(58 days)
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.
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.
The provided document is a 510(k) summary for the Varian Medical Systems On-Board Imager, a medical device used for verifying patient position and treatment fields in relation to anatomical and/or fiducial landmarks during radiation therapy. It outlines the device description, intended use, and substantial equivalence to a predicate device (Varian Medical Systems' On-Board Imager, K040192).
However, the document does not contain specific details regarding acceptance criteria, study design, statistical analysis, or performance metrics that would allow for a complete response to your request. The 510(k) summary primarily focuses on regulatory approval based on equivalence to a previously cleared device.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The document indicates that "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." This chart, if available, would likely contain more technical specifications and potentially some performance data used for the substantial equivalence claim. However, the content of Tab 8 is not included in the provided text.
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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 TherapySystem21 CFR §892.5050Class IIProduct Code: 90 IYE |
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- Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems'On Board Imager, K040192
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- 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.
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- 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.
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- 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.
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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
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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
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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
§ 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.