(193 days)
Not Found
Not Found
No
The device description focuses on mechanical and magnetic targeting mechanisms, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The descriptions indicate the device is an instrument system used for surgical procedures (e.g., preparing the intramedullary canal, drilling screw holes), not a device that provides therapy itself.
No
The device description indicates that the system is "designed to locate and lock in place the distal screw holes" of a femoral nail, and it facilitates surgical procedures like drilling screw holes. This is an intra-operative surgical tool, not a device used to diagnose a medical condition.
No
The device description explicitly lists physical components like reamers, drill bits, a targeting compass, magnetic target insert, and Steinmann pins, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for stabilizing bone fractures of the femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details instruments used for preparing the bone, locating screw holes, and drilling. These are all tools used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
The MAGELLAN™ Magnetic Distal Targeting System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.
Product codes
HSB
Device Description
The MAGELLAN™ Magnetic Distal Targeting System is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; drill bits to drill screw holes proximally, a targeting compass and magnetic target insert to locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) to create the distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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
Because the MAGELLAN Magnetic Distal Targeting System is substantially equivalent to the predicate device in design, material, and intended use, testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.), Russell-Taylor Intramedullary Nail System Instrumentation (Smith and Nephew)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
OCT - 3 1997
Image /page/0/Picture/1 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, downward-pointing triangles arranged side-by-side. The central triangle is slightly offset, creating a visual break in the middle of the "W". A small registered trademark symbol is visible at the bottom right of the logo.
Image /page/0/Picture/2 description: The image shows the logo and contact information for Wright Medical Technology, Inc. The address is 5677 Airline Road, Arlington, TN 38002. The phone number is 901-867-9971.
Contact Person: Date:
Cristie Manuel March 21, 1997
510(k) Summary
Trade/Proprietary Name:
Common Name: Classification: Predicate Device: MAGELLANTM Magnetic Distal Targeting System (proposed name), Product Line Extension Surgical instrument motors and accessories/attachments Class I Preamendments Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.) Russell-Taylor Intramedullary Nail System Instrumentation (Smith and
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Nephew)
Description/Indicated Use
The MAGELLANTM Magnetic Distal Targeting System is designed to locate and lock in place the distal screw holes of the Magellan Intramedullary Femoral Nail without the use of radiographic equipment. The system includes reamers for preparing the intramedullary canal for nail placement; drill bits to drill screw holes proximally, a targeting compass and magnetic target insert to locate the distal screw holes, and targeting Steinmann pins and drill bits (two sizes) to create the distal screw holes. This instrument system is used with power equipment available from other manufacturers, and is certified by the supplier to work with the power source.
The MAGELLANTM Magnetic Distal Targeting System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.
Testing
Because the MAGELLAN™ Magnetic Distal Targeting System is substantially equivalent to the predicate device in design, material, and intended use, testing was not performed.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 1997
Ms. Kim Tompkins ·Director Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K971056 MAGELLAN Maqnetic Distal Trade Name: Targeting System Regulatory Class: II Product Code: HSB Dated: July 3, 1997 Received: July 7, 1997
Dear Ms. Tompkins:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current 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 periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
2
Page 2 - Ms. Kim Tompkins
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 leqally 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) 594-4659. 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Wright Medical Technology, Inc. MAGELLAN " Magnetic Distal Targeting System
C. Indications for Use of the Device
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MAGELLAN™ Magnetic Distal Targeting System
Indications for Use:
The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.
(Please do not write below this line-continue on another page if needed)
- 水 水 * * * * * * 水 Concurrence of CDRH, Office of Device Evaluation (ODE)
Ascòlle
Prescription Use (Per 21 CFR 801.109)
Or
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96) trans
000009