(29 days)
Not Found
No
The device description focuses on the material and mechanical features of a bone screw, with no mention of AI or ML capabilities.
Yes
The device is a screw used for fixation of bone fractures and reconstruction, suggesting a therapeutic purpose.
No
The device is a screw used for fixation of bone fractures and reconstruction, not for diagnosis.
No
The device description clearly states it is a screw manufactured from a specific material and available in different sizes, indicating it is a physical hardware device.
Based on the provided information, the CHARLOTTE™ Snap-Off Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- CHARLOTTE™ Snap-Off Screw Function: The description clearly states the device is used for the fixation of bone fractures or bone reconstruction. This is a surgical implant used directly on the body, not for analyzing samples taken from the body.
The intended use, device description, and lack of any mention of analyzing biological samples all indicate that this is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of Small Bone Fragments
- · Weil osteotomy
- · Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand
Product codes
HWC
Device Description
The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
Screw
- . Manufactured from ASTM F136 (Ti-6A1-4V ELI)
- . Available in one diameter and three lengths
- Self drilling and self tapping features on distal threads .
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)
Wright Pre-amendment No. 223 Knowles Pin
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
JAN 2 6 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the CHARLOTTE™ High-Demand Compression Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | December 22, 2004 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist | |
| Proprietary Name: | CHARLOTTE™ Snap-Off Screw |
| Common Name: | Bone Fixation Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone |
| fixation fastener - Class II | |
| Device Product Code and Panel Code: | 21 CFR 888.3040 Smooth or threaded metallic bone |
| fixation fastener - Class II |
DEVICE INFORMATION
A. INTENDED USE
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of Small Bone Fragments
- · Weil osteotomy
- · Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand
B. DEVICE DESCRIPTION
The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
Screw
- . Manufactured from ASTM F136 (Ti-6A1-4V ELI)
- . Available in one diameter and three lengths
- Self drilling and self tapping features on distal threads .
1
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the Wright Pre-amendment No. 223 Knowles Pin. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ Snap-Off Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is rendered in black and white, and the text is also in black.
Public Health Service
JAN 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K043583
Trade/Device Name: CHROLOTTE™ Snap-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 27, 2004 Received: December 28, 2004
Dear Mr. Reed:
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.
3
Page 2 - Mr. Wesley L. Reed
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
for Mark A. Millmann
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):
Device Name:_CHARLOTTE™ Snap-Off Screw
Indications For Use:
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of Small Bone Fragments
- · Weil osteotomy
- Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
O - Mark - 1 - Wilkinson
1 of 1
- Division of General, Restorative, and Neurological Devices
5190: Number