CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM

K992753 · Varian Assoc., Inc. · MUJ · Sep 3, 1999 · Radiology

Device Facts

• Record ID: K992753
• Device Name: CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
• Applicant: Varian Assoc., Inc.
• Product Code: MUJ · Radiology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60 and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments.

Device Story

CadPlan 6.0 is a 3D treatment modeling workstation for external beam and brachytherapy planning. It processes patient data to calculate radiation dose distributions for linear accelerators, Cobalt-60 units, and electron beam sources. Used by clinicians in oncology settings to design complex treatment approaches, including non-coplanar fields and dynamic wedges. The system outputs treatment plans and data for beam verification and block-cutting devices. It assists healthcare providers in optimizing radiation delivery, aiming to improve treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

3D treatment modeling workstation software. Supports external beam (1-50 MV X-ray, 1-50 MeV electron) and brachytherapy planning. Features include multileaf collimator support, dynamic wedges, and customized blocking. Connectivity includes export capabilities for beam/patient data and block-cutting devices.

Indications for Use

Indicated for patients requiring radiation therapy planning, including 3D radiotherapy, combined modality plans, asymmetric and non-coplanar fields, total body irradiation, and use of multileaf collimators, motorized/dynamic wedges, customized blocking, compensating filters, and bolus.

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

• CadPlan ver. 2.62 Radiation Therapy Treatment Planning

Submission Summary (Full Text)

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# k992753

# SEP , 3 1999

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# Premarket Notification [510K] Summary as required by 21 CFR 807.92

## Date Summary was prepared:

August 12,1999

### Submitter's Name:

Varian Medical Systems 3100 Hansen Way M/S H-055 Palo Alto, CA 94304

### Contact Person:

Linda S. Nash Regulatory Affairs and Quality Assurance Manager Phone [phone] FAX [phone] E-mail [e-mail]

## Device Name:

CadPlan 6.0

Classification Name: Medical charged-particle radiation therapy system

Predicate Device: CadPlan ver. 2.62 Radiation Therapy Treatment Planning

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## Product Description:

CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.

## Intended Use

CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60 and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments.

## Technological Characteristics:

See the attached "Specification Comparison Chart", Tab F.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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SEP 1999

Ms. Linda Nash Requlatory Affairs and Quality Assurance Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, CA 94304-1129

Dear Ms. Nash:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K992753 CadPlan 6.0 Radiation Therapy Treatment Planning System Dated: August 13, 1999 Received: August 16, 1999 Regulatory Class: Il (two) Product Code: 90 MUJ 21 CFR 892.5050

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 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 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 requlatory 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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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# varian® oncology systems

# Indications for Use

510(k) Number (if known):

Device Name: CadPlan 6.0

Indications for Use:

CadPlan 6.0 is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1-50 MV, as well as Cobalt-60, and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments. CadPlan will plan the 3D radiotherapy treatment approaches to combined modality plans, asymmetric and non-coplanar field, total body irradiation, multileaf collimators, motorized and dynamic wedges, customized blocking, compensating filters, and bolus.

CadPlan 6.0 includes export capabilities to verify beam and patient date, dose-planning results, and provide on-line information to block-cutting devices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR (per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Seaymm

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Deyic

510(k) Number

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Varian Associates, Inc. 3045 Hands &: Care . . . . Alle, C ... Jinia 94304-1129 U.S.A. 650.493.4000 FAX: [phone]