(254 days)
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
The provided text describes a 510(k) submission for the ferroFibre™ Stainless Steel Suture. This document focuses on the regulatory clearance for a medical device and does not contain information about an AI/ML powered device, nor does it detail a clinical study with acceptance criteria and reported device performance in the way requested.
The document outlines performance testing conducted to characterize biocompatibility, diameter, and tensile strength according to ISO 10993 standards and USP Monographs. However, it does not provide specific acceptance criteria or reported performance values for these tests. It also does not include details on sample sizes for testing, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) studies, as these types of studies are not relevant for the regulatory approval of a non-AI/ML surgical suture device.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance and clinical study design for this submission. The content is about a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence to existing products.
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510(K) SUMMARY
Subject 510(k) Number
Sponsor
Core Essence Orthopaedies, LLC
301 Oxford Valley Road Suite 905B Yardley, PA 19067
DEC 2 4 2008
FDA Establishment Registration Number
3004613836
Official Contact
Shawn T. Huxel, CEO & President Core Essence Orthopacdics, LLC 301 Oxford Valley Road Suite 905B Yardley, PA 19067 Phone - (215) 310-9534 Fax - (609) 482-4957 Mobile - (908) 896-5893
Proprietary Name
ferroFibre"M Stainless Steel Suture
Common Name
Stainless Steel Suture
Classification Name and Reference
§878.4495 Suture, Nonabsorbable, Steel, Monofilament and Multifilament, Sterile
Regulatory Class
Class II (Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA; Dated June 3, 2003)
Device Product Code (jAQ)
Date Prepared
8 April, 2008
Brief Description of Device
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl
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sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
Indications for Use
forroFibre Stainless Steel Surgical Sutures are indicated for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Discussion of Performance Testing
A collection of tests has been conducted to characterize biocompatibility, diameter and tensile strength in accordance to:
- ISO 10993 standards ੈ
- ੇ USP 31 NF 26 Monographs <861>, < 871>, < 881>
- 0 Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003
Conclusion
ું જ
Corc Essence Orthopacdics ferroFIBRE Stainless Steel Sutures are substantially equivalent to currently marked devices and present no substantial differences in design, material, intended use and function to previously approved products. Additionally, the subject device labeling is consistent both with FDA's guidance as well as current medical practice.
END OF 510(K) SUMMARY
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Core Essence Orthopaedics, LLC % Mr. Shawn T. Huxel CEO and President 301 Oxford Valley Road, Suite 905B Yardley, Pennsylvania 19067
DEC 2 4 2008
Re: K081060
Trade/Device Name: Core Essence Orthopaedics, LLC Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless steel suture Regulatory Class: II Product Code: GAQ Dated: November 28, 2008 Received: December 1, 2008
Dear Mr. Huxel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Riometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Mulkison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510 (K) NUMBER IF KNOWN: _KOR 10 60 MANUFACTURER: Core Essence Orthopaedics, LLC
DEVICE NAME: ferroFibre Stainless Steel Suture
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
Prescription Use XX (Per 21 CFR 801.109)
۔
or
Over-the-Counter Use _ NO (Optional Format 1-2-1996)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Divi on of General, Restorative, and Neurological Devices
510(k) Number /C081060
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.