EZFluence

K171352 · Radformation, Inc. · IYE · Dec 1, 2017 · Radiology

Device Facts

• Record ID: K171352
• Device Name: EZFluence
• Applicant: Radformation, Inc.
• Product Code: IYE · Radiology
• Decision Date: Dec 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.

Device Story

EZFluence is a software plugin (DLL) for Varian Eclipse Treatment Planning System (TPS) used by radiation treatment planning professionals. It ingests patient and plan data from Eclipse to generate optimal fluences for photon treatment fields. The device automatically preserves static multi-leaf collimator (MLC) blocking, adds 'flash' (extending fluence to field edges), and optimizes fluences across multiple beams simultaneously. It also allows users to set maximum dose limits. These automated features aim to improve treatment plan quality and safety compared to manual editing or single-beam compensation. The output is an optimized fluence map used by the clinician to finalize the radiation therapy plan, potentially improving dose homogeneity and reducing setup error risks for patients undergoing external beam radiation therapy.

Clinical Evidence

No clinical trials were performed. Substantial equivalence is supported by bench-level verification and validation testing, including pass/fail criteria for software requirements and hazard analysis.

Technological Characteristics

Pure software (DLL plugin) running on Windows OS. Operates within Varian Eclipse TPS environment. Functions as a dosimetric quality control system for photon radiation therapy. Uses algorithmic optimization for fluence generation, MLC blocking preservation, and flash extension.

Indications for Use

Indicated for radiation treatment planning professionals to generate optimal fluences for homogeneous dose distribution in external beam photon radiation therapy treatment plans.

Regulatory Classification

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.

Predicate Devices

• Eclipse Treatment Planning System (K152393)

Reference Devices

• Eclipse Treatment Planning System Version 13.5 (K141283)

Submission Summary (Full Text)

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December 1, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Radformation, Inc. % Mr. Kurt Sysock Co-founder/CEO 335 Madison Avenue, 16th Floor NEW YORK NY 10017

## Re: K171352

Trade/Device Name: EZFluence Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: October 4, 2017 Received: October 11, 2017

Dear Mr. Sysock:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. 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)

K171352

Device Name EZFluence

Indications for Use (Describe)

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.

Type of Use (Select one or both, as applicable)

X 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

. . . . . . . .

:

Radformation, Inc.

:

510(k) Submission

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This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.

| Table 1 : Submitter's Information | |
|-----------------------------------|------------------------------------------------------|
| Submitter's Name: | Kurt Sysock |
| Company: | Radformation, Inc. |
| Address: | 335 Madison Avenue, 16th Floor<br>New York, NY 10017 |
| Contact Person: | Alan Nelson<br>Chief Science Officer, Radformation |
| Phone: | 518-888-5727 |
| Fax: | ---------- |
| Email: | [e-mail] |
| Date of Summary Preparation | 05/01/2017 |

## 5.1. Submitter's Information

## 5.2. Device Information

| Table 2 : Device Information | | | |
|------------------------------|-----------------------------------------------------------------------------------------|--|--|
| Trade Name: | EZFluence | | |
| Common Name: | Oncology Information System | | |
| Classification Name: | Class II | | |
| Classification: | Medical charged-particle radiation therapy system,<br>dosimetric quality control system | | |
| Regulation Number: | 892.5050 | | |
| Product Code:: | IYE | | |
| Classification Panel: | Radiology | | |

#### 5.3. Predicate Device Information

Eclipse Treatment Planning System (K152393)

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#### 5.4. Device Description

The EZFluence device (model RADEZ) is software is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields. Inputs are obtained from plan and patient data obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. EZFluence runs as a dynamic link library (DLL) plugin to Varian Eclipse.

It is designed to run on the Windows Operating System. EZFluence performs calculations on the plan obtained from Eclipse TPS (Version 13.5 (K141283) and Version 13.7 (K152393)) which is a software device used by trained medical professionals to design and simulate radiation therapy treatment plans for malignant or benign diseases.

#### 5.5. Indications for Use

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.

#### 5.6. Technological Characteristics

EZFluence (Subject Device) makes use of a Predicate Device, Eclipse Treatment Planning System (K152393) for substantial equivalence comparison.

