(90 days)
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms, nor does it describe features or processes typically associated with AI/ML in medical imaging (like automated detection, segmentation, or prediction based on learned patterns). The described features are related to image processing (MPR, surface rendering), tracking, and hardware support.
No
The device is intended for presurgical planning and intra-operative orientation and reference, not for direct therapeutic treatment.
No
The device is described as assisting physicians with pre-surgical planning and providing orientation and reference information during intra-operative procedures, not for making a diagnosis. The input explicitly states that it uses "diagnostic images of the patient acquired specifically to assist the physician with presurgical planning," implying it uses already existing diagnostic images rather than performing a diagnostic function itself.
No
The device description explicitly mentions support for optional hardware accessories: a tracking device, drill guides, and a CT spine phantom. While the software is a key component, the device system includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ViewPoint is described as a device that uses diagnostic images (like CT scans, implied by the mention of a CT spine phantom) to assist physicians with presurgical planning and provide orientation during surgery. It processes these images (MPR and surface rendering) and is used intra-operatively.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is based on processing and displaying medical images.
Therefore, the ViewPoint falls under the category of a medical device used for surgical planning and navigation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows:
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-operative procedures.
The ViewPoint is indicated for use in:
· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
Product codes
84HAW
Device Description
The new features in the 3.0 Software include a detector positioning feature and support for the following optional hardware accessories: a tracking device, drill guides and a CT spine phantom. The indications for use of the ViewPoint have also been expanded to include use in spinal surgeries.
Mentions image processing
MPR and surface rendering.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic images, MR/CT
Anatomical Site
Intra-cranial, spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, intra-operative procedures, OR table
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.)
Average Tool Accuracy: 2.0 - 5.0 mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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)
MAY 1 9 1997
General Information 1.
| Classification: | Class II
Image Assisted Surgery Device | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common/Usual Name: | Image Assisted Surgery Device Option | |
| Proprietary Name: | ViewPoint - 3.0 Operating Software | |
| 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 fo
Image-Interactive Stereotactic and Localization
Systems (ASTM 10th Draft 9/94)." | |
2. Intended Use and Indications for Use
The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows:
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-operative procedures.
The ViewPoint is indicated for use in:
· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
| PICKER INTERNATIONAL, INC. | (VIEW30) | 2/11/97 | I-1 |
|---|---|---|---|
| ---------------------------- | ---------- | --------- | ----- |
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3. Device Description
The new features in the 3.0 Software include a detector positioning feature and support for the following optional hardware accessories: a tracking device, drill guides and a CT spine phantom. The indications for use of the ViewPoint have also been expanded to include use in spinal surgeries.
Safety and Effectiveness 4.
The ViewPoint System operating with the 3.0 software is substantially equivalent to the ViewPoint System described in the 510(k) submissions K961168 and K963221. The following chart has been compiled to demonstrate the substantial equivalence of the ViewPoint operating with the 3.0 software to the predicate device.
| Parameter | Predicate Device
ViewPoint & Optical Digitizer
Option (K961168, K963221) | ViewPoint with 3.0 Software |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tools | A long and short tool with a
minimum of four IREDs per tool.
(See K963221) | Same. |
| Average Tool Accuracy | 2.0 - 5.0 mm (See K961168) | Same. |
| Type of Detector | Infrared signals emitted from
diodes on a hand-held tool 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. (See K963221) | Same. |
| Active Digitizer Volume | Silo shape, with 1 meter diameter
and 1 meter length.
(See K963221) | Same, Detector Positioning
Feature added to guide user in
finding center of active digitizer
volume. |
| Accessories | MR/CT Head Phantoms.
(See K961168) | MR/CT Head Phantoms, CT
Spine Phantom, Tracking
device, Drill Guide. |
| Parameter | Predicate Device
ViewPoint & Optical Digitizer
Option (K961168, K963221) | ViewPoint with 3.0 Software |
| Registration Technique | Scanned Fiducials.
(See K961168) | Scanned Fiducials and
Anatomical Fiducials. |
| Operating Software
Structure | UNIX environment with three
major processes: Import, Surgery
Application and Foot Switch.
Uses a Graphical User Interface to
facilitate interaction with user. | Same structure. Modified
Graphical User Interface with
similar functionality. |
| Image Manipulation | MPR and surface rendering. | Same. |
| Other Features | None.
(See K961168) | Detector Positioning Feature. |
| Intended 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-operative
procedures. (See K961168) | Same. |
| Indications for Use | The ViewPoint is indicated for
use in intra-cranial surgical
procedures involving space
occupying lesions or
malformations (including soft
tissue, vascular and osseous).
(See K961168) | The ViewPoint is indicated for
use in:
• Intra-cranial surgical
procedures involving space
occupying lesions or
malformations (including soft
tissue, vascular and osseous)
• Spinal surgical procedures
involving spinal stabilization,
neural decompression, or
resection of spinal neoplasms. |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(VIEW30)
2/11/97
I - 2
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PICKER INTERNATIONAL, INC.
(VEW30)
:
2/11/97
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قوب سابق
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1997
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc ... . . . 5500 Avion Park Drive Highland Heights, Ohio 44143
Re : K970604 ViewPoint - 3.0 Operating Software Trade Name: Requlatory Class: II Product Code: 84HAW Dated: February 14, 1997 Received: February 18, 1997
Dear Dr. Keeler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
4
Page 2 - Elaine K. Keeler, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. " "
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ViewPoint - 3.0 Operating Software
Indications for Use: ..... .... .... .... . . ... . . . . .
The intended use of the ViewPoint is unchanged by the 3.0 software, but the indications for use have been expanded to include spinal surgical procedures. The intended use and indications for use are as follows:
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-operative procedures.
The ViewPoint is indicated for use in:
- · Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
- · Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(on-Off)
Cardiovascular, Respiratory,
Devices
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use (Optional Format 1-2-96)