THERATRON ELITE

K983917 · Theratronics, Inc. · IWB · Dec 4, 1998 · Radiology

Device Facts

• Record ID: K983917
• Device Name: THERATRON ELITE
• Applicant: Theratronics, Inc.
• Product Code: IWB · Radiology
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The unit is intended to be used in: - delivering the intended dose at a specified position; . - delivering the radiation in accordance with the selected relationship of the . radiation to the patient (fixed or moving beam therapy, beam modifying device, etc.); - . delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

Device Story

Theratron Elite is a cobalt teletherapy device comprising a source head, collimator, gantry, main frame, base, and counterweight. It functions by delivering radiation beams to patients for therapy. The primary evolution from predicate devices (Theratron 780E/1000E) is the replacement of push-button controls with a PC-based remote control console featuring a graphical user interface and 'Record and Verify' communication capability. Operated by clinical staff in a radiation therapy environment, the device allows for precise beam positioning and dose delivery. The PC interface facilitates treatment planning and verification, enhancing operational control and safety. The device benefits patients by providing controlled, accurate radiation therapy while minimizing risks to the patient, operator, and environment.

Clinical Evidence

Bench testing only. Validation demonstrated compliance with product development procedures and confirmed the device meets published specifications and performs equivalently to predicate devices.

Technological Characteristics

Radionuclide radiation therapy system. Components: source head, collimator, gantry, main frame, base, counterweight. Control system: PC-based remote console with graphical user interface and 'Record and Verify' communication. Energy source: Cobalt radiation source.

Indications for Use

Indicated for patients requiring radiation therapy via fixed or moving beam delivery. Used by clinicians for dose delivery at specified positions.

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

• Theratron 780E (K964606)
• Theratron 1000E (K964607)

Submission Summary (Full Text)

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Theratron Elite 510(k) Summary

| Submitter: | Theratronics International Limited<br>413 March Road, P.O. Box 13140<br>Kanata, Ontario<br>Canada K2K 2B7 |
|--------------------|-----------------------------------------------------------------------------------------------------------|
| Phone: | 613-591-2100 |
| Fax: | 613-592-3816 |
| Contact person: | E. S. Martell, Vice President Quality & Regulatory Affairs |
| Date: | Nov 16, 1998 |
| Trade name: | Theratron Elite |
| Common name: | Cobalt Teletherapy device |
| Classif. name: | Radionuclide Radiation Therapy System |
| Equivalent device: | Theratron 780E (K964606), Theratron 1000E (K964607) |

# Description of device:

The Theratron Elite consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate devices Theratron 780E and 1000E. The key difference is that the 'push-button' style control console on the predicate devices has been replaced with a modern PC based remote control console with graphic user interface and 'Record and Verify' communication capability.

# Intended use of device:

The unit is intended to be used in:

- delivering the intended dose at a specified position; .
- delivering the radiation in accordance with the selected relationship of the . radiation to the patient (fixed or moving beam therapy, beam modifying device, etc.);
- . delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

# Summary of comparison to predicate device.

See Section 2.

# Summary of conclusions drawn from nonclinical tests

The Theratron Elite development and validation is in compliance with Theratronics product development procedures. The validation demonstrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use.

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1000 4 DEC

E.S. Martell Vice President Quality and Regulatory Affairs Theratronics International, Ltd. 413 March Road Kanata, Ontario CANADA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983917 Theratron Elite 80 and 100 Dated: October 29, 1998 Received: November 4, 1998 Regulatory class: II Procode: 90 IWB CFR 892.5750

Dear Mr. Martell:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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(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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 at [phone].

Sincerely yours,

Willian Yin
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

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## Intended use of device 3.

The device is intended to be used in:

- Delivering the intended dose of radiation at a specified position; .
- Delivering the radiation in accordance with the selected relationship of the . radiation to the patient (fixed or moving beam therapy, beam modifying device, etc);
- Delivering the radiation without causing unnecessary risk to the patient, the . operator, other persons or the immediate environment.

Vinid C. Flynn

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

**Prescription Use**
(Per 21 CFR 801.109)***_***_ and the image.