(358 days)
CADPLAN is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 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 includes export capabilities to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices.
Varian CADPLAN is a comprehensive 3D RTP system for radiation dose modeling of patients undergoing photon or electron therapy or brachytherapy, based on modern UNIX technology. External beam calculation is fully 3-dimensional supporting coplanar and non-coplanar fields. The beam model takes into account collimator rotation, off-center calculation, and irregular field shape. Different energies and treatment modalities (fixed, isocentric, and arc) can be combined in the same plan; and external beam, intracavitary, and interstitial plans can be combined. Wedges, both static and dynamic, blocks, compensators, and boluses can be used. All images, graphical data, and texts are displayed on one high resolution monitor. Easy to use operation is provided with mouse selectable menus.
The provided text is a 510(k) summary for the Varian CADPLAN Radiation Therapy Treatment Planning (RTP) System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.
The document is purely a regulatory submission outlining the device's purpose and its equivalence to an existing product for market approval. It is from 1997, and the level of detail regarding performance studies for AI/software-as-a-medical-device (SaMD) was not as extensive as it is today.
Therefore, I cannot provide the requested information based on the given text. The text explicitly states:
- "CADPLAN has no significant differences in design, materials, energy source or other technological characteristics compared Considerations: to the predicate device." This indicates that the approval was based on substantial equivalence, not on extensive performance studies proving specific acceptance criteria.
- The document primarily focuses on intended use and technological considerations in comparison to a predicate device (FOCUS by Computerized Medical Systems, Inc.).
To answer your questions, one would need access to the actual performance studies, which are not included in this 510(k) summary document.
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Summary of Safety and Effectiveness Information
Kq62950
- Varian Oncology Systems 1. Submitter: 3045 Hanover Street Palo Alto, CA 94304
JUL 222 1997
Charles H. Will, Manager Contact: Regulatory Compliance & Safety Phone (415) 424-5036 FAX cwill@os.varian.com
Prepared: July 26, 1996
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- Device Name: CADPLAN Radiation Therapy Treatment Planning (RTP) System
- FOCUS, manufactured by 3. Predicate Computerized Medical Systems, Inc. Device:
- Varian CADPLAN is a comprehensive 3D RTP system for 4. Description: radiation dose modeling of patients undergoing photon or electron therapy or brachytherapy, based on modern UNIX technology. External beam calculation is fully 3-dimensional supporting coplanar and non-coplanar fields. The beam model takes into account collimator rotation, off-center calculation, and irregular field shape. Different energies and treatment modalities (fixed, isocentric, and arc) can be combined in the same plan; and external beam, intracavitary, and interstitial plans can be combined. Wedges, both static and dynamic, blocks, compensators, and boluses can be used. All images, graphical data, and texts are displayed on one high resolution monitor. Easy to use operation is provided with mouse selectable menus.
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- Intended Use: CADPLAN is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 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.
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Varian CADPLAN 510(k) Summary of Safety and Effectiveness Information
- CADPLAN includes export capabilities to verify beam 5. Intended Use: and patient data, dose planning results, and provide Cont'd. on-line information to block-cutting devices.
- CADPLAN has no significant differences in design, materials, 6.Technological energy source or other technological characteristics compared Considerations: to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 1997
Charles H. Will Manager Regulatory Compliance & Safety Varian Oncology Systems Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 Re: K962950
Varian Cadplan ver. 2.62, Radiotherapy Treatment Planning System ....... ............................... Dated: June 30, 1997 Received: July 2, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Will:
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 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 (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 requirement, 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 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
h.Liau 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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510(k) Number: K962950
Varian CadPlan, Version 2.62 Device Name:
Indications for use:
I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian: Oncology Systems that the CADPLAN Radiation Therapy Treatment Planning System which is the subject of this premarket notification, is intended to be used for the following:
CADPLAN is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 4 to 50 MV, as well as Cobalt-60, and electron energies from 4 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 includes export capabilities to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices.
Charles H. Will, Manager Regulatory Compliance & Safety
Date
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christer A. Segerstrom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number K962950
Prescription Use _ (Per 21 CFR 801.109)
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.