(63 days)
Not Found
No
The description focuses on independent dose calculation using a different algorithm and comparison to the TPS, without mentioning AI/ML techniques. The "Mentions AI, DNN, or ML" section is explicitly "Not Found".
No
DoseCHECK is a software product designed to independently calculate radiotherapy dose for quality assurance of planned doses, not to directly treat or diagnose a disease.
No
Explanation: The device is a software product used for quality checks of planned radiotherapy doses, not for diagnosing medical conditions. It compares dose distributions to detect errors in treatment planning systems.
Yes
The device description explicitly states "Sun Nuclear's DoseCHECK is a software product" and describes its function as a calculation and comparison tool utilizing existing medical imaging data (DICOM RT Plan, RT Structure Set, and CT Image Set) as inputs. There is no mention of any hardware component being part of the device itself.
Based on the provided information, Sun Nuclear's DoseCHECK is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "independently calculate radiotherapy dose to provide a quality check of the planned dose." This is a quality assurance/quality control function for a medical treatment (radiotherapy), not a diagnostic test performed on biological samples.
- Device Description: The device takes inputs like DICOM RT Plan, RT Structure Set, and CT Image Set, which are related to treatment planning and imaging, not biological samples. It performs dose calculations and comparisons, which are physics-based operations related to radiation therapy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. DoseCHECK does not fit this description.
N/A
Intended Use / Indications for Use
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM RT Plan, RT Structure Set, and CT Image Set
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
Model 1217028 DoseCHECK 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 device.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Sun Nuclear Corporation % Ms. Rene' Hardee Regulatory Affairs Specialist III 3275 Suntree Blvd. MELBOURNE FL 32940
Re: K161946
Trade/Device Name: Model 1217028 DoseCHECK Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 8, 2016 Received: July 15, 2016
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 (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.
1
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 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. 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 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.
Michael D'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) K161946
Device Name
Model 1217028 DoseCHECK
Indications for Use (Describe)
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| 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 is a logo for Sun Nuclear Corporation. The logo features a blue square with a yellow sun-like design inside on the left. To the right of the square, the words "SUN NUCLEAR" are written in a bold, blue font, with the word "corporation" written in a smaller, blue font underneath.
Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
June 10, 2016
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 1217028 DoseCHECK
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Accelerator, Linear, Medical Product code: IYE
Class II
4
Predicate Device(s):
| Model Name: | Mobius3D |
|---|---|
| Common Name: | Secondary check QA software |
| 510(k) # | K140660 |
| Manufacturer: | Mobius Medical Systems, LP |
| Submitted: | May 05, 2014 |
To our knowledge, this predicate has not been subject to a designrelated recall.
2 Description and Use:
DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.
3 Intended Use Statement:
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
ব Technological Characteristics
The primary technological characteristics of the Model 1217028 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) and a comparison of this independent calculation to the TPS dose distribution. The technological characteristics are believed to be substantially equivalent to the predicate device.
5 Performance Data and Comparison with Predicate
Model 1217028 DoseCHECK 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 device.
6 Summarv
Model 1217028 DoseCHECK is believed to be substantially equivalent to the predicate Mobius3D device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1217028 DoseCHECK is as safe, as effective, and performs as well as the predicate device.