(67 days)
Not Found
No
The description details a mechanical device for surgical procedures and makes no mention of AI or ML.
No.
The device is a surgical instrument (screw cannula) used for precise screw placement during ligament reconstruction, rather than directly treating a medical condition itself.
No
The device description indicates that the Acufex Screw Cannula is a tool used for fixation during surgical procedures, not for diagnosing a condition.
No
The device description clearly describes a physical, cylindrical device used for surgical procedures, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Acufex Screw Cannula Function: The description clearly states the Acufex Screw Cannula is used for the fixation of bone-tendon-bone grafts during surgical procedures (ACL/PCL reconstruction). This is a surgical instrument used within the body during a procedure, not for testing specimens outside the body.
The device's function is entirely related to surgical implantation and fixation, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
Product codes
HWC
Device Description
The Acufex Screw Cannula is a cylindrical device that has a distal, screw holding end, and an open back end. The proximal end is shaped to allow for secure grasping of the cannula during insertion. The distal end contains a feature that allows the screw to be held snugly in the cannula. This is accomplished by creating an interference fit between the screw and the cannula walls.
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 9 1231
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is :
This summary was prepared on July 2, 1997
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048
Company Contact B.
Demetrios Tsakonas Clinical/Regulatory Specialist
C. Device Name
| Trade Name: | Acufex® Screw Cannula |
|---|---|
| Common Name: | Screw and Cannula |
| Classification Name: | Screw, Fixation, Bone |
| Cannula, Surgical |
D. Predicate/Legally Marketed Devices
Arthrex® Sheathed Interference Screw 3050 North Horseshoe Drive Naples, FL 33942 510(k) #: K915424
1
E. Device Description
The Acufex Screw Cannula is a cylindrical device that has a distal, screw holding end, and an open back end. The proximal end is shaped to allow for secure grasping of the cannula during insertion. The distal end contains a feature that allows the screw to be held snugly in the cannula. This is accomplished by creating an interference fit between the screw and the cannula walls.
F. Intended Use
The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
2
Substantial Equivalence G.
The Acufex Screw Cannula is intended for use for fixation of bone tendon grafts during ACL/PCL reconstructions. The Acufex Screw Cannula is similar in design, function, materials and intended use to other devices currently marketed and in commercial distribution, namely the Arthrex® Sheathed Interference Screw.
Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.
A summary comparison of the characteristics of the Acufex Screw Cannula and the substantially equivalent device is presented in the table below.
| Attribute | Current Product
Acufex®
Screw Cannula | Substantially Equivalent Product
Arthrex® Sheathed Interference
Screw
510K#: K915424 |
|---------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Indication | Bone Tendon Bone Graft Fixation
ACL & PCL Reconstruction | Bone Tendon Bone Graft Fixation
ACL & PCL Reconstruction |
| Screw Configuration | Interference | Interference |
| Screw Size | Outer Length: 20 - 30 mm
Diameter: 5.5 - 9 mm | Length: 25 - 55 mm
Diameter 6 - 9 mm |
| Screw Material | Titanium | Titanium |
| Cannula/Sheath | Polypropylene | Polyethylene |
| Labeling | Sterile, Single Use Only | Sterile, Single Use Only |
Applicant
Demetrios Joakonas
Date 7/11/97
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith & Nephew, Inc. 130 Forbes Boulevard Mansfield, Massachusetts 02048
SEP 1 9 1997
Re: K972599 Trade Name: Acufex® Screw Cannula Regulatory Class: II Product Code: HWC Dated: July 11, 1997 Received: July 14, 1997
Dear Mr. Tsakonas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Demetrios Tsakonas
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
tallyz
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510 (k) Number (If Known):
Device Name: Acufex Screw Cannula
Indications for Use: The Acufex Screw Cannula is used for fixation of bone-tendonbone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
fcoelee
eral Restorative Devices
Prescription Use
(Per 21 CFR 801.109) √
or Over-The-Counter Use __________