(28 days)
No
The summary describes image acquisition and comparison for patient positioning, but does not mention any AI/ML techniques for image analysis, processing, or decision support. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for imaging and verification of patient position and treatment fields, not for actively treating or alleviating a disease or condition. Its purpose is diagnostic and guidance-related, not therapeutic.
No
The device is used for verification of correct patient positioning and treatment fields, not for diagnosis of a disease or condition. It compares current patient anatomy with reference images to ensure accurate treatment delivery.
No
The device description explicitly states it is a "modified" "On-Board Imager device" which includes a "CBCT option". This indicates a physical hardware component (the imager and CBCT system) is part of the device, not just software.
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 patient position and treatment fields in relation to anatomical landmarks. This is a function related to medical imaging and treatment delivery, not the analysis of biological samples or substances from the human body to provide diagnostic information.
- Device Description: The device acquires cone-beam CT images of the patient on the treatment couch. This is a form of in vivo imaging, meaning it images the patient directly, not in a laboratory setting using samples. The comparison of these images to reference CT scans is for positioning and verification purposes, not for diagnosing a disease or condition based on the analysis of biological materials.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with in vitro diagnostics.
In summary, the On-Board Imager Device is a medical imaging and positioning tool used in the context of radiation therapy treatment, which falls under the category of medical devices, but not specifically in vitro diagnostic devices.
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 On-Board Imager device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339) so that cone-beam CT image acquisition will be available in the treatment room. This will allow users to acquire cone-beam CT images of the patient while they are on the treatment couch in the treatment room. The users can then compare the locations of soft-tissue anatomy seen in reference CT scans with the locations of the same soft-tissue anatomy in the cone-beam CT images. The reference CT images can come from multiple sources including conventional CT scanners, the Acuity simulator or previous cone-beam CT scans acquired using the On-Board Imager.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cone-beam CT, conventional CT
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)
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
OCT 2 9 2004
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the On-Board Imager Device.
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- Submitter: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: September 30, 2004
2. Name of the Device:
Trade/Proprietary Name: Common or Usual Name: Classification Name:
On-Board Imager Device Imaging Accessory to Medical Linear Accelerator Medical Charged Particle Radiation Therapy System 21 CFR §892.5050 Class II Product Code: 90 IYE
3. Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems'On Board Imager, K040192
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- Device Description: The On-Board Imager device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339) so that cone-beam CT image acquisition will be available in the treatment room. This will allow users to acquire cone-beam CT images of the patient while they are on the treatment couch in the treatment room. The users can then compare the locations of soft-tissue anatomy seen in reference CT scans with the locations of the same soft-tissue anatomy in the cone-beam CT images. The reference CT images can come from multiple sources including conventional CT scanners, the Acuity simulator or previous cone-beam CT scans acquired using the On-Board Imager.
-
- 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 6. 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.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center is an abstract emblem of an eagle, which is a common symbol used by the U.S. government. The eagle is depicted with stylized lines, giving it a modern and streamlined appearance.
Public Health Service
OCT 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director, Regulatory Affairs VARIAN Medical Systems, Inc. 3100 Hansen Way M/S E-110 PALO ALTO CA 94304-1038
Re: K042720
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: September 30, 2004 Received: October 1, 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 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 (Premarket Approval), 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 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:
| 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 807.97). You may obtain other general information on your responsibilities under the Act 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PAGE 1 of 1
510(k) Number (if known): K042720 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
Nancy C. Broadlon
ACTIVE