(16 days)
Not Found
No
The summary describes a physical surgical suture device and its performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a tissue-closure device (suture) used for soft tissue approximation, which falls under the category of surgical tools rather than therapeutic devices.
No
This device is a tissue-closure device (suture) used for soft tissue approximation. Its function is to close tissue, not to diagnose a condition.
No
The device description clearly states it is a physical tissue-closure device comprised of Polydioxanone, a synthetic absorbable material, and includes physical components like barbs, loops, and needles. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical device (suture with barbs and loops) used for closing tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
QuillTM PDO Knotless Tissue-Closure Device comprised of Polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory performance testing was conducted to confirm that the QuillTM 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 QuillTM PDO Tissue-Closure device, Variable Loop Design Knotless (Polydioxanone), is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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K123877 Age 1/2
510(k) Summary
JAN 0 2 2013
| Date Prepared: | January 2, 2013 |
|---|---|
| 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 PDO Knotless-Tissue Closure Device, Variable Loop |
| Design (Polydioxanone) | |
| Device Common | |
| Name: | Polydioxanone Absorbable Surgical Suture |
| Device classification: | Absorbable polydioxanone surgical suture |
| Product code, NEW | |
| 21 CFR 878.4840 | |
| Class II | |
| Legally marketed | |
| device to which the | |
| device is substantially | |
| equivalent: | K113744 QuillTM PDO Knotless Tissue-Closure Device, |
| Variable Loop Design, Size -0- | |
| Description of the | |
| device: | 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. | |
| Indications for Use: | QuillTM PDO Knotless Tissue-Closure Device comprised of |
| Polydioxanone is indicated for soft tissue approximation where | |
| use of an absorbable suture is appropriate. |
1
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.
2
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
3
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