RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION

K994355 · Surgical Navigation Technologies, Inc. · IYE · Mar 22, 2000 · Radiology

Device Facts

• Record ID: K994355
• Device Name: RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Mar 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

Device Story

System facilitates patient positioning at linear accelerator (LINAC) isocenter for head/neck stereotactic radiosurgery/radiotherapy. Inputs: CT/MR scan data and real-time optical tracking of infrared markers on a patient-worn biteblock. Operation: Biteblock markers localize treatment site on imaging; high-resolution linear CCD camera array tracks infrared markers to determine spatial relationship between treatment target and LINAC isocenter. Output: Positional data for target alignment. Used in clinical radiotherapy settings by medical staff. Benefits: Enables precise target localization for radiation delivery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

System includes high-resolution linear CCD camera array, computer workstation, biteblock optical positioner, and optical calibration jig. Uses infrared marker tracking for spatial localization. Standalone workstation configuration.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy for head and neck therapeutic targets located outside the cranium, using a photon linear accelerator.

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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## MAR 2 2 2000

## 510(k) Summary

## RadioCameras™ System Head/Neck Application

I. Company: Surgical Navigation Technologies Contact: Angelique Destruel 530 Compton St. Broomfield, CO 80020 [phone]

- II. Product Name: RadioCameras™ System Head/Neck Application
- III. This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures on head and neck lesions outside the cranium. The RadioCameras™ Head/Neck Application uses fiducial markers 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 treatment isocenter relative to the LINAC isocenter. The RadioCameras™ Biteblock System Head/Neck Application consists of a high resolution linear CCD camera array, computer workstation, a biteblock optical positioner, and an optical calibration jig.
- IV. The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on lesions in the head/neck region outside the cranium. The RadioCameras™ Head/Neck Application provides precise positioning of the treatment target at the Linear Accelerator's isocenter.
- V. The RadioCameras™ System Head/Neck Application was shown to be substantially equivalent to commercially available localization and positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery and radiotherapy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2000

Angelique Destruel Clinical and Regulatory Affairs Associate Surgical Navigation Technologies 530 Compton Street Broomfield, CO 80020

Re:

K994355 RadioCameras™ System Head/Neck Application Dated: December 21, 1999 Received: December 23, 1999 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Destruel:

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 pror 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 equivalion 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 resorne to your premarket notification submission does not affect any objogtion you might have under sections 531 through 542 of the Act for devices under 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 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 vou 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 question 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" (21CFR 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/odrh/dsmamain.html".

Sincerely yours,

David S. Platt, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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510(k) Number (if known):

RadioCameras™ Biteblock System Head/Neck Application Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use ----------

David A. Symm
(Optional Format 1-2-96)

Division of Reproductive, Abdominal, Radiological De

510(k) Number