K Number

Device Name

ClearCalc

Manufacturer

Radformation, Inc.

Date Cleared

2020-04-09

(104 days)

Product Code

MUJ

Regulation Number

892.5050

Intended Use

ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.

Device Description

The ClearCalc device (model RADCA) is software intended to assist users in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation. The treatment plans are obtained from supported Treatment Planning System and Application Programming interfaces. It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K090531

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software that performs independent calculations based on existing treatment plan data, without mentioning any AI/ML terms or methodologies.

Therapeutic

No
The device is described as software that assists radiation treatment planners in verifying the accuracy of their calculations, not directly treating a disease or condition. It is a verification tool, not a therapeutic agent.

Diagnostic

The device is intended to assist radiation treatment planners in verifying the accuracy of their treatment planning calculations, not to diagnose a disease or condition in a patient. It performs independent calculations based on existing treatment plans.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that ClearCalc is "software intended to assist users" and is "designed to run on the Windows Operating System." There is no mention of any accompanying hardware component that is part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to assist radiation treatment planners in verifying the accuracy of their calculations for radiation therapy. This is a process related to the planning and delivery of medical treatment, not the examination of specimens taken from the human body.
Device Description: The device is software that performs calculations on treatment plan data. It does not interact with biological samples or perform tests on them.
Lack of IVD Characteristics: The description does not mention any activities typically associated with IVDs, such as analyzing blood, urine, tissue, or other bodily fluids or substances to diagnose, monitor, or predict disease.

Therefore, ClearCalc falls under the category of medical device software used in the planning and quality assurance of radiation therapy, not as an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

MUJ

Device Description

It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Files/Treatment Planning System API-provided data containing CT, Structure Set, and Treatment Plan (including treatment field parameters) data
Files or Treatment Planning System API-provided data containing Treatment Plan (including source positions and dwell times) data

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained radiation oncology personnel

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)

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

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.

K090531

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

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

April 9, 2020

Re: K193640

Trade/Device Name: ClearCalc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 9, 2020 Received: March 9, 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/cfpmp/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) 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

510(k) Number (if known)

K193640

Device Name

ClearCalc

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Residential (Per §1-277-021, Subject to Planning Board Review) On-Site Composting (Per §1-277-021, Subject to Planning Board Review)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 K193640

This 510(k) Sumary 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

Table 1 : Submitter's Information
Submitter's Name:	Kurt Sysock
Company:	Radformation, Inc.
Address:	335 Madison Avenue, 16th Floor
New York, NY 10017
Contact Person:	Alan Nelson
Chief Science Officer, Radformation
Phone:	518-888-5727
Fax:	----------
Email:	anelson@radformation.com
Date of Summary Preparation	12/20/2019

5.2. Device Information

Table 2 : Device Information
Trade Name:	ClearCalc
Common Name:	Oncology Information System
Classification Name:	Class II
Classification:	Medical charged-particle radiation therapy system
Regulation Number:	892.5050
Product Code:	MUJ
Classification Panel:	Radiology

5.3. Predicate Device Information

RadCalc: 510(k) Number K090531; Regulation number 892.5050; Product code: MUJ

5.4. Device Description

5.5. Indications for Use

5.6. Technological Characteristics

ClearCalc (Subject Device) makes use of a Predicate Device, RadCalc (K090531) for substantial equivalence comparison.

5.6.1. ClearCalc vs. RadCalc (K090531)

Lifeline Software, Inc.'s RadCalc Software "is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves."

(https://www.accessdata.fda.gov/cdrh docs/pdf9/K090531.pdf accessed 12/17/2019)

ClearCalc likewise utilizes an independent calculation algorithm to recalculate the incoming treatment plan's MU and dose for external beam plans as well as dose from radioactive sources for brachytherapy plans. The software is very similar in design and function to the RadCalc software.