## 5.6.1. EZFluence vs. Eclipse Treatment Planning System (K152393)

The Eclipse Treatment Planning System (TPS) External Beam Planning workspace has two features that are considered substantially equivalent with the functionality provided by EZFluence:

- 1. Irregular Surface Compensator
- 2. Optimal Fluence Editing

| Table 3: Substantial Equivalence Table for EZFluence | | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------|
| Parameters | Subject Device: EZFluence Radformation | Predicate Device: Eclipse Treatment Planning System, Varian Medical Systems (K152393) | Equivalence |
| Indications for use | Used to assist radiation treatment planners in generating optimal fluences for external beam radiation therapy treatment plans with photon treatment fields. | Used to plan radiotherapy treatments for patients with malignant or benign diseases. | Subject Device is a subset of the Predicate Device |

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| Pure software | Yes | Yes | Equivalent |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended users | Trained medical<br>professionals to design and<br>simulate radiation therapy<br>treatments | Trained medical professionals<br>to design and simulate<br>radiation therapy treatments | Equivalent |
| OTC/Rx | Rx | Rx | Equivalent |
| EZFluence vs. Eclipse Irregular Surface Compensator | | | |
| Functionality | Optimizes optimal fluences<br>for treatment fields to obtain<br>a homogeneous dose in the<br>middle of the patient and to<br>control the maximum dose<br>allowed in the patient. | Optimizes optimal fluences for<br>a specific field to obtain a<br>homogeneous dose at a plane<br>with depth specified by the<br>user. | Minor<br>differences |
| EZFluence vs. Eclipse Optimal Fluence Editing | | | |
| Functionality | Allows user to manually<br>change fluence intensities of<br>an optimal fluence. | Allows user to manually<br>change fluence intensities of<br>an optimal fluence. | Equivalent |

As shown in Table 3, EZFluence's indications for use are a subset of Eclipse TPS's indication for use, and the core functionality provided by EZFluence is substantially equivalent with Eclipse TPS's Irregular Surface Compensator and Optimal Fluence Editing features.

#### 5.6.2. Differences

The minor differences between EZFluence and the Irregular Surface Compensator are as follows:

- 1. EZFluence automatically preserves static multi-leaf collimator blocking by assigning 0 fluence intensity wherever the field was blocked while Eclipse Irregular Surface Compensator does not. By doing this, EZFluence increases safety and efficiency as radiation treatment planners generally have to manually set fluence intensities to 0 wherever there were blocks in the original treatment plan (a step that can easily be forgotten, inadvertently increasing dose, in breast radiotherapy for example, to the heart).
- 2. EZFluence automatically adds "flash" wherever the field does not intersect the body by extending the fluence nearest to the edge of the patient to the edge of the field. High quality breast radiation therapy, for example, always requires flash in order to ensure the breast is adequately dosed with radiation even when there are day-to-day setup errors. The Eclipse Irregular Surface Compensator does not account for flash and so

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the user must manually add flash in order to ensure high quality treatment when they use it for breast treatments. In this way, EZFluence's differences from the Irregular Surface Compensator only increase safety relative to the predicate device.

- 3. Because EZFluence simultaneously generates optimal fluences for multiple beams instead of for single beams as the Eclipse Irregular Surface Compensator does, EZFluence produces optimal fluences that result in a generally more acceptable and high quality homogeneous dose distribution. Thus the differences between EZFluence and Eclipse Irregular Surface Compensator represent an increase in safety and quality by EZFluence.
- EZFluence allows the user to limit the maximum dose to the patient while 4. the Eclipse Irregular Surface Compensator does not have that feature.

#### 5.7. Performance Data

As with the Predicate Device, no clinical trials were performed for EZFluence. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements.

#### 5.8 Conclusion

EZFluence is deemed substantially equivalent to the Predicate Device, Eclipse Treatment Planning System (K152393) due to the similarities with the Irregular Surface Compensator and Optimal Fluence Editing features of Eclipse. Verification and Validation testing and Hazard Analysis demonstrate that EZFluence is as safe and effective as the Predicate Device. The minor technological differences between EZFluence and the Predicate Device do not raise any guestions on the safety and effectiveness of the Subject Device.