(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional treatment planning functionalities.
No
The device is a treatment planning system, which is a tool used by clinicians to plan therapy. It does not directly deliver or produce a therapeutic effect on the patient.
No
The device is a treatment planning system for proton radiation therapy, which uses diagnostic images but is not itself a diagnostic device.
No
The device description explicitly states it is a "computer based device" and mentions a "computer with graphics display and plotter outp", indicating hardware components are included.
Based on the provided information, the Varian ProtonVision device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ProtonVision's function: The description clearly states that ProtonVision is a treatment planning system used for analyzing diagnostic images, contouring, calculating proton dose, and reviewing treatment plans for proton radiation therapy. It works with images and patient data, not with biological samples.
Therefore, ProtonVision falls under the category of medical devices used for treatment planning and delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.
As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose calculation and dosimerice plan review. Proton Vision integrates proton treatment planning with
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ProtonVision 7.0, K000922
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.
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).
Not Found
§ 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
AUG 3 0 2000
K002312
Page 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved top and a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.
alo Alto, CA 94304-1038 +1 650 493 4000 w.varian.com
Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared; July 26, 2000
Submitter's Name:
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Person: Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance (650) 424-6990 Phone FAX (650) 855-7364 E-Mail linda.nash@os.varian.com
Device Name: ProtonVision 7.0
Classification Name: Medical Charged Particle Radiation Therapy Systems
Predicate Device: ProtonVision 7.0, K000922
1
K002312
Page 2 of 2
Product Description:
The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose
calculation and dosimerice plan review. Proton Vision integrates proton treatment planning
with
Intended Use:
The Varian Proton Vision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.
Technological Characteristics :
See attached Specification Comparison Chart, Tab F
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2000
Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems 3100 Hansen Way M/S E-055 Palo Alto, CA 94304-1129
Re: K002312
Proton Vision 7.0.3 Radiation Therapy Treatment Planning System Dated: July 26, 2000 Received: July 31, 2000 21 CFR §892.5050/Procode: 90 MUJ
Dear Ms. Nash:
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, aqainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Aproval), 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 equivalion 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket not ification 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 predication 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 diagnoslic devices), please contact the Office of Compliance at (301) 594-4591. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsmaldsmamain.html".
Sincerely yours.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and expertise.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
Indications For Use
510(k) Number: K 002312
Device Name: ProtonVision 7.0
Indications For Use:
The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.
As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
(PLEASE DØ NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K00231
Prescription Use OR (per 21 CFR 801.109)
Over-The-Counter Use_