(44 days)
Not Found
No
The device description focuses on the physical properties and mechanism of action of a barbed suture, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a barbed suture used for soft tissue approximation, which is a surgical tool, not a therapeutic device designed for treatment or therapy.
No
Explanation: The device is described as a surgical suture used for tissue approximation, which is a therapeutic function, not a diagnostic one. It does not identify or detect medical conditions.
No
The device description clearly describes a physical, absorbable suture made from a polymer, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of absorbable suture is appropriate." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical suture made of a polymer, designed to be implanted in tissue.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a surgical implant.
Therefore, the Contour Thread™ Synthetic Absorbable PDO Barbed Suture is a surgical device, not an IVD.
N/A
Intended Use / 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.
Contour Thread™ Synthetic Absorbable PDO Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable suture is appropriate.
Product codes
NEW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dermis, soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 |
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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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™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
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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
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 |
|---|---|
| --------------- | --------- |
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