OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS

K983669 · Radionics, Inc. · HAW · Nov 18, 1998 · Neurology

Device Facts

• Record ID: K983669
• Device Name: OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

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.

Device Story

OTS with Surface Matching Module is a graphical planning tool for cranial and spinal surgery. It uses patient scan data to facilitate pre-operative and operative planning. The system registers the patient to their scans using a surface matching module; it displays image slices in 3D reconstructed space and reconstructs oblique slices. A probe (pointer) acts as a mouse to operate the program and track position. The system displays the probe tip position in 2D and 3D, providing real-time tracking in 2D image space. Used in clinical settings by surgeons to navigate anatomy, the device assists in surgical targeting when landmarks are not visible or critical structures are nearby, potentially improving surgical precision.

Clinical Evidence

Bench testing only. The system's software features were verified through rigorous testing to ensure safety and reliability for the intended use.

Technological Characteristics

Graphical planning tool for cranial/spinal surgery. Features include 3D image reconstruction, oblique slice generation, and real-time probe tracking. Operates via software-based surface matching registration. Connectivity includes probe-based input. No specific materials or hardware standards cited.

Indications for Use

Indicated for cranial and spinal surgical procedures where anatomical landmarks are obscured or targets are near critical structures.

Regulatory Classification

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.

Predicate Devices

• Radionics Optical Tracking System (K974602)
• Stealth Station Image-Guided Surgery System with SurfaceMerge Registration option (K954276)

Submission Summary (Full Text)

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# 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<br>Matching Module is a graphical planning tool that<br>allows for pre-operative and operative planning of<br>cranial and spinal surgical procedures. The OTS<br>with Surface Matching Module is indicated for use<br>in cranial and spinal surgical procedures in which<br>anatomical landmarks are not clearly visible or<br>where a desired target is close to critical structures. |
| Predicate Devices: | Radionics Optical Tracking System (#K974602)<br>Stealth Station Image-Guided Surgery System<br>(K954276) with SurfaceMerge Registration option |
| Establishment Name and Address: | Radionics Software Applications, Inc.<br>22 Terry Avenue<br>Burlington, MA 01803 |
| Contact Name and Phone | David Cromwick, [phone] |
| 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; .

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## 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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