3D Bolus Software

K180289 · 3D Bolus, Inc. · MUJ · Jul 10, 2018 · Radiology

Device Facts

• Record ID: K180289
• Device Name: 3D Bolus Software
• Applicant: 3D Bolus, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jul 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

Device Story

Software accessory for radiation therapy treatment planning systems (TPS); inputs patient-specific data from TPS; transforms data into 3D-printable designs for bolus or brachytherapy molds; outputs Stereolithography (STL) files; used in radiation oncology clinical settings by radiation therapy professionals; enables in-house 3D printing of patient-specific accessories; improves bolus fit and reduces patient setup time; allows modulation of electron beam radiation for conformal dose delivery; enhances clinical workflow by enabling on-site fabrication.

Clinical Evidence

Bench testing only. Verification and validation performed for all features; system requirements traced to test outcomes. No clinical data presented.

Technological Characteristics

Software-based design tool for 3D-printable radiotherapy accessories. Materials: Polylactic Acid (PLA) and Thermoplastic Polyurethane (TPU) filaments. Connectivity: DICOM RT interface with TPS. Deployment: In-house 3D printing. Software: Version 1.2.2.

Indications for Use

Indicated for any patient prescribed radiation therapy requiring an accessory device for external beam photon or electron radiation therapy or brachytherapy.

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

• .decimal “p.d software (version 5.1)” (K151369)

Reference Devices

• Varian Medical Systems, Inc. “Eclipse Treatment Planning System” (K172163)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2018

3D Bolus, Inc. % Peter Hickey CEO 1344 Summer St Suite 3015 HALIFAX B3H0A8 CANADA

Re: K180289

Trade/Device Name: 3D Bolus Software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 26, 2018 Received: February 1, 2018

Dear Mr. Hickey:

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180289

Device Name 3D Bolus Software

Indications for Use (Describe)

3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for 3D Bolus. The logo has the text "3D Bolus" in grey and pink. The "O" in Bolus is a pink sphere with a silver dome on top. To the right of the logo is a box with the word "Title:" in it.

### 510(k) Summary

The following information is provided following the format of 21 CFR 807.92.

| Submitter: | 3D Bolus, Inc.<br>1344 Summer St, Suite 405<br>Halifax NS B3H 0A8<br>Canada |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter Hickey, CEO<br>Phone: [phone]<br>Email: [e-mail] |
| Date Summary was<br>prepared: | January 17, 2017 |
| Name of the Device:<br>Trade/Proprietary Name:<br>Common or Usual Name:<br>Classification Name:<br>Regulation:<br>Class:<br>Product Code: | 3D Bolus Software<br>Radiation therapy Treatment Planning System<br>System, Planning, Radiation Therapy Treatment<br>21 CFR 892.5050<br>Class II<br>MUJ |
| Predicate Device: | .decimal “p.d software (version 5.1)”, K151369 |
| Reference Device: | Varian Medical Systems, Inc. “Eclipse Treatment Planning System”, K172163 |

### Description of Device:

The 3D Bolus Software is a device consisting of software that is used in conjunction with a radiation therapy treatment planning system (TPS) to produce a software file that can be used with a 3D printer to produce a customized, patient-specific bolus for electron or photon external beam radiation therapy or a customized, patient-specific surface brachytherapy mold. A radiation therapy bolus is used when treating uneven surface areas of a patient, such as at the nose or ears, to make up for missing tissue, or to provide build-up of dose to the skin surface. The use of a 3D printed bolus in postmastectomy radiation therapy has been proven2 to not only improve fit of the bolus, but also

¹ According to an Intra-patient study comparing 3D printed bolus versus standard vinyl gel sheet bolus for postmastectomy chest wall radiation therapy (James L. Robar, et. al. - December 24, 2017) https://www.sciencedirect.com/science/article/pii/S1879850017303843

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Image /page/4/Picture/10 description: The image shows the logo for 3D Bolus. The logo has the text "3D BOLUS" in a stylized font. The "3D" is in pink, and the "BOLUS" is in gray. There is a pink sphere with a silver helmet on top of it between the "D" and the "B" in the logo. There is a box with the word "Title:" in it to the right of the logo.

reduces patient setup time by approximately 30% compared with standard vinyl gel sheet bolus, according to an intra-patient study comparing both methods. Additionally, the 3D Bolus Software designed bolus can modulate electron beam radiation therapy to produce a conformal high dose region around the tumor.

Files for three types of structures can be generated by the 3D Bolus Software and checked by the user on their TPS for correctness. When accepted by the user, the 3D Bolus Software will create a Stereolithography (STL) file for the user to print on a thirdparty 3D printer located within the facility.

Statement of Intended Use: 3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patientspecific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

Statement of Indications For Use: 3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

# Summary of the Technological Characteristics:

3D Bolus Software has a similar Intended Use and Indications For Use as the predicate device. A comparison of the major technological characteristics is provided in the following Comparison Table.

