(122 days)
Not Found
No
The description mentions optimization methods like simulated annealing and gradient descent, which are traditional algorithms used in treatment planning, not necessarily indicative of AI/ML. There is no mention of AI, ML, deep learning, or training/test sets for such models.
No.
The device is a radiation treatment planning package, which helps medical professionals create treatment plans. It does not directly provide therapy to a patient.
No
Explanation: The CORVUS system is a radiation treatment planning package used to create conformal treatment plans. It does not diagnose diseases or conditions; rather, it assists in planning the delivery of radiation therapy based on a defined target volume.
Yes
The device description and performance studies focus entirely on software functionalities, algorithms, and validation of the software's performance in treatment planning. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CORVUS system is a "radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy." This describes a system used for planning a medical procedure (radiation therapy), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the software's capabilities in generating radiation treatment plans, calculating dose distributions, and optimizing beam weights. This aligns with a treatment planning system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the CORVUS system is a medical device used for planning radiation therapy treatments, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
Product codes
MUJ
Device Description
CORVUS is a semi-automatic planning system: For forward planning, the system allows the user to design a treatment plan. For IMRT, rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.
CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.
Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.
The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.
CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical physicists, dosimetrists, and radiation oncologists
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)
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards. The software for this device is considered as a "Major" level of concern. The details of the design verification and validation activities are explained in the submission as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The verification activities included system tests, anomaly verification, code reviews, and run-through integration tests.
The validation activities included clinical workflow, treatment planning software usability, clinical plan quality / optimization comparison, and dosimetric accuracy. The accuracy of treatment plans was evaluated through comparison with medical physics measurements including film and ion chamber measurements.
Conclusion:
Detailed results of these tests are included as part of this submission. The verification and validation results demonstrate that the CORVUS 14 system met its design requirements and specifications, is substantially equivalent to its predicate device, and conforms to the applicable sections of standards that includes:
. IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
IEC 62366-1 Edition 1.0 2020-06 Application of usability engineering to medical devices ●
IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment Coordinates, movements, and ● scales
. IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems
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.
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
§ 892.5050 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.
0
September 20, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
Best Nomos % Vineet Gupta, Ph.D. Director - R&D One Best Drive PITTSBURGH PA 15202
Re: K201350
Trade/Device Name: CORVUS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: August 21, 2020 Received: August 24, 2020
Dear Dr. Gupta:
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 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,
For
Thalia T. Mills, Ph.D. 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
510(k) Number (if known) K201350
Device Name
CORVUS
Indications for Use (Describe)
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
A. SUBMITTERS NAME
Best NOMOS
B. ADDRESS
One Best Drive Pittsburgh, PA 15202
C. CONTACT
| Name: | Vineet Gupta, Ph.D. |
|---|---|
| Phone: | (412) 312-6819 |
| Fax: | (412) 312-6701 |
| Email: | vineet.gupta@nomos.com |
D. DATE PREPARED
May 20, 2020
E. DEVICE NAME
| Device Trade Name: | CORVUS |
|---|---|
| Common Name: | Radiation Therapy Treatment Planning System |
| Classification Name: | Medical charged-particle radiation therapy system |
| (21CFR 892.5050) |
F. DEVICE CLASS
Class II Panel: Radiology Product Code: 90-MUJ Regulation Number: 21CFR 892.5050
Image /page/3/Picture/15 description: The image contains a logo for a healthcare organization. The logo features the word "Best" in a stylized, blue font, with the tagline "healthcare for everyone" written in a smaller, blue font underneath. Above the word "Best" is a graphic of several green figures holding hands in a circle, suggesting unity and community.
One Best Drive (formerly One Conair Drive), Pittsburgh, PA 15202 USA phone 412 312 6700 800 70 NOMOS fax 412 312 6701 www.nomos.com
4
G. PREDICATE DEVICES
CORVUS Radiation Therapy Treatment Planning System 2011 (K151469)
H. STATEMENT OF INDICATIONS FOR USE
The intended use for the CORVUS Radiation Therapy Treatment Planning System has been updated to include the support for forward planning based treatment planning. The indications for use for the CORVUS Radiation Therapy Treatment Planning System has not changed due to this modification to the product. This modification does not change the fundamental principle of using photons for creating conformal treatment plans which is the same as that of its predicate device.
