(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a barbed suture, with no mention of AI or ML technology.
No
The device is a tissue-closure device used for soft tissue approximation, which falls under surgical instruments rather than therapeutic devices that treat a disease or condition.
No
The device is described as a "tissue-closure device" used for "soft tissue approximation," indicating it is an interventional or therapeutic device, not one that diagnoses conditions.
No
The device description clearly states it is a physical, non-absorbable isotactic polymer suture with barbs, which is a hardware medical device, 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 "soft tissue approximation excluding closure of the epidermis." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "Knotless Tissue-Closure Device" made of polypropylene suture with barbs. This is a physical device used for closing wounds or approximating tissue during surgery.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a surgical purpose.
N/A
Intended Use / Indications for Use
Quill™ Quadrahelix Knotless Tissue Closure Device is indicated for soft tissue approximation excluding closure of the epidermis.
Product codes (comma separated list FDA assigned to the subject device)
GAW
Device Description
The Quill™ Quadrahelix Knotless Tissue Closure Device is a non-absorbable isotactic polymer comprised of polypropylene per 21 CFR 878.5010. It is available sterile, undyed (beige) in suture and needle configurations in USP Size 3-0. Each suture has bi-directional quadrahelix barbs along the long axis of the suture monofilament. The Quill™ Quadrahelix Knotless Tissue Closure Device approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues.
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 Quill™ Quadrahelix Knotless Tissue-Closure Device conforms to the defined product requirements for tensile strength and wound security strength. The results of this testing demonstrates that the Quill™ Quadrahelix Knotless Tissue-Closure Device 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.
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.
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K113800 page 1/2
Section 6 – 510(k) Summary
JAN 2 0 2012
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| Date Prepared: | December 22, 2011 |
|---|---|
| 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™ Quadrahelix Knotless Tissue-Closure Device |
| Device Common Name: | Polypropylene Non-Absorbable Surgical Suture |
| Device classification: | Non-Absorbable Polypropylene Surgical Suture |
| Product code, GAW | |
| 21 CFR 878.5010 | |
| Class II | |
| Legally marketed devices to which the device is substantially equivalent: | K052373: Quill™ Nonabsorbable Polypropylene Barbed Suture |
| Description of the device: | The Quill™ Quadrahelix Knotless Tissue Closure Device is a non-absorbable isotactic polymer comprised of polypropylene per 21 CFR 878.5010. It is available sterile, undyed (beige) in suture and needle configurations in USP Size 3-0. Each suture has bi-directional quadrahelix barbs along the long axis of the suture monofilament. The Quill™ Quadrahelix Knotless Tissue Closure Device approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. |
| Indications for Use: | Quill™ Quadrahelix Knotless Tissue Closure Device is indicated for soft tissue approximation excluding closure of the epidermis. |
control control control controllers.
:
CONFIDENTIAL
1
K113800 Page 2/2
Section 6 - 510(k) Summary
Substantial Equivalence: The Quill™ Quadrahelix Knotless Tissue-Closure Device has the same intended use, fundamental scientific technological characteristics, material and size as the predicate device.
Performance tests:
Non-clinical laboratory performance testing was conducted to confirm that the Quill™ Quadrahelix Knotless Tissue-Closure Device conforms to the defined product requirements for tensile strength and wound security strength. The results of this testing demonstrates that the Quill™ Quadrahelix Knotless Tissue-Closure Device is substantially equivalent to the predicate devices.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
JAN 2 0 2012
Re: K113800
Trade/Device Name: Quill™ Quadrahelix Knotless Tissue Closure Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable propylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: December 22, 2011 Received: January 09, 2012
Dear 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 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.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KI13800 510(k) Number (if known):
Device Name: Quill™ Quadrahelix Knotless Tissue Closure Device
Indications for Use:
Quill™ Quadrahelix Knotless Tissue-Closure Device is indicated for soft tissue approximation excluding closure of the epidermis
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keene for NXM
Page 1 of
(Division Sign-(Division Sign-On)
Division of Surgical. (Orthopedic, ovision of Storative Devices
510(k) Number K113500