(64 days)
No
The summary describes a physical bolus designed using standard clinical treatment planning software and additive manufacturing, with no mention of AI or ML in the design or function.
No
The device is described as a radiotherapy accessory intended to help control the radiation dose and modify the shape of a beam from a radiation therapy source, which are supportive functions for a therapeutic treatment rather than being therapeutic itself.
No
The device is a radiotherapy accessory used to modify the radiation dose received by a patient during treatment, not to diagnose a condition.
No
The device description explicitly states the bolus is "produced using additive manufacturing in a soft elastomeric material," indicating it is a physical object, not software only.
Based on the provided information, the VHA Radiotherapy Bolus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The VHA Radiotherapy Bolus is a physical accessory placed on the patient's skin during radiotherapy treatment. It does not analyze or test any biological samples.
- The intended use is to modify the radiation dose delivered to the patient. This is a therapeutic application, not a diagnostic one.
- The device description focuses on its physical properties and how it interacts with the radiation beam. There is no mention of analyzing biological markers or providing diagnostic information.
The VHA Radiotherapy Bolus is clearly described as a radiotherapy accessory used in external beam radiation therapy, which is a treatment modality.
N/A
Intended Use / Indications for Use
The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment.
VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.
Product codes (comma separated list FDA assigned to the subject device)
IXI
Device Description
Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivered, thereby overcoming the skin-sparing effect. Using clinical treatment planning software (TPS) and clinical expertise, a radiotherapy clinician designs the bolus to conform with the patient anatomy. The bolus is produced using additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and acceptance to the clinical treatment plan prior to initiating treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM
Anatomical Site
Various
Indicated Patient Age Range
patients of all ages
Intended User / Care Setting
Radiotherapy Clinic
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)
Performance Testing: Simulated use testing was completed for clinically relevant cases using both electron and photon radiation therapy. All acceptance criteria for performance testing were met.
Biocompatibility Testing: The VHA Radiotherapy Bolus has identical indications for use, identical material and manufacturing method, and an identical worst-case configuration and post processing conditions to the predicate device. Therefore, the subject device leveraged data on hand. All acceptance criteria for biocompatibility were met and the testing adequately addresses biocompatibility for the output devices and their intended use. Biocompatibility testing was in compliance to ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.
0
November 4, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
VHA Dean % Laura Gilmour Principal Consultant LG Strategies, LLC 3903 S. Congress Ave #3930 AUSTIN TX 78704
Re: K222639
Trade/Device Name: VHA Radiotherapy Bolus Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: Class II Product Code: IXI Dated: August 31, 2022 Received: September 1, 2022
Dear Laura Gilmour:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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.
Lora D.
Weidner -S
Digitally signed by
Lora D. Weidner -S
Date: 2022.11.04
15:35:42 -04'00'
for Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222639
Device Name VHA Radiotherapy Bolus
Indications for Use (Describe)
The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment.
VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510(k) Summary
5.1 Applicant/Submitter
| Company Name | VHA DEAN |
|---|---|
| Company Street Address | 810 Vermont Avenue, NW |
| City | Washington |
| State | DC |
| Country | United States |
| Zip Code | 20420 |
| 5.2 Contact Person | |
| Full Name | Beth Ripley, MD, PhD |
| Job Title | Deputy Chief |
| beth.ripley@va.gov | |
| 5.3 Correspondent Information | |
| Full Name | Laura Gilmour |
| Job Title | Principal Consultant, Advanced Manufacturing |
| and Regulatory Strategy | |
| Phone | 901-258-3629 |
| laura.gilmour@va.gov | |
| 5.4 Date of Preparation | |
| Date of Preparation | October 25, 2022 |
5.5 Device Information
Table 5.1 Device Information
| Trade Name | VHA Radiotherapy Bolus |
|---|---|
| Common or Usual Name | Patient specific radiotherapy bolus |
| Classification Name | Radiation therapy beam-shaping block |
| Classification Regulation | 892.5710 |
| Regulatory Class | Class II |
| Product Code | IXI |
K222639
4
5.6 Predicate Device(s)
Table 5.2 Predicate Device(s)
| Predicate Type | 510(k) Number | Device Name | Manufacturer |
|---|---|---|---|
| Primary Device | K214093 | VSP Bolus | 3D Systems |
| Reference Device | K091911 | Bolus Compensator | .decimal |
The predicate devices have not been subject to a design-related recall.
5.7 Device Description
Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivered, thereby overcoming the skin-sparing effect. Using clinical treatment planning software (TPS) and clinical expertise, a radiotherapy clinician designs the bolus to conform with the patient anatomy. The bolus is produced using additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and acceptance to the clinical treatment plan prior to initiating treatment.
