(204 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on calculations and verification testing rather than learning or predictive modeling based on data.
No
This device is designed to assist in planning radiation treatment by predicting collisions, not to treat or diagnose patients. It is a planning and simulation tool for medical professionals, not a therapeutic device.
No
Explanation: The device is intended to assist radiation treatment planners in predicting potential collisions, not to diagnose a medical condition or disease in a patient. It performs calculations on treatment plans.
Yes
The device description explicitly states that CollisionCheck is "software intended to assist users" and runs as a "dynamic link library (DLL) plugin" to another software system (Eclipse TPS). There is no mention of any accompanying hardware component that is part of the device itself.
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 predicting collisions between the treatment machine and the patient or support structures. This is a planning and safety tool for a medical procedure (radiation therapy), not a diagnostic test performed on biological samples.
- Device Description: The device is software that analyzes treatment plans obtained from a treatment planning system. It does not interact with or analyze biological specimens (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease based on the analysis of biological samples.
The device is clearly a software tool designed to improve the safety and efficiency of radiation therapy planning, which falls under the category of medical device software, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The CollisionCheck device (model RADCO) is software intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. The treatment plans are obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. CollisionCheck runs as a dynamic link library (DLL) plugin to Varian Eclipse.
It is designed to run on the Windows Operating System. CollisionCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891), Version 13.5 (K141283), and Version 13.7 (K152393) which is a 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
CT
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 CollisionCheck. 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.
Mobius3D (K153014)
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/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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2017
RADformation, Inc. % Mr. Kurt Sysock Co-founder/CEO 335 Madison Avenue, 16th Floor NEW YORK NY 10017
Re: K171350
Trade/Device Name: CollisionCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE 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.
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
K171350/S001
Device Name CollisionCheck
Indications for Use (Describe)
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
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.
3.1. 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 | 05/01/2017 |
3.2. Device Information
| Table 2 : Device Information | |
|---|---|
| Trade Name: | CollisionCheck |
| 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 |
3.3. Predicate Device Information
Mobius3D (K153014)
4
3.4. Device Description
The CollisionCheck device (model RADCO) is software intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. The treatment plans are obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. CollisionCheck runs as a dynamic link library (DLL) plugin to Varian Eclipse.
It is designed to run on the Windows Operating System. CollisionCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891), Version 13.5 (K141283), and Version 13.7 (K152393) which is a software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
3.5. Indications for Use
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
3.6. Technological Characteristics
CollisionCheck (Subject Device) makes use of a Predicate Device, Mobius3D (K153014) for substantial equivalence comparison.
3.6.1. CollisionCheck vs. Mobius3D (K153014)
Mobius3D provides the following feature (as described on the manufacturer's website at http://mobiusmed.com/mobius3d/ as of March 27, 2017): "Deliverability Analysis: Confirm Before Your Patient Arrives. Mobius3D performs a virtual delivery of the plan and verifies that no gantry collision or violation of your machine's delivery parameters is predicted."
CollisionCheck likewise simulates the plan and verifies that no gantry (treatment machine) collisions occur. The main difference between the implementation of that feature by Mobius3D and CollisionCheck is that Mobius3D takes DICOM plan data as input in order to perform the virtual delivery while CollisionCheck obtains treatment plan information from the Varian Medical Systems Eclipse Treatment Planning System through its scripting API. Furthermore, CollisionCheck does not have any other features besides the gantry collision check while Mobius3D includes many other features that are not related to the gantry collision check.
From Mobius3D's Intended Use statement: "Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy." CollisionCheck is likewise a quality assurance and treatment plan verification tool, but one with the very specific scope of checking for potential treatment machine collisions that might occur in a treatment plan.
5
| Table 3: Substantial Equivalence CollisionCheck vs. Mobius3D | |||
|---|---|---|---|
| Parameters | Subject Device: CollisionCheck | ||
| Radformation | Predicate Device: Mobius3D | ||
| (K153014) | Equivalence | ||
| Indications for | |||
| use | Used to assist radiation | ||
| treatment planners in predicting | |||
| when a treatment plan might | |||
| result in a collision between the | |||
| treatment machine and the | |||
| patient or support structures | Used for quality assurance, | ||
| treatment plan verification, and | |||
| patient alignment and anatomy | |||
| analysis in radiation therapy. | Subject | ||
| Device is a | |||
| subset of the | |||
| Predicate | |||
| Device | |||
| Pure software | Yes | Yes | Equivalent |
| Intended users | Trained radiation oncology | ||
| personnel | Trained radiation oncology | ||
| personnel | Equivalent | ||
| OTC/Rx | Rx | Rx | Equivalent |
| CollisionCheck vs. Mobius3D Deliverability Analysis | |||
| Input | CT, Structure Set, and | ||
| Treatment Plan data accessed | |||
| through the Eclipse Scripting | |||
| API | DICOM files containing CT, | ||
| Structure Set, and Treatment | |||
| Plan (including treatment field | |||
| parameters) data | Minor | ||
| Differences | |||
| Functionality | Simulates the plan and predicts | ||
| whether that no gantry collisions | |||
| occur with patient or support | |||
| structures. | Performs a virtual delivery of the | ||
| plan and verifies that no gantry | |||
| collision is predicted. | Equivalent | ||
| Simulation | |||
| Details | CollisionCheck calculates | ||
| gantry clearance by modeling | |||
| the linac as a cylinder with a | |||
| user-configured value for | |||
| distance between isocenter and | |||
| the face of the gantry. | |||
| CollisionCheck also supports | |||
| additional applicators: | |||
| Stereotactic radiosurgery cones | |||
| (also modeled as a cylinder) | |||
| and Electron Applicators | |||
| (modeled as a rectangular | |||
| prism). | Mobius3D calculates gantry | ||
| clearance in Plan Checks by | |||
| modeling the linac as a cylinder | |||
| with a user-configured value for | |||
| distance between isocenter and | |||
| the face of the gantry. | Minor | ||
| Differences | |||
| Output | CollisionCheck tests thousands | ||
| of sample points against CT | |||
| data and patient and couch | |||
| structures and reports the | |||
| number of sample points that | |||
| resulted in a collision. | |||
| CollisionCheck also displays | |||
| these sample point test results | Mobius3D determines the closest | ||
| distance between the treatment | |||
| head and the patient/couch for | |||
| each beam and displays a | |||
| warning if this distance is |