Intended Use
CORVUS is intended for use as a planning tool for conformal radiation therapy. For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
CORVUS is intended only to suggest a delivery plan. It is the physician's responsibility to verify that the dose distributions which would result from plan implementation are appropriate for a particular patient.
The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. CORVUS produces radiation fields to conform to the projected tumor volume plus margins as desired during planning. The system provides statistical calculations to help achieve target goals while sparing sensitive structures.
Indications for Use
The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray, gamma ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.
The CORVUS system is valid for use only with external beam photon therapy; calculations for electrons and intracavity sources (Brachytherapy) are NOT supported.
5
I. DEVICE DESCRIPTION
CORVUS is a semi-automatic planning system: For forward planning, the system allows the user to design a treatment plan. For IMRT, rather than simply verifying a user-designed plan, the system itself suggests a plan. A clinician then reviews and approves the plan.
CORVUS is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. The treatment beams are weighted so that when they are projected into the treatment space they superimpose to give the desired dose distribution.
Each radiation field is generated using one of several optimization methods provided with the system, including simulated annealing and gradient descent.
The treatment beams are set not only to deliver the prescribed dose to the identified target volume, but also to keep the dose to other sensitive volumes below user-defined limits. Planning is done volumetrically: the beam weights for treating the entire target volume are generated simultaneously. The dose matrix is volumetric. The dose to each point is calculated to be that received from all beams and from all gantry angles. Dosage is calculated using a finite size pencil beam (FSPB) algorithm based on the beam characterization of clinically measured data. The degree to which a treatment plan is optimized is determined in part by constraints placed on the planning algorithm. The user has direct control over these constraints, which include dose goals to the target structures, dose limits to the sensitive structures, and the specification of arcs or fixed gantry positions in the treatment plan.
CORVUS treatment plans need not have the isocenter located within the target volume. An unlimited number of targets falling within the treatment volume can be planned for at the same time. Dose may be prescribed for up to 32 structures, 29 of them user-selectable, any number of which may be separate targets or radiation-sensitive structures. Each structure can have a separate dose prescription.
J. PREDICATE DEVICE INFORMATION
The CORVUS 14 system is substantially equivalent to its primary predicate device CORVUS 2011 (K151469; Decision Date: 25-Nov-2015). The CORVUS 2011 system was determined to be substantially equivalent to its predicate device as of November 2015.
The fundamental scientific technology of the CORVUS 14 with respect to its predicate device (CORVUS 2011) system has not changed. The indications for use of the device has not changed. Based upon the performance testing results for CORVUS 14 (as detailed in the submission), the system raises no new issues of safety or effectiveness.
6
K. COMPARISON TO THE PREDICATE DEVICE
This section provides the summary of comparison of CORVUS 14 to the predicate device.
| Proposed Device | Predicate Device | |
|---|---|---|
| CORVUS 14 | CORVUS 2011 (K151469) | |
| Intended Use | CORVUS is intended for use as a | |
| planning tool for conformal radiation | ||
| therapy. For IMRT, using operator- | ||
| supplied input and patient scans, it | ||
| creates a plan for treatment delivery | ||
| systems and generates a set of beam | ||
| weights that, when applied to a | ||
| compatible system, facilitates delivery | ||
| of an intensity-modulated 3D | ||
| conformal radiation therapy treatment. | ||
| For Forward Planning, CORVUS helps | ||
| the user manually create a plan for | ||
| treatment delivery based on user | ||
| supplied inputs and patient scans | ||
| including dose calculation. Forward | ||
| Planning is supported only for Cobalt- | ||
| 60 based treatment planning |
CORVUS is intended only to suggest a
delivery plan. It is the physician's
responsibility to verify that the dose
distributions which would result from
plan implementation are appropriate
for a particular patient.
The CORVUS system is intended to be
used as an integrated system with a
delivery device for planning and
delivery of conformal radiation
therapy. CORVUS produces radiation
fields to conform to the projected
tumor volume plus margins as desired
during planning. The system provides
statistical calculations to help achieve
target goals while sparing sensitive | CORVUS is intended for use as a
planning tool for conformal radiation
therapy. Using operator-supplied input
and patient scans, it creates a plan for
treatment delivery systems and
generates a set of beam weights that,
when applied to a compatible system,
facilitates delivery of an intensity-
modulated 3D conformal radiation
therapy treatment.
