(140 days)
FDA 510(k) K150547
No
The document explicitly states that the critical treatment planning functions and all algorithms and calculation processing are handled by the external Astroid Dosimetry App (K150547), and the Astroid Planning App is primarily a user interface, record-keeping service, and visualization tool. There is no mention of AI or ML within the description of the Astroid Planning App itself.
No.
The device is a planning and analysis application for proton radiation therapy treatments, not a device that directly administers therapy. It leverages another app for calculations.
No
Explanation: The Astroid Planning App is described as a user interface for proton treatment planning, leveraging another device (Astroid Dosimetry App) for dose calculations and other processing. Its primary functions are record keeping, user interface controls, and visualization tools for treatment planning. It does not perform diagnostic functions to identify or characterize disease.
Yes
The device is described as an "interactive end user application" and its primary purpose is to be the "user interface" for inputting data and reviewing results, with all critical calculations performed by a separate, referenced software device (K150547). This indicates it is a software component without associated hardware.
Based on the provided text, the Astroid Planning App is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Astroid Planning App's Function: The Astroid Planning App is a software application used for planning and analyzing proton radiation therapy treatments. It takes patient data (likely including imaging data) and physician prescriptions to create a treatment plan. It does not analyze biological specimens from the patient's body.
- Focus on Treatment Planning: The entire description focuses on the process of designing and analyzing radiation treatment plans, which is a therapeutic process, not a diagnostic one based on in vitro analysis.
- Leveraging a Dosimetry App: The app leverages a separate dosimetry app (Astroid Dosimetry App) for calculations, but even the dosimetry app's function is related to calculating radiation dose for treatment, not analyzing biological samples.
Therefore, the Astroid Planning App falls under the category of medical device software used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547), which is a library of treatment planning functions accessed through the Thinknode® cloud services framework, for device creation, dose calculation, optimization, and all other dosimetry and processing calculations. Since the Astroid Dosimetry App is responsible for performing the calculations, the scope of this Astroid Planning App is to be the user interface for end users to input treatment planning data and review the results. Typical indications for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician's goals. Since the critical treatment planning functions are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage), user interface controls, and visualization tools.
Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions before the system is utilized for patient treatment.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
The primary purpose of the Astroid Planning App device is for facilitating the planning and analysis of proton radiation therapy treatments. The Astroid Planning App device is an interactive end user application in which the user interacts with the interface to perform proton treatment planning tasks. The data constructed in the Astroid Planning App device will be used as inputs to the Astroid Dosimetry App device [FDA 510(k) K150547], which is the foundational proton dosimetry calculation library that contains all algorithms and calculation processing for the proton treatment planning. The Astroid Planning App device composes and otherwise constructs the calculation requests required for the development of the proton treatment plan, leveraging the functions externally located in the Astroid Dosimetry App to then perform the requested calculations.
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
radiotherapy professionals
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)
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed by .decimal personnel and hospital-based testing partners. Validation tests comparing results of proton dose calculations, with the inclusion of all applicable treatment delivery devices, to experimental and analytical datasets were performed. Additional verification and validation tests were also performed for all other functions available for external use through the system. Usability testing, including analysis of all system displays and user options were also completed. Plan quality studies and full end-to-end testing of the entire planning process as compared to the predicate devices was also completed. These tests show that the Astroid Planning App performed as well as the predicate devices and that the Astroid Planning App is deemed safe and effective for clinical use when properly commissioned for a proton treatment machine.
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.
Eclipse Treatment Planning System K172163, RayStation 4.0.2 K140187
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.
FDA 510(k) K150547
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.
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.decimal, LLC. % Kevin Erhart, Ph.D. Chief Technology Officer 121 Central Park Place SANFORD FL 32771
May 15, 2018
Re: K173940
Trade/Device Name: Astroid Planning App Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 18, 2018 Received: April 19, 2018
Dear Dr. Erhart:
We have reviewed vour 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 (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.
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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,
Michael D. O'Hara
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) K173940
Device Name Astroid Planning App
Indications for Use (Describe)
The Astroid Planning App is an interactive end user application for proton treatment planning for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans. This Astroid Planning App leverages the existing .decimal Astroid Dosimetry App [FDA 510(k) K150547), which is a library of treatment planning functions accessed through the Thinknode® cloud services framework, for device creation, dose calculation, optimization, and all other dosimetry and processing calculations. Since the Astroid Dosimetry App is responsible for performing the calculations, the scope of this Astroid Planning App is to be the user interface for end users to input treatment planning data and review the results. Typical indications for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician's goals. Since the critical treatment planning functions are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage), user interface controls, and visualization tools.
Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions before the system is utilized for patient treatment.
Type of Use (Select one or both, as applicable)
| ☑ 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
Section 807.87 (h) A 510(k) Summary as described in Section 807.92
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
November 2, 2017
Submitter's Name:
.decimal, LLC. 121 Central Park PL Sanford, Florida 32771
Contact Person:
Kevin Erhart Chief Technology Officer Phone: 407-330-3300 407-322-7546 Fax: Email:kerhart@dotdecimal.com
Device Name:
Astroid Planning App
Classification Name:
MUJ 21 CFR 892.5050 Medical charged-particle radiation therapy systems Class II
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Image /page/4/Picture/0 description: The image shows the logo for ".decimal". The text "decimal" is in a sans-serif font, with the "." and "dec" in blue and the "imal" in gray. Below the logo is the text "The benchmark for custom radiation therapy" in a smaller, sans-serif font.
Device Description:
The primary purpose of the Astroid Planning App device is for facilitating the planning and analysis of proton radiation therapy treatments. The Astroid Planning App device is an interactive end user application in which the user interacts with the interface to perform proton treatment planning tasks. The data constructed in the Astroid Planning App device will be used as inputs to the Astroid Dosimetry App device [FDA 510(k) K150547], which is the foundational proton dosimetry calculation library that contains all algorithms and calculation processing for the proton treatment planning. The Astroid Planning App device composes and otherwise constructs the calculation requests required for the development of the proton treatment plan, leveraging the functions externally located in the Astroid Dosimetry App to then perform the requested calculations.
Predicate Device(s):
Eclipse Treatment Planning System K172163 RayStation 4.0.2 K140187
Intended Use:
The Astroid Planning App is an interactive end user application that leverages the existing .decimal Astroid Dosimetry App library [FDA 510(k) K150547] of functions (accessed through the Thinknode® cloud services framework) for device creation, dose calculation, optimization, and many other purposes, for the intended use and primary purpose of enabling radiotherapy professionals to efficiently design and analyze proton radiotherapy treatment plans.
Indications for Use:
Typical indications for use are for the treatment of persons with cancer, over a wide range of potential disease locations. In the most common use case of the software, users will import patient data from existing imaging and contouring software programs, manage physician prescription and intent information, develop a proton treatment plan, and analyze the plan to determine how well it meets the physician's goals. Since the critical treatment planning functions and calculations are handled outside this software application, by a software of known quality and pedigree, the primary and most frequently used functions of this software are the record keeping service (for patient data storage via Thinknode), user interface controls, and visualization tools.
Furthermore, since the accuracy of information computed and displayed by an application such as this is very important to the proper treatment of patients, it is critical that users have the appropriate educational and clinical experience backgrounds to adequately understand and use the product. Additionally, since each radiotherapy treatment machine produces a unique beam of radiation, there is much responsibility on the end users to adequately commission and test this software over the full range of expected treatment conditions, as per industry standards and regulatory requirements, before the system is utilized for patient treatment.
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Summary of Technological Characteristics:
The Astroid Planning App technology is substantially equivalent to both the listed predicate devices. The Astroid Planning App. Eclipse TPS, and RayStation 4.0.2 all provide users with tools to calculate, analyze, and otherwise compare potential treatment plans for proton radiation therapy courses. All three systems include display windows for visualizing patient images, contoured structures, dose calculation results, and dose summary statistics. Unlike the other two predicate systems, the Astroid Planning App leverages a separate library for dose calculation and other radiotherapy calculations [Astroid Dosimetry App, FDA 510(k) K150547], however, this does not detract from the point that the proton treatment planning features contained within all three systems are substantially equivalent in terms of technology, intended uses, and end user profiles.
Summary of Non-Clinical Testing:
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed by .decimal personnel and hospital-based testing partners. Validation tests comparing results of proton dose calculations, with the inclusion of all applicable treatment delivery devices, to experimental and analytical datasets were performed. Additional verification and validation tests were also performed for all other functions available for external use through the system. Usability testing, including analysis of all system displays and user options were also completed. Plan quality studies and full end-to-end testing of the entire planning process as compared to the predicate devices was also completed. These tests show that the Astroid Planning App performed as well as the predicate devices and that the Astroid Planning App is deemed safe and effective for clinical use when properly commissioned for a proton treatment machine.