SNT LINAC ACCESSORIES by SURGICAL NAVIGATION TECHNOLOGIES, INC.

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 Description

AI/ML Overview

This document is a 510(k) submission summary for the SNT Linac Accessories, a device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The document does not contain a table of acceptance criteria or a study proving the device meets said criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted or inferred regarding the device and its submission:

Acceptance Criteria and Device Performance

The document does not provide any specific acceptance criteria or reported device performance metrics in a table format. The submission focuses on substantial equivalence rather than novel performance claims against pre-defined criteria.

Study Details

The document refers to a "summary of safety and effectiveness" but does not describe a detailed study methodology, clinical trial, or performance testing that would include:

Sample sizes (training or test sets)
Data provenance
Number/qualifications of experts
Adjudication methods
MRMC comparative effectiveness study
Standalone performance analysis
Type of ground truth used

The statement "The SNT Linac Accessories were shown to be substantially equivalent to other commercially available linear accelerator accessories" implies that the evaluation was a comparison to predicate devices, but the method of this showing is not detailed. It is highly likely that this involved a comparison of design features, materials, and intended use rather than a performance study with quantitative acceptance criteria. This type of submission often relies on engineering analysis and comparison to existing devices rather than a clinical trial with performance endpoints.

Summary

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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 (303) 439-9709

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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.