(65 days)
Not Found
No
The summary describes a standard radiation therapy treatment planning system with no mention of AI or ML capabilities. The description of the workflow is typical for such systems and does not suggest the use of advanced algorithms like AI/ML for tasks such as image processing, optimization, or analysis.
No.
The device is a software system for treatment planning and analysis of radiation therapy, which aids in administering treatments, but it does not directly apply or deliver a therapeutic action to the patient. It is a tool for planning rather than a therapeutic device itself.
No
Explanation: The device is described as a "treatment planning system," which focuses on planning and optimizing radiation therapy treatments rather than diagnosing medical conditions. It uses patient images to create treatment plans and estimate dose distributions, but its primary function is not to identify or characterize diseases.
Yes
The device description explicitly states that Radiance V2 is a "software program for planning and analysis of radiation therapy plans." The summary focuses on software functionalities like importing images, defining regions, optimizing parameters, and computing dose distributions. While it interacts with external hardware (CT scanners, radiation therapy devices), the device itself, as described, is solely the software system.
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 Radiance V2 is a software system for treatment planning and analysis of radiation therapy. This involves planning how radiation will be delivered to a patient's body, not analyzing samples taken from the body (in vitro).
- Device Description: The description reinforces that it's a treatment planning system that uses patient images to create and analyze radiation therapy plans.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Radiance V2's function is entirely focused on the planning and delivery of a medical treatment (radiation therapy) based on imaging data.
N/A
Intended Use / Indications for Use
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
Product codes
MUJ
Device Description
Radiance V2 is a treatment planning system, that is, a software program for planning and analysis of radiation therapy plans. Typically, a treatment plan is created by importing patient images obtained from a CT scanner, defining regions of interest either manually or semi-automatically, deciding on a treatment setup and objectives, optimizing the treatment parameters, comparing alternative plans to find the best compromise, computing the clinical dose distribution. approving the plan and exporting it.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Externally acquired patient medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinically qualified radiation therapy staff trained in using the system.
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
Non Clinical Data: Validation and Verification Testing carried out on the Radiance V2 indicates that it meets its predefined products requirements and requirements from the following product standards:
• IEC 61217 Radiotherapy equipment - Coordinates, movements and scales
• IEC 62083 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Clinical Data: The predecessor of Radiance V2 system, i.e., Radiance, has been tested clinically. This Clinical Study evaluated the effectiveness and repeatability of the planning process in IORT with Radiance in regard to the current modalities and the current uncertainties in regard to (manual) treatment planning. The changes in Radiance V2 (computation algorithms and beam modeling tool) do not modify basic functionality/workflow in which that study was performed. Therefore the Clinical Study conducted for Radiance and data collected can be safely extrapolated and is also valid for Radiance V2, moreover all new design features have been successfully validated ex-clinic.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification: Traditional 510(k)
510(k) Summary
JAN 3 1 2014
| Submitter Name:
Submitter Address: | GMV Soluciones Globales Internet S.A.U.
Isaac Newton. 11; PTM Tres Cantos
Madrid 28760
Spain | | |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--|
| Phone Number:
Fax Number: | 011 34 91 807 22 70
011 34 91 807 21 99 | | |
| Contact Person: | Carlos Illana Alejandro | | |
| Date Prepared: | 14 November 2013 | | |
| Device Trade Name: | Radiance V2 | | |
| Common Name | Radiation Treatment Planning Software | | |
| Classification Name.
Number &
Product Code: | Medical charged-particle radiation therapy system
21 CFR 892.5050
MUJ | | |
| Predicate Devices: | K112060 | Radiance
cleared 01/06/2012 | |
| | K121653 | INTRABEAM SYSTEM WITH INTRABEAM
SPHERICAL APPLICATORS
Cleared 12/27/2012 | |
| | K102011 | Eclipse Treatment Planning System
Cleared 09/03/2010 | |
| Device Description
and Statement of
Intended Use | Radiance V2 is a treatment planning system, that is, a software
program for planning and analysis of radiation therapy plans.