5.8 Intended Use/Indications for Use
The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment.
VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.
5.9 Comparison of Technological Characteristics with Predicate
VHA DEAN believes that the VHA Radiotherapy Bolus is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has the same intended use and technological characteristics to the device cleared in K214093. Technological characteristics include identical manufacturing method, material, patient population and use environment as K214093. The reference device (K091911) and the subject device have the same input parameters. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate (K214093).
A comparison of the technical characteristics between VHA Radiotherapy Bolus and the predicate device is provided in the following Comparison Table:
5
| Specification/
| Characteristic | Subject Device | Primary Predicate Device |
|---|---|---|
| VHA Radiotherapy Bolus | ||
| VHA DEAN | ||
| K222639 | VSP® Bolus | |
| 3D Systems, Inc. | ||
| K214093 | ||
| Indications for Use | The VHA Radiotherapy Bolus product is a | |
| device that will be placed on the skin of a patient | ||
| as a radiotherapy accessory intended to help | ||
| control the radiation dose received by the | ||
| patient. VHA Radiotherapy Boluses are designed | ||
| by radiation therapy professionals for a unique | ||
| patient and are intended to modify the shape of a | ||
| beam from a radiation therapy source. The VHA | ||
| Radiotherapy Bolus product must be verified and | ||
| approved by the radiation therapy professional | ||
| prior to use on a patient. The VHA Radiotherapy | ||
| Bolus is intended for patients of all ages | ||
| receiving radiotherapy treatment. |
VHA Radiotherapy Bolus was evaluated using 6
MV photons and 9MeV electrons but has not
been assessed for use with protons or at
orthovoltage X-rays | The 3D Systems VSP® Bolus product is a
device that will be placed on the skin of a patient
as a radiotherapy accessory intended to help
control the radiation dose received by the
patient. VSP Bolus is generated using input from
radiation therapy professionals and medical
imaging data to produce a bolus that is specific
to the patient being treated. The VSP Bolus
product is verified and approved by the radiation
therapy professional prior to use on the patient,
and is intended for patients of all ages receiving
radiotherapy treatment.
VSP Bolus was evaluated using 6 MV photons
but has not been assessed for use with protons,
electrons, or at orthovoltage X-rays. |
| Device Input
Parameters | 1. DICOM
2. The device is designed by the radiation
therapy professional. | 1. DICOM
2. Radiotherapy professional input (i.e.
thickness, anatomical location) |
| Device
Manufacturing
Method | Additive Manufacturing (3D Printing) | Additive Manufacturing (3D Printing) |
| Device Material | VisiJet® M2E-BK70 | VisiJet® M2E-BK70 |
| Patient Contact
Material Standards | Biocompatible for intact skin contact | Biocompatible for intact skin contact |
| Device Clinical
Acceptance | Each VHA Radiotherapy Bolus must be verified
and approved by the radiation therapy
professional through a CT scan prior to the first
treatment fraction. | Each VSP® Bolus must be verified and
approved by the radiation therapy professional
through a CT scan prior to the first treatment
fraction. |
| Patient Population | Cancer patients requiring external beam
radiotherapy. | Cancer patients requiring external beam
radiotherapy. |
| Patient Population
Anatomical Sites | Various | Various |
| Use Environment | Radiotherapy Clinic | Radiotherapy Clinic |
| Device
Performance | Clinically oriented validation test cases were
written and executed. The VHA Radiotherapy
Bolus was deemed fit for clinical use by
radiation therapy professionals. | Clinically oriented validation test cases were
written and executed. VSP Bolus was deemed fit
for clinical use by radiation therapy
professionals. |
Table 5.3 Technical Characteristics Comparison Table
6
5.10 Summary of Non-Clinical Testing
The following tests were performed to demonstrate safety based on current industry standards:
5.10.1 Performance Testing
Simulated use testing was completed for clinically relevant cases using both electron and photon radiation therapy. All acceptance criteria for performance testing were met.
5.10.2 Biocompatibility Testing
The VHA Radiotherapy Bolus has identical indications for use, identical material and manufacturing method, and an identical worst-case configuration and post processing conditions to the predicate device. Therefore, the subject device leveraged data on hand. All acceptance criteria for biocompatibility were met and the testing adequality addresses biocompatibility for the output devices and their intended use. Biocompatibility testing was in compliance to ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
5.11 Clinical Testing
No clinical data were provided in order to demonstrate substantial equivalence.
5.12 Conclusion
Based on the testing performed, including performance testing and biocompatibility testing, it can be concluded that the subject device does not raise any new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the VHA Radiotherapy Bolus are assessed to be substantially equivalent to the predicate device.