ChartCheck

K201119 · Radformation, Inc. · IYE · Jun 26, 2020 · Radiology

Device Facts

• Record ID: K201119
• Device Name: ChartCheck
• Applicant: Radformation, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The ChartCheck device is intended for the quality assessment of radiotherapy treatment plans and on treatment chart review.

Device Story

ChartCheck is a cloud-based software for radiotherapy quality assurance. It utilizes an agent service to monitor the ARIA Radiation Therapy Management database, extracting treatment plans, records, imaging, and documentation. Data is uploaded to a cloud-based service that calculates 'check states' (pass/fail/override/condition) based on user-defined logic. Results are presented via a web browser application where radiation oncology personnel review treatment records, view calculated check states, record comments, and approve charts. Administrators use the interface to configure check state colors, default settings, and logic. The device assists clinicians in verifying treatment plans and treatments, potentially improving the efficiency and accuracy of chart reviews.

Clinical Evidence

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

Technological Characteristics

Pure software application. Operates as a cloud-based service with a local agent for database monitoring. Integrates with ARIA Radiation Therapy Management database. Web-based user interface. Logic-based check state calculation.

Indications for Use

Indicated for trained radiation oncology personnel performing quality assessment of radiotherapy treatment plans and on-treatment chart review.

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

• ARIA Radiation Therapy Management (K173838)

Submission Summary (Full Text)

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June 26, 2020

Image /page/0/Picture/1 description: The image shows 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 in blue. Underneath the FDA logo is the text "ADMINISTRATION".

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

Re: K201119

Trade/Device Name: ChartCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 21, 2020 Received: April 27, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201119

Device Name ChartCheck

Indications for Use (Describe)

The ChartCheck device is intended for the quality assessment of radiotherapy treatment plans and on treatment chart review.

| 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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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.

# 5.1. Submitter's Information

#### K201119

| 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 | 04/20/2020 |

### 5.2. Device Information

| Table 2 : Device Information | |
|------------------------------|-----------------------------------------------------------------------------------------|
| Trade Name: | ChartCheck |
| 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

ARIA Radiation Therapy Management (K173838)

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# 5.4. Device Description

The ChartCheck device is software that enables trained radiation oncology personnel to perform quality assessments of treatment plans and treatment chart review utilizing plan, treatment, imaging, and documentation data obtained from the ARIA Radiation Therapy Management database.

ChartCheck contains 3 main components:

- 1. An agent service that is configured by the user to monitor their ARIA Radiation Therapy Management database. The agent watches for new treatment plans, treatment records, documentation, and imaging data. The agent uploads new data to the cloud based checking service.
- 2. A cloud based checking service calculates check states as new records are uploaded from the agent.
- 3. A web application accessed via a web browser which contains several components.
- a. It allows trained radiation oncology personnel to review treatment records, view the check state calculation results, record comments,, and mark the chart checks as approved.
- b. It allows an administrator to set check state colors, configure default settings, and define check state logic.

# 5.5. Indications for Use

The ChartCheck device is intended for the quality assessment of radiotherapy treatment plans and on treatment chart review.

### 5.6. Technological Characteristics

ChartCheck (Subject Device) makes use of a Predicate Device, ARIA Radiation Therapy Management (K173838) for substantial equivalence comparison.

# 5.6.1. ChartCheck vs. ARIA Radiation Therapy Management (K173838)

Varian's ARIA Radiation Therapy Management software "is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments." (https://www.accessdata.fda.gov/cdrh docs/pdf17/K173838.pdf accessed 04/17/2020)

ChartCheck contains a subset of the features found in ARIA Radiation Therapy Management. ChartCheck provides tools to verify treatment plans and treatments utilizing the same treatment data used by ARIA Radiation Therapy Management. The software is very similar in design and function to the ARIA Radiation Therapy Management software, particularly the "ChartQA" module.

510(k) Submission

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| Table 3: Substantial Equivalence ChartCheck vs. ARIA Radiation Therapy Management | | | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Parameters | Subject Device: ChartCheck<br>Radformation | Predicate Device: ARIA<br>Radiation Therapy Management<br>(K173838) | Equivalence |
| Indications for<br>use | The ChartCheck device is<br>intended for the quality<br>assessment of radiotherapy<br>treatment plans and on<br>treatment chart review. | The ARIA Radiation Therapy<br>Management product is a<br>treatment plan and image<br>management application. It<br>enables the authorized user to<br>enter, access, modify, store and<br>archive treatment plan and image<br>data from diagnostic studies,<br>treatment planning, simulation,<br>plan verification and treatment.<br>ARIA Radiation Therapy<br>Management also stores the<br>treatment histories including dose<br>delivered to defined sites and<br>provides tools to verify performed<br>treatments. | Substantially<br>Equivalent |
| Pure software | Yes | Yes | Equivalent |
| Intended users | Trained radiation oncology<br>personnel | Trained radiation oncology<br>personnel | Equivalent |
| OTC/Rx | Rx | Rx | Equivalent |
| ChartCheck vs. ARIA Radiation Therapy Management | | | |
| Input | Treatment planning, treatment,<br>imaging, and documentation<br>data from the ARIA Radiation<br>Therapy Management<br>database. | DICOM treatment records and<br>images from radiation therapy<br>machines. User-entered<br>treatment documentation | Equivalent |
| Functionality | Utilizes treatment, treatment<br>planning, imaging, and<br>documentation data to calculate<br>pass / fail / override / condition<br>check states | Utilizes treatment and treatment<br>planning data to calculate pass /<br>fail / override check states | Substantially<br>Equivalent |
| Output | ChartCheck displays treatment<br>and planned values along with<br>check state indicators.<br>ChartCheck presents control<br>charts | ARIA Radiation Therapy<br>Management displays treatment<br>and planned values along with<br>check state indicators. ARIA<br>Radiation Therapy Management<br>presents control charts | Substantially<br>Equivalent |

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# 5.7. Performance Data

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

### 5.8. Conclusion

ChartCheck is deemed substantially equivalent to the Predicate Device, ARIA Radiation Therapy Management (K173838). The fact that ChartCheck indications for use are a subset of the predicate device's indications for use does not raise any new questions regarding safety and effectiveness. Verification and Validation testing and Hazard Analysis demonstrate that ChartCheck is as safe and effective as the Predicate Device.