(86 days)
Not Found
No
The description focuses on image processing, real-time display based on probe position, and correlation of pre-operative images with intraoperative situations. There is no mention of AI, ML, or any learning algorithms used for image analysis, decision support, or other functions. The device appears to be a navigation system based on image registration and tracking.
No
The device is used for pre-operative and intra-operative image processing and navigation, not for direct therapeutic intervention. It provides information to the user, but does not perform a treatment itself.
No
Explanation: The device processes and displays pre-operative images and provides intra-operative image information based on probe position, correlating it with existing imaging data. It assists in surgical planning and guidance by showing the relationship of the probe to anatomy, but it does not diagnose disease or determine a medical condition. Its function is to provide visual guidance during medical procedures, rather than to identify or characterize medical conditions.
No
The device description explicitly states it is comprised of a "medical workstation and an integrated position sensing probe," indicating it includes hardware components beyond just software.
Based on the provided information, this 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.
- This device uses imaging data: The Family of Viewing Wands processes and displays pre-operative radiographic images (CT and MR) and provides intra-operative image information based on the position of a probe. It does not analyze biological samples.
- The intended use is surgical guidance: The primary purpose of this device is to assist surgeons during pre-operative planning and intra-operative procedures by correlating imaging data with the patient's anatomy in real-time.
Therefore, the Family of Viewing Wands falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intraoperatively to perform the following functions:
- process and display pre-operatively radiographic images on a monitor; .
- provide intra-operative image information based on the position and orientation of a user directed . probe:
- allow for the optical integration and usage of different position sensing technologies (e.g. articulated arm, infrared freehand) and surgical probes (handheld pointers);
- store/retrieve image data on computer access media (e.g. hard disks, archive media); and
- transmit data over local area and wide area networks.
Product codes (comma separated list FDA assigned to the subject device)
84HAW
Device Description
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intraoperative situation. Once a patient's CT or MR images have been transferred to the workstation, the system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and/or MR imaging data
Anatomical Site
cranial and spinal
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
§ 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
Image /page/0/Picture/0 description: The image shows a logo with the letters "ISC" stacked vertically inside a black rectangle. The words "VISUAL DATA" are written along the bottom left curve of the rectangle, and the word "PROCESSING" is written along the top right curve of the rectangle. The text is in a sans-serif font and is white against the black background.
JUN - 4 1997
510(K) SUMMARY
I. COMPANY & CONTACT PERSON
ISG TECHNOLOGIES, INC. 6509 Airport Road Mississauga L4v-1S7 Ontario, Canada
II. DEVICE NAME AND CLASSIFICATION
Family of Viewing Wands
Classification: Stereotatic Instrument (21 CFR 882.4560)
III. DESCRIPTION OF DEVICE
The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intraoperative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.
IV. INTENDED USE
The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used preoperatively and intra-operatively.
V. SUBSTANTIAL EQUIVALENCE
The spinal application as described in this submission is a line (application) extension to the Family of Viewing Wands (K960714) and is substantially equivalent to other devices (Stealth Station - K954276) within the classification of diagnostic devices (21CFR 882.4560) that have been reviewed under the provisions of the Medical Device Amendments and are being marketed in interstate commerce.
COPYRIGHT 1997 ISG TECHNOLOGIES, INC.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Mr. Charles Hall Director, Clinical Development ISG Technologies, Inc. 6509 Airport Road Mississauga, Ontario CANADA L4V 1S7
Re : K970865 Trade Name: ISG Family of Viewing Wands Requlatory Class: II Product Code: 84HAW Dated: March 4, 1997 Received: March 10, 1997
Dear Mr. Hall:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 920) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GM2 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
2
Page 2 - Mr. Charles Hall '
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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
510(k) Number (if known):
Device Name:
ISG Family of Viewing Wands
Indications For Use:
The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intraoperatively to perform the following functions:
- process and display pre-operatively radiographic images on a monitor; .
- provide intra-operative image information based on the position and orientation of a user directed . probe:
- allow for the optical integration and usage of different position sensing technologies (e.g. articulated � arm, infrared freehand) and surgical probes (handheld pointers);
- store/retrieve image data on computer access media (e.g. hard disks, archive media); and �
- transmit data over local area and wide area networks. e
Circumstances: ��
The Family of Viewing Wands is intended to be used pre-operatively:
- when more than one approach (e.g. entry point, transtony, craniotomy size, screw placement) is being t considered:
- when determining the size of any instrumentation: .
continued ...
mor 25 197 11:24
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahan
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970865
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formst 1-2-96)
4
.. Circumstances, continued:
1 2017 08:21
and intra-operatively, when:
- the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) . or with complex anatomy (e.g. scoliosis, fractures, deformity);
- the target, traiectory, or approach is not entirely exposed (e.g. costerior approach for screw . placement):
- the target, trajectory, or approach is in a region where the normal landmarks have been distorted either . by disease (e.g. degenerative disease, osteophytes) or by previous surgery;
- the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air . sinuses, spinal nerve roots or blood vessels) which must be avoided or negotiated; or
- a the target's delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors).
Disease or Conditions:
The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head.
It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine.
The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob's disease if adequate sterilization of the instrument cannot be assured.