(16 days)
QuillTM PDO Knotless Tissue-Closure Device comprised of Polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument 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 0, 2-0 and 3-0 in various lengths affixed to various needle types.
This 510(k) submission describes a Quill™ PDO Knotless-Tissue Closure Device, Variable Loop Design (Polydioxanone), which is an absorbable surgical suture. The device is a sterile, synthetic absorbable tissue-closure device comprised of polyester [poly (p-dioxanone)], with uni-directional barbs and a welded primary and secondary loop design at the distal end. It is available in diameter Size 0, 2-0, and 3-0 in various lengths affixed to various needle types.
The submission focuses on demonstrating substantial equivalence to a predicate device (K113744 Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size -0-) by confirming that the new device, which differs only in suture diameter, meets established performance standards for absorbable sutures.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from USP Monograph for Absorbable Sutures and FDA Guidance) | Reported Device Performance (from Non-clinical Laboratory Testing) |
|---|---|
| Conformance to USP monograph for absorbable sutures for tensile strength. | Device conforms to USP monograph for absorbable sutures for tensile strength. |
| Conformance to USP monograph for absorbable sutures for needle attachment. | Device conforms to USP monograph for absorbable sutures for needle attachment. |
| Performance demonstrated as substantially equivalent to the predicate device in in vitro post-hydrolysis tensile testing. | In vitro post-hydrolysis tensile testing demonstrated substantial equivalence to the predicate device. |
Note: The document explicitly states the new device has "the same design and materials as the Quill™ PDO Knotless Tissue-Closure Device predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter." This implies the acceptance criteria for these performance aspects are to meet or exceed the performance of the predicate device and the general USP standards.
2. Sample size used for the test set and the data provenance
The document specifies "Non-clinical laboratory performance testing was conducted." It also mentions "Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing."
- Sample Size: The document does not explicitly state the sample size used for the non-clinical laboratory performance testing or the in vitro post-hydrolysis tensile testing.
- Data Provenance: The tests are described as "non-clinical laboratory performance testing" and "in vitro," indicating they were conducted in a laboratory setting, likely by the manufacturer, Angiotech. There is no information regarding the country of origin of the data or whether the data was retrospective or prospective in the context of animal or human studies, as these were material and mechanical property tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for this medical device (surgical suture) is established by adherence to recognized standards for material properties (e.g., USP monograph) and performance measures like tensile strength and needle attachment, rather than expert interpretation of images or clinical outcomes that require expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of ambiguous cases (e.g., diagnostic imaging). For non-clinical, laboratory-based material property testing, the "ground truth" is determined by objective measurements and reference to established standards.
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
Not applicable. This submission is for a surgical suture, not an AI-assisted diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a surgical suture, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on:
- Established Standards: Primarily the USP monograph for absorbable sutures.
- Mechanical and Material Properties: Objective measurements of tensile strength, needle attachment, and in vitro post-hydrolysis tensile strength.
- Predicate Device Performance: The new device's performance was compared to that of the legally marketed predicate device (K113744) to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train machine learning models. This submission is for a surgical suture, not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device submission.
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K123877 Age 1/2
510(k) Summary
JAN 0 2 2013
| Date Prepared: | January 2, 2013 |
|---|---|
| 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 PDO Knotless-Tissue Closure Device, Variable LoopDesign (Polydioxanone) |
| Device CommonName: | Polydioxanone Absorbable Surgical Suture |
| Device classification: | Absorbable polydioxanone surgical sutureProduct code, NEW21 CFR 878.4840Class II |
| Legally marketeddevice to which thedevice is substantiallyequivalent: | K113744 QuillTM PDO Knotless Tissue-Closure Device,Variable Loop Design, Size -0- |
| Description of thedevice: | The QuillTM PDO Knotless Tissue-Closure Device, Variable LoopDesign (Polydioxanone) is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue.It is comprised of polyester [poly (p-dioxanone)], dyed with D&CViolet No. 2. The instrument is designed with small uni-directional barbs along the long axis of the suture monofilamentwhich contains a welded primary loop and secondary loop designat the distal end. It is available in diameter Size 0, 2-0 and 3-0 invarious lengths affixed to various needle types. |
| Indications for Use: | QuillTM PDO Knotless Tissue-Closure Device comprised ofPolydioxanone is indicated for soft tissue approximation whereuse of an absorbable suture is appropriate. |
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Substantial Equivalence:
Performance tests:
The QuillITM Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) has the same design and materials as the Quill™ PDO Knotless Tissue-Closure Device predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter.
Non-clinical laboratory performance testing was conducted to confirm that the Quill™ PDO Knotless Tissue-Closure device, Variable Loop Design (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. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing.
The results of this testing demonstrates that the Quill™ PDO Tissue-Closure device, Variable Loop Design Knotless (Polydioxanone), is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. 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 Corporated, DBA Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
January 2, 2013
Re: K123877
Trade/Device Name: Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design Polydioxanone
Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: December 14, 2012 Received: December 18, 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,
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:
Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design Device Name: 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 Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123877
§ 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.