Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Description

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is a synthetic absorbable monofilament suture prepared from a copolymer of glycolide and e-caprolactone (per 21 CFR 878.4493). 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 0, 2-0 and 3-0. Each suture has bi-directional barbs along the long axis of the suture monofilament.

The Quill™ Self-Retaining System (SRS) comprised of MONODERMIM 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 MONODERM™ pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ breaks, the remaining suture passes will hold the wound edges in approximation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ sutures. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and measured performance metrics in the way one would for a new clinical device or AI algorithm.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not available in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Not applicable in the traditional sense for this 510(k))

This 510(k) submission does not establish performance acceptance criteria in the form of specific quantitative metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it report device performance as such. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.

The study referenced is an animal study comparing the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ to MONOCRYL sutures to assess the capabilities of barbs to knots in maintaining wound approximation. However, the document does not provide specific performance data or statistical analysis from this study. It only states that the study was conducted to "assess the capabilities."

Table of "Acceptance Criteria" (Substantial Equivalence Factors) and "Reported Device Performance" (Comparison to Predicates):

Factor for Substantial Equivalence	Predicate Device (MONODERM™ / MONOCRYL) Characteristic	Quill™ SRS comprised of MONODERM™ Characteristic / "Performance"
Intended Use	Soft tissue approximation where absorbable suture is appropriate	Identical
Technological Characteristic	Utilizes knots to secure the suture (MONOCRYL)	Bi-directional barbs along the long axis of the suture monofilament
	(Implied: Provides wound approximation)	The animal study was conducted to "maintain wound approximation" using barbs vs. knots (details not provided)
Material	Polyglycolide/l-lactide (MONODERM) / Poliglecaprone 25 (MONOCRYL)	PGA-PCL (copolymer of glycolide and e-caprolactone) - Identical to MONODERM, Similar to MONOCRYL
Sterilization	EO	Identical
Packaging	Device wound onto inner support card, within a foil pouch, within a poly/tyvek pouch	Identical
Safety and Effectiveness	Safe and effective (as legally marketed predicates)	Stated that differences do not raise questions regarding safety and effectiveness; device is as safe and effective as predicates.

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

Sample Size: Not specified in the provided document. The submission mentions "animal studies" comparing the device to MONOCRYL, but does not provide details on the number of animals or specific experimental groups.
Data Provenance: Not specified. The animal studies would typically be prospective, but the location of the study is not mentioned.

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

Not Applicable. This type of information is generally relevant for studies involving qualitative assessments or diagnostic accuracy by human readers, often in medical imaging or pathology. This 510(k) submission describes a physical medical device (suture) and relies on animal studies for performance, not expert ground truth for a diagnostic task.

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

Not Applicable. Adjudication methods are typically used when multiple human experts provide assessments that need to be reconciled, which is not the case for an animal study of suture performance as described here.

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 a 510(k) submission for a surgical suture, not an AI algorithm or a diagnostic tool that involves human readers.

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

Not Applicable. This is a 510(k) submission for a surgical suture, not an algorithm.

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

The "ground truth" in the context of the animal studies would likely relate to objective measures of wound approximation/healing, tensile strength retention, or inflammatory response, as assessed by veterinary pathologists or other scientific measures in an animal model. Specific methods are not detailed in this submission.

8. The sample size for the training set

Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.

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

Not Applicable. This is a 510(k) submission for a physical medical device (suture), not an algorithm that requires a training set.

Summary

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1. Applicant Contact:

Lois Smart Senior Manager Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA Phone: 443-421-0933 Fax: 703-621-9250 Email: Ismart@aangio.com

K07 2028
Page 1 of 3

AUG - 3 2007

Date Prepared: 07-23-07

2.	Name of Device:	Quill™ Self-Retaining System (SRS) comprised of MONODERM™
	Common Name:	Suture, absorbable, synthetic, polyglycolic acid
	Classification Name:	Absorbable poly(glycolide/l-lactide) surgical sutureRegulation 21 CFR 878.4493, Product Code GAM

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

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

Quill® Synthetic Absorbable Polydioxanone Barbed Suture by Quill Medical, . Inc., 510(k) K051609
MONODERM™ Synthetic Absorbable Surgical Suture by Surgical . Specialties Corp., 510(k) K052437
MONOCRYL (Poliglecaprone 25) suture, undyed by ETHICON, Inc., 510(k) . K964072
MONOCRYL (Poliglecaprone 25) suture, dyed by ETHICON, Inc., 510(k) . K960653

Device Description: 4.

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K 072028
page 2 of 3

ડ. Intended Use of the Device:

QuillTM Self-Retaining System (SRS) comprised of MONODERM™ 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.

Indication for Use and Technologv Comparison:

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is equivalent to the Quill® Synthetic Absorbable Polydioxanone Barbed Suture 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 Quill™ Self-Retaining System (SRS) comprised of MONODERM™ was compared to MONOCRYL in animal studies to assess the capabilities of barbs to knots in order to maintain wound approximation.

Material Comparison:

The Quill™ Self-Retaining System (SRS) comprised of MONODERM™ is equivalent to the MONODERM™ Synthetic Absorbable Surgical Suture manufactured by Surgical Specialties Corp. as identical materials (fiber-needles & packaging materials) and sterilization method/sterilization cycle is utilized. In addition, the MONODERM™ Synthetic Absorbable Surgical Suture has an intended use of soft tissue approximation

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	Quill™ SRScomprised ofMONODERM510(k) TBD	SyntheticAbsorbablePDO BarbedSutures,K051609	MONODERMK052437	MONOCRYLundyed,K964072	MONOCRYLdyed,K960653
Product Code	GAM	Different - NEW	Identical	Identical	Identical
SutureCharacteristic	Synthetic AbsorbableMonofilament	Identical	Identical	Identical	Identical
Intended Use	Soft tissueapproximation	Identical	Identical	Identical	Identical
Technique ofDeployment	Attached needles	Identical	Identical	Identical	Identical
TechnologicalCharacteristic	Bi-directional barbsalong the long axis ofthe suturemonofilament	Identical	Different -Utilizesknots to secure thesuture	Different -Utilizes knots tosecure the suture	Different -Utilizes knots tosecure the suture
Material	PGA-PCL	Different -Polydioxanone	Identical	Similar -Poliglecaprone25	Similar -Poliglecaprone25
Sterilization	EO	Identical	Identical	Identical	Identical
Packaging	Device wound ontoinner support card,within a foil pouchwithin a poly/tyvekpouch	Identical	Identical	Identical	Identical

The comparison of the predicate devices to the new device is summarized below:

7. Safety and Performance:

The difference between the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ and the above mentioned predicate devices do 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.

Conclusion 8.

Based on the design, material, function and intended use discussed herein, Angiotech believes the Quill™ Self-Retaining System (SRS) comprised of MONODERM™ 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 or bird-like symbol composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -3 2007

Angiotech % Lois Smart Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

Re: K072028

Trade/Device Name: Quill" Self-Retaining System (SRS) comprised of MONODERM™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/Llactide) surgical suture Regulatory Class: II Product Code: GAM Dated: July 23, 2007 Received: July 24, 2007

Dear Lois 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 - Lois 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerelv vo 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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Section 4 - Indications for Use Statement

510k number if known:

K0720

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

Indications for Use:

Quill™ Self-Retaining System (SRS) comprised of MONODERM™ 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)

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

510(k) Number

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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.