(76 days)
Not Found
Not Found
No
The summary describes a mechanical component (a connecting rod) for an external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a component of an external fixation system used for the stabilization of fractures, which is a therapeutic purpose.
No
Explanation: The device, a Carbon Fiber Composite Connecting Rod, is intended for the stabilization of fractures as part of an external fixation system. This is a therapeutic function, not a diagnostic one.
No
The device is a physical component (carbon fiber composite connecting rod) used in an external fixation system, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the stabilization of fractures, which is a direct treatment of a physical condition within the body.
- Device Description: The device is a physical component (a connecting rod) used in an external fixation system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or monitoring.
- Using reagents or other chemical substances for testing.
IVDs are used to perform tests on samples taken from the body to provide diagnostic or monitoring information. This device is a surgical implant/component used in the body to provide structural support.
N/A
Intended Use / Indications for Use
This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.
Product codes (comma separated list FDA assigned to the subject device)
888.3040 Fastener
Device Description
The rod is designed to provide a connecting element for the clamps in an external fixation frame. It is manufactured from a carbon fiber reinforced epoxy resin.
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
Testing of this device is presented in the submission. Testinq was performed to determine static bending strength and stiffness, and torsional strength and stiffness. In each test the Hoffmann® II Carbon Rods were compared to the Hoffmann® stainless steel rods and/or Hoffmann® II aluminum rods.
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 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
AUG - I 1996
510(k) Summary
Hoffmann® II Carbon Connecting Rods Trade Name: External Fixation Rod Common Name: Smooth or Threaded Metallic Bone Fixation Classification Name: 888.3040 Fastener
This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.
The rod is designed to provide a connecting element for the clamps in an external fixation frame. It is manufactured from a carbon fiber reinforced epoxy resin.
Equivalency of this device is based on similarities in intended use, materials, design and operational principles to the Hoffmann® Stainless Steel Rods, The Hoffmann® II Aluminum Rods, the Synthes Carbon Fiber Rods and the Carbon Tubes of The Monotube External Fixation System.
The Hoffmann® II Carbon Connecting Rods, the Synthes Carbon Fiber Rods and the Monotube Carbon Tubes are all manufactured from carbon fiber reinforced epoxy composites. All of these rods are designed to mate with external fixation clamps, intended to be used as connecting elements in pin fixation of fractures and are of a varying diameters and lengths to address different anatomic locations.
Testing of this device is presented in the submission. Testinq was performed to determine static bending strength and stiffness, and torsional strength and stiffness. In each test the Hoffmann® II Carbon Rods were compared to the Hoffmann® stainless steel rods and/or Hoffmann® II aluminum rods.
For information contact: John Dichiara
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870