Typically, a treatment plan is created by importing patient images
obtained from a CT scanner, defining regions of interest either
manually or semi-automatically, deciding on a treatment setup and
objectives, optimizing the treatment parameters, comparing
alternative plans to find the best compromise, computing the
clinical dose distribution. approving the plan and exporting it. | | |
1
Statement of Intended Use:
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval bv the intended user.
The system functionality can be configured hased on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
The technological characteristics are essentially the same as those
Summary of Technological Characteristics
of the predicate. All devices produce treatment plans with corresponding dose distributions computed using a three dimensional dosimetry engine. All devices have a function of electronic approval of
treatment plans by trained and authorized staff, and export in DICOM format for commencing treatment or archiving.
From the standpoint of both functionality and workflow the Radiance V2 device is substantially equivalent to the identified predicates as follows:
- · Within Radiance V2 and its predicates. Radiance and Eclipse. the user can adjust parameters to achieve a predicted outcome. rather than make a decision intra-operatively.
- · Radiance V2 and its predicates Radiance and Eclipse are designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with malignancies.
- · Radiance V2 and its predicates Radiance and Eclipse provide treatment plans with estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
- · Radiance V2 and its predicates Radiance and Eclipse use externally acquired medical images and user input to achieve the result.
The Radiance V2 dose distribution computation algorithm for the X-rav source of INTRA BEAM is equivalent to provided computation within INTRABEAM radiation treatment device
Substantial Equivalence
Section 5.0
2
| | itself.
The added functionality of Radiance V2 versus Radiance is
substantial equivalent to other marketed predicate devices and
therefore there are no extra concerns on safety and efficacy of the
proposed Radiance V2 device with respect to its predicates. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non Clinical Data | Validation and Verification Testing carried out on the Radiance
V2 indicates that it meets its predefined products requirements and
requirements from the following product standards:
• IEC 61217 Radiotherapy equipment - Coordinates,
movements and scales
• IEC 62083 Medical electrical equipment - Requirements
for the safety of radiotherapy treatment planning systems |
| Clinical Data | The predecessor of Radiance V2 system, i.e., Radiance, has been
tested clinically. This Clinical Study evaluated the effectiveness
and repeatability of the planning process in IORT with Radiance
in regard to the current modalities and the current uncertainties in
regard to (manual) treatment planning. The changes in Radiance
V2 (computation algorithms and beam modeling tool) do not
modify basic functionality/workflow in which that study was
performed. Therefore the Clinical Study conducted for Radiance
and data collected can be safely extrapolated and is also valid for
Radiance V2, moreover all new design features have been
successfully validated ex-clinic. |
| Conclusion | The information discussed above demonstrates that the Radiance
V2 device is substantially equivalent to the predicate device. |
| Declarations | • This summary includes only information that is also covered in
the body of the 510(k).
• This summary does not contain any puffery or unsubstantiated
labeling claims.
• This summary does not contain any raw data, i.e., contains only
summary data.
• This summary does not contain any trade secret or confidential
commercial information.
• This summary does not contain any patient identification
information. |
.
:
3
| Summary of Technical Characteristics | ||||
|---|---|---|---|---|
| Feature | Device Radiance | |||
| V2 | Radiance | Eclipse | INTRABEAM | |
| System with | ||||
| INTRABEAM | ||||
| Spherical | ||||
| Applicators | ||||
| 510(k) | ||||
| Number | K112060 | K102011 | K121653 | |
| Manufacturer | GMV Soluciones | |||
| Globales Internet | ||||
| S.A.U. | GMV Aerospace | |||
| and Defence S.A. | Varian Medical | |||
| Systems, Inc. | Carl Zeiss | |||
| Meditec AG | ||||
| Classification |
& Product
Code | 21 CFR 892.5050
MUJ | 21 CFR 892.5050
MUJ | 21 CFR 892.5050
MUJ | 21 CFR 892.5900
JAD |
| Indication for
use | Radiance V2 is a
software system
intended for
treatment
planning and
analysis of
intraoperative
radiation therapy
administered
with devices
suitable for
intraoperative
radiotherapy.
