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 Description

Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivery to overcome the skin-sparing effect. The bolus is generated in accordance with a clinical treatment plan. The patient-specific bolus conforms to the patient anatomy to reduces airgaps for complex patient contours. The bolus is produced with 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 accordance to the treatment plan prior to a radiation dose delivery to the patient.

AI/ML Overview

The provided document is a 510(k) summary for the VSP® Bolus, a device used in radiation therapy. It does not describe an AI/ML device or a study comparing AI assistance with human readers. Therefore, I cannot extract information related to AI/ML specific acceptance criteria or an MRMC study from this document.

However, I can provide the acceptance criteria and performance data for the VSP® Bolus as described in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" in a quantitative format for the VSP® Bolus. Instead, it describes performance characteristics and validation activities demonstrating the device's fitness for clinical use and substantial equivalence to a predicate device. The performance is primarily assessed through simulated use testing and biocompatibility.

Criterion Type	Description / Reported Performance
Biocompatibility	- Cytotoxicity: Passed ISO 10993-5 (MEM Elution Test)- Sensitization: Passed ISO 10993-10 (Guinea Pig Maximization Test)- Irritation: Passed ISO 10993-10 (Primary Dermal Irritation Test)- Patient Contact Materials: Biocompatible for intact skin contact.
Simulated Use Testing	- Clinically relevant validation study performed.- VSP Bolus was deemed fit for clinical use by radiation therapy professionals.
Clinical Acceptance (Post-Manufacturing)	Each VSP® Bolus must be validated and approved by the radiation therapy professional through a CT scan prior to the first treatment fraction.
Performance (General)	- Clinically oriented validation test cases were written and executed.- VSP Bolus was deemed fit for clinical use by radiation therapy professionals.
Intended Use	The device is placed on the skin of a patient to help control the radiation dose received, generated using input from radiation therapy professionals and medical imaging data to produce a patient-specific bolus. Verified and approved by professionals prior to use. Intended for patients of all ages receiving radiotherapy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Clinically relevant validation study was performed." However, it does not specify the sample size for this simulated use test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the simulated cases).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document states that "VSP Bolus was deemed fit for clinical use by radiation therapy professionals." However, it does not specify the number of experts used or their specific qualifications (e.g., number of years of experience, specific certifications) for establishing this ground truth in the simulated use testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not explicitly describe an adjudication method for the simulated use testing. It only states that the device was "deemed fit for clinical use by radiation therapy professionals," implying a consensus or approval process, but no specific adjudication method (e.g., 2+1, 3+1) is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the document. This device (VSP® Bolus) is a physical, patient-specific bolus used in radiation therapy and does not involve AI assistance for human readers in its described function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The VSP® Bolus is a physical device, not an algorithm. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device requires human input (radiation therapy professional input, DICOM data) for its design and human verification/approval (radiation therapy professional) prior to use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the simulated use testing, the ground truth was established by the judgment and approval of "radiation therapy professionals" who "deemed [the device] fit for clinical use." This can be considered a form of expert consensus or professional judgment.

8. The sample size for the training set

The document describes performance testing for a physical device and states, "Clinical testing was not performed as part of the development of this product." It refers to "clinically relevant validation study" and "simulated use testing." There is no mention of a training set in the context of machine learning or algorithm development, as this is not an AI/ML device.

9. How the ground truth for the training set was established

As there is no mention of a training set or AI/ML components, this question is not applicable to the provided document.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

3D Systems % Benjamin Johnson Vice President, Portfolio and Regulatory 5381 S Alkire Circle LITTLETON CO 80127

March 30, 2022

Re: K214093

Trade/Device Name: VSP® Bolus Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: Class II Product Code: IXI Dated: March 3, 2022 Received: March 4, 2022

Dear Benjamin Johnson:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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,

Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K214093

Device Name

VSP Bolus

Indications for Use (Describe)

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.

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 3D Systems logo. The logo consists of a stylized cube with the number "3" on each visible face. To the right of the cube is the company name, "3D SYSTEMS," in a simple, sans-serif font. The overall design is clean and modern, with a focus on the company's name and a visual representation of three-dimensional technology.

K214093

510(K) SUMMARY

1. INTRODUCTION

This document contains the 510(k) summary for VSP® Bolus. The content of this summary is based on the requirements of 21 CFR 807.92.

