Contour Thread™ Synthetic Absorbable PDO Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable suture is appropriate.

Device Description

The Contour Thread™ Synthetic Absorbable PDO Barbed Suture is made from the polymer, poly (p-dioxanone). It is available in a dyed (violet) and undyed (clear) incorporating a bi-directional barbed configuration. The sutures are available in various lengths and needle configurations. The Contour Thread™ Synthetic Absorbable PDO Barbed Suture degrades or dissolves over time in tissue. The Contour Thread™ Synthetic Absorbable PDO Barbed Suture 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 Contour Thread™ Synthetic Absorbable PDO Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Contour Thread™ Synthetic Absorbable PDO Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

AI/ML Overview

This document describes a 510(k) premarket notification for the Contour Thread™ Synthetic Absorbable PDO Barbed Suture. The key aspect of this submission is demonstrating substantial equivalence to a predicate device, the Quill™ Synthetic Absorbable Barbed Suture (K051609), rather than presenting independent performance criteria and an associated study with specific quantitative acceptance metrics.

Therefore, the requested information elements related to specific acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies) are not present in this document, as the submission relies on the established safety and effectiveness of the predicate device and the material itself.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or a direct comparison of the Contour Thread™ device's performance against such criteria. Instead, it argues for substantial equivalence to a predicate device.

The "performance data" section states:

"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. There are no differences between the Quill® Synthetic Absorbable Barbed Suture and the Contour Thread™ Synthetic Absorbable PDO 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."

And:

"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 Contour Thread™ Synthetic Absorbable PDO Barbed Suture and the Quill® Synthetic Absorbable Barbed Suture."

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" or its sample size in the context of device performance evaluation. The submission refers to "in vivo barb holding and absorption assessments," "in vivo animal studies," and "human clinical trial results," but does not provide details on their methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided because the submission focuses on substantial equivalence rather than a new standalone performance evaluation requiring expert ground truth for a test set.

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

This information is not provided.

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

This is not applicable as the device is a surgical suture, not an AI-assisted diagnostic or imaging tool.

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

This is not applicable as the device is a surgical suture, not an algorithm. The "standalone" evaluation here refers to the device itself. The document states that "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." These would constitute elements of a standalone evaluation of the physical device.

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

For the safety and performance data mentioned (biocompatibility, in vivo barb holding, absorption assessments, animal studies, human clinical trials), the ground truth would likely be based on:

Biocompatibility: Standardized material testing and biological response assays.
Barb Holding and Absorption: Direct measurement and observation in animal models.
Clinical Trials: Patient outcomes data, clinical assessments by physicians, and potentially histological analysis for absorption.

However, specific details are not elaborated in this document.

8. The sample size for the training set

This concept is not relevant to this device submission, which is for a surgical suture. There is no "training set" in the context of machine learning or AI.

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

This is not applicable, as explained in point 8.

Summary

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K053380

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JAN 1 8 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY

Submitter:	Surgical Specialties Corporation
Address:	100 Dennis DriveReading, PA 19606
Telephone:	610-404-1000
Contact Person:	Elizabeth Lazaro
Title:	Regulatory Affairs Specialist
Date Prepared:	December 1, 2005
Name of Device:	Contour Thread™ Synthetic Absorbable PDO BarbedSuture
Common / UsualClassification Name:	NEWAbsorbable polydioxanone surgical suture
Predicate Device:	Quill™ Synthetic Absorbable Barbed Suture 510(k)number K051609 is identical to Contour Thread™Synthetic Absorbable PDO Barbed Sutures
Indications for Use:	The Contour Thread™ Synthetic Absorbable PDO barbedsutures are indicated to close easily approximated edges ofdermis where use of absorbable suture is appropriate.
Device Description:	The Contour Thread™ Synthetic Absorbable PDO BarbedSuture is made from the polymer, poly (p-dioxanone). It isavailable in a dyed (violet) and undyed (clear)incorporating a bi-directional barbed configuration. Thesutures are available in various lengths and needleconfigurations. The Contour Thread™ SyntheticAbsorbable PDO Barbed Suture degrades or dissolves overtime in tissue.
	The Contour Thread™ Synthetic Absorbable PDO BarbedSuture approximate tissues by using the opposing barbs onthe suture surface to imbed in the tissues after the surgeonprecisely places the suture within the tissues. Each ContourThread™ Synthetic Absorbable PDO Barbed Suture passprovides the security of an interrupted suture strand withoutthe added bulk of a knot. As with interrupted sutures, if the

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Contour Thread™ Synthetic Absorbable PDO Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.

Technological Characteristics:

The Contour Thread™ Synthetic Absorbable PDO Barbed Suture is identical in technological characteristics to the following predicate device:

	Contour Thread™SyntheticAbsorbable PDO BarbedSuture	Quill® Synthetic AbsorbableBarbed Suture
Technique ofDeployment	Subcuticular placement: Needle captures aprecise bite on each side of the incision	Subcuticular placement: Needle captures aprecise bite on each side of the incision.
TechnologicalCharacteristic toApproximate Tissue	Bi-directional barbs along the long axis ofthe suture monofilament catch and cinch toapproximate the tissue as does an interruptedsuture strand but without the need of a knot.	Bi-directional barbs along the long axis ofthe suture monofilament catch and cinch toapproximate the tissue as does aninterrupted suture strand but without theneed of a knot.

Intended Use Comparison:

The Contour Thread™ Synthetic Absorbable PDO Barbed Suture is identical in intended use to the following predicate device:

	Contour Thread™ SyntheticAbsorbable PDO Barbed Suture	Quill®Absorbable BarbedSuture
IndicatedUse	Contour Thread™SyntheticAbsorbable PDO Barbed suturesare indicated to close easilyapproximated edges of dermiswhere use of absorbable sutures isappropriate.	Quill® Absorbable Barbedsutures are indicated toclose easily approximatededges of dermis where useof absorbable sutures isappropriate.

Performance Data:

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

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device. There are no differences between the Quill® Synthetic Absorbable Barbed Suture and the Contour Thread™ Synthetic Absorbable PDO 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 Contour Thread™ Synthetic Absorbable PDO Barbed Suture and the Quill® Synthetic Absorbable Barbed Suture.

Substantial Equivalence:

The Contour Thread™ Synthetic Absorbable PDO Barbed Suture is identical to the product and intended use as The Quill® Synthetic Absorbable Barbed Suture approved in the 510(k) K051609.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K053380

Trade/Device Name: Contour Thread TM Synthetic Absorbable PDO Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: December 2, 2005 Received: December 5, 2005

Dear Ms. Lazaro:

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 - Ms. Lazaro

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 prarketed 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 11 you attitle 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/industry/support/index.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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Indications for Use

510(k) Number (if known): 长0533380 Device Name: Contour Thread™ Synthetic Absorbable PDO Barbed Suture.

Indications for Use:

Contour Thread™ Synthetic Absorbable PDO Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable suture is appropriate.

Prescription Use	✓ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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(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	K053380
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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.