The treatment
plans provide
treatment unit
set-up parameters
and estimates of
dose distributions
expected during
the proposed
treatment, and
may be used to
administer
treatments after
review and
approval by the
intended user.
The system
functionality can | Radiance is a
software system
intended for
treatment
planning and
analysis of
intraoperative
radiation therapy
by means of
electron beams.
The treatment
plans provide
treatment unit
set-up parameters
and estimates of
dose distributions
expected during
the proposed
treatment, and
may be used to
administer
treatments after
review and
approval by the
intended user.
The system
functionality can
be configured
based on user
needs. | The Eclipse
Treatment
Planning System
(Eclipse TPS) is
used to plan
radiotherapy
treatments for
patients with
malignant or
benign diseases.
Eclipse TPS is
used to plan
external beam
irradiation with
photon, electron
and proton
beams, as well as
for internal
irradiation
(brachytherapy)
treatments. In
addition, the
Eclipse Proton
Eye algorithm is
specifically
indicated for
planning proton
treatment of
neoplasms of the
eye. | The
INTRABEAM
System is
intended to be
used for radiation
therapy
treatment. |
| | be configured
based on user
needs.
The intended
users of Radiance
V2 shall be
clinically
qualified
radiation therapy
staff trained in
using the system. | The intended
users of Radiance
shall be clinically
qualified
radiation therapy
staff trained in
using the system. | | |
| System
Design | Software only | Software only | Software only | Hardware and
Software |
| Calculation
for electrons | Dose
distributions
computed using a
three dimensional
dose engine.
Pencil Beam
computation and
Monte Carlo
Computation for
electrons | Dose
distributions
computed using a
three dimensional
dose engine.
Pencil Beam
Computation | Same for
electrons
i.e. Pencil Beam
computations and
Monte Carlo
Computation for
electrons | Not applicable
(X-ray device) |
| Calculation
for photons | Dose Painting
(Planning
calculation
interpolation of
PDD
measurements) | Not applicable | Not applicable | Calibration files
for
INTRABEAM:
PDD scaled with
the dose rate
factor for MU
computation of
photons |
| Input | Externally
acquired patient
medical images
and user input.
Calibration files
for
INTRABEAM. | Same | Same | Calibration files
for
INTRABEAM:
MU/Gy factor +
additional factors |
| Output | Treatment plans
with | Same for
electrons | Same for
electrons | Monitor units |
| | corresponding
dose distributions | | | |
| Plan review
and approval | Allows electronic
approval of
treatment plans
by trained and
authorized staff | Same | Same | None |
| Dose
calculation
algorithm
confirmation | Algorithms
confirmed for a
wide variety of
field geometries,
treatment units,
treatment setups
and patient
positions,
including
different dose
grid resolution
settings. | Same for
electrons | Same for
electrons | Same for MU
computation |
| Beam
modeling tool | Beam modeling
of the treatment
unit based on
relative
measurements
and output
factors | None | Same | Not applicable |
:
.
4
Premarket Notification: Traditional 510(k)
Section 5 Page 6 of 7
5
K.133655
page 6of6
V2
Radiance V2 Premarket Notification: Traditional 510(k)
.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in a simple, abstract design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2014
GMV Soluciones Globales Internet S.A.U. % Ms. Debra Ferland Official Correspondent for GMV Oserve Group P.O. Box 940 CHARLESTOWN NH 03603
Re: K133655
Trade/Device Name: Radiance V2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 25, 2013 Received: December 4, 2013
Dear Ms. Ferland:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2-Ms. Ferland
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/RcportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K133655
Device Name: Radiance V2
Indications For Use:
Radiance V2 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V2 shall be clinically qualified radiation therapy staff trained in using the system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sm.7)
Page 1 of 1
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k). K133655