(247 days)
Not Found
No
The document describes image processing software but does not mention AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a visualization tool used to monitor radiation therapy, providing additional information to the clinical team, but therapeutic decisions should not be made solely based on its images. Therefore, it does not directly provide therapy.
No
The document explicitly states that "BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device." This indicates that it provides information for monitoring treatments rather than diagnosing medical conditions.
No
The device description explicitly states that the BeamSite system consists of a camera, workstation with pre-installed software, and a monitor, indicating it includes hardware components beyond just software.
Based on the provided information, the BeamSite™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- BeamSite's Function: The BeamSite system works by capturing and visualizing Cherenkov light emitted from the patient's skin during radiotherapy. It is an optical system that directly observes the interaction of the radiation beam with the patient's surface. It does not analyze biological specimens.
- Intended Use: The intended use is to visualize the radiation beam relative to surface anatomical landmarks on the patient during treatment. This is a real-time monitoring and visualization tool for the radiotherapy process itself, not for analyzing biological samples to diagnose or monitor a disease state.
In summary, the BeamSite system is a medical device used in vivo (on the living patient) to provide visual feedback during a medical procedure (radiotherapy). It does not perform analysis of biological samples in vitro (outside the living body), which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
BeamSite™ is a system that enables real-time visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the beam on the patient. The BeamSite system consists of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment, as it happens, and review after the treatment, if necessary.
The BeamSite system is designed to be used as a fixed mounted camera having a field of view of the treatment area, to routinely image patient treatments with minimal impact to the clinical workflow. The video images produced are intended to provide additional information about the treatment for the clinical team by displaying the beam size and shape on the patient during treatment. The images produced will provide real-time, direct visual indication that the beam is on, that it is impacting the patient at the intended treatment surface, provides visual feedback regarding the patient's movement relative to the beam, and that surfaces of the body not intended for treatment remain outside the beam path. BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device. However, the images will provide a simple and intuitive means to visually monitor radiation therapy on a routine basis.
Mentions image processing
Yes. Proprietary software performs image processing and displays images on the monitor. Image acquisition electronics performs imaging in sync and out of sync with the treatment beam pulses. Software performs image processing and displays images on the monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (Cherenkov light)
Anatomical Site
Anywhere in the body where radiation treatment is indicated.
Indicated Patient Age Range
Any individual (Adult or Child undergoing radiotherapy)
Intended User / Care Setting
Radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
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)
- BeamSite functional verification testing (system, software and firmware)
- Accelerated age testing to support expected service life claim for the BeamSite Camera
- Electrical Safety Evaluation as per IEC 60601-1:2005 / (R) 2012 and A1: 2012
- Electromagnetic Compatibility testing as per IEC 60601-1-2: 2014
- Software Verification and Validation as per IEC 62304:2006 / A1: 2016
- Usability Testing as per IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366-1: 2015
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 11, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
DoseOptics LLC % Farzeen Christie Consultant 16 Cavendish Court LEBANON NH 03766
Re: K200940
Trade/Device Name: BeamSite™ System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: November 6, 2020 Received: November 9, 2020
Dear Farzeen Christie:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200940
Device Name BeamSite™ System
Indications for Use (Describe)
The BeamSite™ System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals in appropriate hospital and freestanding radiation therapy environments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
DoseOptics LLC BeamSite™ System Traditional 510(k)
5. 510(k) SUMMARY
Revised 12/04/2020
5.1. SUBMITTER
DoseOptics LLC
16 Cavendish Court Lebanon, NH 03766 Phone: (603) 643-5177
Contact Person: Email: Date Prepared:
Farzeen Christie farzeen@doseoptics.com April 7, 2020
5.2. SUBJECT DEVICE
Device Trade Name: Device Common Name: Classification Name:
Regulatory Class: Product Code: Panel:
BeamSite™ System Radiotherapy Visualization System Medical Charged Particle Radiation Therapy System (21 CFR 892.5050) ll IYE Radiology
5.3. PREDICATE DEVICE
PortalVision™ Advanced Imaging Device, K091209 manufactured by Varian Medical Systems.
DEVICE DESCRIPTION 5.4.
BeamSite™ is a system that enables real-time visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the beam on the patient. The BeamSite system consists of a camera, workstation with pre-installed BeamSite software and a monitor to be used by clinical radiotherapy teams to visually observe the treatment, as it happens, and review after the treatment, if necessary.
4
The BeamSite system is designed to be used as a fixed mounted camera having a field of view of the treatment area, to routinely image patient treatments with minimal impact to the clinical workflow. The video images produced are intended to provide additional information about the treatment for the clinical team by displaying the beam size and shape on the patient during treatment. The images produced will provide real-time, direct visual indication that the beam is on, that it is impacting the patient at the intended treatment surface, provides visual feedback regarding the patient's movement relative to the beam, and that surfaces of the body not intended for treatment remain outside the beam path. BeamSite is to be used as a visualization tool. Therapeutic decisions should not be made solely based on the images acquired from this device. However, the images will provide a simple and intuitive means to visually monitor radiation therapy on a routine basis.
5.5. INDICATIONS FOR USE / INTENDED USE
The BeamSite System is intended to be used only with photon external beam radiotherapy during treatment to acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated. BeamSite is used by radiotherapy professionals therapy in appropriate hospital and freestanding radiation environments.
5.6. COMPARISON TO PREDICATE DEVICE
The Predicate Device for the BeamSite System is PortalVision Advanced Imaging Device, K091209, manufactured by Varian Medical Systems.
The PortalVision Advanced Imaging Device is indicated to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.
Whereas, the BeamSite System is indicated for a subset of this indication, namely, it is intended to be used during treatment to acquire and visualize the shape of the treatment radiation beam relative to
5
surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated.
