(16 days)
Not Found
No
The device description and performance studies focus on the physical properties and material composition of surgical sutures and barbed sutures. There is no mention of AI or ML in the intended use, device description, or performance testing.
No.
This device is a surgical suture and tissue-closure device used for approximation and/or ligation of soft tissue, which falls under surgical devices rather than therapeutic devices meant for treating conditions.
No
The device is a surgical suture and tissue-closure device used for approximation and ligation of soft tissues, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes physical surgical sutures and tissue-closure devices made of polypropylene, which are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device for "general soft tissue approximation and/or ligation," including use in surgical procedures on the cardiovascular, ophthalmic, and neurological systems. This is a direct surgical intervention on the body.
- Device Description: The description details a "sterile, synthetic Knotless nonabsorbable surgical suturing device." This is a physical device used to close tissue during surgery.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens outside of the surgical context.
The device described is a surgical suture, which is a medical device used in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene 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 Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue (see below). They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.
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 Polypropylene Surgical Sutures and QuillTM Polypropylene Knotless Tissue-Closure devices conform to the USP monograph for nonabsorbable sutures for diameter and tensile strength (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
Additional chemical characterization testing and biological risk assessment was conducted in order to evaluate the chemical equivalency of the polypropylene raw material. The results of this testing demonstrates that the Polypropylene Surgical Suture and QuillTM Polypropylene Knotless Tissue-Closure devices are 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.
P870064, K904906, K930825, K903584, K926588, K052373, K113800, K130078
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.
0
Section 5 - 510(k) Summary
| Date Prepared: | May 10, 2013 | MAY 1 6 2013 |
|---|---|---|
| Company: | Surgical Specialties Corporation, dba 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: | Sharpoint™ Polypropylene Suture | |
| Look™ Polypropylene Suture | ||
| Quill™ Polypropylene Knotless-Tissue Closure Device | ||
| 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: | P870064 | |
| K904906 | ||
| K930825 | Sharpoint Polypropylene Nonabsorbable | |
| Surgical Suture | ||
| K903584 | ||
| K926588 | Look Inc. Polypropylene Nonabsorbable | |
| Surgical Sutures | ||
| K052373 | ||
| K113800 | ||
| K130078 | Quill™ Nonabsorbable Polypropylene Barbed | |
| Suture |
p 10-3
1
431224 p 2043
Description of the device:
The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue (see below). They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.
Polypropylene suture is indicated for use in general soft tissue Indications for Use: approximation and/or ligation, including use in cardiovascular,
Substantial Equivalence: ophthalmic and neurological procedures. Quill™M
Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Polypropylene Surgical Suture devices have The been demonstrated to be identical in material, design and intended use to the predicate Polypropylene Surgical Suture devices.
The Quill™ Polypropylene Knotless Tissue-Closure devices have been demonstrated to be identical in material, design and intended use to the predicate Quill™ Polypropylene devices.
2
1131224 p 3043
Performance tests:
Non-clinical laboratory performance testing was conducted to confirm that the Polypropylene Surgical Sutures and QuillTM Polypropylene Knotless Tissue-Closure devices conform to the USP monograph for nonabsorbable sutures for diameter and tensile strength (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
Additional chemical characterization testing and biological risk assessment was conducted in order to evaluate the chemical equivalency of the polypropylene raw material. The results of this testing demonstrates that the Polypropylene Surgical Suture and QuillTM Polypropylene Knotless Tissue-Closure devices are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 16, 2013
Surgical Specialties Corporation dba Angiotech % Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K131224
Trade/Device Name: Sharpoint™ Polypropylene Surgical Sutures Polypropylene Surgical Sutures Look" Quill™ Polypropylene Knotless Tissue-Closure Devices Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GA W Dated: April 26, 2013 Received: April 30, 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.
4
Page 2 - Ms. Kirsten Stowell
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 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
Peter D. Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
510k number if known:
Device Name: Polypropylene Sutures
Indications for Use:
Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
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)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131224
6
Section 4 - Indications for Use Statement
510k number if known:
Device Name: Quill™ Polypropylene Knotless Tissue-Closure Device
Indications for Use:
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Prescription Use (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)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131224