(29 days)
Not Found
No
The document describes image processing but does not mention AI, ML, or related concepts like neural networks. The performance studies listed are standard medical device testing and do not indicate AI/ML model validation.
No.
The device is a camera system used for visualizing the treatment beam during radiotherapy, not for administering therapy or directly affecting the patient's condition. It aids the professional in radiotherapy, which is a therapeutic treatment.
No
The device is described as a system for "acquiring and visualizing the shape of the treatment radiation beam relative to surface anatomical landmarks on the patient" and enabling "live visualization of the treatment beam on a patient during radiotherapy." It helps professionals visually observe the patient and the Cherenkov light emitted to review treatment images. This indicates its use is for monitoring and guiding treatment, rather than for diagnosing a medical condition.
No
The device description explicitly states that the BeamSite system consists of a camera, a workstation with software, and a monitor, indicating it includes hardware components beyond just software. The performance studies also include testing for the camera's service life, electrical safety, and electromagnetic compatibility, which are hardware-related tests.
Based on the provided information, the BeamSite™ System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The BeamSite™ System is a camera system that directly observes the patient's skin surface during radiotherapy. It does not analyze blood, tissue, urine, or any other bodily fluid or substance.
- IVDs are used to provide information about a physiological or pathological state. The BeamSite™ System provides visual information about the location of the radiation beam on the patient's surface. While this information is crucial for guiding treatment, it doesn't diagnose a condition or provide information about the patient's internal physiological state in the way an IVD would (e.g., blood glucose levels, presence of a pathogen).
- The intended use and device description clearly state its function is to visualize the treatment beam relative to surface anatomical landmarks. This is a function related to the delivery of therapy, not the diagnosis or monitoring of a disease state through analysis of bodily specimens.
The BeamSite™ System is a medical device used in the context of radiotherapy treatment delivery and visualization.
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
IYE
Device Description
BeamSite™ is a camera system that enables live 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. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, 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 size and shape of the beam on the patient during treatment. The images produced will provide real-time, direct visual indication:
- that the beam is on;
- that the beam is impacting the patient at the intended treatment surface;
- of visible patient's movement relative to the beam; and
- that surfaces of the body, that are not intended for treatment, remain outside the beam path.
In addition, in the modified device, the background images of the treatment area are now continuously displayed before and after treatment, providing an "always on" imaging experience preferred by the therapists. However, like with the original device, only the images acquired during the actual beam irradiation are stored for offline review.
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
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
Cherenkov light, Ambient light
Anatomical Site
anywhere in the body where radiation treatment is indicated.
Indicated Patient Age Range
Any individual (Adult of 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)
The following performance testing was repeated on the proposed device 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
Based on performance testing of modified BeamSite and the evaluation of predicate characteristics, we claim that the modified BeamSite System (V 1.5) to be substantially equivalent to existing legally marketed device, BeamSite (K#200940), and that the differences in technological characteristics do not raise different questions of safety and efficacy.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DoseOptics LLC % Farzeen Christie Consultant 16 Cavendish Ct. LEBANON NH 03766
Re: K212606
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: August 16, 2021 Received: August 17, 2021
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/cfpmn/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,
Julie Sullivan -S
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) K212606
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 apptal 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) |
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DoseOptics LLC BeamSite™ System, V 1.5 Special 510(k)
5. 510(k) SUMMARY
5.1. SUBMITTER
DoseOptics LLC 16 Cavendish Court Lebanon. NH 03766 Phone: (603) 643-5177
| Contact Person: | Farzeen Christie |
|---|---|
| Email: | farzeen@doseoptics.com |
| Date Prepared: | August 16 2021 |
5.2. SUBJECT DEVICE
Device Trade Name: Device Common Name: Classification Name:
Requlatory Class: Product Code: Panel:
BeamSite™ System Radiotherapy Visualization System Medical Charged Particle Radiation Therapy System (21 CFR 892.5050) = IYE Radiology
5.3. PREDICATE DEVICE
BeamSite System, K200940 manufactured by DoseOptics LLC.
