BeamSite

K212606 · Doseoptics, LLC · IYE · Sep 15, 2021 · Radiology

Device Facts

• Record ID: K212606
• Device Name: BeamSite
• Applicant: Doseoptics, LLC
• Product Code: IYE · Radiology
• Decision Date: Sep 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

BeamSite™ is a non-contact, camera-based radiotherapy visualization system. It captures Cherenkov light emitted from patient skin during radiation treatment to map the beam shape and position. The system consists of a fixed-mounted camera, a workstation, and a monitor. It operates in two modes: 'always on' ambient light imaging (before/after beam) and Cherenkov imaging (during beam). Radiotherapy professionals use the system in hospital or freestanding clinics to monitor beam alignment, patient movement, and ensure non-target anatomy remains outside the beam path. Output is displayed in real-time on a workstation monitor; images acquired during irradiation are stored for offline review. The device provides visual confirmation of beam delivery and patient positioning, aiding clinical teams in monitoring treatment; it is not intended for making independent therapeutic decisions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verification included functional testing, accelerated aging, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification/validation (IEC 62304), and usability testing (IEC 60601-1-6, IEC 62366-1).

Technological Characteristics

Camera system with CMOS sensor; intensified camera for Cherenkov light detection. Fixed-mount form factor. Connectivity via cables between treatment room and therapist control area. Software-based image processing and display. Electrical safety per IEC 60601-1:2005/(R)2012 and A1:2012; EMC per IEC 60601-1-2:2014. Non-patient contacting.

Indications for Use

Indicated for patients of any age (adult or child) undergoing photon external beam radiotherapy, for visualization of the treatment beam relative to surface anatomical landmarks.

Regulatory Classification

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.

Predicate Devices

• BeamSite System (K200940)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]

| Contact Person: | Farzeen Christie |
|-----------------|------------------------|
| Email: | [e-mail] |
| 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.

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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:<br>DoseOptics<br>BeamSite System<br>(K200940) | Subject Device:<br>DoseOptics<br>BeamSite System, V 1.5 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications for Use | The BeamSiteTM System is intended to be used only with<br>photon external beam<br>radiotherapy during treatment<br>to acquire and visualize the<br>shape of the treatment<br>radiation beam relative to<br>surface anatomical landmarks<br>on the patient, anywhere in<br>the body where radiation<br>treatment is indicated.<br>BeamSite is used by<br>radiotherapy professionals in<br>appropriate hospital and<br>freestanding radiation therapy<br>environments. | Same |
| Type of Use | Prescription Use | Same |
| Device Role and System Output | Serves as an accessory to<br>LINAC | Same |
| Target Population | Any individual (Adult of Child<br>undergoing radiotherapy) | Same |
| Energy Delivered to the Patient | No energy delivered to the<br>patient by the device | Same |
| Use Environment | Radiation image detection<br>subsystem is inside the<br>treatment room and the PC<br>Workstation to view the<br>images is outside the<br>treatment room in therapist<br>control area | Same |
| Beam Energies Used | All therapeutic X-Ray<br>energies from the linac<br>radiation beam can be<br>imaged | Same |
| Viewing Method | Display of image is on a<br>computer monitor using | Same |
| Characteristic | Predicate Device:<br>DoseOptics<br>BeamSite System<br>(K200940) | Subject Device:<br>DoseOptics<br>BeamSite System, V 1.5 |
| Supporting<br>System<br>Components | custom software application<br>installed on a Windows PC<br>PC Workstation and Cables<br>between treatment room and<br>therapist control area | Same |
| Field Size of<br>Image | 40cm X 40cm | Same |
| Software<br>Features | Image Acquisition, Review,<br>and Storage are possible by<br>the computer and software. | Same |
| Biocompatibility | No contact with patient or<br>clinical staff in the treatment<br>room. | Same |
| Image Source | X-ray treatment beam | Same |
| Types of<br>Images<br>Acquired | Images of the treatment beam<br>field size and shape<br>impinging on the patient<br>anatomy. | Images of the treatment<br>beam field size and<br>shape impinging on the<br>patient anatomy during<br>treatment.<br>Additional Feature: video<br>feed of the treatment<br>area before and after<br>treatment. |
| Beam Image<br>Detection | X-rays interact with tissue on<br>and near the surface of the<br>patient's anatomy and<br>produce visible light by the<br>Cherenkov emission process.<br>The light is imaged by an<br>intensified camera system<br>with a Complementary Metal<br>Oxide Semiconductor<br>(CMOS) sensor. | Same |
| Patient Surface<br>Anatomy<br>Imaging | Patient surface anatomy is<br>visualized between treatment<br>beam pulses utilizing ambient<br>light. | Same |
| Characteristic | Predicate Device:<br>DoseOptics<br>BeamSite System<br>(K200940) | Subject Device:<br>DoseOptics<br>BeamSite System, V 1.5 |
| Image<br>Processing | Image acquisition electronics<br>performs imaging in-sync and<br>out-of-sync with the treatment<br>beam pulses. Software<br>performs image processing<br>and displays images on the<br>monitor. | Same |
| Imaging Modes | User Interface (UI) displays<br>"waiting for beam" message<br>until the treatment beam<br>comes online and transitions<br>to displaying and recording<br>images of the treatment beam<br>intersecting the patient<br>anatomy when the treatment<br>beam comes on. | UI displays ambient light<br>images of the treatment<br>area continuously.<br>UI displays and records<br>images of the treatment<br>beam intersecting the<br>patient anatomy when the<br>treatment beam comes<br>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

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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.