(55 days)
No
The document describes image processing and comparison with planned dose distributions for quality assurance, but does not mention AI, ML, or related terms.
No
The device is a software application intended for radiotherapy beam quality assurance (QA) by converting EPID images to a phantom dose distribution for comparison with a simulated dose. It helps a clinician decide if a treatment delivery device is capable of delivering treatment as prescribed, but it does not directly treat or diagnose a disease.
No
The device is a radiotherapy beam quality assurance (QA) software application, which means it evaluates the accuracy of radiation delivery rather than directly diagnosing patient conditions.
Yes
The device is explicitly described as a "software application" and its function is to process image data acquired by a third-party hardware device (EPID). It does not include or require any proprietary hardware components for its operation.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- EPIDose's Intended Use: The intended use of EPIDose is clearly stated as "radiotherapy beam QA software application intended for two-dimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS)."
- No Human Specimens: The device processes EPID images, which are generated during radiotherapy treatment delivery and represent the radiation beam's interaction with a phantom (or potentially the patient, but the output is a dose distribution in a phantom geometry). It does not analyze specimens derived from the human body (like blood, tissue, urine, etc.).
- Purpose is QA, Not Diagnosis: The purpose of EPIDose is quality assurance (QA) of the radiotherapy beam and treatment delivery system, not to diagnose a physiological or pathological state of a patient. The output is used by a qualified clinician to assess the accuracy of the treatment delivery, not to make a diagnosis about the patient's health.
In summary, EPIDose is a quality assurance tool for radiotherapy equipment and treatment plans, not a diagnostic device that analyzes human specimens to provide information about a patient's health.
N/A
Intended Use / Indications for Use
Model 1214 EPIDose is a radiotherapy beam QA software application intended for twodimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.
Product codes
IYE
Device Description
Sun Nuclear EPIDose product, model 1214, is a software application that converts electronic portal imaging device (EPID) image data -acquired by a third party treatment delivery device (TDD)- to a dose distribution which can subsequently be compared with the planned dose distribution for radiation therapy quality assurance purposes. From this companson of the EPIDose result to the planned dose, a qualified clinician makes the decision whether the TDD along with its accessories (including the treatment planning system, or TPS) is capable of delivering the treatment as prescribed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electronic portal imaging device (EPID) image data
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified 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)
EPIDose performance was verified using measurements internally performed as well as through reference. EPIDose and film results were compared for various clinical and non-clinical cases. For effective comparison of the data sets, gamma analysis was applied using a minimal pass rate of 68% with a 3.5% dose difference and 3.5 mm distance-to-agreement (DTA) tolerance, as recommended by report number 83 of the International Commission on Radiation Units and Measurements (ICRU). The pass rates for all cases were above 94%, greatly exceeding the recommended ICRU level. Given gamma analysis is a currently accepted scientific method for comparing two radiotherapy data sets and given the high level of agreement between EPIDose and film results, it is concluded that these results support a substantial equivalence determination with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimal pass rate of 68% with a 3.5% dose difference and 3.5 mm distance-to-agreement (DTA) tolerance. The pass rates for all cases were above 94%.
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 shows the logo for Sun Nuclear Corporation. The logo consists of a stylized sun symbol on the left, followed by the words "SUN NUCLEAR" in bold, sans-serif font on the top line. Below that, the word "corporation" is written in a smaller, sans-serif font. The sun symbol is a black circle with several horizontal white lines inside, partially obscured by a black shape on the right side.
Your Most Valuable QA & Dosimetry Tools
510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
June 7, 2013
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:
Jeff Kapatoes jeffkapatoes@sunnuclear.com
Classification Name:
Accelerator, Linear, Medical
- Common Name:
Dosimetric Quality Assurance for Patient Specific Radiation Treatment
Proprietary Names:
Model 1214 EPIDose
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system, dosimetric quality control system Product code: IYE
Predicate Device:
Model Name: | RIT113 Film Analysis System |
---|---|
Common Name: | Film Scanning System |
510(k) # | K935928 |
Manufacturer: | Radiation Imaging Technology |
Submitted: | Dec 7, 1993 |
AUG 0 5 2013
1
Image /page/1/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a black square with a stylized sun inside, followed by the words "SUN NUCLEAR" in bold, sans-serif font. Below that, the word "corporation" is written in a smaller, sans-serif font.
2 Description and Use:
Sun Nuclear EPIDose product, model 1214, is a software application that converts electronic portal imaging device (EPID) image data -acquired by a third party treatment delivery device (TDD)- to a dose distribution which can subsequently be compared with the planned dose distribution for radiation therapy quality assurance purposes. From this companson of the EPIDose result to the planned dose, a qualified clinician makes the decision whether the TDD along with its accessories (including the treatment planning system, or TPS) is capable of delivering the treatment as prescribed.
3 Intended Use Statement:
Sun Nuclear Corporation (SNC) Model 1214 EPIDose has the following intended use:
Model 1214 EPIDose is a radiotherapy beam QA software application intended for twodimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.
Apart from format and lanquage refinement, the intended use statements are substantively the same for EPIDose and the predicate device.
ব Technological Characteristics
The significant technological characteristic of EPIDose is the patented method for image to dose conversion, where the image is created by an amorphous silicon (a-Si) array produced in a third-party EPID (US Patent # 8, 130,905, March 6, 2012, "Dosimetry System and Method for Radiation Therapy"). The information density and spatial resolution of the dose distribution are comparable to that of film, while the durability, repeatability and accuracy are comparable to that of the dosimetric diode array.
The predicate device utilizes film for its radiation detector, which also provides a high spatial resolution and a large area that enables measurement of dose distributions that have high dose gradients found in radiotherapy deliveries. The film must be used in conjunction with a known phantom to simulate the correct radiologic characteristics. When this film is exposed to radiation theraov beam and then developed, the result is that the film exhibits an increased optical density. When a film is exposed by a patient radiation therapy treatment plan, this optical density can then be converted to a dose distribution as would be delivered by that radiation therapy treatment.
5 Performance Data and Comparison with Predicate
EPIDose performance was verified using measurements internally performed as well as through reference. EPIDose and film results were compared for various clinical and non-clinical cases. For effective comparison of the data sets, gamma analysis was applied using a minimal pass rate of 68% with a 3.5% dose difference and 3.5 mm distance-to-agreement (DTA) tolerance, as recommended by report number 83 of the International Commission on Radiation Units and Measurements (ICRU). The pass rates for all cases were above 94%, greatly exceeding the recommended ICRU level. Given gamma analysis is a currently accepted scientific method for comparing two radiotherapy data sets and given the high level of agreement between EPIDose and film results, it is concluded that these results support a substantial equivalence determination with the predicate device.
6 Summary
The Model 1214 EPIDose intended use, performance testing, safety and effectiveness reviews demonstrate that this device is as effective, and performs as well or better than the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 5, 2013
Sun Nuclear Corporation % Jeff Kapatoes 3275 Suntree Blvd. MELBOURNE, FL 32940
Re: K131704
Trade/Device Name: Model 1214 EPIDose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 7, 2013 Received: June 11, 2013
Dear Mr. Kapatoes:
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 10 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 docs 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.
Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "THE DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
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Page 2 - Mr. Kapatoes
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 sct 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K131704
Device Name: Model 1214 EPIDose
Indications for Use:
Model 1214 EPIDose is a radiotherapy beam QA software application intended for twodimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.
Prescription Usc X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (2) 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)
Michael D. O'Hara
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131704 210(k)
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