(62 days)
Not Found
No
The device description explicitly states it is "all-mechanical" and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
No
The device is described as an aid to identify anatomical landmarks during fluoroscopic procedures and is placed external to the body. It does not exert a therapeutic effect on the patient.
No
Explanation: The device is an all-mechanical aid used to identify anatomical landmarks during fluoroscopic procedures. It does not diagnose or process medical information to identify a condition or disease.
No
The device description explicitly states it is an "all-mechanical aid" with physical components (polycarbonate plate, control box, movable markers). This indicates it is a hardware device, not software-only.
Based on the provided information, the EVT® Marker Board is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "identify anatomical landmarks during fluoroscopic procedures." This is a function performed in vivo (within the body) during a medical procedure, not in vitro (outside the body) for diagnostic testing of samples.
- Device Description: The device is described as an "all-mechanical aid placed external to the body." This further reinforces that it's a physical tool used during a procedure, not a system for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The EVT® Marker Board is a medical device used to assist in image-guided procedures by providing visible markers on the fluoroscopic image. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
21 CFR 892.1650
Device Description
The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy x-ray system
Anatomical Site
anatomical landmarks
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.
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
APR 2 | 1997
IX. SUMMARY OF SAFETY AND EFFECTIVENESS
SUMMARY OF SAFETY AND EFFECTIVENESS
MANUFACTURER:
Endo Vascular Technologies, inc. 1460 O'Brien Drive Menlo Park, CA 94025-1436 Contact: Luanne Termeer
DEVICE NAME:
The EVT® Marker Board is an accessory to an image intensified fluoroscopy x-ray system, 21 CFR 892.1650, Class II.
SUBSTANTIAL EQUIVALENCE:
The EVT® Marker Board is substantially equivalent to the IZI Medical Products Topographic Marker, (K930752, Class II). The EVT® Marker Board is used external to the body. A control box is used to remotely move the position of the markers that are within the marker board. The IZI Medical Products Topographic Markers have adhesive backing which is peeled off and the markers are positioned directly on the body.
DEVICE DESCRIPTION:
The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers.
INTENDED USE:
The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.