(266 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on data collection, analysis, and workflow integration without suggesting advanced algorithmic learning.
No
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. While it supports radiotherapy, it doesn't directly treat or diagnose a disease or condition in a patient, which is the primary function of a therapeutic device. It is a QA and data management platform for professionals.
No
The device description indicates that SunCHECK is a software platform for collecting, detecting, comparing, calculating, analyzing, displaying, and storing radiotherapy quality assurance and dosimetry data. This functionality supports the management and analysis of QA efforts within a radiation therapy department, rather than directly diagnosing patient conditions.
Yes
The device is described as a "software platform" and a "server-based Web application." While it interacts with data from imaging systems, the device itself is presented as a software solution for data management and analysis, with no mention of accompanying hardware components being part of the submitted device.
Based on the provided information, SunCHECK is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that SunCHECK is for collecting, detecting, comparing, calculating, analyzing, displaying, and storing radiotherapy quality assurance and dosimetry data. This data is related to the performance of radiation therapy equipment and the delivery of radiation, not the analysis of biological samples from a patient to diagnose or monitor a medical condition.
- Device Description: The description reinforces that it's a software platform for integrating patient QA, machine QA, and data management workflows in a radiation therapy department.
- Lack of Biological Sample Analysis: There is no mention of SunCHECK analyzing blood, urine, tissue, or any other biological sample from a patient. IVDs are specifically designed for this purpose.
- Focus on Equipment and Treatment Data: The input modalities (EPID, kV, Cone Beam CT) and the data processed (radiotherapy QA and dosimetry data) are related to the radiation therapy equipment and the treatment delivery process, not the patient's biological state.
In summary, SunCHECK is a software tool for managing and analyzing data related to the quality and delivery of radiation therapy. This falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.
Product codes
IYE
Device Description
SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department's QA efforts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Utilization of the beam output from imaging systems including electronic portal imaging device (EPID), kV and Cone Beam CT that are part of the treatment delivery device.
Utilization of the beam output from an electronic portal imaging device (EPID).
The usage of three dimensional volumetric imaging information.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation therapy professionals
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
Model 1299028 SunCHECK has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Sun Nuclear Corporation % Ms. Rene' Hardee Regulatory Affairs Specialist III 3275 Suntree Blvd. MELBOURNE FL 32940
October 25, 2017
Re: K170307
Trade/Device Name: SunCHECK Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 13, 2017 Received: October 16, 2017
Dear Ms. Hardee:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
Page 2 - Ms. Rene' Hardee
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Division of Industry and Consumer Education (DICE) 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,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170307
Device Name SunCHECK
Indications for Use (Describe)
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 contains the logo for Sun Nuclear Corporation. The logo consists of a blue square with a yellow circle inside, with horizontal lines across the circle. To the right of the square is the text "SUN NUCLEAR" in blue, with the word "corporation" underneath in a smaller font, also in blue. The logo is clean and professional, suggesting a company in the technology or energy sector.
510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions Date Prepared:
September 27, 2017
Submitted by:
Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com
Contact Person:
Rene' Hardee ReneHardee@sunnuclear.com
Ph: 321-259-6862 extension 2304
Classification Name:
Accelerator, Linear, Medical
- Common Name:
Secondary check QA software
Proprietary Names:
Model 1299028 SunCHECK
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Accelerator, Linear, Medical
Product code: IYE
Class II
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Predicate Devices:
Primary Predicate:
| 1. | Model Name: | PerFRACTION |
|---|---|---|
| 2. | Common Name: | Secondary check QA software |
| 3. | 510(k) # | K141800 |
| 4. | Manufacturer: | Sun Nuclear Corporation |
| 5. | Submitted: | July 03, 2014 |
To our knowledge, this predicate has not been subject to a design-related recall.
Reference Device:
| 2. | Model Name: | DoseCHECK |
|---|---|---|
| Common Name: | Secondary check QA software | |
| 510(k) # | K161946 | |
| Manufacturer: | Sun Nuclear Corporation | |
| Submitted: | July 15, 2016 |
To our knowledge, this predicate has not been subject to a design-related recall.
2 Description and Use:
SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department's QA efforts.
3 Intended Use Statement:
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.
5
4 Technological Characteristics
The primary technological characteristics of the Model 1299028 SunCHECK can be broken up into 4 modules of functionality:
| Primary Software Technological Characteristics |
|---|
| 1. Utilization of the beam output from imaging systems including electronic portal |
| imaging device (EPID), kV and Cone Beam CT that are part of the treatment |
| delivery device to perform standardized QA of the treatment delivery device and |
| associated imaging systems. |
| 2. The usage of three dimensional volumetric imaging information and beam intensity |
| values in DICOM-RT format to compute a dose volume (also in DICOM-RT format) |
| and a comparison of this independent calculation to the TPS dose distribution. |
| 3. Utilization of the beam output from an electronic portal imaging device (EPID) that is |
| part of the treatment delivery device to perform a consistency check between |
| fraction delivery. |
-
- Data storage and display.