Both devices require the ionizing radiation beam to be exposing the patient at the time they acquire their images.
The BeamSite System is not a substitute for the predicate but provides additional information to the user when compared to the PortalVision Advanced Imaging Device in that it presents a visual image of the actual shape of the irradiation field on the patient in relation to a visual image of the patient anatomical surface in and around the irradiation field.
Both devices require image analysis and presentation software to display images on a monitor to the user for further human analysis and decision making.
| Characteristic | Predicate Device:
PortalVision Advanced
Imaging Device
(K091209) | Subject Device:
DoseOptics
BeamSite System |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PortalVision Advanced
Imaging device is used to
acquire images of anatomical
landmarks, fiducial markers,
the shape of the treatment
beam and dosimetric signals
to guide the delivery of
radiation anywhere in the
body where radiation
treatment is indicated. | The BeamSite System
is intended to be used
only with photon
external beam
radiotherapy during
treatment to acquire
and visualize the shape
of the treatment
radiation beam relative
to surface anatomical
landmarks on the
patient, anywhere in the
body where radiation
treatment is indicated.
BeamSite is used by
radiotherapy
professionals in
appropriate hospital
and freestanding
radiation therapy
environments. |
| Characteristic | Predicate Device:
PortalVision Advanced
Imaging Device
(K091209) | Subject Device:
DoseOptics
BeamSite System |
| Indications for
Use | The PortalVision Advanced
Imaging device is used to
acquire images of anatomical
landmarks, fiducial markers,
the shape of the treatment
beam and dosimetric signals
to guide the delivery of
radiation anywhere in the
body where radiation
treatment is indicated. | The BeamSite System
is intended to be used
only with photon
external beam
radiotherapy during
treatment to acquire
and visualize the shape
of the treatment
radiation beam relative
to surface anatomical
landmarks on the
patient, anywhere in the
body where radiation
treatment is indicated.
BeamSite is used by
radiotherapy
professionals in
appropriate hospital
and freestanding
radiation therapy
environments. |
| Type of Use | Prescription Use | Same |
| Device Role and
System Output | Serves as an accessory to
LINAC | Same |
| Target
Population | Any individual (Adult or Child
undergoing radiotherapy) | Same |
| Energy
Delivered to the
Patient | No energy delivered to the
patient by the device | Same |
| Use
Environment | Radiation image detection
subsystem is inside the
treatment room and the PC
Workstation to view the
images is outside the
treatment room in therapist
control area | Same |
| Beam Energies
Used | All therapeutic X-Ray
energies from the linac | Same |
| Characteristic | Predicate Device:
PortalVision Advanced
Imaging Device
(K091209) | Subject Device:
DoseOptics
BeamSite System |
| | radiation beam can be
imaged | |
| Viewing Method | Display of image is on a
computer monitor using
custom software application
installed on a Windows PC | Same |
| Supporting
System
Components | PC Work Station and Cables
between treatment room and
therapist control area | Same |
| Field Size of
Image | Radiation Beam can be
viewed within the 40cm X
30cm detector area of the
Image Detection Unit. | 40cm X 40cm |
| Software
Features | Image Acquisition, Review,
and Storage are possible by
the computer and software. | Same |
| Biocompatibility | No contact with patient or
clinical staff in the treatment
room. | Same |
| Image Source | X-ray treatment beam | Same |
| Image
Acquisition
Geometry | Images of the exit treatment
beam field size and shape. | Images of the treatment
beam field size and
shape impinging on the
patient anatomy. |
| Image Detection | Flat-panel Amorphous Silicon
detector | X-rays interact with
tissue on and near the
surface of patient's
anatomy and produce
concomitant light output
by the Cherenkov
emission process. The
light is imaged by an
intensified camera
system with a
Complementary Metal
Oxide Semiconductor
(CMOS) sensor. |
| Characteristic | Predicate Device:
PortalVision Advanced
Imaging Device
(K091209) | Subject Device:
DoseOptics
BeamSite System |
| Image patient
surface
anatomy | Not possible | Patient surface
anatomy is visualized
between treatment
beam pulses utilizing
ambient light. |
| Image
Processing | Proprietary software performs
image processing and
displays images on the
monitor. | Image acquisition
electronics performs
imaging in sync and out
of sync with the
treatment beam pulses.
Software performs
image processing and
displays images on the
monitor. |
6
Page 5-4
7
8
Although PortalVision Advanced Imaging Device and the BeamSite System acquire their images using different technologies, both are accessories to a medical linear accelerator, both require an active ionizing radiation beam and both do acquire and visualize the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient, anywhere in the body where radiation treatment is indicated.
For both devices, the patient receives their radiation therapy whether or not either device is in use. Neither device interacts directly with the patient, but both utilize information present in the treatment beam. Since the BeamSite System is not a substitute for the PortalVision Advanced Imaging Device, but provides new visual information to the user, the technological differences do not raise new or different concerns of safety and effectiveness.
9
5.7. PERFORMANCE TESTING SUMMARY (NON-CLINICAL)
The following performance data are provided in support of the substantial equivalence determination.
- . BeamSite functional verification testing (system, software and firmware)
- . Accelerated age testing to support expected service life claim for the BeamSite Camera
- Electrical Safety Evaluation as per IEC 60601-1:2005 / (R) 2012 . and A1: 2012
- Electromagnetic Compatibility testing as per IEC 60601-1-2: 2014 .
- Software Verification and Validation as per IEC 62304:2006 / A1: ● 2016
- Usability Testing as per IEC 60601-1-6 Edition 3.1 2013-10 and . IEC 62366-1: 2015
5.8. CONCLUSIONS
Based on performance testing of BeamSite and the evaluation of predicate characteristics, we claim the BeamSite System to be substantially equivalent to existing legally marketed device, PortalVision (K#091209).