2. SUBMITTER

	Name:	3D Systems, Inc.
	Address:	5381 South Alkire CircleLittleton, CO 80127, USAPhone: (720) 643-1001Fax: (720) 643-1009
	Official Contact:	Benjamin JohnsonVice President, Portfolio & Regulatory, Healthcare
3.	Date Prepared:	December 20th, 2021
	DEVICETrade Name:Common Name:Classification Name:	VSP® BolusPatient-specific Radiotherapy BolusRadiation therapy beam-shaping block
	Classification:	Class II, 21 CFR 892.5710
4.	Product Code:	IXI
	PREDICATE DEVICES

Predicate device: BOLUS COMPENSATOR, .DECIMAL INC. (K091911)

5. DESCRIPTION OF THE DEVICE

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6. INTENDED USE

The 3D Systems bolus product is placed on the skin of a patient with the intended use of helping control the dose received by that patient when undergoing radiation therapy treatment. The bolus will be manufactured according to the unique, patient-specific shape requested by a clinical customer. The 3D Systems bolus product is intended for patients of all ages requiring external beam radiotherapy, and is intended for prescription use only.

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intended use and technological characteristics of the subject device are either identical or substantially equivalent to the predicate device, differing only in the materials and manufacturing methods to produce the device. The potential impact on substantial equivalence of each technological difference was addressed by risk analysis and clinically oriented testing.

A comparison of the technical characteristics between VSP® Bolus and predicate device is provided in the following Comparison Table.

Predicate Comparison Table
Attribute	VSP® BolusSubject Device	Bolus CompensatorPredicate Device

Indications for Use	The 3D Systems VSP® Bolus product is a devicethat will be placed on the skin of a patient as aradiotherapy accessory intended to help controlthe radiation dose received by the patient. VSPBolus is generated using input from radiationtherapy professionals and medical imaging data toproduce a bolus that is specific to the patientbeing treated. The VSP Bolus product is verifiedand approved by the radiation therapyprofessional prior to use on the patient, and isintended for patients of all ages receivingradiotherapy treatment.VSP Bolus was evaluated using 6 MV photons buthas not been assessed for use with protons,electrons, or at orthovoltage X-rays.	The Bolus Compensators are used byradiation therapy professionals for thetreatment of cancer patients. They aredesigned by radiation therapy professionalsfor a unique patient and are intended tomodify the shape of abeam from a radiationtherapy source. Each Bolus Compensatormust be validated and approved by theradiation therapy professional prior to use ona patient.
Device InputParameters	1. DICOM2. Radiotherapy professional input (i.e.thickness, anatomical location)	1. DICOM2. The device is designed by the radiationtherapy professional.
ManufacturingMethod	Additive Manufacturing (3D Printing)	Subtractive Manufacturing (Machining)
Device Material	VisiJet® M2E-BK70	Deep Blue Wax
Patient ContactMaterials	Biocompatible for intact skin contact.	"negligible irritation to skin at ambienttemperatures"1
Device ClinicalAcceptance	Each VSP® Bolus must be validated and approvedby the radiation therapy professional through a CTscan prior to the first treatment fraction.	Each Bolus Compensator must be validatedand approved by the radiation therapyprofessional to use on a patient.

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Image /page/5/Picture/0 description: The image shows the 3D Systems logo. On the left is a cube-like shape with the number 3D on each of the three visible sides. To the right of the cube is the company name, "3D SYSTEMS," in a sans-serif font. The logo is in grayscale.

Predicate Comparison Table
Attribute	VSP® BolusSubject Device	Bolus CompensatorPredicate Device
Target Population	Cancer patients requiring external beamradiotherapy	Cancer Patients requiring external beamradiation therapy
Target PopulationAnatomical Sites	Various	Various
Use Environment	Radiotherapy Clinic	Radiotherapy Clinic
Performance	Clinically oriented validation test cases werewritten and executed. VSP Bolus was deemed fitfor clinical use by radiation therapy professionals.	Clinically oriented validation test cases werewritten and executed in house .decimalpersonnel including Board Certified MedicalPhysicists where Bolus Compensators wasdeemed fit for clinical use.

Deep Blue Wax MSDS, QAF-312 Rev 071814 1)

8. SUMMARY OF CLINICAL TESTING

Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence, safety, or effectiveness of the device since testing can be performed such that no human subjects are exposed to risk.

9. SUMMARY OF PERFROMANCE TESTING

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the VSP Bolus was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medica Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization
. Irritation

Simulated Use Testing

Clinically relevant validation study was performed.

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Image /page/6/Picture/0 description: The image shows the 3D Systems logo. On the left is a 3D cube with the number 3 in it. To the right of the cube is the text "3D SYSTEMS" in a sans-serif font. The text is gray and the cube is silver.

10. CONCLUSION

The VSP® Bolus has the same intended use and similar or substantially equivalent technological characteristics as the predicate. Minor differences in the technological characteristics do not raise new or different questions of safety and effectiveness.

Regulation Number and Section

§ 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.