These technological characteristics are believed to be substantially equivalent to the predicate devices as seen in the below table.
- Data storage and display.
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Image /page/6/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a blue square with a yellow sun inside on the left, and the words "SUN NUCLEAR" in blue on the right. Below the words "SUN NUCLEAR" is the word "corporation" in a smaller blue font.
Your Most Valuable QA & Dosimetry Tools
| Areas of
Comparison | Subject Device:
Sun Nuclear Model 1299028
SunCHECK | Primary Predicate Device:
Sun Nuclear PerFRACTION
(K141800) | Reference Predicate Device:
Sun Nuclear DoseCHECK
(K161946) | Similarities and Differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | The primary technological
characteristics of the Model
1299028 SunCHECK are:
• PerFRACTION Technology
• DoseCHECK Technology
• SNC Machine Technology
• Data Storage
• Data Display
Application Server:
• Dual Intel Xeon Processor 2.4
GHz (6 Cores each with
hyperthreading)
• 64 GB (8x8 GB) 2133 MHz DDR4
RDIMM
• Dual NVidia Quadro M4000 8GB
• OS: 200 GB minimum usable
free space
• Recommendation for Data
Drive: 5.76 TB minimum RAID 5e
• Minimum 1 GB/s Ethernet with
teaming considered
• Microsoft Windows Server 2012
R3
Client Machine:
• Google Chrome browser
(recommended) or Internet
Explorer 11.0 (depending upon the
computer's operating system)
• Pentium 4 Dual Core
• CPU Speed: 1.6 GHz
• Total RAM: 2 GB
• Display resolution: 1280 x 1024
• Color depth: 32-bit
• Minimum Windows 7 OS | The primary technological
characteristics of PerFRACTION
are:
• The usage of EPID data to
perform an independent
secondary calculation.
• Comparison of the calculation to
the TPS calculated data.
Application Server:
• Dual Intel Xeon Processor 2.4 GHz
(6 Cores each with hyperthreading)
• 64 GB (8x8 GB) 2133 MHz DDR4
RDIMM
• Dual NVidia Quadro M4000 8GB
• OS: 200 GB minimum usable
free space
• Recommendation for Data
Drive: 5.76 TB minimum RAID 5e
• Minimum 1 GB/s Ethernet with
teaming considered
• Microsoft Windows Server 2012
R3
Client Machine:
• Google Chrome browser
(recommended) or Internet
Explorer 11.0 (depending upon the
computer's operating system)
• Pentium 4 Dual Core
• CPU Speed: 1.6 GHz
• Total RAM: 2 GB
• Display resolution: 1280 x 1024
• Color depth: 32-bit
• Minimum Windows 7 OS | The primary technological
characteristics of DoseCHECK are:
• the usage of three dimensional
volumetric imaging information and
beam intensity values in DICOM-RT
format to compute a dose volume
(also in DICOM-RT format)
• to support electron point dose
calculations
Application Server:
• Dual Intel Xeon Processor 2.4 GHz (6
Cores each with hyperthreading)
• 64 GB (8x8 GB) 2133 MHz DDR4
RDIMM
• Dual NVidia Quadro M4000 8GB
• OS: 200 GB minimum usable
free space
• Recommendation for Data
Drive: 5.76 TB minimum RAID 5e
• Minimum 1 GB/s Ethernet with
teaming considered
• Microsoft Windows Server 2012 R3
Client Machine:
• Google Chrome browser
(recommended) or Internet Explorer
11.0 (depending upon the computer's
operating system).
• Pentium 4 Dual Core
• CPU Speed: 1.6 GHz
• Total RAM: 2 GB
• Display resolution: 1280 x 1024
• Color depth: 32-bit
• Minimum Windows 7 OS | Similarities
The SunCHECK Technology
encompasses both the
PerFRACTION and DoseCHECK
Technologies.
Differences
SunCHECK includes the
additional technology of Class I
listed SNC Machine and data
storage and display. |
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Image /page/7/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a blue square with a yellow sun inside on the left, and the words "SUN NUCLEAR" in blue on the right. Below the words "SUN NUCLEAR" is the word "corporation" in a smaller blue font.
5 Performance Data and Comparison with Predicate
Model 1299028 SunCHECK has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate devices.
6 Summary
Model 1299028 SunCHECK is believed to be substantially equivalent to the predicate devices due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1299028 SunCHECK is as safe, as effective, and performs as well as the predicate devices.