(31 days)
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Monoderm™ 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 Size 2-0 in various lengths affixed to various needle types.
The provided document is a 510(k) summary for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. It describes the device, its indication for use, and a general statement about performance testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information to fully address all parts of your prompt.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative values or pass/fail thresholds. The document generally refers to conforming to the USP monograph for absorbable sutures and demonstrating substantial equivalence.
- Reported Device Performance: The document states that "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices." No specific performance metrics (e.g., actual tensile strength values, degradation rates) are provided.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Conformance to USP monograph for absorbable sutures for tensile strength and needle attachment. | Conforms |
| Substantial equivalence to predicate devices (Quill™ Monoderm™, Quill™ PDO Knotless Tissue-Closure Device, V-Loc™ 90 Absorbable Wound Closure Device) through simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing. | Demonstrated substantially equivalent to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: The document only mentions "testing" and "simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing." It does not specify country of origin, retrospective or prospective nature, or where the testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a surgical suture, and the performance tests described are mechanical and material characterization studies, not image interpretation or diagnostic studies that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/imaging device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical laboratory performance testing (tensile strength, needle attachment), the "ground truth" would be established by standardized measurement techniques and USP monograph specifications.
- For the simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing, the "ground truth" would be the measured physical properties of the device and the predicate devices, compared against each other.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device that requires a training set. The performance tests are experimental studies, not algorithm training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: The provided 510(k) summary offers a high-level overview of the device and the types of performance testing conducted to support substantial equivalence. It lacks the detailed quantitative data, sample sizes, and specific methodologies that would be required to fully answer most of your detailed questions, particularly those related to clinical studies, AI performance, or expert-adjudicated ground truth, as those concepts do not apply to this type of device and submission.
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K 122898 Page 1/2
510(k) Summary
Date Prepared: October 16, 2012 Company: Angiotech 100 Dennis Dr. Reading, PA 19606 Contact: . Kirsten Stowell Regulatory Affairs Manager Phone: 610-404-3367 Fax: 610-404-3924 Email: kstowell@angio.com Device trade name: QuillTM Monoderm Knotless-Tissue Closure Device, Variable Loop Design Device Common Absorbable poly(glycolide/1-lactide) Surgical Suture Name: Device classification: Absorbable poly(glycolide/l-lactide) Surgical Suture Product code, GAM 21 CFR 878.4493 Class II Legally marketed K113744: Quill™ PDO Knotless Tissue-Closure Device devices to which the (Polydioxanone) device is substantially K072028: QuillTM Self-Retaining System (SRS) equivalent: comprised of Monoderm™ K100257: V-Loc™ 90 Absorbable Wound Closure Device The Quill™ Monoderm™ Knotless Tissue-Closure Device, Description of the Variable Loop Design is a sterile, synthetic absorbable tissuedevice: 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 Size 2-0 in various lengths affixed to various needle types.
OCT 22 2012
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K122996 Page 2/2
Indications for Use:
Quill™M Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Monoderm™ Knotless Tissue-Closure device, Substantial Equivalence: Variable Loop Design is identical in material composition and size range as the Quill™ Monoderm™ predicate. The proposed device is identical in design to the Quill™ PDO Knotless Tissue-Closure Device predicate. In addition, the propsed device has the same intended use as all three 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 simulated use tensile testing in porcine tissue and in vitro post-hydrolysis 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Specialties Corporated, DBA Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
OCT
22 2012
Re: K122898
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: Class II Product Code: GAM Dated: September 14, 2012 Received: September 21, 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
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Page 2 - Ms. Kirsten Stowell
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
sincerely yours,
Mark N. Melkerson
Director
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: Quil!™ 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)
Daniel Kramer MM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122898
§ 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.