(90 days)
The Smith & Nephew ENDOBUTTON DIRECT Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).
The ENDOBUTTON DIRECT is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON DIRECT allows for the device to be endoscopically delivered from a single access point. The harvested graft is looped through the closed portion of the ENDOBUTTON DIRECT and by pulling on a lead suture attached to the top of the ENDOBUTTON DIRECT the construct is moved through the tunnel. The trailing suture located distal to the graft is then used to flip the device into position, lying flat across the tunnel opening on top of the femoral cortex.
The provided text is for a 510(k) Summary for a medical device called the "Smith & Nephew ENDOBUTTON DIRECT." This document focuses on demonstrating substantial equivalence to a predicate device, not on demonstrating performance against specific acceptance criteria through a clinical study involving human readers or AI.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable or available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The 510(k) Summary for the ENDOBUTTON DIRECT does not present acceptance criteria for device performance in the way described (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Smith & Nephew Endobutton CL, K980155) in terms of design, materials, function, and intended use.
The "performance" described is limited to:
| Acceptance Criteria Type | Reported Device Performance | Comments |
|---|---|---|
| Bench Top Testing (Tensile Testing) | Differences in the new device and the predicate device do not raise any new issues of safety and efficacy. | No specific numerical acceptance criteria or performance values (e.g., tensile strength in Newtons) are provided. The statement indicates a qualitative assessment of equivalence. |
| Material Equivalence | Button material is the same as the predicate device. | Demonstrates equivalence, not specific performance metrics against an acceptance criterion. |
| Design Equivalence | Similar design to the predicate device, allowing for endoscopic delivery and flipping into position. | Focuses on functional similarity to the predicate, not performance against pre-defined acceptance criteria. |
| Function Equivalence | Provides cortical fixation in the repair of tendons and ligaments, similar to the predicate. | Equivalence in intended functional outcome. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No "test set" in the context of imaging or AI performance is mentioned. The performance testing was bench-top tensile testing. The sample size for this testing is not specified, nor is the provenance of any "data" as it pertains to human or AI performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this device's regulatory submission, which relies on bench-top mechanical testing and comparison to a predicate device.
4. Adjudication Method
Not Applicable. No adjudication method is mentioned as there is no "test set" requiring expert review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155. The bench top testing included tensile testing..." There is no mention of an MRMC study, human readers, or AI assistance.
6. Standalone (Algorithm Only) Performance Study
No. This is a mechanical fixation device, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
Not Applicable. The "ground truth" for this device's regulatory submission is based on the performance of the predicate device and engineering principles demonstrated through bench-top testing (e.g., tensile strength, material properties). It's not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.
8. Sample Size for the Training Set
Not Applicable. This is a mechanical device, not an AI system. There is no concept of a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is not relevant.
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SECTION V 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 ENDOBUTTON DIRECT
Date Prepared: January 5, 2011
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Deana Boushell Principle Regulatory Affairs Specialist (508) 337-4036 Phone: (508) 261-3620 FAX:
C. Device Name
| Trade Name: | Smith & Nephew ENDOBUTTON Direct |
|---|---|
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Regulation Name: | Single/multiple component metallic bone fixationappliances and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | MAI |
D. Predicate Devices
The Smith & Nephew ENDOBUTTON DIRECT is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew Endobutton CL (K980155).
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K102952 p. 2 of 2
E. Description of Device
The ENDOBUTTON DIRECT is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON DIRECT allows for the device to be endoscopically delivered from a single access point. The harvested graft is looped through the closed portion of the ENDOBUTTON DIRECT and by pulling on a lead suture attached to the top of the ENDOBUTTON DIRECT the construct is moved through the tunnel. The trailing suture located distal to the graft is then used to flip the device into position, lying flat across the tunnel opening on top of the femoral cortex.
F. Intended Use
The Smith & Nephew ENDOBUTTON DIRECT is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).
G. Comparison of Technological Characteristics
The Smith & Nephew ENDOBUTTON DIRECT is substantially equivalent in design, materials, function and intended use to the Smith & Nephew Endobutton CL, cleared in K980155. The proposed and the predicate devices both have the same intended use, button material and are offered in a range of sizes.
H. Summary Performance Data
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155. The bench top testing included tensile testing and demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Inc. c/o Ms. Deana Boushell Principal Regulatory Specialist 150 Minuteman Road Andover, Massachusetts 01810
JAN - 5 2011
Re: K102982
Trade/Device Name: Smith & Nephew ENDOBUTTON DIRECT Regulation Number: 21 CFR 888,3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: October 6, 2010 Received: October 7, 2010
Dear Ms. Boushell:
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 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
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Page 2 -- Ms. Deana Boushell
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.
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.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K102982 510(k) Number (if known):
Device Name: Smith & Nephew ENDOBUTTON DIRECT
JAN - 5 2011
Indications For Use:
The Smith & Nephew ENDOBUTTON DIRECT Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(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)
M. Melkeron
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102982
Page 16
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.