(84 days)
Not Found
No
The document describes image processing and quantitative image matching, but does not mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development like training/test sets or performance metrics like AUC.
No
The device is designed to assist staff in treatment plan preparation, approval, and quality assurance, which are aspects of managing therapy, not directly delivering a therapeutic effect.
No
The device is designed to assist radiation therapy staff in preparing and approving treatment plans, performing quality assurance of treatments, and reviewing treatment images for patient setup corrections. While it processes images and data from "diagnostic studies," its primary function is not to diagnose medical conditions but rather to manage and verify treatment-related information.
Yes
The device is described as a "treatment plan and image management application" and a "Radiological Image processing system." While it interacts with data from various sources (diagnostic studies, treatment planning, simulation, plan verification, and treatment), the description focuses solely on the software functionalities for managing, viewing, manipulating, and processing this data. There is no mention of any hardware components being part of the Vision device itself. The client-server architecture further supports the idea of a software-based system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that Vision is a treatment plan and image management application used in radiation therapy. Its functions involve:
- Managing and manipulating medical images (from diagnostic studies, treatment planning, etc.).
- Defining, manipulating, and scheduling treatment plans.
- Tracking treatment histories and delivered dose.
- Performing quality assurance of treatments, including image review and matching for patient setup corrections.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its focus is on managing and processing medical imaging data and treatment planning information.
Therefore, Vision falls under the category of a medical device used in the treatment and planning process, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, vision is dosigned to abservate of the treatments, i.e. to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ, IYE, KPQ
Device Description
The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.
The Vision device (K042956) has been modified to introduce a module called Offline Review. Off-line Review allows the authorized user to review treatment images and provide capabilities to do quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images.
The Vision device is based on the client-server architecture, and thus all Vision clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision).
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
radiation therapy staff
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.
Vision™, K042956
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.
Not Found
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
510(k) Summary
The following information is provided following the format of 21CFR 807.92 for Vision™ with Off-Line Review feature.
NOV 2 3 2005
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- Submitter: Varian Medical Systems 3100 Hansen Way M/S E110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: August 29, 2005
2. Name of Device:
Trade/Proprietary name: Vision™ (with Off-Line Review) Common or Usual Name: Image Database Classification Name: Radiological Image processing system 21CFR §892.5840 Class II Product Code: 90 LLZ
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- Predicate Device: Vision™, K042956
4. Description of the Device:
The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling.
The Vision device (K042956) has been modified to introduce a module called Offline Review. Off-line Review allows the authorized user to review treatment images and provide capabilities to do quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images.
1
The Vision device is based on the client-server architecture, and thus all Vision clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision).
5. Intended Use Statement:
The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments.
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- Summary of Technological Characteristics: The Substantial Equivalence Comparison chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 8 of the submission.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re.: K052391
NOV 2 3 2005
Trade/Device Name: Vision™ (with Off-Line Review) Regulation Number: 21 CFR 892.5050 21 CFR 892.5840 Regulation Name: Medical charged-particle radiation therapy system; Radiation therapy simulation system Regulatory Class: II Product Code: IYE; KPQ
Dated: August 29, 2005 Received: August 31, 2005
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icler with anow you'ts oogin mannelling of substantial equivalence of your device to a legally premarked predication: "The I Dr. missification 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), please If you desire specific acriee tor your de following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, production other general information on your responsibilities under the Act from the 007.777. I va may ooum barees, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Device Name: Vision™ with Off-Line Review
Indications For Use:
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, vision is dosigned to abservate of the treatments, i.e. to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel h. Dyson
livision Sig 510(k) Number
(Optional Format 3-10-98)