(71 days)
Not Found
Not Found
No
The summary describes a mechanical external fixator for bone fractures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the stabilization of fractures, which is a therapeutic purpose.
No
Explanation: The device is described as a fixator intended for the stabilization of fractures, which is a therapeutic rather than a diagnostic function. It provides physical support and connection for bone fragments, not information for diagnosis.
No
The device description explicitly states it consists of "frame elements," "pins (Schanz screws)," "an external bridging frame," "two 4.0 mm Adjustable Clamps," "a carbon fiber rod," and "two protective end caps." These are all physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Synthes 4.0 Adjustable Clamp for Distal Radius Fixator is part of a construct used for the stabilization of fractures of the distal radius. It's a physical device that is implanted or attached externally to provide structural support.
- No Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural.
Therefore, based on the provided information, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthes 4.0 Adjustable Clamp for Distal Radius Fixator -MR Safe is part of a construct intended for the stabilization of fractures of the distal radius.
Product codes
LXT
Device Description
Synthes Distal Radius Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Distal Radius Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two 4.0 mm Adjustable Clamps, a carbon fiber rod and two protective end caps. This device is intended for use in the MR environment. The Distal Radius Fixator is available as a complete sterile assembly or as individual, nonsterile components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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.
Not Found
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
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SEP - 5 2003
Ko31973
Page ____ 1 3.0 510(k) Summary Synthes (USA) Sponsor: 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Bonnie Smith Contact: Device Name: Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe Classification: Class II, 21 CFR 888.3030: "Single/multiple component bone fixation appliances and accessories." Predicate Device: Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator Synthes Distal Radius Fixator consists of frame elements that form a Device Description: construct intended to treat fractures of the distal radius. The Distal Radius Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two 4.0 mm Adjustable Clamps, a carbon fiber rod and two protective end caps. This device is intended for use in the MR environment. The Distal Radius Fixator is available as a complete sterile assembly or as individual, nonsterile components. Intended for the stabilization of fractures of the distal radius. Intended Use: Clamps - Stainless steel, titanium alloy and cobalt alloy Materials: Substantial Documentation is provided which demonstrates that the Synthes 4.0 mm Equivalence: Adjustable Clamp for Distal Radius Fixator -MR Safe is substantially equivalent to other legally marketed Synthes devices.
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the agency's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K031973
Trade/Device Name: Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator -- MR Safe
Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 25, 2003 Received: June 26, 2003
Dear Ms. Smith:
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.
2
Page 2 - Ms. Bonnie J. Smith
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkersen
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
3
2.0 Indications for Use Statement
Page __ 1 ____ of ____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
DEVICE NAME:-
Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe
INDICATIONS:
Synthes 4.0 Adjustable Clamp for Distal Radius Fixator -MR Safe is part of a construct intended for the stabilization of fractures of the distal radius.
Mark N Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031973
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
CONFIDENTIAL
Over-the-Counter Use
Premarket Notification 510(k): Synthes (USA) 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe 0004