical
Packaging	Device wound onto innersupport card, within a foilpouch within a poly/tyvekpouch	Identical	Identical	Identical

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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.

8. Conclusion

く

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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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-like symbol with three flowing ribbons or lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

Surgical Specialties Corporation % Angiotech Trudy D. Estridge, Ph.D. Director, Regulatory Affairs 13921 Park Center Road, Suite 200 Herndon, Virginia 20171

Re: K080985

Trade/Device Name: Elta Advanced Wound Wash Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: April 4, 2008 Received: April 7, 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

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

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.

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 Wilkerson

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:

K080985

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

Indications for Use:

QuillTM Self-Retaining System (SRS) comprised of PDO 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)

eilre of
(Division Sign-Off) fr

Division of General, Restorative, and Neurological Devices

510(k) Number K080985

QuillTM SRS comprised of PDO - Special 510(k)

Attachment F Page 1 of 1

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.