(91 days)
Ka35928
Not Found
No
The description focuses on hardware (diode arrays) and standard software functions for data acquisition, display, comparison (gamma, dose difference, DTA), and reporting. There is no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed for quality assurance and dosimetry of radiation therapy equipment, not for directly treating patients. It measures and compares radiation dose distributions to ensure the accuracy of treatment planning systems.
No
The device is a quality assurance (QA) system used to measure radiation dose distributions for comparison with simulated dose distributions from a treatment planning system. It is used to verify the accuracy of a patient's radiation therapy plan prior to treatment, not to diagnose a medical condition in a patient.
No
The device description explicitly states that the devices are "diode detector arrays" embedded in a PMMA phantom, which are physical hardware components used for measuring radiation dose distributions. While software is used for analysis and comparison, the core device includes significant hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution... calculated by the treatment planning system (TPS)." This is a quality assurance (QA) process for radiation therapy equipment and treatment plans, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device measures radiation dose using diode detector arrays embedded in a phantom. It does not interact with or analyze biological samples (like blood, urine, tissue, etc.).
- Lack of Biological Sample Analysis: The entire description focuses on measuring physical radiation dose and comparing it to a calculated plan. There is no mention of analyzing any biological material.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
Model 1220 ArcCHECK is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Model 1177 MapCHECK 2 and Model 1220 ArcCHECK devices are diode detector arrays that allow the user to perform radiation therapy delivery quality assurance (QA) and dosimetrv.
The MapCHECK 2 is a two-dimensional detector array intended to measure radiation dose distribution. The 1527 diode detectors are embedded in polymethyl methacrylate (PMMA) phantom in an array size of 32 cm, with a detector spacing of 7.07 mm and a weight of 7.1 kg. With the provided software installed on the user's computer and connected to the MapCHECK 2 with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.
The ArcCHECK is a three-dimensional cylindrical detector array designed for coherent measurement geometry during rotational treatment delivery. The 1386 diode detectors are embedded in a PMMA phantom on a cylindrical geometric surface with an array size of 21 cm diameter x 21 cm length, with a detector spacing of 10 mm and a weight of 16 kg. This cylindrical array allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. With the provided software installed on the user's computer and connected to the ArcCHECK with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.
Both MapCHECK 2 and ArcCHECK use the same software application that includes functions for array and dose calibration; measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan; saving the measurement; importing the treatment planning system (TPS) calculated dose distribution; comparing the measured and planned dose distributions using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria; and a report of this analysis that includes percent pass rates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MapCHECK 2 and the ArcCHECK have been tested in non-clinical and clinical settings, and it was shown that these devices perform within their design specifications. Tests that compare known patient treatment plan outputs with that measured by these devices have been conducted; the results were found to have correlation with the actual treatment plan.
Tests were also performed to compare the results of the MapCHECK 2 and the ArcCHECK with film dosimetry devices. It was determined that the results had good correlation.
Performance testing also indicated compliance with relevant electrical safety and EMC standards.
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.
Ka35928
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 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, uppercase letters. Below "SUN NUCLEAR" is the word "corporation" in a smaller, non-bold font. The logo is simple and professional, conveying a sense of reliability and expertise.
Your Most Valuable QA & Dosimetry Tools
Section 6 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
General Provisions 1
Date Prepared:
May 17, 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 jkapatoes@sunnuclear.com
Classification Name:
Accelerator, Linear, Medical
Common Name:
Dosimetric Quality Assurance for Patient Specific Radiation Treatment
Proprietary Names:
Model 1177 MapCHECK 2 Model 1220 ArcCHECK
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) # Ka35928 Manufacturer: Radiation Imaging Technology Dec 7, 1993 Submitted:
AUG 20 2013
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Image /page/1/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.
2 Description and Use:
The Model 1177 MapCHECK 2 and Model 1220 ArcCHECK devices are diode detector arrays that allow the user to perform radiation therapy delivery quality assurance (QA) and dosimetrv.
