(73 days)
Not Found
No
The summary describes a mechanical implant for surgical fixation and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
This device is an implantable fixation device used during surgery, not a device that itself provides therapy.
No
The device is a fixation device used in surgery to secure soft tissue grafts to bone, which is a therapeutic function, not a diagnostic one. It doesn't identify or analyze a condition.
No
The device description clearly states it is a "polymer implant" and an "intra-tunnel device," indicating it is a physical hardware component, not software.
Based on the provided information, the Smith & Nephew BIOSURE SYNC Tibial Fixation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of soft tissue to bone during cruciate ligament reconstruction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as an intra-tunnel device and a polymer implant. These are physical devices used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to physically secure tissue during a reconstructive procedure.
N/A
Intended Use / Indications for Use
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is indicated for use in combination with BIOSURE PK Screws for fixation of soft tissue to bone during cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is an intra-tunnel device used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The fixation device is a polymer implant for use with BIOSURE PK Screws (25 mm length). The device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (specifically for cruciate ligament reconstruction)
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)
Performance testing demonstrates that the insertion and fixation properties of the Smith & Nephew BIOSURE SYNC Tibial Fixation Device are substantially equivalent to the predicate devices. Based on the indications for use, the technological characteristics, and comparison to predicate devices, the BIOSURE SYNC Tibial Fixation Device has been demonstrated to be substantially equivalent to 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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
093943
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew BIOSURE™ SYNC Tibial Fixation Device
Date Prepared: December 21, 2009
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Julie Acker, RAC Sr. Regulatory Affairs Specialist T 508-261-3618 F 508-261-3620 e-mail julie.acker@smith-nephew.com
C. Device Name
| Trade Name: | BIOSURE SYNC Tibial Fixation Device |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| per 21 CFR §888.3040 |
Predicate Devices D.
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew BIOSURE® PK Screw (K083635), Smith & Nephew GTS Sleeve (K040542) and the DePuy Mitek Intrafix (K983560).
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E. Description of Device
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is an intra-tunnel device used to secure soft tissue grafts to bone during cruciate ligament reconstruction procedures. The fixation device is a polymer implant for use with BIOSURE PK Screws (25 mm length). The device is provided sterile, for single use only.
Intended Use F.
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is indicated for use in combination with BIOSURE PK Screws for fixation of soft tissue to bone during cruciate ligament reconstruction.
G. Comparison of Technological Characteristics
The proposed Smith & Nephew BIOSURE SYNC Tibial Fixation Device and the predicate devices have the same intended use and basic fundamental scientific technology. The proposed device and the predicate devices are intended to fixate soft tissue grafts to bone by intra-tunnel compression of the graft. The proposed and predicate devices are manufactured of non-absorbable material, and performance testing demonstrates that the proposed devices are as safe and as effective as currently marketed predicate devices.
H. Summary Performance Data
Performance testing demonstrates that the insertion and fixation properties of the Smith & Nephew BIOSURE SYNC Tibial Fixation Device are substantially equivalent to the predicate devices. Based on the indications for use, the technological characteristics, and comparison to predicate devices, the BIOSURE SYNC Tibial Fixation Device has been demonstrated to be substantially equivalent to predicate devices.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of a human figure embracing a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc., Endoscopy Division % Ms. Julie Acker, RAC Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachuesetts 01810
MAR ~ 5 2010
Re: K093943
Trade/Device Name: BIOSURE SYNC Tibial Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: . Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: December 21, 2009 Received: December 22, 2009
Dear Ms. Acker:
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 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.
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Page 2 - Ms. Julie Acker, RAC
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.html 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,
Mark A. Mulkeran
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: BIOSURE SYNC Tibial Fixation Device
Indications for Use:
The Smith & Nephew BIOSURE SYNC Tibial Fixation Device is indicated for use in combination with BIOSURE PK Screws for fixation of soft tissue to bone during cruciate ligament reconstruction.
Prescription Use (Per 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)
Smuts for mxn
(Division Sign-Off)
Division of Surgical. O rthopedic. and Restorative Devices
510(k) Number K093943