(63 days)
Not Found
No
The 510(k) summary describes a mechanical device (interference screws) and its performance based on physical properties (insertion torque, pullout force). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
This device is used for the fixation of ligaments and tendons in patients requiring repair, which directly addresses a medical condition or injury.
No
The device is described as an interference screw used for fixation of ligaments and tendons, which suggests a therapeutic or surgical tool, not one used for diagnosis. There is no mention of it being used to identify or predict medical conditions.
No
The device description clearly states it is a physical titanium screw, which is a hardware component.
Based on the provided information, the Smith & Nephew Interference Screws are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of ligaments and tendons in patients requiring repair. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical screw made of titanium alloy, designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The description of the Smith & Nephew Interference Screws does not involve any such testing of specimens.
Therefore, the Smith & Nephew Interference Screws are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament and tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Smith & Nephew Titanium Interference Screws are available in various geometric configurations. The Smith & Nephew Titanium Interference Screws arc made with titanium alloy material. The range in diameters and lengths, combined with the variations in geometric configurations, provide the surgeon with a wide variety of sizes/configurations to choose from. Screws are available in both cannulated and non-cannulated styles. The screws may be purchased either sterile or non-sterile, to be sterilized by the end user.
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)
Comparison of the results of the insertion torque testing and pullout force demonstrated that there were no statistically significant differences between the Smith & Nephew Titanium Interference Screw and the 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.
K895711, K900132, K932027, K921481
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
SECTION IV
040331
page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA
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 Titanium Interference Screws
Date Prepared: February 6, 2004
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Blvd., Mansfield, MA 02048
B. Company Contact
Denise Lima Regulatory Affairs Specialist Ph: (508)337-4036 Fax: (508)261-3620
C. Device Name
| Trade Name: | Smith & Nephew Titanium Interference Screws |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
D. Predicate Devices
The Smith & Nephew Titanium Interference Screws are substantially equivalcnt in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: K895711 and K900132, Acufex Interference Screws; K932027, Oregon (Dyonics) Fixation System; K921481, Cannuflex Interference Screws.
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040331
page 2 of 2
Description of Device E.
The Smith & Nephew Titanium Interference Screws are available in various geometric configurations. The Smith & Nephew Titanium Interference Screws arc made with titanium alloy material. The range in diameters and lengths, combined with the variations in geometric configurations, provide the surgeon with a wide variety of sizes/configurations to choose from. Screws are available in both cannulated and non-cannulated styles. The screws may be purchased either sterile or non-sterile, to be sterilized by the end user.
Intended Use F.
The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament and tendon repair.
G. Comparison of Technological Characteristics
Although there are some dimensional variations between the Smith & Nephew Titanium Interference Screw and the predicate devices, there are no new issues raised concerning safety or efficacy of the device.
H. Summary Performance Data
Comparison of the results of the insertion torque testing and pullout force demonstrated that there were no statistically significant differences between the Smith & Nephew Titanium Interference Screw and the predicate devices.
Denise Lima 2/6/04
Denise Lima
Regulatory Affairs Specialist
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Ms. Denise Lima Regulatory Affairs Specialist II Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover. Massachusetts 01810
Re: K040331
Trade/Device Name: Smith & Nephew Titanium Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 10, 2004 Received: February 12, 2004
Dear Ms. Lima:
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 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. Denise Lima
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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mair McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
510(k) Number (if known): K040231
Device Name: Smith & Nephew Titanium Screws
Indications For Use:
The Smith & Nephew Interference Screws are used for fixation of ligaments and tendons in patients requiring ligament or tendon repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Mark A. Millman
livision Division of General, Restorative. and Neurological Devices
510(k) Number K 040531