(43 days)
Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is a synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)] monofilament suture material, dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the length of the device, and a welded loop at the distal end which is used to form the secondary variable loop, used to secure the device at the distal end. The device is available in diameter Size 0 in various lengths affixed to various needle types.
The Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) was evaluated through non-clinical laboratory performance testing to establish its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Monograph for Absorbable Sutures) | Reported Device Performance | Outcome |
|---|---|---|
| Tensile Strength (as applicable) | Confirmed to USP monograph | Met |
| Needle Attachment | Confirmed to USP monograph | Met |
2. Sample Size and Data Provenance:
The sample size for the non-clinical laboratory testing is not specified in the provided document. The data provenance is from non-clinical laboratory testing, indicating that it's a prospective study conducted specifically for this device evaluation. The country of origin of the data is not explicitly stated, but the submission is to the US FDA.
3. Number of Experts and Qualifications:
This was a non-clinical laboratory study involving physical performance tests according to a standard. Therefore, there were no human experts used to establish ground truth in the traditional sense of medical image or diagnostic interpretation. The "ground truth" was the adherence to objective performance standards outlined in the USP monograph.
4. Adjudication Method:
As this was a non-clinical laboratory study with objective performance criteria, there was no adjudication method as typically applied in studies involving human interpretation or subjective assessments. Performance was measured against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed. This was a non-clinical performance study to demonstrate compliance with material and mechanical standards, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone non-clinical performance study was done. The device's performance (tensile strength and needle attachment) was evaluated against the USP monograph for absorbable sutures, without human intervention in the performance of the device itself.
7. Type of Ground Truth Used:
The ground truth used was objective performance standards defined by the USP Monograph for Absorbable Sutures for tensile strength and needle attachment. This is a scientific and regulatory standard.
8. Sample Size for the Training Set:
Not applicable. This was a non-clinical laboratory performance study, not a study involving machine learning or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set was used, no ground truth needed to be established for it.
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FEB - 1 2012
Section 5 – 510(k) Summary
| Date Prepared: | January 31, 2011 |
|---|---|
| Company: | Angiotech100 Dennis Dr.Reading, PA 19606 |
| Contact: | Kirsten StowellRegulatory Affairs ManagerPhone: 610-404-3367Fax: 610-404-3924Email: kstowell@angio.com |
| Device trade name: | Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) |
| Device Common Name: | Polydioxanone Absorbable Surgical Suture |
| Device classification: | Absorbable Polydioxanone Surgical SutureProduct code, NEW21 CFR 878.4840Class II |
| Legally marketed devices to which the device is substantially equivalent: | K051609: Quill Synthetic Absorbable Barbed SutureK082662: V-Loc 180 Absorbable Wound Closure Device |
| Description of the device: | The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is a synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)] monofilament suture material, dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the length of the device, and a welded loop at the distal end which is used to form the secondary variable loop, used to secure the device at the distal end. The device is available in diameter Size 0 in various lengths affixed to various needle types. |
| Indications for Use: | Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. |
/
K113744
P 1 of 2
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Substantial The Quill™ Knotless Tissue-Closure Device comprised of PDO Equivalence: (Polydioxanone) has the same design and materials as its predicates, including the same intended use, technological characteristics and size ranges as the predicate devices. The intended use is identical to both predicate devices. The material and chemical composition of the proposed device is identical to the predicate Quill Synthetic Absorbable Barbed Suture (K051609). The design of the proposed device is similar to the predicate V-Loc 180 Absorbable Wound Closure Device regarding the uni-directional barbs and the welded loop on the distal end. The technique used for deployment of the device is similar to the predicate V-Loc 180 Absorbable Wound Closure Device (K082662). Performance tests: Non-clinical laboratory performance testing was conducted to confirm that the QuillTM Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and needle attachment. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures. Issued June 3, 2003.
The results of this testing demonstrates that the Ouill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is substantially equivalent in safety and performance to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle faces left and is enclosed within a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2012
Angiotech % Ms. Kirsten Stowell 100 Dennis Drive Reading, Pennsylvania 19606
Re: K113744
Trade/Device Name: Quill PDO Knotless Tissue-Closure Device (Polydioxanone) Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: December 19, 2011 Received: January 09, 2012
Dear Ms. Stowell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Kirsten Stowell
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely, yours,
Mark M Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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:
Device Name: Quill™ PDO Knotless Tissue-Closure Device, Polydioxanone
Indications for Use:
Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Prescription Use __ X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Sacrofa MEM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113744
CONFIDENTIAL
§ 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.