(84 days)
No
The 510(k) summary describes a mechanical implant for orthopedic fixation and does not mention any software, image processing, AI, or ML capabilities.
No.
The device is described as a titanium implant used for fixation of tendons and ligaments during orthopedic reconstruction procedures, indicating it's a surgical implant rather than a device that delivers therapy.
No
The device description indicates it is a machined titanium implant for fixation during orthopedic reconstruction procedures, not for identifying a condition or disease.
No
The device description clearly states it is a "machined titanium implant," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Smith & Nephew EndoButton Direct Fixation Device is an implantable device used during surgery to fix tendons and ligaments within the body. It is a surgical tool and implant, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "fixation of tendons and ligaments during orthopedic reconstruction procedures." This is a surgical procedure, not a diagnostic process.
The information provided about the device's design, materials, and performance testing all relate to its function as a surgical implant for structural support, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Smith & Nephew EndoButton Direct is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) or Posterior Cruciate Ligament (PCL) Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
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 device is available in 5-10mm lengths to accommodate different graft sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew EndoButton CL, cleared in K980155. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
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.
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
K070167 page 'f2
APR 1 2 2007
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 Fixation Device
Date Prepared: January 16, 2007
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:
FAX: (508) 261-3620
C. Device Name
| Trade Name: | Smith & Nephew EndoButton Direct |
|---|---|
| Common Name: | Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
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 (K922559).
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
,
1
page 24
single access point. The device is available in 5-10mm lengths to accommodate different graft sizes.
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) or Posterior Cruciate Ligament (PCL) Reconstruction.
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. The proposed and the predicate devices both have the same intended use, are manufactured from the same material and are offered in a similar size range.
H. Summary Performance Data
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew EndoButton CL, cleared in K980155 . The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Endoscopy Division % Ms. Deana Boushell Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
APR 1 2 2007
Re: K070167
Trade/Device Name: Smith & Nephew EndoButton Direct Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: January 16, 2007 Received: January 18, 2007
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.
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
3
Page 2 - Ms. Deana Boushell
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
[signature]
Mark N. Me lkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 1
ട്ടി.D
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew EndoButton Direct
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) or Posterior Cruciate Ligament (PCL) Reconstruction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use No
U I
(Per 21 CFR 801 Subpart D)
(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)
Qurbare muchm
Division Sign Off
Restorative. and Neurological D
510(k) Number K070167