(50 days)
Not Found
No
The description focuses on deterministic calculations based on user-provided data and a pre-defined beam model, with no mention of learning or adaptive algorithms.
No
The device is a dose calculator, which is used for planning and calculating radiation therapy doses, but it does not directly treat or diagnose a medical condition.
No
The device computes a radiotherapy dose volume for treatment planning, not for diagnosing a medical condition.
Yes
The device description explicitly states "The Sun Nuclear Dose Calculator is a software product" and "The Dose Calculator software application is considered to be a software module". There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, the Sun Nuclear Dose Calculator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Sun Nuclear Dose Calculator is a software product that computes a radiotherapy dose volume based on imaging data and beam intensity values. It is used in the planning and delivery of external beam radiation therapy.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from a patient. Its inputs are imaging data and treatment parameters, not biological specimens.
Therefore, the Sun Nuclear Dose Calculator falls under the category of a medical device used in radiation therapy planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.
Product codes
IYE
Device Description
Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume.
The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product.
The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
three dimensional volumetric imaging information (e.g., computed tomography)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 1218028 Dose Calculator 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
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.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2015
Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Manager 3275 Suntree Boulevard MELBOURNE FL 32940
Re: K150848
Trade/Device Name: Model 1218028 Dose Calculator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 13, 2015 Received: March 31, 2015
Dear Mr. Luker:
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. Isting 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.
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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/Resourcesfor You/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 O'Hara
For
Robert Ochs, Ph.D. Acting 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 Form
510(k) Number (if known): _ K150848
Device Name: Model 1218028 Dose Calculator
Indications for Use:
The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K150848 510(k)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Image /page/3/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.
Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
March 12, 2015
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:
James Luker JamesLuker@sunnuclear.com
Ph: 321-259-6862 extension 2428
Classification Name:
Accelerator, Linear, Medical
Common Name:
Secondary check QA software
Proprietary Names:
Model 1218028 Dose Calculator
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 Device(s):
| Model Name: | Mobius 3D |
|---|---|
| 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:
Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume.
The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product.
The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.
3 Intended Use Statement:
The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.
ব Technological Characteristics
The primary technological characteristics of the Model 1218028 Dose Calculator 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). The technological characteristics are believed to be substantially equivalent to the predicate device.
5 Performance Data and Comparison with Predicate
Model 1218028 Dose Calculator 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 1218028 Dose Calculator is believed to be substantially equivalent to the predicate Mobius 3D device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1218028 Dose Calculator is as safe, as effective, and performs as well as the predicate device.