PEACOCK SYSTEM

K963258 · Nomos Corp. · IYE · Nov 18, 1996 · Radiology

Device Facts

• Record ID: K963258
• Device Name: PEACOCK SYSTEM
• Applicant: Nomos Corp.
• Product Code: IYE · Radiology
• Decision Date: Nov 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.

Device Story

Integrated radiation therapy system; combines CORVUS treatment planning and MIMiC beam-shaping delivery. Input: patient tumor volume data. Operation: CORVUS generates treatment plan; MIMiC multileaf collimator modulates radiation field while accelerator gantry moves. Output: dynamic conformal radiation therapy delivery. Used in clinical radiation oncology settings; operated by radiation oncologists and medical physicists. System enables precise dose delivery to tumor volumes while sparing surrounding healthy tissue.

Clinical Evidence

Physics and clinical testing performed; demonstrated system performs as intended.

Technological Characteristics

Integrated radiation therapy planning and delivery system. Includes CORVUS planning software and MIMiC dynamic multileaf collimator. Operates as accessory to linear accelerator. Class II (21 CFR 892.5050, 21 CFR 892.5710).

Indications for Use

Indicated for patients requiring dynamic conformal radiation therapy to treat tumor volumes via modulated radiation fields.

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.

Predicate Devices

• Peacock™ Plan (K940663)
• MIMiC™ (K940412)
• Varian Varisource HDR Afterloader (K852842)
• GE Target Planning System (K896353)
• Arc Therapy (K802809)

Submission Summary (Full Text)

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# Premarket Notification - Peacock™ System

NOV 18 1996

K96 3258

Summary of Safety and Effectiveness

Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act

August 19, 1996

1. General Provisions

Trade/Proprietary Name

NOMOS PEACOCK System consisting of:

CORVUS (cleared as Peacock™ Plan; K940663)

MIMiC™ (K940412)

Common/Usual Name

Integrated radiation therapy treatment planning and delivery system

Radiation therapy treatment planning system (CORVUS)

Linear accelerator mounted treatment delivery system (MIMiC)

Applicant Name and Address

NOMOS Corporation

2591 Wexford Bayne Road

Sewickley, PA 15143

2. Names of Predicate Devices¹

Integrated PEACOCK Treatment Planning and Delivery System:

Varian Varisource HDR Afterloader with integrated planning system (K852842)

GE Target Planning System (K896353) & Arc Therapy (K802809)

These systems were marketed prior to and/or following enactment of the Medical

Device Amendments on May 28, 1976.

3. Classification

Radiation therapy simulation systems were reviewed by the Radiological Devices Classification Panel and placed in Class II (21 CFR 892.5050); an accessory to a medical charged particle radiation therapy system.

MIMiC, a radiation therapy beam-shaping block, is classified as class II according to 21 CFR 892.5710; a radiation therapy beam shaping block.

These devices are reviewed by the Radiological Devices Panel of the Division of Reproductive, Abdominal, ENT, and Radiological Devices.

4. Performance Standards

Not applicable.

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Premarket Notification - Peacock™ System

5. Intended Use and Device Description

This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.

6. Summary of Substantial Equivalence

The Peacock System is similar in design, construction, materials, intended use and performance characteristics to the predicate treatment planning systems and multileaf collimators. Physics and clinical testing has demonstrated that the Peacock System performs as intended. No new issues of safety or effectiveness are introduced by using this device.

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