(52 days)
Not Found
No
The summary mentions "image processing, analysis, and display functions" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description focuses on integrating existing technologies for surgical planning and localization.
No
The device is used for pre-surgical planning and intra-operative localization, which are diagnostic and guidance functions, not therapeutic.
No
The device uses diagnostic images but does not perform diagnosis itself. Its intended use is for pre-surgical planning and to orient physicians during surgery.
No
The device description explicitly mentions integrating with a "non-mechanical 3-dimensional digitizer," which is a hardware component.
Based on the provided information, the ViewPoint device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- ViewPoint analyzes medical images: The ViewPoint device processes and analyzes diagnostic images (CT and MR) acquired directly from the patient. It does not interact with or analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for "presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures," which is based on image analysis, not biological sample analysis.
Therefore, the ViewPoint falls under the category of medical devices that utilize imaging for surgical planning and guidance, rather than IVDs.
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
This device integrates 3-D studies from computerized tomography (CT) and magnetic resonance (MR), and medical super-computers with image processing, analysis, and display functions already cleared by the FDA, with a non-mechanical 3-dimensional digitizer in order to provide pre-operative surgical planning and real-time intra-operative localization with accuracy similar to that of framestereotaxy without the limitations of frame-application.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computerized tomography (CT) and magnetic resonance (MR)
Anatomical Site
intra-cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 1 6 1996
1. General Information
Classification: Class II Image Processing System (Accessory) Common/Usual Name: Image assisted surgery device ViewPoint™ Proprietary Name: Establishment Registration: Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965
Performance Standards:
No Applicable Standards.
2. Intended Uses:
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).
3. Device Description:
This device integrates 3-D studies from computerized tomography (CT) and magnetic resonance (MR), and medical super-computers with image processing, analysis, and display functions already cleared by the FDA, with a non-mechanical 3-dimensional digitizer in order to provide pre-operative surgical planning and real-time intra-operative localization with accuracy similar to that of framestereotaxy without the limitations of frame-application.
4. Safety and Effectiveness
i
The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been compiled to demonstrate ViewPoint's substantial equivalence to these devices.
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SUBSTANTIAL EQUIVALENCE CHART
| Parameter | ISG Viewing Wand
(K911783) | SNT StealthStation
(K954276) | Picker ViStar
(K905070) | ViewPoint |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of Digitizer | A six-jointed, six
degree of freedom
electrogoniometer is
mounted to the OR
table t-rail or head
holder and is used for
position and angle
measurement. The
angular position of
each joint is
measured using
proprietary potentio-
meter type sensors. | A manual surgical
instrument that has
been modified to
incorporate low
voltage LEDs onto
the handle is used as
a probe. The location
of the probe is
tracked by three
optical cameras and is
compared to the
location of the
reference system. | NA | Ultrasonic pulses
emitted from two
locations on hand-
held wand are
detected by 4
microphones in a
detector array which
is mounted to the
OR table. |
| Registration
Technique | Scanned Fiducials,
Surface fitting,
anatomical features. | Laitinen Stereo-
adapter non-invasive
stereotactic frame | NA | Scanned Fiducials |
| Type of Sterilization | Instrumented Arm:
cleaned and draped.
Probes: autoclaved or
gas sterilized | Reference arc and
Optical probe are
auto-claved. | NA | Wand is ETO
sterilizable. |
| Parameter | ISG Viewing Wand
(K911783) | SNT StealthStation
(K954276) | Picker ViStar
(K905070) | ViewPoint |
| Computer | Hewlett Packard
Apollo Series 700,
Unix System 5
Operating System, X-
Windows/MOTIF | Silicon Graphics Indy
workstation with a
minimal configuration
of a UNIX/X-
windows operating
system. | Stardent 3000
supercomputer using
parallel RISC
architecture. | DEC 3000 Model
700 superscalar RISC
microprocessor with
64 bit word. UNIX
System with X-
windows/MOTIF. |
| RAM Memory | 64 MBytes. | 64 MBytes. | 64 MBytes.
