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 Description

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 proven to not only improve fit of the bolus, but also 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.

AI/ML Overview

The provided text is a 510(k) summary for the "3D Bolus Software". It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone algorithm performance metrics).

The document states:

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

This language indicates that testing was conducted to ensure the software functions as designed and meets its requirements. However, it lacks the quantifiable details necessary to fill out the requested table and answer the specific study-related questions.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The document confirms that testing occurred and was successful in demonstrating substantial equivalence, but it does not disclose the specific criteria or methods used.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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.1344 Summer St, Suite 405Halifax NS B3H 0A8Canada
	Contact Name: Peter Hickey, CEOPhone: (902)-442-9091Email: peter.hickey@3DBolus.com
Date Summary wasprepared:	January 17, 2017
Name of the Device:Trade/Proprietary Name:Common or Usual Name:Classification Name:Regulation:Class:Product Code:	3D Bolus SoftwareRadiation therapy Treatment Planning SystemSystem, Planning, Radiation Therapy Treatment21 CFR 892.5050Class IIMUJ
Predicate Device:	.decimal “p.d software (version 5.1)”, K151369
Reference Device:	Varian Medical Systems, Inc. “Eclipse Treatment Planning System”, K172163

Description of Device:

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.

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)K151369	3D Bolus Software (v1.2.2)
Intended Use	The intended use of the p.dsoftware is to aid radiationtherapy professionals in thedesign, construction, andtesting of radiotherapy beammodifying devices. Thesoftware is intended tointerface with most majortreatment planning systems	3D Bolus Software isindicated for, and intendedfor use as, an accessory to aradiation therapy treatmentplanning system (TPS) todesign patient-specific 3D-printable objects intended foruse during external beamphoton or electron radiation

	and design devices that arecompatible with most majorradiotherapy linearaccelerators and particletherapy delivery systems. Andwhile the primary intent is forthe software to design andmeasure devices that aremanufactured by .decimal,this does not exclude, in somecases, the software being usedwith devices that areconstructed on-site or byother vendors (with explicitpermission from .decimal).	therapy, or brachytherapy.
Indications for Use	The p.d software is used byradiation therapyprofessionals to assist in thedesign, manufacturing, andquality assurance testing ofvarious radiation therapydevices used for cancerpatients. The p.d softwareperforms three distinct,primary functions which eachare described below.1) The p.d software takes adesign of a compensatingfilter from a TreatmentPlanning System andconverts the TreatmentPlanning Systemcompensator filter files intoa .decimal file format. Thisfile can then beelectronically submitted to.decimal through the	3D Bolus Software isindicated for, and intendedfor use as, an accessory to aradiation therapy treatmentplanning system (TPS) todesign patient-specific 3D-printable objects intended foruse during external beamphoton or electron radiationtherapy, or brachytherapy.

	software, so that we canmanufacture the device.
	2) The p.d software candesign a beam shaping andcompensating filters basedon Treatment PlanningSystem and other usersupplied data. The devicedesigns for compensatingfilters will be transferredback into the TreatmentPlanning System for finaldose verification beforedevices are ordered andused for patient treatment.
	3) The p.d software canperform quality assurancetesting of the physicalcharacteristics of treatmentdevices using data fromvarious types of scannedimages, includingcomputed tomographyimages.
Target Population	Cancer patients requiringexternal beam radiotherapy	Any patient prescribedradiation therapy requiringan applicable accessorydevice.
Anatomical Site(s)	Various	Various
Use Environment	Radiation oncology clinicalsetting	Radiation oncology clinicalsetting
Product Material	Deep Blue Wax	Printed using Polylactic Acid(PLA) and ThermoplasticPolyurethane (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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Title:

510k Summary

Electron Product	Milled variable thickness bolus	3D printed variable thicknessbolus
Photon Product	Milled uniform thickness bolus	3D printed uniform thicknessbolus
BrachytherapyProduct	None	3D printed brachytherapymold with source trajectorytubes.
Patient Product Plan	From treatment planningsystem. p.d software modifiesplan for milling at .decimal.Finished product is shipped tothe treatment facility.	From treatment planningsystem. 3D Bolus softwaremodifies plan for 3D printingwithin the treatment facility.
Communication withTreatment PlanningSystem	DICOM file format, but othervendor specific or generic fileformats are also utilized.	DICOM RT
Quality Assurance	Product designed by p.dsoftware is checked foraccuracy on the treatmentplanning system before beingsent for milling at .decimal.	Product designed by 3D bolussoftware is checked foraccuracy on the treatmentplanning system beforeprinting by in-house 3Dprinter.
Biocompatibility	"Negligible irritation to skin atambient temperatures."(From .decimal Deep BlueWax MSDS)	It is recommended to placefood-safe plastic wrapbetween the patient's skinand the accessory forcleanliness.

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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 BEAMPLANNING	Yes	Yes, for photon beam bolus
	ELECTRON BEAMPLANNING	Yes
COMPENSATORPLANNING		Yes
	PLAN FOR HIGH DOSERATE AFTERLOADER	Yes
MANUAL LOW DOSERATE		Yes
	BRACHYTHERAPY:SEEDS, LINESOURCES, WIRE
DICOM RTCOMMUNICATION	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.

Regulation Number and Section

§ 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.