(98 days)
Not Found
No
The description focuses on hardware components, data acquisition, and basic data transfer/display. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision support.
No
A therapeutic device is used to treat or cure a disease or condition. This device is intended for radiotherapy dosimetry measurements and quality assurance, which means it helps in planning and verifying radiation treatments but does not directly administer therapy to a patient.
No
The device is intended for radiotherapy dosimetry measurements, commissioning a treatment planning system (TPS) computer, and periodic beam quality assurance (QA) tests. It measures charge produced by ionizing radiation to provide dose distributions and parameter analysis, which are all related to measurement and quality assurance of radiation delivery, not for diagnosing medical conditions in patients.
No
The device description explicitly lists multiple hardware components, including a linear array of radiation detectors, a waterproof enclosure, control electronics, and a cable. While it includes software (SNC Dosimetry and embedded code), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for radiotherapy dosimetry measurements for commissioning and quality assurance of a treatment planning system. This is a measurement and calibration tool used in the process of delivering radiation therapy, not a test performed on a biological sample from a patient to diagnose or monitor a medical condition.
- Device Description: The device measures ionizing radiation in a water phantom, which simulates the human body's response to radiation. It does not interact with or analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device measures physical properties (radiation dose) in a controlled environment (water phantom).
Therefore, the Model 1203 WaterProof PROFILER falls under the category of a medical device used in the delivery and quality control of radiation therapy, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.
Product codes
IYE
Device Description
The WaterProof PROFILER, model 1203, is a linear array of radiation detectors that are housed in a water proof enclosure that mounts to the 3D SCANNER's movement mechanisms. The electronics in the array measures charge produced in the detectors due to ionizing radiation. The WaterProof PROFILER provides measurement updates to the 3D SCANNER. The 3D SCANNER correlates the dose information with motor position information and transfers the data to a computer running SNC Dosimetry. SNC Dosimetry then provides a graphical user interface for viewing the measured dose distributions and its parameter analysis; it also provides a tool for exporting the data to treatment planning systems.
The WaterProof PROFILER includes five components:
-
- a linear array of radiation detectors;
-
- a water proof enclosure;
-
- a means for connecting to the 3D SCANNER's movement mechanisms;
-
- control electronics and embedded code to manage and transmit the data recorded from the radiation detectors;
-
- a cable that connects the water proof enclosure to the 3D SCANNER
The WaterProof PROFILER has applications in:
-
- delivery device data collection for commissioning a treatment planning system,
-
- quality assurance measurements of a treatment delivery device, and
-
- testing of a treatment delivery device at the manufactures facility.
To satisfy the applications above, the WaterProof PROFILER is capable of performing relative dose measurements, which may then be used to calculate QA parameters such as: field edge, field size, beam center, penumbra, wedge angles (dynamic and physical), symmetry and flatness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical physicist responsible for the QA program.
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)
The WaterProof PROFILER has been bench tested and shown that these devices perform within their design specifications. Tests that compare known static and dynamic fields required during treatment planning system commissioning have been performed; the results were found to have correlation between the WaterProof PROFILER and its predicate devices.
Performance testing also indicated compliance with relevant electrical safety and EMC standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5. 2014
Sun Nuclear Corporation % Ms. Noel Downey Project Manager 3275 Suntree Boulevard MELBOURNE FL 32940
Re: K142431
Trade/Device Name: Model 1203 - WaterProof Profiler Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 5, 2014 Received: November 10, 2014
Dear Ms. Downey:
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/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 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
2
Indications for Use
510(k) Number (if known) K142431
Device Name Model 1203 - Waterproof Profiler
Indications for Use (Describe)
The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (OA) tests as defined by the medical physicist responsible for the QA program.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Image /page/3/Picture/1 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. The logo is simple and modern, and it conveys the company's focus on nuclear energy.
Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
August 27, 2014
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:
Noel Downey
PH: 321-259-6862 ext. 242
Classification Name:
Accelerator, Linear, Medical
Common Name:
Detector Array
Proprietary Names:
Model 1203 WaterProof PROFILER
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system Product code: IYE
Primary Predicate Device:
| Model Name: | Model 1174 PROFILER 2 |
|---|---|
| Common Name: | Radiation Field Analyzer |
| 510(k) #: | K063021 |
| Manufacturer: | Sun Nuclear Corporation |
| Submitted: | 10/2/2006 |
4
Image /page/4/Picture/1 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. To the right of the image is the text "SUN NUCLEAR" in blue, with the word "corporation" underneath in a smaller font.
Secondary Predicate Device:
Model Name: Common Name: 510(k) # Manufacturer: Submitted:
Model 1230 3D SCANNER Water Phantom Ionizing Radiation Dosimetry Scanner K101992 Sun Nuclear Corporation July 13, 2010
Description and Use: 2
The WaterProof PROFILER, model 1203, is a linear array of radiation detectors that are housed in a water proof enclosure that mounts to the 3D SCANNER's movement mechanisms. The electronics in the array measures charge produced in the detectors due to ionizing radiation. The WaterProof PROFILER provides measurement updates to the 3D SCANNER. The 3D SCANNER correlates the dose information with motor position information and transfers the data to a computer running SNC Dosimetry. SNC Dosimetry then provides a graphical user interface for viewing the measured dose distributions and its parameter analysis; it also provides a tool for exporting the data to treatment planning systems.
The WaterProof PROFILER includes five components:
-
- a linear array of radiation detectors;
-
- a water proof enclosure;
-
- a means for connecting to the 3D SCANNER's movement mechanisms;
-
- control electronics and embedded code to manage and transmit the data recorded from the radiation detectors;
-
- a cable that connects the water proof enclosure to the 3D SCANNER
The WaterProof PROFILER has applications in:
-
- delivery device data collection for commissioning a treatment planning system,
-
- quality assurance measurements of a treatment delivery device, and
-
- testing of a treatment delivery device at the manufactures facility.
To satisfy the applications above, the WaterProof PROFILER is capable of performing relative dose measurements, which may then be used to calculate QA parameters such as: field edge, field size, beam center, penumbra, wedge angles (dynamic and physical), symmetry and flatness.
Intended Use Statements: 3
The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.
5
Image /page/5/Picture/1 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of 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 large, bold, blue letters, with the word "corporation" written in smaller, blue letters below.
Technological Characteristics ব
The primary technological characteristic of the WaterProof PROFILER is the array geometry, which facilitates measurement of static or dynamic dose deliveries in most beam configurations. The array length is 504mm and detector spacing is 4 mm.
The 1D array of diodes is embedded in a waterproof polycarbonate phantom at a depth of 0.8 g/cm2. Connection to the 3D SCANNER (K101992) provides remote control of positioning in a water bath as well as data acquisition in 100 ms update periods.
Performance Data and Comparison with Predicate 5
The WaterProof PROFILER has been bench tested and shown that these devices perform within their design specifications. Tests that compare known static and dynamic fields required during treatment planning system commissioning have been performed; the results were found to have correlation between the WaterProof PROFILER and its predicate devices.
Performance testing also indicated compliance with relevant electrical safety and EMC standards.
| | WaterProof
PROFILER | PROFILER 2 | 3D SCANNER |
|----------------------|------------------------|------------------------|--------------------------------------|
| Number of Arrays | 1 | 2 | 0 |
| Array Length | 50.4cm | X: 22.4cm
Y: 32.8cm | 50cm |
| | | | |
| Detectors per Array | 127 | X: 57
Y: 83 | 1 |
| | | | |
| Detector Density | 4mm/detector | 4mm/detector | 1 detector translated
across 50cm |
| Detector Area | 0.8x0.8mm | 0.8x0.8mm | User definable |
| Detector Sensitivity | 32nC/Gy | 32nC/Gy | User definable |
| Buildup | 1.0 g/cm2 | 0.8 g/cm2 | User definable |
| Waterproof | Yes | No | User definable |
| Sampling rate | 100ms | 100ms | 50ms |
Table of specification differences between WaterProof PROFILER, PROFILER 2 and the 3D SCANNER
Summary 6
The Model 1203 WaterProof PROFILER is deemed substantially equivalent to the predicate devices. 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 WaterProof PROFILER and the predicates do not raise new types of safety or effectiveness questions.