Expandable to 128
MBytes. | 128 MBytes.
Expandable to 256
MBytes. |
| Image Storage
Capabilities | 1.0 GByte disk
storage. DAT drive
and QIC tape. | 500 MBytes of hard
disk space and a DAT
archive/backup
device | 760 MBytes disk
storage, 1/4" cartridge
tape drive, magnetic
tape drive. Optional
optical disk drive. | 2.1 GBytes of disk
storage. Optional 1.3
GByte optical disk
drive. 1/2" 9-track
tape system. |
| Monitor | 19 inch, 1280 x 1024
high resolution color
monitor, 72 Hz, non-
interlaced | High-resolution
monitor capable of
displaying 256 grey
levels | 19 inch, 1280 x 1024
high resolution color
monitor, 60 Hz, non-
interlaced. | 20 inch, 1280 x 1024
high resolution color
monitor, 72 Hz, non-
interlaced. |
| Networking | Ethernet networking
capabilities. | Supports the DICOM
v3.0 imaging /
networking protocol. | Ethernet TCP/IP. | Networking software
for direct link to MR
and CT systems.
Supports the DICOM
v3.0 imaging /
networking protocol. |
| Parameter | ISG Viewing Wand
(K911783) | SNT StealthStation
(K954276) | Picker ViStar
(K905070) | ViewPoint |
| Graphical Interface | 4 viewports with
control panel.
Standard viewports:
coronal view, sagittal
view, axial view and
3D view. | 4 viewports with
control panel.
Standard viewports:
coronal view, sagittal
view, axial view and
navigational view.
Probe position
indicated by cross-
hairs. | 1 to 256 individual
viewports, image sizes
from 64 x 64 to 1024
x 1024 pixels, ability
to window, level,
zoom, pan, apply
filters and draw. | 4 viewports with 512
x 512 resolution.
Control panel with
status information
and menu selections.
Ability for graphical
overlays. Layout of
viewports depends on
mode of operation. |
| Image Manipulation
& Reformatting
Capabilities | Multiplanar
Reformatting, Surface
Rendering. Able to
show diagnostic
images at the location
of the articulated
arm. | Multiplanar
Reformatting, Surface
Rendering. Able to
show diagnostic
images at any
Laitinen coordinate in
surgical space as
identified by the
probe. | Multiplanar
Reformatting, Angiographic
Rendering, Surface
Rendering, Cubeview,
Cine Display. | Multiplanar
Reformatting,
Surface Rendering.
Able to show
diagnostic images at
the location of the
probe tip. |
| Parameter | ISG Viewing Wand
(K911783) | SNT StealthStation
(K954276) | Picker ViStar
(K905070) | ViewPoint |
| Intended Use | The Viewing Wand is intended for use with patients who have imaged space occupying lesions
or malformations (both soft tissue and osseous) such as: intra-cerebral tumors and cysts, skull-
based tumors and cysts, vascular malformations such as cavernous malformations and arterio-
venous malformations, epilepsy, acute sinusitis with complications, chronic sinusitis and
cerebrospinal fluid leaks. There are no known restrictions on patient population other than
patients with Creutzfeld-Jakob's disease. The Wand is intended for use during planning and
surgery provided the attainable correlation accuracy is adequate for the intended use. | The StealthStation is intended for use for precise stereotactic determination of cranial and
neurological targets and is suitable for locating tumors during open surgery, and for
percutaneous tumor biopsy and ventriculostomy. | The ViStar systems used with HPQ and 2055HP systems do not change the existing indications
which are: The Picker International Vista HPQ and 2055 HP systems are indicated for use as
NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting
NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice
relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure
of the head and whole body. When interpreted by a trained physician, these images yield
information that can be useful in the determination of a diagnosis. | 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). |
PICKER INTERNATIONAL, INC. (VIEWHD)
(3/21/96)
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PICKER INTERNATIONAL, INC. (VIEWHD)
--
(3/21/96)
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