(15 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture with barbs and loops, with no mention of AI or ML.
No
A therapeutic device is one that treats or manages a disease or condition. This device is a surgical suture used for soft tissue approximation, which is a structural component for wound closure rather than treating a disease or condition.
No
This device is a tissue-closure device (suture) used for soft tissue approximation. It is a therapy device, not a diagnostic device, as it is used for treatment rather than for identifying a medical condition.
No
The device description clearly describes a physical, sterile, synthetic absorbable tissue-closure device with barbs, loops, and needles, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical suture with barbs and loops, designed for physically closing tissue. This is a surgical implant/device, not a diagnostic tool.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the suture (tensile strength, needle attachment) and its equivalence to other surgical sutures. This is typical for surgical devices, not IVDs.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Quill Monoderm Knotless Tissue-Closure Device comprised of Monoderm 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)
GAM
Device Description
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 Sizes 2-0 to 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
Not Found
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 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 Quill Monoderm Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices.
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.
K122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design, Size 2-0, K113744: Quill PDO Knotless Tissue-Closure Device (Polydioxanone), K072028: Quill Self-Retaining System (SRS) comprised of Monoderm
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
Not Found
§ 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.
0
K123409 page 1/2
510(k) Summary
NOV 2 0 2012
| Date Prepared: | October 24, 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: | Quill TM Monoderm Knotless-Tissue Closure Device, Variable Loop Design |
| Device Common Name: | Absorbable poly(glycolide/l-lactide) Surgical Suture |
| Device classification: | Absorbable poly(glycolide/l-lactide) Surgical Suture |
| Product code, GAM | |
| 21 CFR 878.4493 | |
| Class II | |
| Legally marketed devices to which the device is substantially equivalent: | K122898 Quill TM Monoderm TM Knotless Tissue-Closure Device, Variable Loop Design, Size 2-0 |
| K113744: Quill TM PDO Knotless Tissue-Closure Device (Polydioxanone) | |
| K072028: Quill TM Self-Retaining System (SRS) comprised of Monoderm TM | |
| Description of the device: | The Quill TM Monoderm TM 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 2-0 to 0 in various lengths affixed to various needle types. |
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K123409 page 2/2
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QuillTM Indications for Use: Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The QuillTM Monoderm™ Knotless Tissue-Closure device, Substantial Variable Loop Design is identical in material composition and Equivalence: size range as the Quili™ Monoderm™ predicates. The proposed device is identical in design to the Quill™ Monoderm™ Knotless Tissue-Closure Device and Quill™ PDO Knotless Tissue-Closure Device predicate devices. In addition, the proposed 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 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, 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, with its wings forming three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Avenue Reading, Pennsylvania 19606
Novermber 20, 2012
Re: K123409
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: October 24, 2012 Received: November 5, 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
3
Page 2 - Ms. Kirsten Stowell
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/Resourcesfor You/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
4
Section 4 - Indications for Use Statement
K123409 510k number if known:
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 2012.11.19 16:09:25 -05'00'
(Division Sign-Off) Division of Surgical Devices K123409 510 (k) Number
CONFIDENTIAL