(14 days)
Not Found
No
The summary describes a passive optical tracking system using infrared signals and reflective markers, with no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML development.
No.
The device is intended for presurgical planning and intra-operative orientation and reference, not for treating a disease or condition.
Yes
The re-usable component specifies 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 to provide orientation and reference information during intra-operative procedures." This clearly indicates its use in a diagnostic capacity to aid in medical procedures.
No
The device description explicitly mentions a "position sensor assembly" that emits an infrared signal and reflective markers mounted on tools, 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:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ViewPoint Passive Tool Option, as described, is a surgical navigation system. It uses diagnostic images and optical tracking to assist physicians during surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "presurgical planning and to provide orientation and reference information during intra-operative procedures," using "diagnostic images of the patient acquired specifically to assist the physician." This is a surgical guidance function, not an in vitro diagnostic function.
Therefore, the ViewPoint Passive Tool Option falls under the category of surgical navigation or guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ViewPoint Passive Tool Option does not change the existing intended use and indications for use for the ViewPoint as defined below.
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 t resection of spinal neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Passive Tool Option for the ViewPoint system allows for optical tracking of wireless tools. The position sensor assembly provided with this option emits an infrared signal that is reflected off reflective markers mounted on the tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic images
Anatomical Site
Intra-cranial, Spinal
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): 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
3/30/99
SUMMARY C TY AND EFFECTIVENESS (As required by 21 CFR 807.92)
| 1. | General Information | |||
|---|---|---|---|---|
| Classification: | Class II | |||
| Image Assisted Surgery Device | ||||
| Common/Usual Name: | Image Assisted Surgery Device Option | |||
| Proprietary Name: | ViewPoint Passive Tool Option | |||
| Establishment Registration: | Picker International, Inc. | |||
| World Headquarters | ||||
| 595 Miner Road | ||||
| Highland Heights, Ohio 44143 | ||||
| Contact: Elaine K. Keeler, Ph.D. | ||||
| Phone Number: (440) 473-3000 | ||||
| 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. |
2. Intended Uses
The ViewPoint Passive Tool Option does not change the existing intended use and indications for use for the ViewPoint as defined below.
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 t resection of spinal neoplasms.
3. Device Description
The Passive Tool Option for the ViewPoint system allows for optical tracking of wireless tools. The position sensor assembly provided with this option emits an infrared signal that is reflected off reflective markers mounted on the tools.
| PICKER INTERNATIONAL, INC. | (PASSIVE) 03/12/99 | I - 1 |
|---|---|---|
| ---------------------------- | -------------------- | ------- |
1
Safety and Effectiveness 4.
The ViewPoint system with the Passive Tool Option is substantially equivalent to the ViewPoint system described in the 510(k) submission K970604. The following chart has been compiled to demonstrate this substantial equivalency.
| Parameter | ViewPoint Passive Tool Option | Predicate Device - ViewPoint 3.0
Software (K970604) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tools | A long and short wireless tool
with a minimum of three
reflective markers per tool. | A long and short tool with a minimum
of four IREDs per tool. |
| Average Tool Accuracy | Same. | 2.0 - 5.0 mm |
| Type of Detector | Infrared signals emitted from the
Position Sensor Assembly (PSA)
are reflected off of reflective
markers mounted on the tool.
The reflected signal is detected by
the PSA with two optical
detectors. The assembly is either
on a mobile pedestal, mounted to
the OR table or mounted to the
ceiling. | 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. |
| Active Digitizer Volume | Same. | Silo shape comprised of 0.5m radius
hemisphere and a cylinder with 0.5m
radius and 0.5m length. Detector
Positioning Feature added to guide
user in finding center of active
digitizer volume. |
| Registration Technique | Same. | Scanned Fiducials and Anatomical
Fiducials. |
| Operating Software
Structure | Same. | UNIX environment with three major
processes: Import, Surgery
Application and Foot Switch. Uses a
Graphical User Interface to facilitate
interaction with user. |
| Image Manipulation | Same. | MPR and surface rendering. |
| Other Features | Same. | Detector Positioning Feature. |
| Parameter | ViewPoint Passive Tool Option | Predicate Device - ViewPoint 3.0
Software (K970604) |
| Intended Use | Same. | 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. |
| Indications for Use | Same. | 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.
03/12/99 (PASSIVE)
2
3
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1999
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143
K990868 Re: Trade Name: ViewPoint Passive Tool Option Regulatory Class: II Product Code: HAW Dated: March 12, 1999 Received: March 16, 1999
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celina M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): _
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
ViewPoint Passive Tool Option Device Name:
Indications for Use:
The ViewPoint Passive Tool Option does not change the existing intended use and indications for use for the ViewPoint as defined below.
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) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division | General Restorative Devices |
| 510(k) Number | K990868 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)