CORVUS is intended only to suggest a
delivery plan. It is the physician's
responsibility to verify that the dose
distributions which would result from
plan implementation are appropriate
for a particular patient.
The CORVUS system is intended to be
used as an integrated system with a
modulating device for planning and
delivery of conformal radiation
therapy. The modulating device can be
the NOMOS MIMiC, nomosSTAT
MLC, or a supported MLC. CORVUS
produces radiation fields which are
modulated to conform to the projected
tumor volume plus margins. The
system tries to achieve target goals
while sparing sensitive structures. |
| Indications for
Use | structures.
The CORVUS system is a radiation
treatment planning package designed to | The CORVUS system is a radiation
treatment planning package designed to |
| allow medical physicists, dosimetrists,
and radiation oncologists to create
conformal treatment plans using
photon (x-ray, gamma ray) external
beam radiation therapy. The treatment
plans generated by CORVUS are based
upon treatment machine-specific data
and are intended to provide a guide to
delivering external beam radiation
therapy which conforms to the target
volume defined by the radiation
oncologist.
The CORVUS system is valid for use
only with external beam photon
therapy; calculations for electrons and
intracavity sources (Brachytherapy) are
NOT supported. | allow medical physicists, dosimetrists,
and radiation oncologists to create
conformal treatment plans using
photon (x-ray, gamma ray) external
beam radiation therapy. The treatment
plans generated by CORVUS are based
upon treatment machine-specific data
and are intended to provide a guide to
delivering external beam radiation
therapy which conforms to the target
volume defined by the radiation
oncologist.
The CORVUS system is valid for use
only with external beam photon
therapy; calculations for electrons and
intracavity sources (Brachytherapy) are
NOT supported | |
Table 1 Indications for Use & Intended Use Comparison
7
| Comparison Item | Proposed Device
CORVUS 14 | Predicate Device
CORVUS 2011 (K151469) |
|----------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------|
| Product Code | 90-MUJ | 90-MUJ |
| Class | II | II |
| Regulation Number | 892.5050 | 892.5050 |
| Operating System | Mac OS X | Mac OS X |
| Treatment Planning Support for
X-Rays | MLC-IMRT, Serial Tomotherapy
(MIMiC-IMRT) | MLC-IMRT, Serial Tomotherapy
(MIMiC-IMRT) |
| Treatment Planning Support for
Cobalt-60 (Gamma Rays) | Serial Tomotherapy (MIMiC-IMRT),
MLC-IMRT, Forward Planning | Serial Tomotherapy (MIMiC-
IMRT) |
Table 2 General Comparison
CORVUS 14 contains all of the features of CORVUS 2011 (K151469) and adds the feature of supporting Cobalt-60 based external beam radiation treatment planning based on IMRT and Forward Planning. The similarities and differences are discussed in detail as part of this submission.
In both products, CORVUS 14 and CORVUS 2011, the pencil-beam algorithm is used and dose calculation can be performed using either a homogeneous option or an Effective Path Length (EPL) option. The dose calculation based on the Lateral Disequilibrium Inclusive option is only supported for X-Ray based treatment planning in CORVUS 14 as it was in the
8
predicate device CORVUS 2011 (K151469). The optimization algorithms used in both products are the same.
The target population and indications for use are similar to that of the predicate devices. In addition, the fundamental technical characteristics are the same as those of the predicate devices and any minor differences in features do not raise any concerns for safety, performance, or effectiveness of the device. The characteristics/features of CORVUS 14 with respect to the predicate device is described in the comparison chart in the submission.
L. SUMMARY OF TESTING
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, is substantially equivalent, and the product conforms to the required standards. The software for this device is considered as a "Major" level of concern. The details of the design verification and validation activities are explained in the submission as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The verification activities included system tests, anomaly verification, code reviews, and run-though integration tests.
The validation activities included clinical workflow, treatment planning software usability, clinical plan quality / optimization comparison, and dosimetric accuracy. The accuracy of treatment plans was evaluated through comparison with medical physics measurements including film and ion chamber measurements.
Conclusion:
Detailed results of these tests are included as part of this submission. The verification and validation results demonstrate that the CORVUS 14 system met its design requirements and specifications, is substantially equivalent to its predicate device, and conforms to the applicable sections of standards that includes:
- . IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
- IEC 62366-1 Edition 1.0 2020-06 Application of usability engineering to medical devices ●
- IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment Coordinates, movements, and ● scales
- . IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems