THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY

K984563 · Accuray, Inc. · IWB · Jul 14, 1999 · Radiology

Device Facts

• Record ID: K984563
• Device Name: THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
• Applicant: Accuray, Inc.
• Product Code: IWB · Radiology
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CyberKnife system is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS) and cervico-thoracic spine (CTS), head and neck.

Device Story

CyberKnife System provides image-guided stereotactic radiosurgery and precision radiotherapy. Input: 3D patient anatomy data from treatment planning system and real-time orthogonal X-ray images for position verification. Operation: 6 MV linear accelerator mounted on a six-axis manipulator for automated positioning and pointing; system uses real-time imaging to dynamically adjust beam delivery based on patient position. Output: Targeted radiation dose to lesions/tumors. Used in clinical settings by trained professionals. Benefits: Enables precise, image-guided delivery of radiation to complex anatomical targets in the brain, skull base, and spine, potentially sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technical comparison of system specifications, including mechanical isocenter accuracy, dosimetry reproducibility, and treatment planning capabilities.

Technological Characteristics

6 MV standing wave linear accelerator; X-band microwave frequency; six-axis manipulator for beam positioning; heavy metal secondary collimators (5-60 mm); SGI 440-based treatment planning system; real-time orthogonal X-ray imaging for guidance; stationary treatment couch.

Indications for Use

Indicated for patients requiring stereotactic radiosurgery or precision radiotherapy for lesions, tumors, and conditions of the brain, base of skull, cervico-thoracic spine, and head and neck.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• Varian Clinac™ 600SR (K913174)

Reference Devices

• X-Knife (K923522)
• Laitenen Stereoadapter headframe (K881131)
• Uniframe head immobilization system (K933227)

Submission Summary (Full Text)

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JUL 14 1999

K984563

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A C C U R A Y

## 510(k) Summary of Safety and Effectiveness

| Establishment: | Accuray Incorporated<br>570 Del Rey Avenue<br>Sunnyvale, CA 94086<br>[phone] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Luanne Termeer<br>Regulatory Affairs Manager |
| Summary Date: | 12/20/98 |
| Device Name: | The CyberKnife™ System for Stereotactic<br>Radiosurgery/Radiotherapy |
| Predicate Device: | Varian Clinac™ 600SR, K913174 |
| Device Description: | The CyberKnife® System for Stereotactic<br>Radiosurgery/Radiotherapy is a treatment planning, imaging, and<br>treatment delivery system for image-guided stereotactic<br>radiosurgery and precision radiotherapy. The treatment planning<br>system provides 3-dimensional viewing of the patient anatomy<br>with appropriate dose calculation of the target volume and<br>surrounding tissue structures. The imaging system provides real-<br>time, orthogonal x-ray images of the patient in the treatment<br>position to verify treatment position and accuracy and provides<br>information suitable for dynamically positioning and pointing a<br>linear accelerator. The treatment delivery system consists of a<br>linear accelerator which provides 6 MV x-rays. A six-access<br>manipulator provides automated positioning and pointing of the<br>linear accelerator. The treatment couch provides positioning of the<br>patient. |

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Intended Use: The CyberKnife system is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS) and cervico-thoracic spine (CTS), head and neck.

Summary of Technological Characteristics:

See the Feature Comparison Chart on the following page.

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## FEATURE COMPARISON CHART

| Feature | Varian Clinac 600SR –<br>K913174 | Accuray CyberKnife®<br>System For Stereotactic<br>Radiosurgery/Radiotherapy |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Use | Provide x-radiation for use in stereotactic radiosurgery.<br>Treatment Planning with X-Knife, K923522 | Provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy |
| Single dose and fractionated<br>treatments | Yes | Yes |
| Microwave band | S | X |
| X-ray energy | 6MV (standing wave linac) | 6 MV (standing wave linac) |
| Dose rate | 800 cGy/min | 300 cGy/min |
| Microwave generator | High power magnetron | High power magnetron |
| Bending magnet | In-line | In-line |
| Isocenter floor height | 128 cm | 127 cm (nominal isocenter, system is not isocentric) |
| SAD | 100 cm | 80 cm |
| End of collimator to isocenter | 23 cm | 40 cm |
| Source/target positioning | Two-axis manipulator | Six-axis manipulator |
| Treatment table | Rotates patient about third axis | Stationary |
| Mechanical Isocenter Accuracy | $≥ 0.10$ cm radius circle | $≥ 0.05$ cm RMS for all treatment nodes |
| Dosimetry system reproducibility<br>with position | $± 2%$ or 1 MU whichever is<br>greater at any fixed gantry angle | $± 3%$ or 3 MU which ever is greater<br>at any fixed treatment node |
| Beam collimation | Heavy metal secondary<br>collimators allow selection of<br>narrow beams sizes 12.5 to 40<br>mm (12 steps) | Heavy metal secondary collimators<br>allow selection of narrow beams<br>sizes 5 to 60 mm (12 steps) |
| Head restraint | BRW or GTC head ring | Laitenen Stereoadapter headframe,<br>K881131<br>Uniframe head immobilization<br>system, K933227 |
| Target location reference | Metal localization rods connected<br>to headframe | Patient's skull |
| Treatment Planning System<br>(TPS) | Yes | Yes |
| TPS platform | HP715/75, 64MB/1GB | SGI 440, 128MB/2GB |
| Safety interlocks | Yes | Yes |
| Emergency stop | Yes | Yes |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Luanne Ng Requlatory Affairs Manager Accuray, Inc. 570 Del Rey Avenue Sunnyvale, CA 94086

Re: K984563

CyberKnife™ System for Trade Name: Steriotactic Radiosurgery/Radiotherapy Regulatory Class: II Product Code: 90-IWB and 90-MUJ Dated: April 15, 1999 Received: April 16, 1999

Dear Ms. Ng:

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 prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified 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 (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 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 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(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a dassification 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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510(k) Number (if known):_K984563

Device Name The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy

Indications For Use: To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rat. G. Palla

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K984563

Prescription Use
Per 21 CFR 801.109

OR

Over-The Counter Use