| | PREDICATE COMPARISON TABLE | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATTRIBUTE | PREDICATE | DEVICE |
| | .decimal p.d software (v5.1)<br>K151369 | 3D Bolus Software (v1.2.2) |
| Intended Use | The intended use of the p.d<br>software is to aid radiation<br>therapy professionals in the<br>design, construction, and<br>testing of radiotherapy beam<br>modifying devices. The<br>software is intended to<br>interface with most major<br>treatment planning systems | 3D Bolus Software is<br>indicated for, and intended<br>for use as, an accessory to a<br>radiation therapy treatment<br>planning system (TPS) to<br>design patient-specific 3D-<br>printable objects intended for<br>use during external beam<br>photon or electron radiation |
| | | |
| | and design devices that are<br>compatible with most major<br>radiotherapy linear<br>accelerators and particle<br>therapy delivery systems. And<br>while the primary intent is for<br>the software to design and<br>measure devices that are<br>manufactured by .decimal,<br>this does not exclude, in some<br>cases, the software being used<br>with devices that are<br>constructed on-site or by<br>other vendors (with explicit<br>permission from .decimal). | therapy, or brachytherapy. |
| Indications for Use | The p.d software is used by<br>radiation therapy<br>professionals to assist in the<br>design, manufacturing, and<br>quality assurance testing of<br>various radiation therapy<br>devices used for cancer<br>patients. The p.d software<br>performs three distinct,<br>primary functions which each<br>are described below.<br><br>1) The p.d software takes a<br>design of a compensating<br>filter from a Treatment<br>Planning System and<br>converts the Treatment<br>Planning System<br>compensator filter files into<br>a .decimal file format. This<br>file can then be<br>electronically submitted to<br>.decimal through the | 3D Bolus Software is<br>indicated for, and intended<br>for use as, an accessory to a<br>radiation therapy treatment<br>planning system (TPS) to<br>design patient-specific 3D-<br>printable objects intended for<br>use during external beam<br>photon or electron radiation<br>therapy, or brachytherapy. |
| | | |
| | software, so that we can<br>manufacture the device. | |
| | 2) The p.d software can<br>design a beam shaping and<br>compensating filters based<br>on Treatment Planning<br>System and other user<br>supplied data. The device<br>designs for compensating<br>filters will be transferred<br>back into the Treatment<br>Planning System for final<br>dose verification before<br>devices are ordered and<br>used for patient treatment. | |
| | 3) The p.d software can<br>perform quality assurance<br>testing of the physical<br>characteristics of treatment<br>devices using data from<br>various types of scanned<br>images, including<br>computed tomography<br>images. | |
| Target Population | Cancer patients requiring<br>external beam radiotherapy | Any patient prescribed<br>radiation therapy requiring<br>an applicable accessory<br>device. |
| Anatomical Site(s) | Various | Various |
| Use Environment | Radiation oncology clinical<br>setting | Radiation oncology clinical<br>setting |
| Product Material | Deep Blue Wax | Printed using Polylactic Acid<br>(PLA) and Thermoplastic<br>Polyurethane (TPU) filaments |

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Image /page/5/Picture/0 description: The image shows the logo for 3D Bolus. The logo is in gray and pink, with the words "3D BOLUS" in a bold, sans-serif font. The "O" in "BOLUS" is replaced by a pink sphere with a silver hemisphere on top. To the right of the logo is the word "Title:" in black text.

510k Summary

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Image /page/6/Picture/0 description: The image shows the logo for 3D Bolus. The logo is in gray and pink. The word "Title:" is on the right side of the image.

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| Title: |
|--------|
| |

510k Summary

| Electron Product | Milled variable thickness bolus | 3D printed variable thickness<br>bolus |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photon Product | Milled uniform thickness bolus | 3D printed uniform thickness<br>bolus |
| Brachytherapy<br>Product | None | 3D printed brachytherapy<br>mold with source trajectory<br>tubes. |
| Patient Product Plan | From treatment planning<br>system. p.d software modifies<br>plan for milling at .decimal.<br>Finished product is shipped to<br>the treatment facility. | From treatment planning<br>system. 3D Bolus software<br>modifies plan for 3D printing<br>within the treatment facility. |
| Communication with<br>Treatment Planning<br>System | DICOM file format, but other<br>vendor specific or generic file<br>formats are also utilized. | DICOM RT |
| Quality Assurance | Product designed by p.d<br>software is checked for<br>accuracy on the treatment<br>planning system before being<br>sent for milling at .decimal. | Product designed by 3D bolus<br>software is checked for<br>accuracy on the treatment<br>planning system before<br>printing by in-house 3D<br>printer. |
| Biocompatibility | "Negligible irritation to skin at<br>ambient temperatures."<br>(From .decimal Deep Blue<br>Wax MSDS) | It is recommended to place<br>food-safe plastic wrap<br>between the patient's skin<br>and the accessory for<br>cleanliness. |

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Image /page/8/Picture/0 description: The image shows the logo for 3D Bolus. The logo is in gray and pink. The "O" in Bolus is a pink sphere with a silver dome on top.

| REFERENCE DEVICE COMPARISON | | |
|-----------------------------|------------------------------------------------|----------------------------|
| ATTRIBUTE | REFERENCE DEVICE | DEVICE |
| | Eclipse Treatment Planning | 3D Bolus Software (v1.2.2) |
| | System | |
| | K172163 | |
| PHOTON BEAM<br>PLANNING | Yes | Yes, for photon beam bolus |
| | ELECTRON BEAM<br>PLANNING | Yes |
| COMPENSATOR<br>PLANNING | | Yes |
| | PLAN FOR HIGH DOSE<br>RATE AFTERLOADER | Yes |
| MANUAL LOW DOSE<br>RATE | | Yes |
| | BRACHYTHERAPY:<br>SEEDS, LINE<br>SOURCES, WIRE | |
| DICOM RT<br>COMMUNICATION | Yes | Yes |

### Non-clinical Testing

Verification and Validation were performed for all features. System requirements can be traced to the test outcomes.

## Conclusion of Non-Clinical testing

The outcome was that the product conformed to requirements, the defined user needs and intended uses and that there were no remaining software anomalies which affect safety or effectiveness.

## Argument for Substantial Equivalence to the Predicate Device

A subset of features of the subject device are different from the predicate. These differences do not adversely impact performance of the device for its intended use nor do the differences raise new safety concerns. The nonclinical testing performed includes essential performance testing, functional performance characteristics testing and software verification and validation testing. All tests confirmed that the 3D Bolus System performs as intended and is substantially equivalent to the predicate.