(90 days)
No
The device description and intended use focus on a mechanical implant for orthopedic fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an implant used for fixation of tendons and ligaments during orthopedic reconstruction procedures, indicating it is an assistive device rather than one that treats or cures a disease or condition.
No
The device is described as an implant used for fixation of tendons and ligaments during orthopedic reconstruction procedures, indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a machined titanium implant assembled with a continuous loop of polyester tape, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of tendons and ligaments during orthopedic reconstruction procedures." This describes a surgical implant used directly in the body to support and stabilize tissues.
- Device Description: The description details a "machined titanium implant assembled with a continuous loop of polyester tape." This is a physical device implanted during surgery.
- Lack of IVD characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. The description of the ENDOBUTTON does not involve any such testing or analysis of biological samples.
Therefore, the Smith & Nephew ENDOBUTTON Continuous Loop is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.
Product codes
JDR, MBI, HWC
Device Description
The ENDOBUTTON CL is a machined titanium implant assembled with a continuous loop of polyester tape. It is oblong in shape with four holes through which suture is threaded. The polyester loop is preattached to the center holes. The device is designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point. The device is available with premeasured loops of tape ranging from 20mm-50mm to accommodate different graft sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendons and ligaments (specifically in Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions)
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 Arthrex Tightrope™ Acromioclavicular (AC) Device, cleared via K052776. The testing also demonstrates that the expanding the indications for use do not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K081098 page 1 of 2
SECTION IV
JUL 1 6 2008
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.
Indication Expansion - ENDOBUTTON Continuous Loop Fixation Devices
Date Prepared: April 16, 2008
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist Phone: (508) 261-3705 FAX: (210) 690-2559
C. Device Name
Trade Name: ENDOBUTTON Continuous Loop
Common Name: Suture Retention device, Non-absorbable (polyester) surgical suture
Classification Name: Fastener, Fixation, Non-degradable, Soft tissue Non-absorbable surgical suture
D. Predicate Devices
The indication for fixation of tendons and ligaments in orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions is substantially equivalent to the currently marketed indications for use of the following legally marketed devices in commercial distribution: the ConMed Linvatec XO Button™ (cleared via K070780) and the Arthrex Tightrope™ Acromioclavicular (AC) Device (cleared via K052776).
E. Description of Device
ENDOBUTTON CL
1
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The ENDOBUTTON CL is a machined titanium implant assembled with a continuous loop of polyester tape. It is oblong in shape with four holes through which suture is threaded. The polyester loop is preattached to the center holes. The device is designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point. The device is available with premeasured loops of tape ranging from 20mm-50mm to accommodate different graft sizes.
ENDOBUTTON
The ENDOBUTTON is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. It is oblong in shape with four holes through which suture is threaded. The design of the ENDOBUTTON allows for the device to be endoscopically delivered from a single access point.
F. Intended Use
The intended use of the currently available ENDOBUTTON Fixation Devices remains unchanged. The Smith & Nephew ENDOBUTTON Fixation Devices are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.
G. Comparison of Technological Characteristics
There are no changes to the existing devices. Technological Characteristics remain the same.
H. Summary Performance Data
The performance testing conducted demonstrates substantial equivalence to the Arthrex Tightrope™ Acromioclavicular (AC) Device, cleared via K052776. The testing also demonstrates that the expanding the indications for use do not raise any new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes, positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew % Endoscopy Division Ms. Christina Flores Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
JUL 1 6 2008
K081098 Trade/Device Name: Endobutton Continuous Loop (CL) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class Il Product Code: JDR, MBI, HWC Dated: April 16, 2008 Received: April 17, 2008
Dear Ms. Flores:
Re:
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 iscuance 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.
3
Page 2 - Ms. Christina Flores
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) 276-0120. 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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ro8109
5 10(k) Number (if known):
Device Name: ENDOBUTTON Continuous Loop (CL)
Indications For Use:
The Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and Iigaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use No
(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)
Jarbare Bneim
Division of General, Restorative, and Neurological Devices
510(k) Number K081098
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