(28 days)
Not Found
No
The document describes a traditional radiation therapy simulator with mechanical and electronic components for imaging and positioning, with no mention of AI or ML capabilities.
No
This device is described as a "Radiation Therapy Simulator" used for planning and confirming the position and size of therapeutic irradiation fields, rather than delivering the therapy itself.
No
The device is used for radiation therapy simulation, specifically for visualizing the treatment volume and confirming the position and size of the therapeutic irradiation field. It is a planning and verification tool for radiation therapy, not a diagnostic device used to identify or characterize diseases.
No
The device description clearly outlines significant hardware components including a drive stand, gantry, x-ray tube, collimator, detector support arm, patient support couch, and control panels. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the device is used for "visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied" directly on the patient using x-rays. This is an in-vivo (within the living body) process, not an in-vitro (outside the living body) process involving specimens.
- The intended use and device description focus on imaging and positioning for radiation therapy. The device's function is to simulate the radiation treatment process on the patient's body using imaging, not to analyze biological samples.
Therefore, the Varian Acuity Radiation Therapy Simulator is a medical device used for imaging and planning in radiation therapy, but it does not fit the definition of an In Vitro Diagnostic device.
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.
Product codes
90 KPQ
Device Description
The Varian Acuity is a Radiation Therapy Simulator. Its main function is to provide the means of planning the subsequent treatment of patients on therapy machines capable of delivering tumorcidal doses of photons or electron to specific target volumes in the human body. It achieves this by providing low dose level x-ray images (either radiographic or fluoroscopic) to duplicate the therapy treatment fields, along with machine coordinates and patient positional information. It is capable of simulating single, multiple or dynamic treatment fields.
Some version of the Simulator will also be able to provide digital tomographic imaging and real-time image capture, viewing and enhancement.
The Acuity consists of a drive stand which supports a vertically rotatable gantry. The stand also provides a housing for much of the simulator's electronics and its 3-phase xray generator. The stand is itself supported on a sub-floor-level baseframe which also extends forward from the stands area to provide support and horizontal rotation for a patient support couch.
The gantry provides mounting for an x-ray tube and beam shaping collimator and diametrically opposite these, a detector support arm assembly. All of which can be positioned anywhere around the simulator's isocenter via rotation of the gantry.
The detector support arm is a robotic type mechanism providing support and positional adjustment for a flat panel digital image acquisition device and film cassette holder.
Mechanical movements of the simulator are controlled either from an in-room handheld pendant or from a control room console. In addition, control panels mounted on each side of the couch provide control of couch movements, laser lights and contain emergency off buttons.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human body (target volumes to be treated with radiation therapy)
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)
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
VARIAN
medical systems
OCT 11 2002
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
September 12, 2002
Submitter's Name:
Varian Medical Systems, Inc. 3100 Hansen Way m/s F055 Palo Alto, CA 94304
Contact Person:
Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Phone (650) 424-6990 (650) 842-5051 FAX E-mail: linda.nash@varian.com
Device Name:
Acuity
Classification Name:
Radiation therapy simulation system
Oncology Systems 100 Hansen Way alo Alto, CA 94304-1038 +1 650 493 4000 ww.varian.com
1
Predicate Device:
Varian Ximatron C-Series Radiation Therapy Simulatory with Version 4.2 Software, K964138.
Product Description:
The Varian Acuity is a Radiation Therapy Simulator. Its main function is to provide the means of planning the subsequent treatment of patients on therapy machines capable of delivering tumorcidal doses of photons or electron to specific target volumes in the human body. It achieves this by providing low dose level x-ray images (either radiographic or fluoroscopic) to duplicate the therapy treatment fields, along with machine coordinates and patient positional information. It is capable of simulating single, multiple or dynamic treatment fields.
Some version of the Simulator will also be able to provide digital tomographic imaging and real-time image capture, viewing and enhancement.
The Acuity consists of a drive stand which supports a vertically rotatable gantry. The stand also provides a housing for much of the simulator's electronics and its 3-phase xray generator. The stand is itself supported on a sub-floor-level baseframe which also extends forward from the stands area to provide support and horizontal rotation for a patient support couch.
The gantry provides mounting for an x-ray tube and beam shaping collimator and diametrically opposite these, a detector support arm assembly. All of which can be positioned anywhere around the simulator's isocenter via rotation of the gantry.
The detector support arm is a robotic type mechanism providing support and positional adjustment for a flat panel digital image acquisition device and film cassette holder.
Mechanical movements of the simulator are controlled either from an in-room handheld pendant or from a control room console. In addition, control panels mounted on each side of the couch provide control of couch movements, laser lights and contain emergency off buttons.
Intended 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
2
exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.
Technological Characteristics:
See the attached "Specification Comparison Chart", Tab G
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three wavy lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurnace VARIAN Medical Systems
Oncology Systems 3100 Hansen Way PALO ALTO CA 94304-1038 Re: K023052 Trade/Device Name: Acuity Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPQ Dated: September 12, 2002 Received: September 13, 2002
Dear Ms. Nash:
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 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.
4
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page l of
510(k) Number (if known): K023052
Device Name: ACUITY
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Optional Format 3-10-98)
David A. Hepburn
(Division Sign-Off)
Γ ar of Reproductive, Abdominal,
E ological Devices K023052
E (k) Number