(185 days)
No
The description focuses on optical tracking, image-guided localization, and geometric transformations, with no mention of AI or ML algorithms for image analysis, planning, or tracking. The performance studies also focus on accuracy of the tracking system and transformation equations, not on AI/ML model performance.
No
The device is a surgical planning and guidance tool, not a device that directly treats a condition or disease.
No
The device is described as a "graphical planning tool" and an "interactive, image-guided means of localizing targets in surgical procedures" for pre- and intraoperative planning. Its primary function is to assist surgeons in localizing targets rather than diagnosing a disease or condition in a patient.
No
The device description explicitly states that the OTS consists of a camera array, a computer workstation, application software, and probes, indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Optical Tracking System (OTS) is a surgical planning and guidance tool. It uses imaging data (CT and MR) and optical tracking to help surgeons localize targets and navigate during procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "preoperative and operative planning of surgical procedures" and "localizing targets in surgical procedures." This is a surgical navigation and guidance function, not an in vitro diagnostic function.
Therefore, the OTS falls under the category of surgical navigation or guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
Product codes
84HAW
Device Description
The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation.
Key Metrics
Not Found
Predicate Device(s)
Radionics Operating Arm System, K951262 and K961844; StealthStation Stereotactic System, manufactured by Surgical Navigation Technologies, Inc., K954276.
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).
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PAGE of
Optical Tracking System 510(k) Submission
K96480
Appendix 1
JUN - 3 1997
Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Surgical Planning and Guidance System |
| Device Trade Name: | Optical Tracking System (OTS) |
| Intended Uses: | The Optical Tracking System (OTS) is a graphical |
| planning tool that allows for pre-operative and | |
| operative planning of surgical procedures. The | |
| OTS is indicated for use in surgical procedures in | |
| which anatomical landmarks are not clearly visible | |
| or where a desired target is close to critical | |
| structures. | |
| Predicate Devices: | Radionics Operating Arm System, K951262 and |
| K961844; | |
| StealthStation Stereotactic System, manufactured by | |
| Surgical Navigation Technologies, Inc., K954276. | |
| Establishment Name and Address: | Radionics Software Applications, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone: | Amy J. LaForte, PhD, |
| (617) 272-1233 | |
| Establishment registration number: | 1222895 |
| Performance Standard: | None established under Section 514. |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Description of the Device and Basis for Substantial Equivalence
The Optical Tracking System (OTS), addressed in this premarket notification, has the same intended use and similar technological characteristics as the commercially available Radionics Operating Arm System and the StealthStation Stereotactic System. The OTS is a modification of the Operating Arm System but substitutes a camera array for the operating arm to track the position of probes and various tools. This is the same camera
Image /page/0/Figure/11 description: The image is a black and white image that is mostly black. There is a small amount of white at the bottom of the image. The white area is not very clear, but it appears to be a small amount of text.
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array utilized by StealthStation. The OTS provides an interactive, image-guided means of localizing targets in surgical procedures. In addition to the camera array, the OTS consists of a computer workstation, application software, and probes. Upon calibration of the system in the surgical environment, the surgeon selects points on the patient using a probe which are interpreted by the computer and related to corresponding points on the image.
Safety Summary
RSA Optical Tracking System (OTS) systems testing verifies that the stereotactic CT and MR localizer transformation equations are correctly encoded into the application software. Further, it verifies that all target coordinate input and displays are accurate. The results from the OTS are compared to a phantom with targets of known position. The camera array is accurate to a mean value of 0.3 mm. This accuracy is maintained over a period of extended operation.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions ensure that the user understands all aspects of the Optical Tracking System: hardware, computer, and software and its intended functionality. This information promotes safe and effective use of the device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with a wing-like shape above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Amy J. LaForte, Ph.D. Senior Regulatory Engineer Radionics Software Applications, Inc. P.O. Box 358 22 Terry Avenue Burlington, Massachusetts 01803-0658
K964801 Re : Trade Name: Optical Tracking System Requlatory Class: II Product Code: 84HAW Dated: March 3, 1997 Received: March 4, 1997
Dear Dr. LaForte:
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 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 requlatory 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.
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Page 2 - Amy J. LaForte, 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 qeneral 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, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of /
510(k) Number (if known): _ 196 48 0 /
Optical Tracking System 510(k) Submission Device Name:
Indications for Use
The following is the indications for use of the OTS :
The Optical Tracking System (OTS) is a graphical planning tool that allows for preoperative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
(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 K964801
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use