VHA Radiotherapy Bolus

K222639 · Vha Dean · IXI · Nov 4, 2022 · Radiology

Device Facts

• Record ID: K222639
• Device Name: VHA Radiotherapy Bolus
• Applicant: Vha Dean
• Product Code: IXI · Radiology
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Patient-specific radiotherapy accessory; used in external beam radiation therapy (EBRT) to modify radiation beam shape and control dose depth; overcomes skin-sparing effect. Input: DICOM medical imaging data; clinician-defined parameters (anatomical location, thickness). Operation: Radiotherapy professionals design bolus using clinical treatment planning software; additive manufacturing (3D printing) produces soft elastomeric bolus conforming to patient anatomy. Usage: Radiotherapy clinic; verified/approved by clinician via CT scan prior to first treatment fraction. Benefit: Improved dose distribution tailored to unique patient anatomy.

Clinical Evidence

No clinical data provided. Bench testing only: simulated use testing performed for clinically relevant cases using 6 MV photons and 9 MeV electrons; biocompatibility testing conducted per ISO 10993-1, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Material: VisiJet M2E-BK70 (biocompatible for intact skin). Manufacturing: Additive manufacturing (3D printing). Form factor: Patient-specific, soft elastomeric. Standards: ISO 10993-1, 10993-5, 10993-10. Connectivity: DICOM input from clinical treatment planning software.

Indications for Use

Indicated for patients of all ages requiring external beam radiotherapy treatment to control radiation dose delivery. Not assessed for use with protons or orthovoltage X-rays.

Regulatory Classification

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.

Predicate Devices

• VSP Bolus (K214093)

Reference Devices

• Bolus Compensator (K091911)

Submission Summary (Full Text)

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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

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

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## 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 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 |
| Email | [e-mail] |
| 5.3 Correspondent Information | |
| Full Name | Laura Gilmour |
| Job Title | Principal Consultant, Advanced Manufacturing<br>and Regulatory Strategy |
| Phone | 901-258-3629 |
| Email | [e-mail] |
| 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

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## 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:

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| Specification/<br>Characteristic | Subject Device | Primary Predicate Device |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VHA Radiotherapy Bolus<br>VHA DEAN<br>K222639 | VSP® Bolus<br>3D Systems, Inc.<br>K214093 |
| Indications for Use | The VHA Radiotherapy Bolus product is a<br>device that will be placed on the skin of a patient<br>as a radiotherapy accessory intended to help<br>control the radiation dose received by the<br>patient. VHA Radiotherapy Boluses are designed<br>by radiation therapy professionals for a unique<br>patient and are intended to modify the shape of a<br>beam from a radiation therapy source. The VHA<br>Radiotherapy Bolus product must be verified and<br>approved by the radiation therapy professional<br>prior to use on a patient. The VHA Radiotherapy<br>Bolus is intended for patients of all ages<br>receiving radiotherapy treatment.<br><br>VHA Radiotherapy Bolus was evaluated using 6<br>MV photons and 9MeV electrons but has not<br>been assessed for use with protons or at<br>orthovoltage X-rays | The 3D Systems VSP® Bolus product is a<br>device that will be placed on the skin of a patient<br>as a radiotherapy accessory intended to help<br>control the radiation dose received by the<br>patient. VSP Bolus is generated using input from<br>radiation therapy professionals and medical<br>imaging data to produce a bolus that is specific<br>to the patient being treated. The VSP Bolus<br>product is verified and approved by the radiation<br>therapy professional prior to use on the patient,<br>and is intended for patients of all ages receiving<br>radiotherapy treatment.<br><br>VSP Bolus was evaluated using 6 MV photons<br>but has not been assessed for use with protons,<br>electrons, or at orthovoltage X-rays. |
| Device Input<br>Parameters | 1. DICOM<br>2. The device is designed by the radiation<br>therapy professional. | 1. DICOM<br>2. Radiotherapy professional input (i.e.<br>thickness, anatomical location) |
| Device<br>Manufacturing<br>Method | Additive Manufacturing (3D Printing) | Additive Manufacturing (3D Printing) |
| Device Material | VisiJet® M2E-BK70 | VisiJet® M2E-BK70 |
| Patient Contact<br>Material Standards | Biocompatible for intact skin contact | Biocompatible for intact skin contact |
| Device Clinical<br>Acceptance | Each VHA Radiotherapy Bolus must be verified<br>and approved by the radiation therapy<br>professional through a CT scan prior to the first<br>treatment fraction. | Each VSP® Bolus must be verified and<br>approved by the radiation therapy professional<br>through a CT scan prior to the first treatment<br>fraction. |
| Patient Population | Cancer patients requiring external beam<br>radiotherapy. | Cancer patients requiring external beam<br>radiotherapy. |
| Patient Population<br>Anatomical Sites | Various | Various |
| Use Environment | Radiotherapy Clinic | Radiotherapy Clinic |
| Device<br>Performance | Clinically oriented validation test cases were<br>written and executed. The VHA Radiotherapy<br>Bolus was deemed fit for clinical use by<br>radiation therapy professionals. | Clinically oriented validation test cases were<br>written and executed. VSP Bolus was deemed fit<br>for clinical use by radiation therapy<br>professionals. |

Table 5.3 Technical Characteristics Comparison Table

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## 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.