(28 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 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.
This 510(k) summary and associated FDA letter for the Varian Medical Systems' On-Board Imager Device (K042720) does not contain details about specific acceptance criteria, a study proving performance against those criteria, or the methodology for such a study.
The document states that the device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339). The basis for clearance is substantial equivalence to existing predicate devices (Varian Medical Systems' On Board Imager, K040192, and the Acuity simulator's CBCT option, K033339). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not require new efficacy studies.
Therefore, I cannot provide the requested table and detailed study information. However, I can infer some aspects based on the nature of 510(k) submissions for substantial equivalence.
Here's an explanation of what can and cannot be provided from the given text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or a performance study. Its clearance is based on substantial equivalence to predicate devices, implying that its performance is expected to be similar or identical to the cleared predicate devices, which would have had their own validation data.
2. Sample size used for the test set and the data provenance
- Cannot be provided. No test set or performance study data is described. The clearance is based on comparison to predicate devices, not new clinical or performance data for this specific iteration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This document predates widespread AI in medical imaging devices and does not describe any MRMC studies or AI components. The device is for "verification of correct patient position" using imaging, not for interpretation tasks typically associated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not a standalone algorithm submission. It is a physical imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth establishment method is described as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided. This document discusses a hardware modification being cleared via substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as there is no mention of a training set for a machine learning model.
In summary: The provided 510(k) documentation focuses on the technological characteristics and intended use of a modified medical device, asserting its substantial equivalence to previously cleared devices. It does not include primary performance data or study details for this specific submission, which is typical for substantial equivalence clearances of device modifications.
{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.
-
- 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
-
- 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.
{1}------------------------------------------------
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
{3}------------------------------------------------
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
§ 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.