(20 days)
Not Found
No
The 510(k) summary describes a standard bone screw and its intended use, materials, and predicate devices. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No.
This device is a bone screw used for fixation and reattachment, not for treating a disease or condition in a therapeutic manner.
No
The device is described as a cannulated bone screw, intended for fixation of bone fractures and other orthopedic conditions, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states the materials used (stainless steel and titanium) and its function as a bone screw for fixation, indicating it is a physical hardware device.
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 Description: The description clearly states the device is a "Cannulated Bone Screw" made of implant-quality materials. It is designed for "bone fixation in the human body."
- Intended Use: The intended uses are for surgical procedures involving bone (fractures, osteotomies, etc.) and tendon reattachment, all of which are performed within the human body.
This device is an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to. Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.
Product codes
HWC
Device Description
The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant-quality titanium. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation in the human body.
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)
Not Found
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.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three parallel lines curving upwards, with a wavy line beneath them, possibly representing a stylized human figure or a symbol of health and well-being.
APR 3 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Abrahim Lavi, Ph.D., M.B.A. President/CFO Vilex, Inc. 1801 Route 51 Building 10 Large, Pennsylvania 15025-0724
K991151 and K991197 Rc: Tradc Name: Cannulated Screws Regulatory Class: II Product Code: HWC Dated: April 1 and 6, 1999 Received: April 6 and 8, 1999
Dear Dr. Lavi:
This letter is being issued in response to your conversation with Mr. Aric Kaisc on April 28, I his letter is being Issued in response to your convensions with our letter dated April 1999, in willch you stated that the materials used to manufacture some of the forms an 26, 1999, Inconectly ucsembed the materials above. The corrected Intended Use Aorms are described by the submissions released as one replace our letter dated April 26, 1999.
enclosed and this letter is intended to supercede and replace our letter dated April 26,
We have reviewed your Section 510(k) notification of intent to market the devices we nave reviewed your becaller in the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior multations for use saled in the enered the Medical Device Amendments, or to devices that to May 26, 1770, the charement cate with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls Cosment for (Act). " Fouring), ral controls provisions of the Act include requirements for provisions of the ret. The Eckevices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major (1 rehations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the r urent Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through pcriodic (QS) inspections, the Food and Drug Administration (FDA) will verify through porculars. Failure to comply with the GMP regulation may result in regulatory
1
Page 2 - Abrahim Lavi. Ph.D., M.B.A.
action. In addition, FDA may publish further announcements concerning your devices 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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
1 Page
K991151 510 (k) NUMBER (IF KNOWN) : Vilex Cannulated Bone Screw/DuVal Cannulated Bone Screw DEVICE NAME :
INDICATIONS FOR USE:
The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to. Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant-quality titanium. When properly used with Vilex instrumentation, this screw safe purchase and compression for cortical and achieves cancellous bone fixation in the human body.
(PLEASE DO NOT WRITE BELOW THIS LAND-CONTINUE ON 'ANOTHER PAGE r.
Fi IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1--96)
(Division Sign-Off)
General Restorative Devices
6.1