(84 days)
No
The description focuses on image guidance, tracking technology, surgical planning, and registration techniques, with no mention of AI or ML.
No
The device is an image guidance system intended to assist surgeons in precisely locating anatomical structures during procedures. It does not exert a therapeutic effect itself but rather provides guidance.
No
The InstaTrak 3000 System is an image guidance system intended to aid surgeons in precisely locating anatomical structures during surgery. It does not diagnose medical conditions or diseases.
No
The device description explicitly mentions "the addition of several components," "a computer upgrade," "new instruments have been added to which tracking sensors have been built in or may be attached," and "utilizes the same clinically proven electromagnetic tracking technology as its predecessor." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the InstaTrak 3000 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to aid the surgeon in precisely locating anatomical structures during surgical procedures. This is a surgical guidance system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system that uses image guidance and tracking technology to assist the surgeon during surgery. It focuses on real-time positioning of surgical instruments relative to pre-operative images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
The InstaTrak 3000 System falls under the category of surgical navigation or image-guided surgery systems, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The InstaTrak System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 is essentially identical to the InstaTrak System cleared under K960330 and the Pediatric InstaTrak System cleared under K981998 which are both indicated for use during sinus surgery. The changes to the system include a computer upgrade, software enhancements, additional indications and the addition of several components. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures.
The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base or axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user.
The original InstaTrak System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through either an automatic or fiducial registration. The indications for use include sinus cleared under K960330 and pediatric sinus surgery (K981998). In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor. A newer version of a Sun computer has been substituted to provide 3D display capability which includes 3D models and planar images on top of 3D models, oblique and trajectory matching views. Additionally, a surgical planning capability has been added. This allows the surgeon to plan a trajectory prior to surgery and to observe the pre-surgical track in relation to the actual track during the surgical procedure. A new registration technique has been added whereby the surface of the anatomy can be registered to. New instruments have been added to which tracking sensors have been built in or may be attached. These, along with the surface registration and the new displays allow the system to be used in the proposed indications encompassing axial skeletal, and cranial surgery, in addition to the cleared and pending indications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR
Anatomical Site
anywhere on the human body, sinus, skull, cranial, a long bone or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, open or percutaneous 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)
Testing was performed using the new components of the InstaTrak 3000 System to determine if the new components affected device accuracy. The results showed that the device performed within the specification while using the new components.
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.
K960330, K981998, K954276, K911783
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
DEC 31 1998
510(k) Summary VISUALIZATION TECHNOLOGY INC INSTATRAK 3000
1. SPONSOR
Visualization Technology, Inc. 200 Research Drive Wilmington, MA 01887 Telephone: (978) 933-1000
..
Contact Person: Peter Ohanian
-
- DEVICE NAME
| Proprietary Name: | InstaTrak 3000 |
|---|---|
| Common/Usual Name: | Interactive Image Guided Surgical System |
| Classification Name: | Computed Tomography X-Ray System |
3. PREDICATE DEVICES
InstaTrak System, subject of K960330,
Pediatric InstaTrak System, subject of K981998,
Stealth Station manufactured by Surgical Navigation Technologies, subject of K954276
Viewing Wand manufactured by ISG Technologies, Inc., subject of K911783.
DEVICE DESCRIPTION 4.
The InstaTrak System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 is essentially identical to the InstaTrak System cleared under K960330 and the Pediatric InstaTrak System cleared under K981998 which are both indicated for use during sinus surgery. The changes to the system include a computer upgrade, software enhancements, additional indications and the addition of several components. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The
1
InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures.
The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base or axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user.
The original InstaTrak System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through either an automatic or fiducial registration. The indications for use include sinus cleared under K960330 and pediatric sinus surgery (K981998). In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor. A newer version of a Sun computer has been substituted to provide 3D display capability which includes 3D models and planar images on top of 3D models, oblique and trajectory matching views. Additionally, a surgical planning capability has been added. This allows the surgeon to plan a trajectory prior to surgery and to observe the pre-surgical track in relation to the actual track during the surgical procedure. A new registration technique has been added whereby the surface of the anatomy can be registered to. New instruments have been added to which tracking sensors have been built in or may be attached. These, along with the surface registration and the new displays allow the system to be used in the proposed indications encompassing axial skeletal, and cranial surgery, in addition to the cleared and pending indications.
5. INTENDED USE
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial and axial skeletal visible on medical images such as CT or MR.
2
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The InstaTrak 3000 and the Stealth Station are similar in intended use in that they both are indicated for locating anatomical structures anywhere on the human body in open or percutaneous procedures. The InstaTrak 3000 is identical to both the original InstaTrak System the ISG Technologies Viewing Wand devices in that they are both intraoperative image-guidance systems intended for skull base surgery and sinus surgery.
The InstaTrak 3000 is essentially identical in technological characteristics to the InstaTrak System cleared under K960330 with the exception of computer and software enhancements and some additional components. The InstaTrak System uses the same electromagnetic position sensing, patient headset and automatic headset registration as the original InstaTrak System cleared under K960330.
The InstaTrak 3000, the original InstaTrak System and the ISG Viewing Wand all use a computer, monitor and hard disk storage system. All of the systems offer image guidance using CT or MR scans with the exception of the original InstaTrak System, which only offers CT scans.
There are several new components in the InstaTrak 3000 System. The new components include a nasal specula, mouth gag, pharyngeal retractor, straight extended aspirator, sterile disposable pointer, transmitter, receiver and a head frame. The new components used in the InstaTrak System have been added to accommodate the various applications.
The nasal speculum, mouth gag, and pharyngeal retractor are essentially identical to standard commercial devices and are exempt from the 510(k) premarket notification process. The extended straight aspirator and the disposable pointer are essentially identical to the aspirator and pointer described in the original 510(k) (K960330) for the InstaTrak System.
7. PERFORMANCE TESTING
Testing was performed using the new components of the InstaTrak 3000 System to determine if the new components affected device accuracy. The results showed that the device performed within the specification while using the new components.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 31 1998
Visualization Technology, Inc. C/o Mary McNamara-Cullinane Medical Device Consultants 49 Plain Street North Attleboro, MA 02760
Re:
K983529 Insta Trak 3000 Dated: October 7, 1998 Received: October 8, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 LLZ
Dear Ms. McNamara-Cullinane:
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 legally marketed predicate 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 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 requirements, 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.
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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K98 35 d 9
Device Name: Visualization Technology, Inc. InstaTrak 3000
Indications For Use:
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983529
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Visualization Technology, Inc. 510(k) 10/7/98 CONFIDENTIAL
Skull Based InstaTrak System
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