(45 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.
Yes
The device is described as a "tissue-closure device" used for "soft tissue approximation," which is a therapeutic function aimed at treating or alleviating a medical condition (tissue damage requiring closure).
No
The device is described as a "Tissue-Closure Device" used for "soft tissue approximation," indicating a therapeutic rather than diagnostic function. Its performance studies focus on tensile strength and needle attachment, which are relevant to its function in closing tissue, not to diagnosing a condition.
No
The device description clearly states it is a physical tissue-closure device made of polypropylene with barbs and needles, which are hardware components. There is no mention of 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 comprised of Polypropylene." This is a physical medical device used for suturing or closing tissue during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other substances to perform tests.
IVDs are used to examine specimens from the body to provide information about the body. This device is used on the body to physically close tissue.
N/A
Intended Use / Indications for Use
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Product codes
GAW
Device Description
The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. 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 Size 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, excluding closure of the epidermis
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™ Polypropylene Knotless Tissue-Closure device, Variable Loop Design, conforms to the USP monograph for nonabsorbable 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.
The results of this testing demonstrates that the QuillTM Polypropylene 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Section 5 - 510(k) Summary
control concession in the consideration
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Date Prepared: | January 9, 2013 | FEB 2 8 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: | Quill™ Polypropylene Knotless-Tissue Closure Device, Variable | |
| Loop Design | ||
| Device Common | ||
| Name: | Nonabsorbable polypropylene surgical suture | |
| Device classification: | Nonabsorbable 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 | ||
| K113744: | Quill™ PDO Knotless Tissue-Closure Device | |
| (Polydioxanone), Variable Loop Design | ||
| K123409: | Quill™ Monoderm™ Knotless Tissue-Closure | |
| Device, Variable Loop Design | ||
| Description of the | ||
| device: | The Quill™ Polypropylene Knotless Tissue-Closure Device, | |
| Variable Loop Design is a sterile, synthetic nonabsorbable tissue- | ||
| closure device that is intended for use in the closure of soft tissue, | ||
| excluding closure of the epidermis. It is comprised of high | ||
| molecular weight, isotactic polypropylene, undyed, or dyed blue | ||
| with Phthalocyaninato (2-) Copper. 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 | ||
| Size 0 in various lengths affixed to various needle types. |
・
. . . . . .
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K130078 page 2/2
Indications for Use:
Substantial Equivalence:
Performance tests:
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
The QuillTM Polypropylene Knotless Tissue-Closure device, Variable Loop Design is identical in material composition and intended use to the QuillTM Polypropylene Barbed Suture predicate. The proposed device is identical in design to the QuillTM PDO and QuillTM Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design predicate devices.
Non-clinical laboratory performance testing was conducted to confirm that the Quill™ Polypropylene Knotless Tissue-Closure device, Variable Loop Design, conforms to the USP monograph for nonabsorbable 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.
The results of this testing demonstrates that the QuillTM Polypropylene Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
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 Corporation, DBA Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
February 28, 2013
Re: K130078
Trade/Device Name: Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable poly-propylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: January 09, 2013 Received: January 15, 2013
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, .
FOR
PeterDA 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
K130078 510k number if known:
Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Device Name: Design
Indications for Use:
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene 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 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 Krauses
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130078