RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM

K981346 · Surgical Navigation Technologies, Inc. · IYE · Jul 10, 1998 · Radiology

Device Facts

• Record ID: K981346
• Device Name: RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jul 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The RadioCameras™ Biteblock Positioning and Localization System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise localization of the treatment site relative to the LINAC isocenter.

Device Story

System facilitates patient positioning at linear accelerator isocenter for stereotactic radiosurgery/radiotherapy; targets cranial lesions. Components include optical camera array, computer workstation, biteblock with fiducial markers, and optical calibration jig. Workflow: fiducial markers placed on patient biteblock; system uses optical tracking of infrared markers on biteblock to localize treatment site relative to LINAC isocenter during CT/MR scans and treatment. Physician/technician operates system in clinical setting. Output provides spatial localization data to align patient precisely with radiation beam. Benefits include improved accuracy in targeting cranial lesions during radiotherapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises optical camera array, computer workstation, biteblock with fiducial markers, and optical calibration jig. Utilizes optical tracking of infrared markers for spatial localization. Intended for use with linear accelerators. Class II device (21 CFR 892.5050).

Indications for Use

Indicated for use with a Linear Accelerator to perform stereotactic radiosurgery or radiotherapy on cranial lesions.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Submission Summary (Full Text)

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JUL 10 1998

## 510(k) Summary

## RadioCameras™ Biteblock Localization and Positioning System

Company: I.

Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 [phone]

RadioCameras™ Biteblock Localization and Positioning System Product Name: II.

This submission describes a system that is intended to be used to place patients at III. The isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy the isocines on cranial lesions. The RadioCameras™ System uses fiducial markers procedures on cramal lessons. "The ent site on CT or MR scans and optical tracking
on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the of mirators manors on the LINAC isocenter. The RadioCameras™ System treatinent isocontor relative is as and a array, computer workstation, a biteblock optical positioner, and an optical calibration jig.

- The RadioCameras™ System was shown to be substantially equivalent to the IV. The RadioCalificas - Bystem was class on and positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery and radiotherapy.

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## JUL 10 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Roger White Group Director Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020

Re:

K981346 RadioCameras™ Biteblock Localization and Positioning System Dated: April 13, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. White:

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 morked in invested commerce prior to May 28, 1976, the ensetment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the povisions of the Poderal Food, Drog, and Connectic Act (Act. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actionished requirements for annual registration, listing of devices, good manufacturing proctice, libeling, and problems against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematice Approval), it may be subject Title 21 Parts 800 to 806 A minimalians affecting you device can be found in the Code of Federal Regulations Title 21, Parts 800 to 895. A substantially equivalent desement on a compliance with the Curred Cool Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR) Part 820) and that, the periodic QS inspections, the Food and Drug Administration (FDA). Will verify such assemptions. Failure to comply with the GMP regulation may result in regulatory and in addition, FDA may publish further wheninger does not offer your device in the Echnal Register. Please note: this response to your premarket notification submission docs not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial quivalence of your device to a legally marketed production 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 yitry disgnotic devices), please contact the Office of Campione at (30 l Art of 1 and manufactions on the promotions on the promotion and advertising of your device, please contact the Office of Complises of Concellent, the prounding the explation catitled, "Misbranding by reference to premarket assisted (2) CFR 807.97). Other general information on your responsibilities under the Art may be obtained from the Division of Small Manufacturers Assistance at its toll-for muniter [phone] or [phone] or at its Internet address "http://www.fda.gov/odr/dismaddsmanain.html"

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K18/346

RadioCameras™ Biteblock Positioning and Localization System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The RadioCameras™ Biteblock Positioning and Localization System is indicated
Stated The RadioCameras™ Bitcolock I ostudions in Derform Sterescactic Radiosurgery or
for use with a Linear Accelerator to perform Suctem provides r for use with a Linear Accelerator to perolin Siccessons over on ovides precise
Radiotherapy on cranial lesions. The RadioCameras™ System provides precise Radiotherapy on cranial lessons. The Ratherations of the arrants isocenter.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Lhard le. Seym

on of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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