(18 days)
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No
The document describes a traditional radiation therapy planning system and does not mention AI, ML, or related concepts.
No
CadPlan 6.0 is a treatment planning system, not a device that directly delivers therapy or has a therapeutic effect on the patient. It models treatments for therapeutic devices like linear accelerators.
No
Explanation: The device is used for planning radiation therapy treatments, and does not determine the presence or absence of a disease.
Yes
The description focuses solely on the software's functionality for treatment planning and data export, without mentioning any associated hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CadPlan 6.0 is a radiation therapy treatment planning system. Its intended use is to plan radiation treatments for patients using external beam and brachytherapy. This involves calculating radiation doses and planning how the radiation will be delivered to the patient's body.
The description clearly indicates that CadPlan 6.0 is a tool for planning medical treatments, not for analyzing biological samples.
N/A
Intended Use / 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 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.
Product codes
90 MUJ
Device Description
CadPlan 6.0 is a comprehensive 3D Treatment Modeling Workstation for external beam and brachytherapy planning.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CadPlan ver. 2.62 Radiation Therapy Treatment Planning
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 (650) 424-6990 FAX (650) 855-7364 E-mail linda.nash@os.varian.com
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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Page 1 of 2
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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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wings.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
3
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: 650.424.4830