(30 days)
Not Found
No
The document describes a graphical planning tool for surgical procedures with a "Surface Matching Module" for patient registration. While it uses scanned images and involves image processing for registration, there is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The description focuses on traditional image-guided surgery functionalities and compares the device to predicate devices with similar features.
No
The device is described as a "graphical planning tool" that assists in pre-operative and operative planning of surgical procedures, displaying information, and tracking probe position. It does not directly interact with or treat the patient's condition.
No
Explanation: The device is described as a "graphical planning tool" for surgical procedures and an "Image-Guided Surgery System." It assists in planning and navigation during surgery but does not provide a diagnosis.
No
The device description explicitly states it is a "graphical planning tool" and mentions the use of a "Pointer (probe)" which is a hardware component used for tracking position. It also refers to "Optical Tracking System" which implies hardware for optical tracking. While it has software components, it is not solely software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is a "graphical planning tool" used for "pre-operative and operative planning of cranial and spinal surgical procedures." It uses scanned images (like CT or MRI) and helps guide surgical instruments in real-time.
- 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 and tracking the position of surgical tools relative to the patient's anatomy as depicted in those images.
Therefore, the device falls under the category of a surgical planning and navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optical Tracking System (OTS) with Surface Mixing Module is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS with Surface Matching Module is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The OTS with Surface Matching Module is a graphical planning tool that allows for preoperative and operative planning of cranial and spinal surgical procedures. The Surface Matching Module offers an alternate method of registering the patient to their scans. The OTS with Surface Matching Module, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available OTS, and Stealth Station Image-Guided Surgery System with SurfaceMerge registration option. Like the commercially available OTS, the OTS with Surface Matching Module offers the following functionality: Ability to plan frameless stereotactic surgical procedures from scanned images; Ability to plan stereotactic procedures performed with a Radionics CRW framed system; Display of image slices in 3D reconstructed space; Ability to display probe tip position in 2D and 3D displays; Ability to display "real-time" position of the probe in 2D image space; Ability to reconstruct oblique slices; Use of Pointer (probe) as a Mouse to operate program.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The RSA Surface Matching system testing rigorously tests the features of the software. The results of the testing indicate that the OTS with Surface Matching Module is safe and reliable for its intended use.
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.
Radionics Optical Tracking System (#K974602), Stealth Station Image-Guided Surgery System (K954276) with SurfaceMerge Registration option
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
12983669 Optical Tracking System with Surface Matching Module 510(k)
Appendix A: Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Optical Frameless Planning System |
| Device Trade Name: | OTS with Surface Matching Module |
| Intended Use: | The Optical Tracking System (OTS) with Surface |
| Matching Module is a graphical planning tool that | |
| allows for pre-operative and operative planning of | |
| cranial and spinal surgical procedures. The OTS | |
| with Surface Matching Module is indicated for use | |
| in cranial and spinal surgical procedures in which | |
| anatomical landmarks are not clearly visible or | |
| where a desired target is close to critical structures. | |
| Predicate Devices: | Radionics Optical Tracking System (#K974602) |
| Stealth Station Image-Guided Surgery System | |
| (K954276) with SurfaceMerge Registration option | |
| Establishment Name and Address: | Radionics Software Applications, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone | David Cromwick, (781) 272-1233 |
| Date Summary was prepared | October 2, 1998 |
| Establishment Registration Number: | 1222895 |
| Performance Standards: | 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 OTS with Surface Matching Module is a graphical planning tool that allows for preoperative and operative planning of cranial and spinal surgical procedures. The Surface Matching Module offers an alternate method of registering the patient to their scans. The OTS with Surface Matching Module, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available OTS, and Stealth Station Image-Guided Surgery System with SurfaceMerge registration option. Like the commercially available OTS, the OTS with Surface Matching Module offers the following functionality:
- Ability to plan frameless stereotactic surgical procedures from scanned images; ●
- Ability to plan stereotactic procedures performed with a Radionics CRW framed . system;
- . Display of image slices in 3D reconstructed space;
- Ability to display probe tip position in 2D and 3D displays; ●
- Ability to display "real-time" position of the probe in 2D image space; .
1
Optical Tracking System with Surface Matching Module 510(k)
Appendix A: Summary of Safety and Effectiveness
Description of the Device and Basis for Substantial Equivalence (Continued)
- Ability to reconstruct oblique slices; .
- . Use of Pointer (probe) as a Mouse to operate program.
Safety Summary
The RSA Surface Matching system testing rigorously tests the features of the software. The results of the testing indicate that the OTS with Surface Matching Module is safe and reliable for its intended use.
General Safety and Effectiveness Concerns
The device labeling contains Instructions for Use which include indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. In addition, thorough training and support is provided to clinics that acquire and use the OTS. 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 features a stylized image of an eagle with three lines representing its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
Mr. David Cromwick Radionics, Inc. Director of Regulatory Affairs and Quality Assurance 22 Terry Avenue Burlington, Massachusetts 01803
Re: K983669
Trade Name: Optical Tracking System With Surface Matching Module, Model OTS Regulatory Class: II Product Code: HAW Dated: October 12, 1998 Received: October 19, 1998
Dear Mr. Cromwick:
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 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 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.
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Page 2 - Mr. David Cromwick
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/dsma/dsmamain.html".
Sincerely yours.
signature
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Optical Tracking System with Surface Matching Module 510(k)
Section II: Indications for Use
Indications for Use:
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions.
Prescription Use
(Per 21 CFR 801.109)
sedlo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. 14983669
Optical Tracking System with Surface Matching Module 510(k) II-1