(74 days)
No
The summary describes a conventional imaging and simulation device with a new CBCT feature. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on image acquisition, reconstruction, and manipulation, which are standard functions of imaging systems.
No
This device is a simulator used for planning and positioning in radiation therapy, not for delivering the therapy itself. It assists in visualizing and confirming the treatment field, and acquiring planning data, rather than directly treating a condition.
No.
The device is used for radiation therapy simulation, treatment planning, and patient positioning, not for diagnosing diseases or conditions. While it acquires imaging data, its primary purpose is to assist in the treatment of known conditions rather than in diagnosis. The "Summary of Performance Studies" section also mentions testing in accordance with "Diagnostic x-ray systems," but this refers to the type of x-ray technology used, not the diagnostic purpose of the device itself.
No
The device description explicitly states that Acuity with CBCT is a "new feature to the Varian Medical Systems Radiation Therapy Simulator, 'Acuity'" and that it "combines conventional and CT simulation into one product." This indicates the device includes hardware components (the simulator, x-ray system, gantry) in addition to the software for image acquisition, reconstruction, viewing, and manipulation. The performance studies also reference testing against performance standards for ionizing radiation emitting products and diagnostic x-ray systems, further confirming the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Acuity Radiation Therapy Simulator with CBCT is an imaging device that uses X-rays to visualize internal structures of the patient's body in vivo (within the living body). It's used for radiation therapy simulation, treatment planning, and patient positioning.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
Product codes
KPR
Device Description
Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D multislice planning data in patient set-ups where conventional (Computerized Tomography) CT imaging is not possible. CBCT is a new feature to the Varian Medical Systems Radiation Therapy Simulator, "Acuity" (K023052), and acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning. CBCT provides Acuity the capability of acquiring and reconstructing 15-17cm of volumetric data in one gantry rotation. This represents approximately 340 0.5mm slices. Acuity combines conventional and CT simulation into one product. Acuity can change from radiographic and fluoroscopic mode for isocenter localization to CT acquisition mode for treatment planning. This is accomplished with no movement of the patient from the actual treatment position.
Mentions image processing
Acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray system (fluoroscopic and/or radiographic), Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation Oncologist
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)
Acuity with Conebeam Computed Tomography was tested in accordance with 21 CFR §1020 - Performance standards for ionizing radiation emitting products. Specifically §1020.30 - Diagnostic x-ray systems and their major components and §1020.33 - Computed tomography (CT) equipment. The results of the tests demonstrated that the Acuity CBCT met the performance standards requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.
0
DEC 3 0 2003
Image /page/0/Picture/1 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "i" that resembles a medical symbol. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 115A tel +1 650 493 4000 www.varian.com
510(k) Summary
$K033339$ P.142
The following information is provided following the format of 21 CFR 807.92 for the Acuity with Conebeam Computed Tomography
- Submitter:
Varian Medical Systems 3100 Hansen Way M/S H055 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: October 16, 2003
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- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
Acuity with Conebeam Computed Tomography Acuity with Conebeam Computed Tomography Acuity CBCT Stationary x-ray system 21 CFR §892.1680 Class II Product Code: KPR
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
3. Predicate Devices to claim substantial equivalence:
- a. Acuity Radiation Therapy Simulator, K023052
- b. Ximatron Scanvision, K981056
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- Description of the Device: Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D multislice planning data in patient set-ups where conventional (Computerized Tomography) CT imaging is not possible. CBCT is a new feature to the Varian Medical Systems Radiation Therapy Simulator, "Acuity" (K023052), and acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning. CBCT provides Acuity the capability of acquiring and reconstructing 15-17cm of volumetric data in one gantry rotation. This represents approximately 340 0.5mm slices. Acuity combines conventional and CT simulation into one product. Acuity can change from radiographic and fluoroscopic mode for isocenter localization to CT acquisition mode for treatment planning. This is accomplished with no movement of the patient from the actual treatment position.
1
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- Intended Use Statement: The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
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- Summary of the Technological Characteristics: the Acuity Radiation Therapy Simulator, K023052 has been modified to include Conebeam Computerized Tomography as a new feature. This new feature will allow the Acuity Radiation Therapy Simulator to acquire 3D multi-slice planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning which is substantially equivalent to the Varian Medical Systems Scanvision device, K981056. The substantial equivalence comparison chart provides a comparison of the technological charactcristics to those of the predicate devices. The chart is located in Tab G.
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- Performance Standards Acuity with Conebeam Computed Tomography was tested in accordance with 21 CFR&1020 - Performance standards for ionizing radiation emitting products. Specifically §1020.30 - Diagnostic x-ray systems and their major components and §1020.33 - Computed tomography (CT) equipment. The results of the tests demonstrated that the Acuity CBCT met the performance standards requirements.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a bird, symbolizing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Mr. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K033339
Trade/Device Name: Acuity with ConeBeam Computerized Tomography Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPO Dated: October 16, 2003 Received: October 17, 2003
Dear Mr. 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 application (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 such 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 that I Driner I 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.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
510(k) Number (if known): Device Name: Acuity with Conebeam Computed Tomography
Indications For Use:
The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
Daniel A. Leppanen
(Division Sign-Off)
Division of Reproductive, Abdon and Radiological Devices 510(k) Number