5.4. DEVICE DESCRIPTION
BeamSite™ is a camera system that enables live 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. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient's skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, 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 size and shape of the beam on the patient during treatment. The images produced will provide real-time, direct visual indication:
- that the beam is on; ●
- . that the beam is impacting the patient at the intended treatment surface;
- of visible patient's movement relative to the beam; and ●
- that surfaces of the body, that are not intended for treatment, ● remain outside the beam path.
In addition, in the modified device, the background images of the treatment area are now continuously displayed before and after treatment, providing an "always on" imaging experience preferred by the therapists. However, like with the original device, only the images acquired during the actual beam irradiation are stored for offline review.
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 in appropriate hospital and freestanding radiation therapy environments.
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COMPARISON TO PREDICATE DEVICE 5.6.
| Characteristic | Predicate Device:
DoseOptics
BeamSite System
(K200940) | Subject Device:
DoseOptics
BeamSite System, V 1.5 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications for Use | The BeamSiteTM 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. | Same |
| Type of Use | Prescription Use | Same |
| Device Role and System Output | Serves as an accessory to
LINAC | Same |
| Target Population | Any individual (Adult of 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
radiation beam can be
imaged | Same |
| Viewing Method | Display of image is on a
computer monitor using | Same |
| Characteristic | Predicate Device:
DoseOptics
BeamSite System
(K200940) | Subject Device:
DoseOptics
BeamSite System, V 1.5 |
| Supporting
System
Components | custom software application
installed on a Windows PC
PC Workstation and Cables
between treatment room and
therapist control area | Same |
| Field Size of
Image | 40cm X 40cm | Same |
| 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 |
| Types of
Images
Acquired | Images of the treatment beam
field size and shape
impinging on the patient
anatomy. | Images of the treatment
beam field size and
shape impinging on the
patient anatomy during
treatment.
Additional Feature: video
feed of the treatment
area before and after
treatment. |
| Beam Image
Detection | X-rays interact with tissue on
and near the surface of the
patient's anatomy and
produce visible light by the
Cherenkov emission process.
The light is imaged by an
intensified camera system
with a Complementary Metal
Oxide Semiconductor
(CMOS) sensor. | Same |
| Patient Surface
Anatomy
Imaging | Patient surface anatomy is
visualized between treatment
beam pulses utilizing ambient
light. | Same |
| Characteristic | Predicate Device:
DoseOptics
BeamSite System
(K200940) | Subject Device:
DoseOptics
BeamSite System, V 1.5 |
| Image
Processing | 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. | Same |
| Imaging Modes | User Interface (UI) displays
"waiting for beam" message
until the treatment beam
comes online and transitions
to displaying and recording
images of the treatment beam
intersecting the patient
anatomy when the treatment
beam comes on. | UI displays ambient light
images of the treatment
area continuously.
UI displays and records
images of the treatment
beam intersecting the
patient anatomy when the
treatment beam comes
on. |
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Page 5-5
The Predicate Device for the BeamSite System V 1.5 is the previously cleared BeamSite (K200940), manufactured by DoseOptics LLC. The indications for use for the proposed device is identical to the indications for use of the cleared device.
the proposed device differs in few technological However. characteristics from the cleared device. The proposed device has an additional feature of continuously displaying ambient light background images of the treatment area to the user even when the beam is not on, further referred to as "always on" mode. This way, a continuous video feedback is provided to the user. This live video is not recorded. The feature of displaying Cherenkov images, recording and providing playback options is identical to the predicate device. There is no change to the main objective / intended use of the device.
In addition to the technological characteristic change of having the always on capability, a few device components have been changed in the proposed device. These changes and technological differences do not raise new or different concerns of safety and effectiveness. The performance testing conducted on the predicate device were repeated
8
on the proposed modified device to show that the differences did not affect the performance and specifications of the proposed device.
5.7. PERFORMANCE TESTING SUMMARY (NON-CLINICAL)
The following performance testing was repeated on the proposed device 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: o 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 modified BeamSite and the evaluation of predicate characteristics, we claim that the modified BeamSite System (V 1.5) to be substantially equivalent to existing legally marketed device, BeamSite (K#200940), and that the differences in technological characteristics do not raise different questions of safety and efficacy.