APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER

K955844 · Varian Assoc., Inc. · JAQ · Jul 26, 1996 · Radiology

Device Facts

• Record ID: K955844
• Device Name: APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
• Applicant: Varian Assoc., Inc.
• Product Code: JAQ · Radiology
• Decision Date: Jul 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

Device Story

Applicators for Varian VariSource Remote High Dose Rate (HDR) Afterloader; part of remote-controlled radionuclide applicator system. Device uses electromechanical drive to position iridium-192 source (encapsulated in wire) at precise internal/surface body locations for brachytherapy. Operated by trained medical personnel; remote control eliminates personnel radiation exposure during source placement. Source resides in tungsten-shielded safe between treatments; radiation detector monitors source position. Applicator shape/materials determine treatment location. Benefits: reduced exposure times for prescribed dose; improved safety for medical staff.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and material characteristics compared to predicate devices.

Technological Characteristics

Applicators constructed from low density polyethylene, PTFE, and stainless steel. System utilizes electromechanical drive for source positioning. Includes tungsten-shielded safe and radiation detector for safety monitoring. Energy source: iridium-192 radioisotope.

Indications for Use

Indicated for patients requiring radiation brachytherapy via high specific activity radioisotope source placement at internal or surface body locations.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• Omnitron PulmoCath (K901615/F)
• Omnitron GYN Applicator System (K913908/B)
• Applicators for Varian VariSource Remote High Dose Rate Afterloader (K952913)

Submission Summary (Full Text)

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K955844

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

JUL 26 1996

1. Submitter: Varian Oncology Systems
3045 Hanover Street
Palo Alto, CA 94304

Contact: Charles H. Will, Manager
Regulatory Compliance & Safety
Phone: [phone]
FAX: [phone]

Prepared: December 20, 1995

2. Device Name: Applicators and Accessories for Varian VariSource Remote High Dose Rate Afterloader

3. Predicate Device: Omnitron PulmoCath
K901615/F
Cleared on November 27, 1992

Omnitron GYN Applicator System
K913908/B
Cleared on March 6, 1992

Applicators for Varian VariSource Remote High Dose Rate Afterloader
K952913
Cleared on November 22, 1995

4. Description: The applicators for the Varian VariSource Remote High Dose Rate Afterloader are part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity to be placed at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be located for treatment.

5. Intended Use: The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by

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properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

6. Technological Considerations:

The applicators for the Varian VariSource Remote High Dose Rate Afterloader are identical or equivalent to the predicate devices in materials. Where a certain predicate device applicator contains low density polyethylene, the equivalent Varian applicator also contains low density polyethylene. Where a certain predicate device applicator contains PTFE and stainless steel, the equivalent Varian applicator contains PTFE and stainless steel.