(86 days)
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No
The device description and performance studies focus solely on the mechanical properties and design of a surgical implant (a nail for femur fractures). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as an implant used for fracture fixation, which is a structural support device, not a therapeutic device meant to treat or cure a disease or condition through a biological or chemical mechanism.
No
Explanation: The device is an implantable medical device (Supracondylar Nail) used for fracture fixation, not for diagnosing medical conditions. Its intended use and description clearly indicate it is a therapeutic device.
No
The device description clearly describes a physical implantable medical device (a cannulated rod/nail) made of material and with specific dimensions and features for surgical insertion and fixation of bone fractures. There is no mention of software as the primary or sole component of the device.
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 the "fixation of various types of fractures of the supracondylar or distal region of the femur". This is a surgical procedure performed in vivo (within the living body) to treat a physical condition.
- Device Description: The description details a "cannulated rod designed to be inserted through the condylar notch in order to fix fractures of the femur". This is a physical implant used during surgery.
- 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 treatment.
IVD devices are used in vitro (outside the living body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.
Product codes
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Device Description
The Supracondylar Nail is a cannulated rod designed to be inserted through the condylar notch in order to fix fractures of the femur. The nail is available in 9 through 13 mm diameters with varying lengths. Each nail contains multiple distal and proximal holes/slots for insertion of locking screws with a cone-shaped head for ease of insertion. The nail is fluted for revasularization. Longer length nails are curved. The holes/slots accept cortical screws for locking of the nail.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femur
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 Supracondylar Nail was tested in four-point bend testing for bending strength and bending rigidity. Results showed significant bending strength and bending rigidity for all nail diameters and designs. Slotted nails demonstrated a reduction in bending strength and bending rigidity. The Supracondylar Nail testing results were compared to predicate devices in terms of design and material, indicating superior strength capabilities for the Zimmer Supracondylar Nail.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Intramedullary Supracondylar Nail, marketed by Smith & Nephew Richards, -Inc., AIM Supracondylar Nail, marketed by Ace Orthopedic Manufacturing -Company
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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in lowercase letters.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
SEP 2 5 1996
Summary of Safety and Effectiveness Supracondylar Intramedullary Nail
Submitted by .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Prepared by .
Lynnette Whitaker Manager Regulatory Affairs Telephone: 219-372-4561 Telefax: 219-372-4605
- Date .
June 28, 1996
Trade Name .
Supracondylar Intramedullary Nail
Common Name .
Intramedullary Rod
. Classification Name
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
Image /page/0/Picture/20 description: The image shows a hexagonal design composed of six identical triangular sections arranged around a central point. Each triangular section contains a smaller triangle within it, creating a pattern of nested triangles. The overall design has a symmetrical and geometric appearance.
1
Predicate Devices
- Intramedullary Supracondylar Nail, marketed by Smith & Nephew Richards, -Inc.
- AIM Supracondylar Nail, marketed by Ace Orthopedic Manufacturing -Company
Device Description
The Supracondylar Nail is a cannulated rod designed to be inserted through the condylar notch in order to fix fractures of the femur. The nail is available in 9 through 13 mm diameters with varying lengths. Each nail contains multiple distal and proximal holes/slots for insertion of locking screws with a cone-shaped head for ease of insertion. The nail is fluted for revasularization. Longer length nails are curved. The holes/slots accept cortical screws for locking of the nail.
Intended Use
The Supracondylar Nail is intended for use in fixation of various types of fractures of the supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures.
Performance Data
The Supracondylar Nail was tested in four-point bend testing for bending strength and bending rigidity. Results showed significant bending strength and bending rigidity for all nail diameters and designs. Slotted nails demonstrated a reduction in bending strength and bending rigidity. The Supracondylar Nail testing results were compared to predicate devices in terms of design and material, indicating superior strength capabilities for the Zimmer Supracondylar Nail.
RA06602K.510