(11 days)
Not Found
No
The 510(k) summary describes a mechanical screw for bone fixation and does not mention any AI or ML components or functionalities.
No
The device is a screw indicated for fixation of bone fractures or for bone reconstruction, which is a structural support rather than a therapeutic treatment process.
No
Explanation: The device is a screw used for fixation of bone fractures and reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a screw manufactured from a specific material (ASTM F136) and available in different sizes, indicating it is a physical hardware device, not software only.
Based on the provided information, the CHARLOTTE™ Snap-Off Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the fixation of bone fractures and bone reconstruction, specifically in the foot and hand. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a screw made of titanium, designed for physical implantation into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The CHARLOTTE™ Snap-Off Screw is an in vivo (within the body) device used for surgical fixation.
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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
Screw
- Manufactured from ASTM F136 (Ti-6AI-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
foot and hand
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
APR 1 ] 2005
1/2
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 use of the CHARLOTTE™ Snap-Off Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | March 30, 2005 |
| 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-6AI-4V ELI) .
- Available in one diameter and three lengths .
- Self drilling and self tapping features on distal threads .
1
2/2
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the previously cleared CHARLOTTE™ Snap-Off Screw (K043583). 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
Image /page/2/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" around the perimeter. Inside the circle is a stylized image of an eagle's head with three parallel lines representing the feathers.
APR 1 1 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: K050819
Trade/Device Name: CHARLOTTE™ 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: March 30, 2005 Received: March 31, 2005
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,
Hypt Elwdie
Miriam C. Provost, Ph.D. Acting 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
X
(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)
1 of 1
Stupt Purda
(Division Division of General, Restorative, and Neurological Devices
510(k) Number_ 6050819