(116 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 bi-directional barbs along the length that eliminate the need to tie knots during approximation. The device is available in various lengths in diameter sizes 2 through 4-0 with various needles attached to each end.
This document describes the K120827 Quill™ PDO Knotless Tissue-Closure Device. The provided text does not contain a specific table of acceptance criteria or detailed results of a study that directly proves the device meets quantitative criteria. Instead, it relies on a demonstration of "substantial equivalence" to predicate devices through performance testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of acceptance criteria or quantitative performance metrics. The submission relies on a qualitative statement of substantial equivalence.
Reported Device Performance (Qualitative):
"The results of this testing demonstrates that the Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is substantially equivalent in safety and performance to the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
The text states: "Pre-clinical animal performance testing was conducted to confirm and support the information provided in the QuillTM Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) Instructions for Use."
- Sample Size for Test Set: Not specified.
- Data Provenance: "Pre-clinical animal performance testing." The country of origin is not specified, but it's typically understood to be conducted under the manufacturer's internal protocols. This is a form of prospective testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The "ground truth" for this device's performance would primarily be derived from the animal model's physiological response to the suture (e.g., tissue approximation efficacy, absorption rate, inflammatory response) rather than expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of medical data (e.g., in diagnostic imaging studies) to establish a consensus ground truth. For animal performance testing of a physical device, the assessment would be based on direct observation, physical measurements, and histological analysis, not on expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are relevant for diagnostic AI tools where human readers are interpreting data. This submission is for a physical medical device (suture) and its performance in animal models, not an AI algorithm assisting human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. A standalone study typically refers to the performance of an AI algorithm without human involvement. This submission is for a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for this type of device performance testing would be based on:
- Direct observation and measurement of the suture's physical interaction with tissue (e.g., tissue approximation).
- Histological analysis of tissue response (e.g., inflammation, foreign body reaction, absorption characteristics).
- Mechanical testing (e.g., tensile strength over time, knot security) although the text specifically mentions "Knotless" suggests this might be different.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device; its development relies on engineering principles and materials science, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
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Section 5 – 510(k) Summary
JUL 1 3 2012
| Date Prepared: | March 16, 2012 | |
|---|---|---|
| Company: | Angiotech100 Dennis Dr.Reading, PA 19606 | |
| Contact: | Kirsten StowellRegulatory Affairs ManagerPhone:Fax:Email: | 610-404-3367610-404-3924kstowell@angio.com |
| Device trade name: | Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) | |
| Device CommonName: | Polydioxanone Absorbable Surgical Suture | |
| Device classification: | Absorbable Polydioxanone Surgical SutureProduct code, NEW21 CFR 878.4840Class II | |
| Legally marketeddevices to which thedevice is substantiallyequivalent: | K051609K080680K080985N18331 | Quill Synthetic Absorbable Barbed SutureEthicon PDS II™ (Polydioxanone) Sutures |
| Description of thedevice: | The Quill™ Knotless Tissue-Closure Device comprised of PDO(Polydioxanone) is a synthetic absorbable tissue-closure devicethat is intended for use in the closure of soft tissue. It iscomprised of polyester [poly (p-dioxanone)] monofilament suturematerial, dyed with D&C Violet No. 2. The device is designedwith small bi-directional barbs along the length that eliminate theneed to tie knots during approximation. The device is available invarious lengths in diameter sizes 2 through 4-0 with variousneedles attached to each end. | |
| Indications for Use: | Quill™ PDO Knotless Tissue-Closure Device, comprised ofPolydioxanone, is indicated for soft tissue approximation whereuse of an absorbable suture is appropriate. |
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K120827 page 2/2
Substantial Equivalence:
Performance tests:
The Quill™ Knotless Tissue-Closure Device comprised of PDO (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 The intended use is identical to both predicate devices. design, material and chemical composition of the proposed device is identical to the predicate Quill Synthetic Absorbable Barbed Suture (K051609, K080680, K080985).
Pre-clinical animal performance testing was conducted to confirm and support the information provided in the QuillTM Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) Instructions for Use.
The results of this testing demonstrates that the Quill™ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
JUL 1 3 2012
Re: K120827
Trade/Device Name: Quill™ Knotless Tissue-Closure Device, Polydioxanone Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: July 02, 2012 Received: July 05, 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
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Page 2 - Ms. Kirsten Stowell
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/ReportalProblem/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,
for
Mark N. Mallery
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: QuillTM 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)
Daniel Kline for mm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120827
§ 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.