OPTICAL TRACKING SYSTEM (OTS)

K990632 · Radionics, Inc. · HAW · Apr 29, 1999 · Neurology

Device Facts

• Record ID: K990632
• Device Name: OPTICAL TRACKING SYSTEM (OTS)
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

Device Story

Optical Tracking System (OTS) functions as graphical planning and intraoperative navigation tool for cranial and spinal surgery; used in OR by surgeons. Device tracks surgical instruments relative to patient anatomy; provides real-time visual guidance during procedures like biopsies, craniotomies, and spinal implants. System transforms spatial tracking data into graphical overlays; assists surgeon in navigating complex anatomical structures. Output displayed on monitor; aids clinical decision-making by providing precise instrument localization; potentially improves surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use similarities to predicate devices.

Technological Characteristics

Stereotaxic instrument utilizing optical tracking technology for intraoperative navigation. System functions as a graphical planning tool. Hardware includes optical sensors and tracking markers. Connectivity and software architecture are consistent with previously cleared Radionics OTS systems.

Indications for Use

Indicated for patients undergoing cranial and spinal surgical procedures, including catheter shunt placement, vascular malformations, frameless cranial biopsy, ENT procedures, craniotomies, tumor resections, spinal implant procedures, spinal biopsy, laminectomy, diskectomy, and decompression for spinal tumor.

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 (K964801, K974602)
• Surgical Navigation Technologies StealthStation Stereotactic System (K954276, K971247)

Submission Summary (Full Text)

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4/29/99

5.0 510(k) Summary

K990632

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.

- 1. The submitter of this premarket notification is:
Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: [phone] Fax: [phone] Contact Name: Lisa Misterka Benati

This summary was prepared on February 25, 1999.

- 2. The name of this device is:

| Classification Name: | Stereotaxic instrument |
|----------------------|-----------------------------------------|
| Common/Usual Name: | Intraoperative Guidance Device |
| Proprietary Name: | Radionics Optical Tracking System (OTS) |

- 3. This device is substantially equivalent to:
Radionics Optical Tracking System [K964801, K974602]

Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247].

- 4. The submission describes a revised indications for the Optical Tracking System to provide for use in frameless cranial biopsy procedures.
- 5. The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. Example procedures include, but are not limited to:

Catheter shunt placement Vascular malformations Frameless cranial biopsy Various ENT procedures Craniotomies Tumor resections

Spinal implant procedures Spinal biopsy Laminectomy Diskectomy Decompression for spinal tumor.

- 6. The technological characteristics are the same or similar to those found in the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Ms. Lisa Misterka Benati Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516

Re: K990632 Trade Name: Optical Tracking System (Modification) Regulatory Class: II Product Code: HAW Dated: February 25, 1999 Received: February 26, 1999

Dear Ms. Benati:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 - Ms. Lisa Misterka Benati

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 vour 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Optical Tracking System (OTS) - Revised Indications for Use

Indications for Use:

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

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