(58 days)
Not Found
No
The description focuses on image comparison and fiducial marker detection, which are standard image processing techniques and do not inherently indicate AI/ML. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is used for patient positioning and verification, not for treating a disease or condition.
No
The device is used for verification of patient position and treatment fields, not for diagnosing a medical condition or disease.
No
The device description explicitly states it is a modification to an "On-Board Imager," which is a hardware device used for acquiring digital kV X-ray images. The modifications described relate to image comparison and acquisition capabilities, implying changes to the software controlling the hardware, but the core device remains a hardware imager.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for verification of correct patient position and verification of treatment fields using X-ray images. This is a function related to medical imaging and treatment delivery, not the analysis of biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The device acquires and compares X-ray images to reference images or data sets to facilitate patient positioning corrections. This is a physical positioning and imaging system, not a system for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on biological markers.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body. This device operates in vivo (within the body) by taking X-ray images of the patient.
N/A
Intended Use / Indications for Use
The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
Product codes
90 IYE
Device Description
The present device (K040192) is cleared to make corrections to a patient's position based on a comparison of the newly acquired digital kV Xray images with digital reference images generated during treatment planning or simulation. Regarding this submission, the On-Board Imager has been modified to include correction of a patient's position based on comparison of fiducial markers in digital images to fiducial markers that are in reference 3-D volumetric data sets and allow for gated radiographic image acquisitions and fluoroscopic pretreatment visual verification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital kV Xray images, digital images, radiographic image acquisitions, fluoroscopic pretreatment visual verification
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 = 4 2004
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the On-Board Imager Device.
- 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: June 4, 2004
| Name of the Device: | On-Board Imager |
|---|---|
| Trade/Proprietary Name: | On-Board Imager Device |
| Common or Usual Name: | Imaging Accessory to Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation Therapy |
| System | |
| 21 CFR §892.5050 | |
| Class II | |
| Product Code: 90 IYE |
-
- Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems'On Board Imager, K040192
-
- Device Description: The present device (K040192) is cleared to make corrections to a patient's position based on a comparison of the newly acquired digital kV Xray images with digital reference images generated during treatment planning or simulation. Regarding this submission, the On-Board Imager has been modified to include correction of a patient's position based on comparison of fiducial markers in digital images to fiducial markers that are in reference 3-D volumetric data sets and allow for gated radiographic image acquisitions and fluoroscopic pretreatment visual verification.
-
- Intended Use Statement: The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
-
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like figure with three curved lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2004
Ms. Vy Tran Corporate Director, Regulatory Affairs VARIAN Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K041519
Trade/Device Name: On-Board Imaging Device Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II Product Code: 90 IYE Dated: July 16, 2004 Received: July 19, 2004
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 for association 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 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
2
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hantoling of substantial equivalence of your device to a legally premarket notification. The PDA miding of casion 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 advice for your device to for the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (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 Audultionally, for questions on the promote the regulation entitled, "Misbranding Other of Comphanes at (301) 37 + 1057 + 1057 + 1007.97) you may obtain. Other general by recreence to premarred nombilities under the Act may be obtained from the Division of Small information on your responsionities and consumer Assistance at its toll-free number (800) 638-2041 or 1911) 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
3
510(k) Number (if known): K041519 Device Name: On-Board Imager Device
Indications For Use:
The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
(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
(Per 21 CFR 801.109)
Nancy C. Gordon
(Division Sign-Off)
Division of Reproductive, Abdeminal, and Radiological Devic 510(k) Number