SunCHECK

K170307 · Sun Nuclear Corporation · IYE · Oct 25, 2017 · Radiology

Device Facts

• Record ID: K170307
• Device Name: SunCHECK
• Applicant: Sun Nuclear Corporation
• Product Code: IYE · Radiology
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.

Device Story

SunCHECK is a server-based web application platform for radiation therapy departments; integrates patient QA, machine QA, and data management workflows. Inputs include DICOM-RT beam intensity values, 3D volumetric imaging, and beam output data from EPID, kV, and Cone Beam CT imaging systems. Device performs independent dose calculations, compares results to Treatment Planning System (TPS) dose distributions, and monitors consistency between fraction deliveries. Operates on a centralized server accessible via networked PCs; provides a single GUI for data display and storage. Enables radiation therapy professionals to verify treatment delivery accuracy and manage departmental QA efforts. Benefits include centralized oversight of QA workflows and improved verification of radiation dose delivery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing demonstrated that the device performs within design specifications and equivalently to predicate devices.

Technological Characteristics

Server-based web application; utilizes DICOM-RT data, EPID, kV, and Cone Beam CT imaging inputs. Hardware requirements: Dual Intel Xeon 2.4 GHz processors, 64 GB RAM, Dual NVidia Quadro M4000 GPUs, Windows Server 2012 R3. Connectivity via 1 GB/s Ethernet. Software modules include PerFRACTION (EPID-based secondary calculation), DoseCHECK (3D volumetric dose computation), and SNC Machine QA. Data storage and display functionality included.

Indications for Use

Indicated for use by radiation therapy professionals to perform quality assurance and dosimetry data management for radiotherapy treatment delivery devices and associated imaging systems.

Regulatory Classification

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.

Predicate Devices

• PerFRACTION (K141800)

Reference Devices

• DoseCHECK (K161946)

Submission Summary (Full Text)

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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

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### 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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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# 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: [phone] Web: www.sunnuclear.com

Contact Person:

Rene' Hardee [e-mail]

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.

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#### 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<br>imaging device (EPID), kV and Cone Beam CT that are part of the treatment<br>delivery device to perform standardized QA of the treatment delivery device and<br>associated imaging systems. |
| 2. The usage of three dimensional volumetric imaging information and beam intensity<br>values in DICOM-RT format to compute a dose volume (also in DICOM-RT format)<br>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<br>part of the treatment delivery device to perform a consistency check between<br>fraction delivery. |

- 4. Data storage and display.
These technological characteristics are believed to be substantially equivalent to the predicate devices as seen in the below table.

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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<br>Comparison | Subject Device:<br>Sun Nuclear Model 1299028<br>SunCHECK | Primary Predicate Device:<br>Sun Nuclear PerFRACTION<br>(K141800) | Reference Predicate Device:<br>Sun Nuclear DoseCHECK<br>(K161946) | Similarities and Differences |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | The primary technological<br>characteristics of the Model<br>1299028 SunCHECK are:<br>• PerFRACTION Technology<br>• DoseCHECK Technology<br>• SNC Machine Technology<br>• Data Storage<br>• Data Display<br>Application Server:<br>• Dual Intel Xeon Processor 2.4<br>GHz (6 Cores each with<br>hyperthreading)<br>• 64 GB (8x8 GB) 2133 MHz DDR4<br>RDIMM<br>• Dual NVidia Quadro M4000 8GB<br>• OS: 200 GB minimum usable<br>free space<br>• Recommendation for Data<br>Drive: 5.76 TB minimum RAID 5e<br>• Minimum 1 GB/s Ethernet with<br>teaming considered<br>• Microsoft Windows Server 2012<br>R3<br>Client Machine:<br>• Google Chrome browser<br>(recommended) or Internet<br>Explorer 11.0 (depending upon the<br>computer's operating system)<br>• Pentium 4 Dual Core<br>• CPU Speed: 1.6 GHz<br>• Total RAM: 2 GB<br>• Display resolution: 1280 x 1024<br>• Color depth: 32-bit<br>• Minimum Windows 7 OS | The primary technological<br>characteristics of PerFRACTION<br>are:<br>• The usage of EPID data to<br>perform an independent<br>secondary calculation.<br>• Comparison of the calculation to<br>the TPS calculated data.<br>Application Server:<br>• Dual Intel Xeon Processor 2.4 GHz<br>(6 Cores each with hyperthreading)<br>• 64 GB (8x8 GB) 2133 MHz DDR4<br>RDIMM<br>• Dual NVidia Quadro M4000 8GB<br>• OS: 200 GB minimum usable<br>free space<br>• Recommendation for Data<br>Drive: 5.76 TB minimum RAID 5e<br>• Minimum 1 GB/s Ethernet with<br>teaming considered<br>• Microsoft Windows Server 2012<br>R3<br>Client Machine:<br>• Google Chrome browser<br>(recommended) or Internet<br>Explorer 11.0 (depending upon the<br>computer's operating system)<br>• Pentium 4 Dual Core<br>• CPU Speed: 1.6 GHz<br>• Total RAM: 2 GB<br>• Display resolution: 1280 x 1024<br>• Color depth: 32-bit<br>• Minimum Windows 7 OS | The primary technological<br>characteristics of DoseCHECK are:<br>• the usage of three dimensional<br>volumetric imaging information and<br>beam intensity values in DICOM-RT<br>format to compute a dose volume<br>(also in DICOM-RT format)<br>• to support electron point dose<br>calculations<br>Application Server:<br>• Dual Intel Xeon Processor 2.4 GHz (6<br>Cores each with hyperthreading)<br>• 64 GB (8x8 GB) 2133 MHz DDR4<br>RDIMM<br>• Dual NVidia Quadro M4000 8GB<br>• OS: 200 GB minimum usable<br>free space<br>• Recommendation for Data<br>Drive: 5.76 TB minimum RAID 5e<br>• Minimum 1 GB/s Ethernet with<br>teaming considered<br>• Microsoft Windows Server 2012 R3<br>Client Machine:<br>• Google Chrome browser<br>(recommended) or Internet Explorer<br>11.0 (depending upon the computer's<br>operating system).<br>• Pentium 4 Dual Core<br>• CPU Speed: 1.6 GHz<br>• Total RAM: 2 GB<br>• Display resolution: 1280 x 1024<br>• Color depth: 32-bit<br>• Minimum Windows 7 OS | Similarities<br>The SunCHECK Technology<br>encompasses both the<br>PerFRACTION and DoseCHECK<br>Technologies.<br>Differences<br>SunCHECK includes the<br>additional technology of Class I<br>listed SNC Machine and data<br>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.