NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS

K984245 · Radionics, Inc. · HAW · Dec 18, 1998 · Neurology

Device Facts

• Record ID: K984245
• Device Name: NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to: Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures

Device Story

The Radionics Non-Invasive Dynamic Reference Frame (DRF) is an accessory for the Optical Tracking System (OTS). It consists of a headband securing a light array to the patient's head. The device functions as a registration tool, maintaining system alignment during surgery. It enables preoperative and operative planning by integrating with the OTS workstation, which displays anatomical images. Used in clinical settings by surgeons, the device allows for navigation during procedures where anatomical structures are not clearly visible or targets are near critical regions. By maintaining registration, it assists in surgical accuracy for procedures like tumor resections and shunt placements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Consists of a headband and light array. Functions as a stereotaxic instrument accessory for optical tracking. Designed for non-invasive patient attachment. Operates as part of the Radionics Optical Tracking System (OTS) workstation environment.

Indications for Use

Indicated for patients undergoing cranial and spinal surgical procedures where anatomical structures are obscured or targets are near critical regions, including catheter shunt placement, craniotomies, tumor resections, skull lesioning, vascular malformations, and ENT procedures.

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 Cranial DRF
• Radionics Spinal DRF

Submission Summary (Full Text)

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## 6.0 510(k) Summary:

K984245

## 510(k) Summary

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

- The submitter of this premarket notification is: 1
Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc, 22 Terry Avenue Burlington, MA 01803 Tel .: [phone] Fax: [phone]

This summary was prepared on November 25, 1998.

- The name of the device is the Radionics Non-Invasive Dynamic Reference Frame 2 (DRF) for use with Radionics Optical Tracking System (OTS). The common name is an Intraoperative Guidance Device, and its classification name is a stereotaxic instrument (accessory).
- 3 The above device is substantially equivalent to the Radionics Cranial and Spinal DRFs for OTS.
- The above device consists of a headband that secures a light array to the patient. 4 When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images.
- The device allows a light array to be secured to a patient non-invasively. Like its 5 Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
- The technological characteristics are the same or similar to those found with the 6 predicate device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of three human profiles facing right, with a stylized design above them that could represent wings or flowing hair.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1998

Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516

K984245 Re:

> Trade Name: Radionics Non-Invasive Dynamic Reference Frame Regulatory Class: II Product Code: HAW Dated: November 25, 1998 Received: November 27, 1998

Dear Mr. O'Connell:

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 - Mr. Kevin J. O'Connell

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/dsmamain.html".

Sincerely yours,

fo coles

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) Non-Inyasive Dynamic Reference Frame

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. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to:

> Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division Sian-Off كما Division of General Restorative Devices كمك 510(k) Number

PRESCRIPTION USE

(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)