(159 days)
No
The summary describes software for designing 3D-printable boluses based on TPS data, but there is no mention of AI or ML algorithms being used in the design process. The software generates files for user review and printing, which is a deterministic process based on the TPS input.
No
Explanation: The device is software that designs patient-specific objects for radiation therapy, but it is not directly involved in the delivery of therapy. It's an accessory to a radiation therapy treatment planning system, not a therapeutic device itself.
No
The device is described as software used to design patient-specific 3D-printable objects (boluses or molds) for radiation therapy, to address issues like uneven surface areas or to modulate electron beams. It is an accessory to a radiation therapy treatment planning system, but its function is to create physical objects for treatment delivery, not to diagnose medical conditions or interpret physiological data for diagnostic purposes.
Yes
The device description explicitly states that the "3D Bolus Software is a device consisting of software" and its output is a "software file" (STL file) for use with a third-party 3D printer. It does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The 3D Bolus Software is used to design patient-specific 3D-printable objects (boluses and molds) for use during radiation therapy. These objects are applied externally to the patient's body to modify the radiation dose distribution.
- Lack of Specimen Analysis: The software does not analyze any biological specimens from the patient. Its input is related to the patient's anatomy and treatment plan, not biological samples.
- Intended Use: The intended use is as an accessory to a radiation therapy treatment planning system to create physical objects for treatment delivery, not for diagnostic purposes based on specimen analysis.
Therefore, the 3D Bolus Software falls under the category of a medical device used in radiation therapy, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MUJ
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 proven2 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation oncology clinical setting
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)
Non-clinical Testing: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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
1
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
2
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) | |
|---|---|
| ☑ 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 405
Halifax NS B3H 0A8
Canada |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter Hickey, CEO
Phone: (902)-442-9091
Email: peter.hickey@3DBolus.com |
| Date Summary was
prepared: | January 17, 2017 |
| Name of the Device:
Trade/Proprietary Name:
Common or Usual Name:
Classification Name:
Regulation:
Class:
Product Code: | 3D Bolus Software
Radiation therapy Treatment Planning System
System, Planning, Radiation Therapy Treatment
21 CFR 892.5050
Class II
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) | ||
| K151369 | 3D Bolus Software (v1.2.2) | |
| Intended Use | The intended use of the p.d | |
| software is to aid radiation | ||
| therapy professionals in the | ||
| design, construction, and | ||
| testing of radiotherapy beam | ||
| modifying devices. The | ||
| software is intended to | ||
| interface with most major | ||
| treatment planning systems | 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 | ||
| and design devices that are | ||
| compatible with most major | ||
| radiotherapy linear | ||
| accelerators and particle | ||
| therapy delivery systems. And | ||
| while the primary intent is for | ||
| the software to design and | ||
| measure devices that are | ||
| manufactured by .decimal, | ||
| this does not exclude, in some | ||
| cases, the software being used | ||
| with devices that are | ||
| constructed on-site or by | ||
| other vendors (with explicit | ||
| permission from .decimal). | therapy, or brachytherapy. | |
| Indications for Use | The p.d software is used by | |
| radiation therapy | ||
| professionals to assist in the | ||
| design, manufacturing, and | ||
| quality assurance testing of | ||
| various radiation therapy | ||
| devices used for cancer | ||
| patients. The p.d software | ||
| performs three distinct, | ||
| primary functions which each | ||
| are described below. |
- The p.d software takes a
design of a compensating
filter from a Treatment
Planning System and
converts the Treatment
Planning System
compensator filter files into
a .decimal file format. This
file can then be
electronically submitted to
.decimal through the | 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. |
| | | |
| | software, so that we can
manufacture the device. | |
| | 2) The p.d software can
design a beam shaping and
compensating filters based
on Treatment Planning
System and other user
supplied data. The device
designs for compensating
filters will be transferred
back into the Treatment
Planning System for final
dose verification before
devices are ordered and
used for patient treatment. | |
| | 3) The p.d software can
perform quality assurance
testing of the physical
characteristics of treatment
devices using data from
various types of scanned
images, including
computed tomography
images. | |
| Target Population | Cancer patients requiring
external beam radiotherapy | Any patient prescribed
radiation therapy requiring
an applicable accessory
device. |
| Anatomical Site(s) | Various | Various |
| Use Environment | Radiation oncology clinical
setting | Radiation oncology clinical
setting |
| Product Material | Deep Blue Wax | Printed using Polylactic Acid
(PLA) and Thermoplastic
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
bolus |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photon Product | Milled uniform thickness bolus | 3D printed uniform thickness
bolus |
| Brachytherapy
Product | None | 3D printed brachytherapy
mold with source trajectory
tubes. |
| Patient Product Plan | From treatment planning
system. p.d software modifies
plan for milling at .decimal.
Finished product is shipped to
the treatment facility. | From treatment planning
system. 3D Bolus software
modifies plan for 3D printing
within the treatment facility. |
| Communication with
Treatment Planning
System | DICOM file format, but other
vendor specific or generic file
formats are also utilized. | DICOM RT |
| Quality Assurance | Product designed by p.d
software is checked for
accuracy on the treatment
planning system before being
sent for milling at .decimal. | Product designed by 3D bolus
software is checked for
accuracy on the treatment
planning system before
printing by in-house 3D
printer. |
| Biocompatibility | "Negligible irritation to skin at
ambient temperatures."
(From .decimal Deep Blue
Wax MSDS) | It is recommended to place
food-safe plastic wrap
between the patient's skin
and the accessory for
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 | ||
| PLANNING | Yes | Yes, for photon beam bolus |
| ELECTRON BEAM | ||
| PLANNING | Yes | |
| COMPENSATOR | ||
| PLANNING | Yes | |
| PLAN FOR HIGH DOSE | ||
| RATE AFTERLOADER | Yes | |
| MANUAL LOW DOSE | ||
| RATE | Yes | |
| BRACHYTHERAPY: | ||
| SEEDS, LINE | ||
| SOURCES, WIRE | ||
| DICOM RT | ||
| 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.