(8 days)
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 1 to 3-0, in various lengths affixed to various needle types.
This document describes the premarket notification (510(k)) for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| USP Monograph for Absorbable Sutures: | |
| - Tensile Strength | Conforms to USP monograph |
| - Needle Attachment | Conforms to USP monograph |
| Substantial Equivalence to Predicate Devices: | |
| - In vitro post-hydrolysis tensile testing | Demonstrates substantial equivalence to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the "test set" in the context of human data or clinical study. The performance testing described is non-clinical laboratory performance testing. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to human subjects is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance is established through non-clinical laboratory testing according to established standards (USP monograph) and direct comparison to predicate devices, not through expert consensus on a test set of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of this device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical suture, not an algorithm or software.
7. The Type of Ground Truth Used
The ground truth used for this device includes:
- USP Monograph Standards: For tensile strength and needle attachment. These are well-defined, established standards for absorbable sutures.
- Predicate Device Performance Data: For in vitro post-hydrolysis tensile testing, the performance of the predicate devices serves as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (suture) and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K123836 Page 1/2
510(k) Summary
DEC 2 1 2012
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| Date Prepared: | December 12, 2012 |
|---|---|
| Company: | Angiotech100 Dennis Dr.Reading, PA 19606 |
| Contact: | Kirsten StowellRegulatory Affairs ManagerPhone: 610-404-3367Fax: 610-404-3924Email: kstowell@angio.com |
| Device trade name: | QuillTM MonodermTM Knotless-Tissue Closure Device, VariableLoop Design |
| Device CommonName: | Absorbable poly(glycolide/l-lactide) Surgical Suture |
| Device classification: | Absorbable poly(glycolide/l-lactide) Surgical SutureProduct code, GAM21 CFR 878.4493Class II |
| Legally marketeddevices to which thedevice is substantiallyequivalent: | K123409 QuillTM MonodermTM Knotless Tissue-ClosureDevice, Variable Loop Design, Size -0-K122898 QuillTM MonodermTM Knotless Tissue-ClosureDevice, Variable Loop Design, Size 2-0 |
| Description of thedevice: | The QuillTM MonodermTM Knotless Tissue-Closure Device,Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue.It is comprised of a copolymer of glycolide and e-caprolactone,undyed, or dyed with D&C Violet No. 2. The device is designedwith small uni-directional barbs along the long axis of the suturemonofilament which contains a welded primary loop andsecondary loop design at the distal end. It is available in diameterSizes 1 to 3-0, in various lengths affixed to various needle types. |
| Indications for Use: | QuillTM Knotless Tissue-Closure Device comprised ofMonodermTM is indicated for soft tissue approximation where useof an absorbable suture is appropriate. |
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K123836 Page 2/2
Substantial Equivalence: The QuillTM Monoderm™ Knotless Tissue-Closure device. Variable Loop Design is identical in material composition and size range as the Quill™ Monoderm™ predicates. The proposed device is identical in design to the Quill™ Monoderm™ Knotless Tissue-Closure Device predicate devices. In addition, the proposed device has the same intended use as both predicate devices.
Performance tests:
Non-clinical laboratory performance testing was conducted to confirm that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, 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. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate devices including in vitro posthydrolysis tensile testing.
The results of this testing demonstrates that the QuillTM Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Surgical Specialties Corporation, DBA Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
December 21, 2012
Re: K123836
Trade/Device Name: Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design
Regulation Number: 21 CFR 878.4493
Regulation Name: Absorbable poly (glycolide/l-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: December 12, 2012 Received: December 13, 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 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
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Page 2 - Ms. Kirsten Stowell
forth in the quality systems (OS) 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical 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: K123836
Device Name: Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design
Indications for Use;
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ 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 Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123836
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.