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.

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

AI/ML Overview

This document is a 510(k) premarket notification for the Sun Nuclear Corporation Model 1203 - WaterProof Profiler. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than a typical clinical study with acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not directly applicable.

However, I can extract the information provided about the device's technical specifications and the comparison made for demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

This document describes technical characteristics and a comparison against predicate devices, but it does not specify explicit "acceptance criteria" in the sense of performance metrics with thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic algorithm). Instead, the performance evaluation for this device, a radiotherapy dosimetry measurement tool, focuses on its ability to perform its intended measurements and its compliance with relevant standards.

The table below summarizes the key performance specifications of the Model 1203 WaterProof PROFILER compared to its predicate devices, as presented in the document. The "acceptance criteria" here are implied by the ability to function as intended and similarity to predicate devices.

Feature / Performance Metric	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Model 1203 WaterProof PROFILER)
Intended Use	For radiotherapy dosimetry measurements for commissioning a TPS computer and periodic beam QA tests.	Intended for radiotherapy dosimetry measurements for commissioning a TPS computer and periodic beam QA tests. (Matches Predicate's intent).
Relative Dose Measurements	Capable of performing relative dose measurements for QA parameters (field edge, field size, beam center, penumbra, wedge angles, symmetry, flatness).	Capable of performing relative dose measurements, which may then be used to calculate QA parameters (field edge, field size, beam center, penumbra, wedge angles, symmetry, flatness).
Bench Testing	Perform within design specifications, correlation with predicate devices for known static and dynamic fields.	Bench tested; performs within design specifications. Results found to have correlation between WaterProof PROFILER and its predicate devices.
Array Length	Similar to predicate devices' combined or individual array lengths sufficient for 50cm scanning.	50.4cm
Detectors per Array	Sufficient for intended measurement resolution.	127
Detector Density	4mm/detector	4mm/detector (Matches predicate PROFILER 2)
Detector Area	0.8x0.8mm	0.8x0.8mm (Matches predicate PROFILER 2)
Detector Sensitivity	32nC/Gy	32nC/Gy (Matches predicate PROFILER 2)
Buildup	1.0 g/cm2	1.0 g/cm2 (Slight difference from PROFILER 2's 0.8 g/cm2, but within acceptable range for dosimetry).
Waterproof	Desirable feature for intended use.	Yes (Key differentiating feature from PROFILER 2)
Sampling Rate	100ms or faster.	100ms (Matches predicate PROFILER 2).
Electrical Safety & EMC	Compliance with relevant standards.	Performance testing indicated compliance with relevant electrical safety and EMC standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical data for an AI/diagnostic algorithm. The device is a physical measurement tool.

Test Set Description: The "performance data" refers to bench testing of the physical device.
Sample Size: Not applicable in the traditional sense of a patient cohort. The testing involves the device itself and its components.
Data Provenance: The testing was conducted by Sun Nuclear Corporation as part of the device's design and verification process. Specific country of origin for the data is not mentioned beyond the manufacturing location. The testing is assumed to be prospective as it's part of the device's development and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth. Ground truth for dosimetry measurements would typically involve established physics principles, reference detectors, and phantoms.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication described for the device's performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical dosimetry measurement tool, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a "standalone" measurement tool. Its performance was evaluated through "bench testing" to ensure it met design specifications and correlated with predicate devices. This is analogous to a standalone performance evaluation for a physical device.

7. The Type of Ground Truth Used

The "ground truth" for evaluating this device would be established physical dosimetry standards, reference measurement devices, and known radiation fields. The document states: "Tests that compare known static and dynamic fields required during treatment planning system commissioning have been performed." This implies that the device's measurements were compared against these "known" or established values.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware measurement tool, not a machine learning algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there is no training set mentioned in the context of this device.

Summary

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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.

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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 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

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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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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

noeld@sunnuclear.com

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

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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 includes five components:

1. a linear array of radiation detectors;
1. a water proof enclosure;
1. a means for connecting to the 3D SCANNER's movement mechanisms;
1. control electronics and embedded code to manage and transmit the data recorded from the radiation detectors;
1. a cable that connects the water proof enclosure to the 3D SCANNER

The WaterProof PROFILER has applications in:

1. delivery device data collection for commissioning a treatment planning system,
1. quality assurance measurements of a treatment delivery device, and
1. 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

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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.

	WaterProofPROFILER	PROFILER 2	3D SCANNER
Number of Arrays	1	2	0
Array Length	50.4cm	X: 22.4cmY: 32.8cm	50cm

Detectors per Array	127	X: 57Y: 83	1

Detector Density	4mm/detector	4mm/detector	1 detector translatedacross 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.

Regulation Number and Section

§ 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.