(16 days)
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.
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. 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.
The provided text describes the performance tests conducted for the Polypropylene Surgical Suture and Quill™ Polypropylene Knotless Tissue-Closure Devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the devices conform to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures regarding diameter and tensile strength.
| Acceptance Criteria (from USP Monograph for Nonabsorbable Sutures) | Reported Device Performance (from Non-clinical Laboratory Testing) |
|---|---|
| Conformity to specified diameter requirements | Devices conform to specified diameter requirements |
| Conformity to specified tensile strength requirements | Devices conform to specified tensile strength requirements |
| Chemical equivalency to predicate devices | Chemical characterization and biological risk assessment demonstrates chemical equivalency |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for the non-clinical laboratory performance testing. It only mentions that "Non-clinical laboratory performance testing was conducted." The data provenance is implied to be retrospective as it involves testing of manufactured devices to confirm adherence to existing standards and comparison to predicate devices, rather than a prospective study to generate new clinical data. The country of origin for the data is not explicitly stated but is implied to be in the USA given the FDA context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the ground truth for these non-clinical performance tests is established by adherence to a standardized monograph (USP) and direct physical/chemical testing, not by expert interpretation or consensus.
4. Adjudication Method for the Test Set:
This information is not applicable for non-clinical laboratory performance testing. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical laboratory performance study, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a physical surgical suture, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical performance tests is based on established industry standards and physical/chemical properties, specifically:
- The USP (United States Pharmacopeia) monograph for nonabsorbable sutures for diameter and tensile strength.
- Chemical characterization and biological risk assessment to evaluate chemical equivalency.
8. The Sample Size for the Training Set:
This information is not applicable as the study described is a non-clinical performance test for a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above (no training set for a physical medical device).
{0}------------------------------------------------
Section 5 - 510(k) Summary
| Date Prepared: | May 10, 2013 | MAY 1 6 2013 |
|---|---|---|
| Company: | Surgical Specialties Corporation, dba Angiotech100 Dennis Dr.Reading, PA 19606 | |
| Contact: | Kirsten StowellRegulatory Affairs ManagerPhone: 610-404-3367Fax: 610-404-3924Email: kstowell@angio.com | |
| Device trade name: | Sharpoint™ Polypropylene SutureLook™ Polypropylene SutureQuill™ Polypropylene Knotless-Tissue Closure Device | |
| Device Common Name: | Nonabsorbable polypropylene surgical suture | |
| Device classification: | Nonabsorbable polypropylene surgical sutureProduct code, GAW21 CFR 878.5010Class II | |
| Legally marketed devices to which the device is substantially equivalent: | P870064K904906K930825 | Sharpoint Polypropylene NonabsorbableSurgical Suture |
| K903584K926588 | Look Inc. Polypropylene NonabsorbableSurgical Sutures | |
| K052373K113800K130078 | Quill™ Nonabsorbable Polypropylene BarbedSuture |
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
§ 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.