(90 days)
No
The description focuses on presenting data and performing calculations based on user-specified constraints, with no mention of AI/ML terms or learning from data.
No
The device is described as a software for quality assessment of radiotherapy treatment plans and does not directly treat or diagnose a disease.
No
ClearCheck is intended for quality assessment of radiotherapy treatment plans, specifically to evaluate the quality of an Eclipse treatment plan based on user-specified Dose Constraints and Plan Check Parameters. It does not diagnose diseases or patient conditions.
Yes
The device description explicitly states that ClearCheck is a "software intended to present treatment plans" and runs as a "dynamic link library (dll) plugin" and a "standalone Windows Operating System executable application." It interacts with existing software (Eclipse TPS) and does not mention any accompanying hardware components.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "quality assessment of radiotherapy treatment plans." This is related to the planning and delivery of radiation therapy, which is a medical treatment applied to the patient's body.
- Device Description: The device is software that analyzes treatment plans generated by a treatment planning system. It performs calculations on this plan data.
- Nature of Input: The input is a radiotherapy treatment plan, which is a digital representation of how radiation will be delivered to a patient. It is not a biological sample (like blood, urine, tissue, etc.).
- Nature of Output: The output is a quality assessment of the treatment plan, presented in a user-friendly format for review and approval. It is not a diagnostic result derived from analyzing a biological sample.
IVD devices are specifically designed to examine specimens derived from the human body (in vitro) to provide information for diagnostic, monitoring, or compatibility purposes. ClearCheck does not interact with or analyze biological specimens. It operates on data related to a medical treatment plan.
N/A
Intended Use / Indications for Use
ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The ClearCheck device (model RADCC) is a software intended to present treatment plans obtained from Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems in a user friendly way (numerical form of data) for user approval of the treatment plan. ClearCheck runs as a dynamic link library (dll) plugin to Varian Eclipse. It is designed to run on the Windows Operating System and generated reports can be viewed on Internet Explorer. ClearCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891) and Version 13.5 (K141283)) which is a software used by trained medical professionals to design and simulate radiation therapy treatments for malignant or benign diseases. ClearCheck has two components:
- A standalone Windows Operating System executable application that is used for 1. administrative operations to set specified default settings and user settings.
-
- A plan evaluation application that is a dynamic link library (dll) file that is a plugin to the Varian Medical Systems Eclipse TPS. The plugin is designed to evaluate the quality of an Eclipse treatment plan. Plan quality is based on user specified Dose Constraints and Plan Check Parameters.
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 physicists, medical dosimetrists, and radiation oncologists
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 ClearCheck. 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.
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.
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
§ 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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
Radformation % Mr. Parul Chansoria Regulatory Consultant Elexes 6494 Tralee Village Drive DR DUBLIN CA 94568
Re: K162468 Trade/Device Name: ClearCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 28, 2016 Received: October 28, 2016
Dear Mr. Chansoria:
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 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
2
Indications for Use
510(k) Number (if known)
Device Name ClearCheck
Indications for Use (Describe)
ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Type of Use (Select one or both, as applicable)
Radformation 510(k) Submission
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 5. 510(k) Summary
5
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
| Table 1 : Submitter's Information | |
|---|---|
| Submitter's Name: | Kurt Sysock |
| Company: | Radformation, LLC |
| Address: | 429 East 52nd Street, Unit 4G, |
| New York, NY 10022 | |
| Contact Person: | Parul Chansoria |
| Founder, Elexes | |
| Phone: | 650-528-2445 |
| Fax: | ---------- |
| Email: | parul@elexes.com |
| Date of Summary | |
| Preparation: | August 24th, 2016 |
5.2 Device Information
| Table 2: Device Information | |
|---|---|
| Trade Name: | ClearCheck |
| Common Name: | Oncology Information System |
| Classification | |
| Name: | Class II |
| Classification | Medical charged-particle radiation therapy system, dosimetric |
| quality control system | |
| Regulation Number: | 892.5050 |
| Product Code: | IYE |
| Classification | |
| Panel: | Radiology |
5.3 Predicate Device Information
Model 1216 Quality Reports (K142142)
5.4 Device Description
The ClearCheck device (model RADCC) is a software intended to present treatment plans obtained from Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems in a user friendly way (numerical form of data) for user approval of the treatment plan. ClearCheck runs as a dynamic link library (dll) plugin to Varian Eclipse.
6
It is designed to run on the Windows Operating System and generated reports can be viewed on Internet Explorer. ClearCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891) and Version 13.5 (K141283)) which is a software used by trained medical professionals to design and simulate radiation therapy treatments for malignant or benign diseases.
ClearCheck has two components:
- A standalone Windows Operating System executable application that is used for 1. administrative operations to set specified default settings and user settings.
-
- A plan evaluation application that is a dynamic link library (dll) file that is a plugin to the Varian Medical Systems Eclipse TPS. The plugin is designed to evaluate the quality of an Eclipse treatment plan. Plan quality is based on user specified Dose Constraints and Plan Check Parameters.
