(34 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a bone screw and washer, with no mention of AI or ML technology.
No
The device is described as being used for the fixation of bone fractures or for bone reconstruction, which are surgical procedures, not therapeutic treatments.
No
This device is a surgical implant (screw and washer) used for fixation of bone fractures and reconstruction, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it is a screw and washer manufactured from Stainless Steel, indicating it is a physical hardware device.
Based on the provided information, the CHARLOTTE™ 7.0 MUC Screw and Washer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of bone fractures or bone reconstruction. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a screw and washer made of stainless steel, designed for physical implantation to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The CHARLOTTE™ 7.0 MUC Screw and Washer is a surgical implant used for mechanical support and fixation within the body.
N/A
Intended Use / Indications for Use
The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis
Product codes
HWC
Device Description
The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones, long bones, small bones, foot, hand, ankle
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design features, material, and indications for use of the CHARLOTTE™ 7.0 MUC Screw and Washer are substantially equivalent to the previously cleared CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers. This was confirmed by testing conforming to ASTM 543-02.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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MAR 2 9 2007
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™ 7.0 MUC Screw and Washer.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Wright Medical Technology, Inc.
March 28, 2007
Wesley Reed
Regulatory Affairs Specialist II
CHARLOTTE™ 7.0 MUC Screw and Washer
Screw and Washer
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II
Orthopedics/87/HWC
DEVICE INFORMATION
A. INTENDED USE
The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis
B. DEVICE DESCRIPTION
The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ 7.0 MUC Screw and Washer are substantially equivalent to the previously cleared CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ 7.0 MUC Screw and Washer 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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. c/o Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
MAR 2 9 2007
Re: K070525
Trade/Device Name: CHARLOTTE™ 7.0 MUC Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 8, 2007 Received: February 28, 2007
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
3
Page 2 - Mr. Wesley L. Reed
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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Bucher
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
070525
Indications for Use
510(k) Number (if known):
Device Name:_CHARLOTTE™ 7.0 MUC Screw and Washer
Indications For Use:
The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures
- Fracture management in the foot or hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- Treatment of inferior tibio fibular diastasis
- Hindfoot arthrodesis
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)
1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Tailgatebend