(147 days)
Not Found
No
The summary describes a device that uses infrared technology for positioning and orientation, with no mention of AI or ML.
No.
The device is described as assisting with presurgical planning and providing orientation and reference during surgery, which are diagnostic and guidance functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that "The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning..." and provides "orientation and reference information during intra-cranial surgical procedures." While its primary role might be surgical planning and guidance, it leverages "diagnostic images" for this purpose.
No
The device description explicitly states the use of "infrared emitting diodes" and a "probe" to determine position and orientation, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device uses diagnostic images to assist with presurgical planning and provide orientation during intra-cranial surgical procedures. This is a surgical navigation and planning tool, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on determining the position and orientation of a probe during surgery using infrared technology. This is a physical localization function, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
Therefore, this device falls under the category of surgical planning and navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
Product codes
Not Found
Device Description
The Optical Digitizer Option uses infrared emitting diodes to determine the position and orientation of the probe during intra-operative localization. This option has accuracy and resolution similar to that provided with the ultrasonic digitizer currently used with ViewPoint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
diagnostic images
Anatomical Site
intra-cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, intra-cranial surgical procedures
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
JAN | 0 1997
General Information 1.
JAN | 3 |997
| Classification: | Class II
Image Assisted Surgery Device |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Image Assisted Surgery Device Option |
| Proprietary Name: | ViewPoint - Optical Digitizer Option |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act.
The device does comply with the draft voluntary
industry standard titled "Neurological Standard for
Image-Interactive Stereotactic and Localization
Systems (ASTM 10th Draft 9/94)." |
Intended Uses 2.
The Optical Digitizer Option for ViewPoint does not change the intended use of the ViewPoint system.
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
8/12/96
I - I
1
3. Device Description
The Optical Digitizer Option uses infrared emitting diodes to determine the position and orientation of the probe during intra-operative localization. This option has accuracy and resolution similar to that provided with the ultrasonic digitizer currently used with ViewPoint.
4. Safety and Effectiveness
The ViewPoint System with the Optical Digitizer Option is substantially equivalent to the ViewPoint System described in the 510(k) K961168 in safety and effectiveness. The following chart has been compiled to demonstrate the Optical Digitizer's substantial equivalence to this device.
| Parameter | ViewPoint with Optical
Digitizer Option | Predicate Device
ViewPoint (K961168) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Digitizer | Infrared signals emitted from
diodes on a hand-held wand
are detected by a Position
Sensor Assembly with two
optical detectors. The
assembly is either on a
mobile pedestal, mounted to
the OR table or mounted to
the ceiling. | Ultrasonic pulses emitted
from two locations on a
hand-held wand are detected
by four microphones in a
detector array which is
mounted to the OR table. |
| Active Digitizer Volume | Silo shape, with 1 meter
diameter and 1 meter length. | 0.75 cubic meter (26.5 cu. ft.) |
| Max. Digitizer Rate | 30 Hz for one or two tools;
for three tools, the rate is 30
Hz for one of the tools and 15
Hz for the other two. | 100 pts/sec/emitter |
| Wand/Localizer Average
Accuracy | Same | 2.0 - 5.0 mm |
| Registration Technique | Same | Scanned Fiducials |
| Type of Sterilization | Same | Wand is ETO Sterilizable. |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(OPTICAL)
2
| Parameter | ViewPoint with Optical
Digitizer Option | Predicate Device
ViewPoint (K961168) |
|--------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer | Same | A superscalar RISC
microprocessor with
sufficient RAM memory and
image storage capabilities.
Single high resolution
monitor. Networking
capabilities which support
DICOM v3.0. |
| Operating Software | Same operating software,
selections for the optical
wands and Position Sensor
Assembly have been added. | Operating software uses a
graphical user interface to
facilitate user interaction.
Multiplanar reformatting and
surface rendering capabilities
included. Software is able to
show diagnostic images at the
location of the probe tip. |
| Intended Use | The Optical Digitizer Option
for ViewPoint does not
change the intended use of
the ViewPoint system. | The ViewPoint is intended
for use as a device which
uses diagnostic images of the
patient acquired specifically
to assist the physician with
presurgical planning and to
provide orientation and
reference information during
intra-cranial surgical
procedures involving space
occupying lesions or
malformations (including soft
tissue, vascular and osseous). |
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8/12/96
I - 3
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