SNT LINAC ACCESSORIES

K971893 · Surgical Navigation Technologies, Inc. · IYE · Nov 13, 1997 · Radiology

Device Facts

• Record ID: K971893
• Device Name: SNT LINAC ACCESSORIES
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.

Device Story

SNT Linac Accessories facilitate stereotactic radiosurgery and radiotherapy on cranial lesions using a linear accelerator. The system comprises a secondary collimation system, patient mounting hardware for stereotactic headrings, and positioning components for isocenter alignment via laser. Used in clinical radiation oncology settings by trained medical professionals. The device ensures precise patient immobilization and beam collimation relative to the linear accelerator isocenter, enabling accurate dose delivery to cranial targets. Benefits include enhanced targeting precision for intracranial procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical accessories for linear accelerators including secondary collimation systems, headring mounting hardware, and laser-guided patient positioning components. Class II device (21 CFR 892.5050).

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or radiotherapy for 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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## Summary of Safety and Effectiveness

SNT Linac Accessories

NOV 1 3 1997

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

- II. Product Name: SNT Linac Accessories
- III. The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.
- I V. The SNT Linac Accessories were shown to be substantially equivalent to other commercially available linear accelerator accessories.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 3 1997

Roger N. White Group Director, Regulatory Affairs Surgical Navigation Technologies, Inc. 530 Compton Street Broomfield, CO 80020

Re:

K971893 SNT Linac Accessories Dated: August 15, 1997 Received: August 18, 1997 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, 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 misbranion.

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 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 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 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 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" (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.

William Yui

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

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Page _ l __ of_ l

510(k) Number (if known): ___ 9 71 89 3

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjuction with a laser alignment system.

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Concurrence of CDRH, Office Of Device Evaluation (ODE)

Ermit C. Simpson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number

Prescription Use " (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)