5.5 Indications for Use
ClearCheck is intended for quality assessment of radiotherapy treatment plans
5.6 Technological Characteristics
The ClearCheck (Subject Device) makes use of a Predicate Device, the Model 1216 Quality Reports (142142).
| Table 3 : Substantial Equivalence Table for ClearCheck | |||
|---|---|---|---|
| Parameters | Subject Device: | ||
| ClearCheck | |||
| Radformation | Predicate Device: | ||
| Model 1216 Quality Reports | |||
| Sun Nuclear Corporation | |||
| (K142142) | Equivalence | ||
| Indications for use | ClearCheck is intended for | ||
| quality assessment of | |||
| radiotherapy treatment plans | Model 1216 Quality Reports is | ||
| intended for quality assessment of | |||
| radiotherapy treatment plans and the | |||
| radiotherapy treatment planning | |||
| process. | Equivalent | ||
| Pure Software | |||
| Device | Yes | Yes | Equivalent |
| Intended users | Medical physicists, medical | ||
| dosimetrists, and radiation | |||
| oncologists | Medical physicists, medical | ||
| dosimetrists, and radiation | |||
| oncologists | Equivalent | ||
| OTC/Rx | Rx | Rx | Equivalent |
5.6.1 ClearCheck vs. Model 1216 Quality Reports (K142142)
7
| Table 3 : Substantial Equivalence Table for ClearCheck | |||
|---|---|---|---|
| Parameters | Subject Device: | ||
| ClearCheck | |||
| Radformation | Predicate Device: | ||
| Model 1216 Quality Reports | |||
| Sun Nuclear Corporation | |||
| (K142142) | Equivalence | ||
| ClearCheck software runs on a | |||
| standard PC running a Windows | |||
| Operating System (OS). The | |||
| software holds all vital data in | |||
| memory during each analysis and | |||
| report generation session. | Model 1216 Quality Reports software | ||
| runs on a standard PC running a | |||
| Windows Operating System (OS). The | |||
| software holds all vital data in memory | |||
| during each analysis and report | |||
| generation session. | Equivalent | ||
| Operating | |||
| System | Windows 7 ( 32- or 64-bit), | ||
| Windows 8 (32- or 64-bit), | |||
| Windows 10 (32- or 64-bit), | |||
| Windows Server 2008, 2008 RS, | |||
| and 2012. | Windows 7 (32- or 64-bit), Windows 8 | ||
| (32- or 64- bit), and Windows Server | |||
| 2008, 2008 R2, and 2012. | Equivalent | ||
| CPU | 2.4+ GHz and Multi-core | ||
| processors (2+ cores, 4+ threads) | 2.4+ GHz and Multi-core processors (2+ | ||
| cores, 4+ threads) | Equivalent | ||
| Hard Drive | |||
| Space | Software components fully | ||
| installed require only ~3.5MB, | |||
| but storage requirement for | |||
| patient data are much larger and | |||
| vary from clinic-to-clinic. A | |||
| minimum of 100 GB hard drive | |||
| is suggested for larger patient | |||
| template sets. | Software components fully installed | ||
| require ~20 MB, but storage requirements | |||
| for patient data and archives are much | |||
| larger but will vary clinic-to-clinic. A | |||
| minimum of 900 GB hard drive is | |||
| suggested with larger drives for DICOM | |||
| archives. | Differ | ||
| Display | |||
| Resolution and | |||
| Color Depth | 1280 x 1024, 24- or 32- bit color | ||
| depth. | 1920 x 1080 screen resolution, 24- or 32- | ||
| bit color depth. | Differ |
5.6.2 Similarities
- The intended use is same for the Subject and the Predicate Device. ●
- Both the Predicate and the Subject Devices are pure software devices meant for ● prescription use
- The Subject and the Predicate Devices are classified under the Product Code IYE ● and the common name "oncology information system"
- The intended user of the Subject Device is the same as the Predicate Device ●
- The Subject and Predicate Devices require similar processors and operating systems. However, ClearCheck is supported by an additional Operating System Windows 10 (32- Or 64-bit)
- . Both Subject and Predicate Devices run on a standard PC with a Windows Operating System (OS). The software devices hold all vital data in memory during each analysis and report generation session.
8
5.6.3 Differences
- The install size of the Subject Device is only ~3.5MB whereas the install size of . the Predicate Device is 20 MB of storage requirement. ClearCheck recommends 100GB of storage space and Predicate Device recommends 900GB of storage space. This is because ClearCheck only saves constraint templates whereas Model 1216 Quality Reports stores DICOM datasets which are much larger when compared to constraint template files. Thus, ClearCheck requires much less storage. However, these differences don't raise any new questions for safety and effectiveness of the Subject Device w.r.t. the Predicate Device.
- The color depth for both the Predicate and Subject Devices are the same. The resolution required for the Subject Device (1280x1024: D-VHS, HD DVD, Bluray, HDV (miniDV), and the Predicate Device (1920x1080: HDV (miniDV), AVCHD, HD DVD, Blu-ray, HDCAM SR) are different. The Subject Device ClearCheck can work with the small size monitors without any impact on the image quality (1280 x 1024). Hence, this difference doesn't raise any new questions for safety and effectiveness of the Subject Device w.r.t. the Predicate Device.
5.7 Performance Data
As with the Predicate Device, no clinical trials were performed for ClearCheck. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements.
5.8 Conclusion
ClearCheck is deemed substantially equivalent to the Predicate Device. Model 1216 Quality Reports (K142142) due to the similarities in intended use and function. Verification and Validation testing and Hazard Analysis demonstrate that ClearCheck is as safe and effective as the Predicate Device. The minor technological differences between ClearCheck and the Predicate Device do not raise any questions on the safety and effectiveness of the Subject Device.