(92 days)
Not Found
No
The description focuses on patient-specific bolus generation based on medical imaging and professional input, without mentioning AI/ML algorithms for analysis, planning, or generation.
No.
The device is a radiotherapy accessory used to control the radiation dose received by a patient, not a device that directly provides therapy itself. It modifies the dose delivered by external beam radiation therapy.
No
Explanation: The device is described as a radiotherapy accessory used to control radiation dose, not to diagnose a condition. It is part of the treatment delivery rather than diagnosis.
No
The device description explicitly states the bolus is "produced with additive manufacturing in a soft elastomeric material," indicating a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VSP Bolus Function: The VSP Bolus is a physical device placed on the skin of a patient during radiation therapy. Its purpose is to modify the radiation dose delivery externally, not to analyze biological samples.
- Intended Use: The intended use clearly states it's a "radiotherapy accessory intended to help control the radiation dose received by the patient." This is an external therapeutic support function, not an in vitro diagnostic function.
- Device Description: The description reinforces that it's a physical object placed on the patient's skin to "change the depth of the radiation dose delivery."
The VSP Bolus is a medical device used in the delivery of radiation therapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 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.
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 professional / 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)
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.
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.
BOLUS COMPENSATOR, .DECIMAL INC. (K091911)
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.
Not Found
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
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
1
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
2
Indications for Use
Submission Number (if known)
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 Circle | |
| Littleton, CO 80127, USA | ||
| Phone: (720) 643-1001 | ||
| Fax: (720) 643-1009 | ||
| Official Contact: | Benjamin Johnson | |
| Vice President, Portfolio & Regulatory, Healthcare | ||
| 3. | Date Prepared: | December 20th, 2021 |
| DEVICE | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | VSP® Bolus | |
| Patient-specific Radiotherapy Bolus | ||
| Radiation 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
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.
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Image /page/4/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 company name, 3D Systems, in gray lettering.
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® Bolus | |
| Subject Device | Bolus Compensator | |
| Predicate Device | ||
| Indications for Use | 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. | The Bolus Compensators are used by
radiation therapy professionals for the
treatment of cancer patients. They are
designed by radiation therapy professionals
for a unique patient and are intended to
modify the shape of abeam from a radiation
therapy source. Each Bolus Compensator
must be validated and approved by the
radiation therapy professional prior to use on
a patient. |
| Device Input
Parameters | 1. DICOM
2. Radiotherapy professional input (i.e.
thickness, anatomical location) | 1. DICOM
2. The device is designed by the radiation
therapy professional. |
| Manufacturing
Method | Additive Manufacturing (3D Printing) | Subtractive Manufacturing (Machining) |
| Device Material | VisiJet® M2E-BK70 | Deep Blue Wax |
| Patient Contact
Materials | Biocompatible for intact skin contact. | "negligible irritation to skin at ambient
temperatures"1 |
| Device Clinical
Acceptance | Each VSP® Bolus must be validated and approved
by the radiation therapy professional through a CT
scan prior to the first treatment fraction. | Each Bolus Compensator must be validated
and approved by the radiation therapy
professional 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® Bolus | |
| Subject Device | Bolus Compensator | |
| Predicate Device | ||
| Target Population | Cancer patients requiring external beam | |
| radiotherapy | Cancer Patients requiring external beam | |
| radiation therapy | ||
| Target Population | ||
| Anatomical Sites | Various | Various |
| Use Environment | Radiotherapy Clinic | Radiotherapy Clinic |
| Performance | Clinically oriented validation test cases were | |
| written and executed. VSP Bolus was deemed fit | ||
| for clinical use by radiation therapy professionals. | Clinically oriented validation test cases were | |
| written and executed in house .decimal | ||
| personnel including Board Certified Medical | ||
| Physicists where Bolus Compensators was | ||
| deemed 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.
6
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.