Table 3: Substantial Equivalence ClearCalc vs. RadCalc
Parameters	Subject Device: ClearCalc
Radformation	Predicate Device: RadCalc
(K090531)	Equivalence
Indications for
use	Used to assist radiation
treatment planners in
determining if their treatment
planning calculations are
accurate using an independent
Monitor Unit (MU) and dose
calculation algorithm.	The intended use of the RadCalc
Software is a means of validating
the monitors units or radiation
dose to points that have been
calculated by the primary
radiation therapy planning
system for external beam
radiation therapy and/or
brachytherapy treatments. In
addition to this, RadCalc
Software can also be used as the
primary means of calculating
monitor units for external beam
radiation treatments in situations
where the physician does not
order the use of a radiation
therapy plan.	Substantially
Equivalent
Pure software	Yes	Yes	Equivalent
Intended users	Trained radiation oncology
personnel	Trained radiation oncology
personnel	Equivalent
OTC/Rx	Rx	Rx	Equivalent
	ClearCalc vs. RadCalc Photon MU and Dose Calculation
Input	Files/Treatment Planning
System API-provided data
containing CT, Structure Set,
and Treatment Plan (including
treatment field parameters) data	Files containing Structure Set,
and Treatment Plan (including
treatment field parameters) data	Minor
differences
Functionality	Utilizes a Finite-Size Pencil
Beam (FSPB) algorithm to
calculate MU/Dose on a
per-field basis.
ClearCalc utilizes the full 3D
geometry of the patient for
heterogeneity corrections and
simulating the scatter conditions
of the actual patient.	Utilizes a Clarkson summation
algorithm to calculate MU/Dose
on a per-field basis.
RadCalc utilizes a consistent flat
phantom geometry using
radiological equivalent depth for
heterogeneity corrections and
includes modules that allow the
user to indicate changes in
scatter conditions (e.g. for breast
treatments).	Minor
differences
Output	ClearCalc calculates the dose
from fields in a plan and
displays results for per-field MU	RadCalc calculates the dose
from fields in a plan and displays
results for per-field MU and	Equivalent
	and provides a difference metric
for evaluation in tabular format.
Users can also evaluate global
point doses, as well as per-field
doses.	provides a difference metric for
evaluation in tabular format.
Users can also evaluate global
point doses, as well as per-field
doses.
	ClearCalc vs. RadCalc Electron MU and Dose Calculation
Input	Files/Treatment Planning
System API-provided data
containing CT, Structure Set,
and Treatment Plan (including
treatment field parameters) data	Files containing Treatment Plan
(including treatment field
parameters) data	Minor
differences
Functionality	Utilize a library of custom
cutouts and compute cutout
factors using a sector
integration method.	Utilize a library of custom cutouts
and compute cutout factors using
a sector integration or square
root method.	Minor
differences
Output	ClearCalc calculates dose
based on electron field
parameters and cutout
geometry, and displays results
for per-field MU and dose and
provides a difference metric for
evaluation in tabular format.	RadCalc calculates dose based
on electron field parameters and
cutout geometry, and displays results
for per-field MU and dose and
provides a difference metric for
evaluation in tabular format.	Equivalent
	ClearCalc vs. RadCalc Brachytherapy Dose Calculation
Input	Files or Treatment Planning
System API-provided data
containing Treatment Plan
(including source positions and
dwell times) data	Files containing Treatment Plan
(including source positions and
dwell times) data	Minor
differences
Functionality	Utilizes the AAPM TG-43
protocol for its brachytherapy
dose calculations	Utilizes the AAPM TG-43
protocol for its brachytherapy
dose calculations	Equivalent
Output	ClearCalc calculates dose to
arbitrary calculation point
locations and presents
difference metrics comparing
the TPS dose vs. ClearCalc
dose in a tabular format	RadCalc calculates dose to
arbitrary calculation point
locations and presents difference
metrics comparing the TPS dose
vs. RadCalc dose in a tabular
format	Equivalent

5.7. Performance Data

5.8. Conclusion

ClearCalc is deemed substantially equivalent to the Predicate Device, RadCalc (K090531). Verification and Validation testing and Hazard Analysis demonstrate that ClearCalc is as safe and effective as the Predicate Device. The minor technological differences between ClearCalc and the Predicate Device with regard to the independent MU and dose calculation do not raise any questions on the safety and effectiveness of the Subject Device.