The MapCHECK 2 is a two-dimensional detector array intended to measure radiation dose distribution. The 1527 diode detectors are embedded in polymethyl methacrylate (PMMA) phantom in an array size of 32 cm, with a detector spacing of 7.07 mm and a weight of 7.1 kg. With the provided software installed on the user's computer and connected to the MapCHECK 2 with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.
The ArcCHECK is a three-dimensional cylindrical detector array designed for coherent measurement geometry during rotational treatment delivery. The 1386 diode detectors are embedded in a PMMA phantom on a cylindrical geometric surface with an array size of 21 cm diameter x 21 cm length, with a detector spacing of 10 mm and a weight of 16 kg. This cylindrical array allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. With the provided software installed on the user's computer and connected to the ArcCHECK with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.
Both MapCHECK 2 and ArcCHECK use the same software application that includes functions for array and dose calibration; measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan; saving the measurement; importing the treatment planning system (TPS) calculated dose distribution; comparing the measured and planned dose distributions using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria; and a report of this analysis that includes percent pass rates.
3 Intended Use Statements:
Sun Nuclear Corporation (SNC) Model 1177 MapCHECK 2 and Model 1220 ArcCHECK have the following intended use:
Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
Model 1220 ArcCHECK is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
4 Technological Characteristics
The primary technological characteristic of the MapCHECK 2 and the ArcCHECK is the high spatial resolution of the diode detector with an array size and a detector density that enables measurement of dose distributions that have high dose gradients found in radiotherapy deliveries. The spatial resolution of the diode detector is 0.8 mm x 0.8 mm, resulting in very little dose volume averaging over the high dose gradient regions in the plan.
The MapCHECK 2 serves as a 2D phantom with the array of detectors located on a 2D surface embedded at a radiological depth of 2 g/cm². The ArcCHECK serves as a 3D
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Image /page/2/Picture/0 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, uppercase letters. Below that, the word "corporation" is written in a smaller, lowercase font. The logo is simple and professional, conveying a sense of reliability and expertise.
phantom with the detectors located on a 3D cylindrical surface embedded at a radiological depth of 3 g/cm².
The predicate device utilizes silver halide film for its radiation detector, which also provides a high spatial resolution and a large area (25 cm x 30 cm) 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 from a radiation therapy 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
The MapCHECK 2 and the ArcCHECK have been tested in non-clinical and clinical settings, and it was shown that these devices perform within their design specifications. Tests that compare known patient treatment plan outputs with that measured by these devices have been conducted; the results were found to have correlation with the actual treatment plan.
Tests were also performed to compare the results of the MapCHECK 2 and the ArcCHECK with film dosimetry devices. It was determined that the results had good correlation.
Performance testing also indicated compliance with relevant electrical safety and EMC standards.
6 Summary
The Model 1177 MapCHECK 2 and the Model 1220 ArcCHECK are deemed substantially equivalent to the predicate device. The intended use, performance testing, safety and effectiveness reviews demonstrate that these devices are as safe, as effective, and perform as well or better than the predicate device. The minor technological differences between the MapCHECK 2, the ArcCHECK and the predicate do not raise new types of safety or effectiveness questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
JEFF KAPATOES PRODUCT MANAGER SUN NUCLEAR CORPORATION 3275 SUNTREE BLVD. MELBOURNE FL 32940
Re: K131466
Trade/Device Name: MapCheck 2, ArcCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 18, 2013 Received: July 19, 2013
Dear Dr. 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 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 (sec 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Dr. Kapatoes
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 vours,
Sammy H. Presto
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K131466
Device Name:Model 1177 MapCHECK2 and Model 1220 ArcCHECK
Indications for Use:
Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
ArcCHECK, Model 1220 is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).
Perscription 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)
Flaminghi. Meroe
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_k131466
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