← Product Code [NEW](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEW) · K053380 # CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (K053380) _Surgical Specialties Corp · NEW · Jan 18, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEW/K053380 ## Device Facts - **Applicant:** Surgical Specialties Corp - **Product Code:** [NEW](/submissions/SU/subpart-e%E2%80%94surgical-devices/NEW.md) - **Decision Date:** Jan 18, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4840 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Contour Thread™ Synthetic Absorbable PDO barbed sutures are indicated to close easily approximated edges of dermis where use of absorbable suture is appropriate. ## Device Story Contour Thread™ is a synthetic absorbable polydioxanone (PDO) monofilament suture featuring bi-directional barbs. Designed for subcuticular placement, the device is used by surgeons to approximate tissue edges. The barbs catch and cinch within the tissue, providing the security of an interrupted suture strand without requiring a knot. The suture is available in dyed (violet) and undyed (clear) versions with various lengths and needle configurations. It degrades/dissolves in tissue over time. If a strand breaks, remaining passes maintain wound approximation. The device benefits patients by eliminating knot-related bulk and simplifying the closure process. ## Clinical Evidence Evidence includes biocompatibility data, simulated use evaluations, in vivo barb holding and absorption assessments, in vivo animal studies, and human clinical trial results. No specific numerical performance metrics (e.g., sensitivity, specificity) are provided as the device is a mechanical surgical suture. ## Technological Characteristics Material: Poly (p-dioxanone) (PDO). Configuration: Monofilament with bi-directional barbs. Deployment: Subcuticular placement. Sterilization: Not specified. Connectivity: None. Software: None. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Quill™ Synthetic Absorbable Barbed Suture ([K051609](/device/K051609.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K053380 1/3 ## JAN 1 8 2006 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY | Submitter: | Surgical Specialties Corporation | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 100 Dennis Drive
Reading, 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 Barbed
Suture | | Common / Usual
Classification Name: | NEW
Absorbable 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 barbed
sutures are indicated to close easily approximated edges of
dermis 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 | Image /page/0/Picture/5 description: The image contains the number 12, which is circled. The number is written in a simple, sans-serif font. The circle is slightly elongated, resembling an oval shape. The image is in black and white. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {1}------------------------------------------------ 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™Synthetic
Absorbable PDO Barbed
Suture | Quill® Synthetic Absorbable
Barbed Suture | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technique of
Deployment | Subcuticular placement: Needle captures a
precise bite on each side of the incision | Subcuticular placement: Needle captures a
precise bite on each side of the incision. | | Technological
Characteristic to
Approximate Tissue | Bi-directional barbs along the long axis of
the suture monofilament catch and cinch to
approximate the tissue as does an interrupted
suture strand but without the need of a knot. | Bi-directional barbs along the long axis of
the suture monofilament catch and cinch to
approximate the tissue as does an
interrupted suture strand but without the
need 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™ Synthetic
Absorbable PDO Barbed Suture | Quill®Absorbable Barbed
Suture | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indicated
Use | Contour Thread™Synthetic
Absorbable PDO Barbed sutures
are indicated to close easily
approximated edges of dermis
where use of absorbable sutures is
appropriate. | Quill® Absorbable Barbed
sutures are indicated to
close easily approximated
edges of dermis where use
of absorbable sutures is
appropriate. | #### 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 13 {2}------------------------------------------------ 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. {3}------------------------------------------------ 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. {4}------------------------------------------------ #### 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 {5}------------------------------------------------ # 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) | |------------------|----------------------------------------------------------------------------------| |------------------|----------------------------------------------------------------------------------| (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 | |---------------|---------| |---------------|---------| Page 1of 1 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEW/K053380](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEW/K053380) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com