(28 days)
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 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.
The provided document is a 510(k) Premarket Notification for the Varian Acuity Radiation Therapy Simulator. It describes the device's intended use and technological characteristics, and states its substantial equivalence to a predicate device. However, this document does not contain a detailed study proving the device meets acceptance criteria in the way a clinical trial or performance study report would.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials or performance studies that define and meet specific acceptance criteria with detailed statistical analysis. The "acceptance criteria" referred to in your request are typically part of a comprehensive performance study, which is not present in this type of regulatory submission.
Therefore, for your specific requests, most of the information is not available in this document:
- A table of acceptance criteria and the reported device performance: This information is not provided. The 510(k) submission states the device's function and intended use, but not specific performance metrics against defined acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable/not provided. This document doesn't detail a specific test set or clinical study of this nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method: Not applicable/not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not mention an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a radiation therapy simulator, not an AI algorithm.
- The type of ground truth used: Not applicable/not provided.
- The sample size for the training set: Not applicable/not provided. This is a hardware device, not an AI algorithm requiring a training set in this context.
- How the ground truth for the training set was established: Not applicable/not provided.
Summary based on the provided document:
The document describes the Varian Acuity Radiation Therapy Simulator, a device designed to provide low-dose x-ray images (radiographic or fluoroscopic) to duplicate therapy treatment fields and obtain machine coordinates and patient positional information for radiation therapy planning.
The predicate device for establishing substantial equivalence is the "Varian Ximatron C-Series Radiation Therapy Simulatory with Version 4.2 Software, K964138."
The intended use of the Acuity is for radiation therapy simulation, using fluoroscopic and/or radiographic x-ray systems for visualizing the volume to be exposed and confirming the position and size of the therapeutic irradiation field.
The basis for regulatory clearance (510(k)) is demonstrating substantial equivalence to the predicate device, not necessarily meeting a pre-defined set of objective performance acceptance criteria through an independent study as one might see for novel technologies or AI devices. The substantial equivalence relies on comparing technological characteristics with those of the predicate. The document mentions an attached "Specification Comparison Chart" (Tab G), which would outline these characteristic comparisons, but this chart is not included in the provided text.
{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
§ 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.