(89 days)
Not Found
No
The summary describes a mechanical fixation device and does not mention any AI or ML components or functions.
No
The device is a non-absorbable fixation device used to aid in fracture repair, providing mechanical support rather than delivering a therapeutic agent or performing a therapeutic function on its own.
No
The device is described as an "adjunct in fracture repair providing fixation during the healing process," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it consists of physical components: "two machined titanium ENDOBUTTON fixation devices on a continuous Polyester suture loop." This indicates it is a hardware device, not software-only.
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.
- Device Description and Intended Use: The description clearly states that the Smith & Nephew Ultraslide Device is a surgical implant used for fixation during fracture repair following syndesmotic trauma. It is a physical device implanted in the body to provide mechanical support.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples, nor does it provide diagnostic information about a patient's condition. Its function is purely mechanical and supportive.
Therefore, based on the provided information, the Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Ultraslide Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.
Product codes
HTN
Device Description
The Smith & Nephew Ultraslide Device allows for endoscopic fixation following a syndesmotic trauma as Coracoclavicular Separations or Ankle Syndesmotic Disruptions. The device consists of three components; two machined titanium ENDOBUTTON fixation devices on a continuous Polyester suture loop. It is prethreaded with a traction suture that is used for positioning of the fixation button. Although non-absorbable, the Ultraslide device does not require removal,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
syndesmotic trauma, acromioclavicular, coracoclavicular, ankle syndesmosis, anterior inferior tibiofibular ligament, posterior inferior tibiofibular ligament
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
Statistical comparison of the test data of the cyclical displacement values and tensile strength demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices.
Key Metrics
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
Endoscopy Sinth ? Hernew by 150 Minon nom Band Arthoven, MA. (1) 810
SECTION IV
2000 000 078 140 140 1118 www.tmth.nephose.com
K082095-R
We are
OCT 2 1 2002
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.
Traditional 510(k) Submission of Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device
Date Prepared: July 22, 2008
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Kathy Reddig Regulatory Affairs Specialist II 978-749-1321 (Phone) 978-749-1443 (Fax) kathy.reddig@smith-nephew.com
C. Device Name
| Trade Name: | Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device |
|---|---|
| Common Name: | Non-Absorbable Suture /Button Retention Device |
| Classification Name: | Single / multiple component metallic bone fixation appliances and accessories |
D. Predicate Devices
The Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is substantially equivalent in design, indications and fundamental scientific technology to the following legally marketed devices in commercial distribution: Arthrex Tightrope™ Acromioclavicular (AC) Device (cleared via K052776) and the Arthrex Tightrope™ Syndesmosis Device (cleared via K043248).
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E. Description of Device
The Smith & Nephew Ultraslide Device allows for endoscopic fixation following a syndesmotic trauma as Coracoclavicular Separations or Ankle Syndesmotic Disruptions. The device consists of three components; two machined titanium ENDOBUTTON fixation devices on a continuous Polyester suture loop. It is prethreaded with a traction suture that is used for positioning of the fixation button. Although non-absorbable, the Ultraslide device does not require removal,
F. Intended Use
The Smith & Nephew Ultraslide Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.
G. Comparison of Technological Characteristics
The Smith & Nephew Ultraslide Device is substantially equivalent in design and function to the currently marketed Arthrex Tightrope™. The proposed and the predicate devices both have the same indications and the same fundamental scientific technology.
H. Summary Performance Data
Statistical comparison of the test data of the cyclical displacement values and tensile strength demonstrates that there are no statistically significant differences between the Smith & Nephew Ultraslide Device and the predicate devices.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Endoscopy Division % Ms. Kathy Reddig Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
OCT 2 1 2008
Re: K082095
Trade/Device Name: Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTN Dated: July 22, 2008 Received: July 24, 2008
Dear Ms. Reddig:
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
3
Page 2 - Ms. Kathy Reddig
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.
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 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 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 N. Miller
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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Indications for Use
510(k) Number (if known):
K08 2095
Device Name: Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device
Indications For Use:
The Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No
er 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)
Mark A. Millerson
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Neurological Devices
510(k) Number
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