(171 days)
RayStation K100552
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's functionality does not mention any AI/ML processes.
No.
The device is a software system for treatment planning and analysis, not the therapeutic device itself that delivers the treatment.
No
Explanation: The device is described as a "treatment planning system." Its function is to plan and analyze radiation therapy treatments, compute dose distributions, and provide set-up parameters for treatment units. It does not perform diagnosis; rather, it aids in the planning phase after a diagnosis has been made.
Yes
The device description explicitly states "radiance is a treatment planning system, that is, a software program for planning and analysis of radiation therapy plans." The entire description focuses on software functionalities like importing images, defining regions, optimizing parameters, computing dose distributions, and exporting plans. There is no mention of any accompanying hardware component that is 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 is for "treatment planning and analysis of intraoperative radiation therapy by means of electron beams." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a "treatment planning system" that uses patient images to create and analyze radiation therapy plans. This aligns with therapeutic planning, not in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on samples taken from the human body to provide diagnostic information.
Therefore, radiance is a medical device used for treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 intended users of radiance shall be clinically qualified radiation therapy staff trained in using the system.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
radiance 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
patient images obtained from a CT scanner
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
RayStation K100552
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
radiance Premarket Notification: Traditional 510(k)
510(k) Summary
| Submitter Name: | GMV Aerospace and Defence S.A. |
|---|---|
| Submitter Address: | Isaac Newton, 11; PTM Tres Cantos |
| Madrid 28760 | |
| Spain | |
| Phone Number: | 011 34 91 807 22 70 |
| Fax Number: | 011 34 91 807 21 99 |
| Contact Person: | Carlos Illana Alejandro |
| Date Prepared: | 15 July 2011 |
| Device Trade Name: | radiance |
| Common Name | Radiation Treatment Planning Software |
| Classification Name, | |
| Number & | |
| Product Code: | Medical charged-particle radiation therapy system |
| 21 CFR 892.5050 | |
| MUJ | |
| Predicate Devices: | RayStation K100552 cleared 12 March 2010 |
| Device Description | |
| and Statement of | |
| Intended Use | radiance 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. | |
| Statement of Intended Use: | |
| 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 |
1
| Summary of
Technological
Characteristics | The technological characteristics are essentially the same as those
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. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The radiance device is substantially equivalent to the RayStation
(K100552), with respect to technical and design features. The
submitted devices pose the same types of questions about safety or
effectiveness as the existing device. |
| Conclusion | The information discussed above demonstrates that the radiance
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. |
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| Feature | Device radiance | RayStation | Eclipse | NOVAC7 |
|---|---|---|---|---|
| 510(k) | ||||
| Number | K100552 | K102011 | K990209 | |
| Manufacturer | GMV Aerospace | |||
| and Defence S.A. | RaySearch | |||
| Laboratories AB | Varian Medical | |||
| Systems, Inc. | HITESYS S.P.A. | |||
| Classification |
& Product
Code | 21 CFR 892.5050
MUJ | 21 CFR 892.5050
MUJ | 21 CFR 892.5050
MUJ | 21 CFR 892.5050
IYE |
| Intended Use | 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 intended
users of radiance
shall be clinically | RayStation is a
software system
designed for
treatment
planning and
analysis of
radiation therapy.
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
RayStation shall
be clinically
qualified
radiation therapy | 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 NOVAC7 is
an electron linear
accelerator used
for radiation
therapy during
surgical
procedures in an
operating room
for the treatment
of malignant and
benign conditions.
Know as
intraoperative
radiation therapy
(IORT), this
technique allows
delivery of high
doses of radiation
directly aimed at
tumors or other
sites while
avoiding dosage
to surgically
mobilized normal
tissues.
The NOVAC7 is a
mobile and
articulated
machine that can
be moved towards
the patient and put
in the appropriate
position to carry
out the necessary
radiotherapy.
Applicators direct
the electron beam
to the surgical area
of interest |
| | qualified
radiation therapy
staff trained in
using the system. | staff trained in
using the
system. | | |
| System
Design | Software only | Same | Software only | Hardware and
Software |
| Calculation | Dose
distributions
computed using a
three dimensional
dose engine. | Same | Same for
electrons | Same for MU
computation |
| Input | Externally
acquired patient
medical images
and user input | Same | Same | Same for MU:
MU/Gy factor +
additional factors |
| Output | Treatment plans
with
corresponding
dose distributions | Same | Same for
electrons | Monitor units |
| 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 MU
computation |
.
Summary of Technical Characteristics
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4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Document Control Room - WO
JAN - 6 2012
GMV Aerospace and Defence S.A. % Mr. William F. Greenrose Official Correspondant and Regulatory Consultant for GMV Aerospace and Defence S.A. Oserve America. Inc. 220 River Road CLAREMONT NH 03743-5647
· Re: K112060
Trade/Device Name: radiance Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: December 8, 2011 Received: December 13, 2011
Dear Mr. Greenrose:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be ferm mrketing your device as described in your Section 510(k) premarket will anow you to begin mainening your intilal equivalence of your device to a legally marketed nonthoution. The I Driven a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific at res see you Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Theos, promotions of the mart 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/Safety/ReportaProblem/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 Tou may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K112060 510(k) Number (if known):
radiance Device Name:
Indications For Use:
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 intended users of radiance 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 CDRH, Office of Device Evaluation (ODE)
Marn Pastil
Page 1 of 1
Office of In Vitro Diag
510K. K112060