(48 days)
Not Found
No
The summary describes a physical medical device (suture) and its mechanical properties and performance, with no mention of software, algorithms, or AI/ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device, a suture, is used for soft tissue approximation, which is a supportive function rather than a direct treatment.
No
The device is a surgical suture used for tissue approximation, not for diagnosing conditions or diseases. Its purpose is to physically hold tissues together.
No
The device is a physical suture made from a polymer, designed for soft tissue approximation. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The description clearly states that the Quill® Synthetic Absorbable Barbed Sutures are used for "soft tissue approximation" and are "imbed[ded] in the tissues" within the body.
- Lack of Diagnostic Function: The device's purpose is to physically hold tissues together, not to analyze biological samples or provide diagnostic information.
Therefore, based on the provided information, the Quill® Synthetic Absorbable Barbed Suture is a surgical device used for tissue repair, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue.
The Quill® Synthetic Absorbable Barbed Sutures 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 Quill® Synthetic Absorbable Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quil® Synthetic Absorbable 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
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 Quill® Synthetic Absorbable Barbed Suture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042075, K050548, K024117, K973313
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
1/4
Section E - 510(k) Summary
1. Applicant Contact:
Lois Smart Director, Quality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Drive, Suite 150 Research Triangle Park, NC 27713 Phone: 919-806-1961 Fax: 919-806-1953 Email: Ismart@quillmedical.com
Date Prepared: 6-16-05
Name of Device: Quill® Synthetic Absorbable Barbed Suture 2. Common Name: Polydioxanone Absorbable Surgical Sutures Absorbable Polydioxanone Surgical Suture Classification Name: Regulation 21 CFR 878.4840, Product Code NEW
3. Identification of device(s) to which the submitted claims equivalence:
The Quill® Synthetic Absorbable Barbed Suture is substantially equivalent to the following predicate devices:
- For Material Safety and Technological Characteristics: .
- For Indication for Use: .
1
Ko 5160744
Section E - 510(k) Summary (continued)
4. Device Description:
The Quill® Synthetic Absorbable Barbed Suture is made from the polymer, poly(p-dioxanone). It is available in a dyed form (violet) in various suture lengths (minimum opposing barbed segment of 1 3/8" x 1 3/8") and needle configurations. The Quill® Synthetic Absorbable Barbed Suture degrades or dissolves over time in tissue.
The Quill® Synthetic Absorbable Barbed Sutures 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 Quill® Synthetic Absorbable Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Quil® Synthetic Absorbable Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
5. Intended Use of the Device:
Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
2
51609$_{3/4}$
Section E - 510(k) Summary (continued)
Characteristics of the device in comparison to those of the predicate device(s) 6.
Technological Characteristic Comparison:
The Quill® Synthetic Absorbable Barbed Suture is equivalent in technological characteristics to the following predicate devices:
| | Quill® Synthetic
Absorbable Barbed
Suture | Contour Midface
Opposing Uni-
directional
Thread | Insorb™
Absorbable
Staple |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Technique of
Deployment | Subcuticular placement:
Needle captures a precise
bite on each side of the
incision. | Subcuticular placement:
Needle placement (or
placed by introducer). | Subcuticular placement:
Mechanically placed by
a stapler to capture 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. | Opposing unidirectional
cogs along the long axis
of the suture
monofilament to fixate
the cheek subdermis in an
elevated position. | Cleats of the u-shaped
staple approximate
tissue after the stapler is
retracted. |
| Predicate | PDS II Suture:
N18331 | Contour Extended
Length Threads
K041593 | Traditional absorbable
staples (two-piece
staple and receiver):
K915489 & K915693 |
Intended Use Comparison:
The Quill® Synthetic Absorbable Barbed Suture is equivalent in intended use to the following predicate devices:
| Y-Knot Suture Clip | Insorb™ Absorbable Staple | |
|---|---|---|
| Intended Use | For use in general soft tissue | |
| approximation and/or ligation | ||
| with #1 and #2 braided polyester | ||
| suture. | For use in abdominal, thoracic, gynecologic, | |
| orthopedic, plastic and reconstructive surgery | ||
| for the subcuticular closure of skin where an | ||
| absorbable tissue fastener is desired for | ||
| temporary tissue approximation. | ||
| Performance | ||
| Data Used for | ||
| Clearance | Mechanical Performance Testing | |
| (Y-Knot suture fixation | ||
| compared to a knotted suture) | An Animal Study | |
| Mechanical Performance Testing | ||
| Package Testing | ||
| Predicate | Ethibond Extra Polyester Suture | Traditional absorbable staples (two-piece |
| staple and receiver) |
3
KOS16094/4
Section E - 510(k) Summary (continued)
Material Safety Comparison:
The Quill® Synthetic Absorbable Barbed Suture is equivalent in material to the predicate device, Quill® Synthetic Absorbable Barbed Suture, cleared by 510k K042075.
7. Safety and Performance:
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. The difference between the Quill® Synthetic Absorbable Barbed Suture and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the 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 Quill® Synthetic Absorbable Barbed Suture.
8. Conclusion
Based on the design, materials, function, intended use and performance evaluations discussed herein, Quill Medical believes the Quill® Synthetic Absorbable Barbed Suture is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines representing the bird's body and head. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2005
Ms. Lois V. Smart Director, Ouality Assurance and Regulatory Affairs Quill Medical, Inc. 2505 Meridian Parkway, Suite 150 Research Triangle Park, North Carolina 27713
Re: K051609
Trade/Device Name: Quill™ Synthetic Absorbable Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: June 16, 2005 Received: June 17, 2005
Dear Ms. 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.
5
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
6
Section D - Statement of Indications for Use
K051609 510k number if known:
Quill® Synthetic Absorbable Barbed Suture Device Name:
Indications for Use:
. .
Quill® Synthetic Absorbable Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Prescription Use ﺳﮯ (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)
En Rh
Revision Sign Off
Civision Sign-Off) Division of General, Restorative and Neurological Devices
Page Number K051609