The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding a Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K15112). This device is a nonabsorbable polypropylene surgical suture.

Based on the provided text, a "study" in the traditional sense of evaluating an AI or software device to meet acceptance criteria with various types of ground truth and reader studies was not conducted. The document describes a substantial equivalence determination for a medical device (suture), not an AI/software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD performance evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence determination for a physical medical device (suture), the "acceptance criteria" and "reported device performance" are framed around demonstrating equivalence to a predicate device and adherence to recognized standards.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to USP monograph for nonabsorbable sutures	Testing demonstrated conformance to the USP monograph.
Conformance to FDA's Class II Special Controls Guidance Document	Testing performed in accordance with this guidance document.
Substantial equivalence to predicate device (K130078)	"The results of this testing demonstrate that the Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device." The only difference is suture diameter.
	Specific performance metrics (e.g., tensile strength, knot security) are implied by USP conformance but not explicitly detailed in the summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document refers to "Non-clinical laboratory performance testing." This typically involves in-vitro or bench testing of the physical suture material. No information about sample size, country of origin, or whether the data was retrospective or prospective is provided in this summary. It is laboratory data, not patient data in the context of disease diagnosis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study involving expert review for establishing ground truth for diagnostic or prognostic purposes. The "ground truth" for a suture's physical properties would be established through standardized laboratory testing methods and measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. 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:

Not applicable. This is not an AI/SaMD device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device would be based on the physical and mechanical properties of the suture as measured by standardized laboratory methods (e.g., tensile strength, dimension conformity, material composition checks) as defined by the USP monograph for surgical sutures.

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD device that requires training data.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/SaMD device that requires training data and corresponding ground truth.

Summary regarding AI/SaMD criteria applicability:

The provided document describes the FDA's 510(k) clearance for a physical medical device (surgical suture) based on substantial equivalence. It does not provide information relevant to the assessment of an AI/Software as a Medical Device (SaMD), as it is not such a device. Therefore, most of the detailed questions regarding AI/SaMD acceptance criteria, study design, ground truth, and reader studies are not applicable to this document. The "performance tests" mentioned are non-clinical laboratory tests to ensure the physical device meets established material and manufacturing standards and is equivalent to the predicate device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2015

Angiotech Ms. Hilary Wells Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

Re: K15112

Trade/Device Name: Quill" Polypropylene Knotless Tissue-Closure Device, Variable Loop Design Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: August 9, 2015 Received: August 11, 2015

Dear Ms. Wells:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K151112

Device Name

QuillTM Polypropylene Knotless Tissue-Closure Device, Variable Loop Design

Indications for Use (Describe)

Quil™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	September 8, 2015
Company:	Angiotech100 Dennis Dr.Reading, PA 19606
Contact:	Hilary WellsRegulatory Affairs ManagerPhone: 847-271-5235Fax: 610-404-3924Email: hwells@surgicalspecialties.com
Device trade name:	Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design
Device Common Name:	Nonabsorbable Polypropylene Surgical Suture
Device classification:	Nonabsorbable Polypropylene Surgical SutureProduct code, GAW21 CFR 878.5010Class II
Legally marketed device to which the device is substantially equivalent:	K130078: Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design, Size 0-
Description of the device:	The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.
Indications for Use:	Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis
Substantial	The proposed additional diameter sizes, Size 1 & 2, of the QuillTM
Equivalence:	Polypropylene Knotless Tissue-Closure Device, Variable LoopDesign product line have the same material, design, intended useand technological characteristics as the predicate device. Theonly difference between the proposed and predicate device is thesuture diameter.
Performance tests:	Non-clinical laboratory performance testing was conducted toconfirm that the QuillTM Polypropylene Knotless Tissue-ClosureDevice, Variable Loop Design conforms to the USP monograph

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for nonabsorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device.

The results of this testing demonstrate that the Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
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.(b)
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.