RADIOCAMERAS PATIENT POSITIONING SYSTEM

K980750 · Surgical Navigation Technologies, Inc. · IYE · May 20, 1998 · Radiology

Device Facts

• Record ID: K980750
• Device Name: RADIOCAMERAS PATIENT POSITIONING SYSTEM
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The RadioCameras™ System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

Device Story

RadioCameras™ Patient Positioning System facilitates patient alignment for stereotactic radiosurgery or radiotherapy. System inputs include infrared marker signals tracked via high-resolution linear CCD camera array. Device transforms spatial marker data into patient position coordinates relative to linear accelerator isocenter. Components include camera array, computer workstation, optical positioner, and optical calibration jig. Used in clinical radiotherapy/radiosurgery settings by trained personnel. Output provides precise spatial guidance for patient positioning, enabling accurate targeting of cranial lesions during radiation delivery. System ensures alignment accuracy required for stereotactic procedures.

Clinical Evidence

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

Technological Characteristics

System utilizes optical tracking of infrared markers. Hardware includes high-resolution linear CCD camera array, computer workstation, optical positioner, and optical calibration jig. Operates as a standalone positioning system for linear accelerators. Class II device (21 CFR 892.5050).

Indications for Use

Indicated for patients undergoing stereotactic radiosurgery or radiotherapy for cranial lesions, requiring precise positioning at a linear accelerator isocenter.

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)

{0}------------------------------------------------

K980750

## 510(k) Summary

## RadioCameras™ Patient Positioning System

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

RadioCameras™ Patient 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 procedures. The RadioCameras™ System uses optical tracking of infrared markers as the method of locating the position of the patient. The RadioCameras™ System consists of a high resolution linear CCD camera array, computer workstation, an optical Positioner, and an optical calibration jig.
- IV. The RadioCameras™ System was shown to be substantially equivalent to other commercially available patient positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery and radiotherapy.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 0 1998

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

Re:

K980750 RadioCameras™ Patient Positioning System Dated: February 24, 1998 Received: February 26, 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 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/odrh/dsmaldsmamain.html".

Sincerely yours,
Kilian Yi

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

Enclosure

{2}------------------------------------------------

Page 1 __ of _ 1

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The RadioCameras™ System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

David C. Gypson

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number.

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _____________

(Optional Format 1-2-96)