(122 days)
Not Found
No
The description focuses on data management, reporting, and auditing functions using standardized metrics and user-defined constraints. There is no mention of AI/ML terms, training/test sets for model development, or performance metrics typically associated with AI/ML algorithms.
No.
This device is a software application intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process, not for providing therapy directly.
No
The device is intended for quality assessment of radiotherapy treatment plans and the planning process, not for diagnosing medical conditions.
Yes
The device is explicitly described as a "multi-functional information and data management software application" and its functions are entirely software-based, processing data and generating reports. 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:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Function: Model 1216 Quality Reports is a software application that processes and analyzes data related to radiotherapy treatment plans. It uses DICOM data from Treatment Planning Systems, which includes images and radiation therapy objects. Its purpose is to assess the quality of the treatment plan and the planning process itself, not to analyze biological specimens from a patient.
- Intended Use: The intended use is for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process. This is a quality control and assessment function within the radiotherapy workflow, not a diagnostic test performed on a patient sample.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It's a tool for evaluating the technical aspects of a medical treatment plan, not for diagnosing a condition or monitoring a patient's biological state through laboratory analysis.
N/A
Intended Use / Indications for Use
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
Model 1216 Quality Reports is a multi-functional information and data management software application intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists.
Model 1216 Quality Reports receives DICOM data from Treatment Planning Systems (TPS) which are capable of providing such data. The data may include images, radiation therapy (RT) objects such as RT Plan, RT Structure Set and RT Dose. The user may also capture data through manual input.
The application allows the user to:
- Create reports and charts which may be sent to the institution's Electronic Medical Record (EMR) system.
- Measure quality with standardized metrics that are based on the institution's chosen standards.
- Capture information from the clinical team during pre-treatment planning.
- Establish benchmark and progress data to demonstrate continuous improvement.
- Audit the Dose Volume Histogram (DVH) from the TPS.
- Facilitate quantitative review of the estimated dose via a single DVH metric.
- Customize and save a library of non-dosimetric plan parameters and compare them against user defined constraints.
- Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM data from Treatment Planning Systems (TPS)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians who are familiar with radiation therapy, such as 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)
Bench testing using simulated clinical workflows.
Verification tests were written and executed to ensure that the system was working as designed.
Pass/fail criteria were used to verify requirements and to ensure that risk mitigations functioned as intended.
Regression tests were performed.
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.
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
§ 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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Consultant 2640 Nobility Avenue MELBOURNE FL 32934
Re: K142142
Trade/Device Name: Ouality Reports, Model 1216 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 5, 2014 Received: November 10, 2014
Dear Mr. Luker:
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 D. O'Hara
for
Janine M. Morris 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) K142142
Device Name Model 1216 Quality Reports
Indications for Use (Describe)
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo features a blue square with a yellow sun inside on the left. To the right of the square, the words "SUN NUCLEAR" are written in blue, with the word "corporation" written in a smaller font below.
Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
August 2, 2014
Submitted by:
Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com
Contact Person:
Jonathan Lee jonathanlee@sunnuclear.com
Ph: 321-259-6862 extension 423
Classification Name:
21 CFR § 892.5050 IYE Medical charged-particle radiation therapy system Class II
Common Name:
Oncology Information system
Proprietary Names:
Model 1216 Quality Reports
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system, dosimetric quality control system Product code: IYE
Predicate Device(s):
| Model Name: | MOSAIQ Release 2.50 |
|---|---|
| Common Name: | Oncology Information System |
| 510(k) # | K123230 |
| Manufacturer: | IMPAC Medical Systems, Inc. |
| Submitted: | November 6, 2012 |
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Model Name: MOSAIQ Release 2.40 Oncology Information System Common Name: 510(k) # K120067 Manufacturer: IMPAC Medical Systems, Inc. Submitted: January 9, 2012
2 Description and Use:
Model 1216 Quality Reports is a multi-functional information and data management software application intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists.
Model 1216 Quality Reports receives DICOM data from Treatment Planning Systems (TPS) which are capable of providing such data. The data may include images, radiation therapy (RT) objects such as RT Plan, RT Structure Set and RT Dose. The user may also capture data through manual input.
The application allows the user to:
- Create reports and charts which may be sent to the institution's Electronic . Medical Record (EMR) system.
- Measure quality with standardized metrics that are based on the institution's ● chosen standards.
- Capture information from the clinical team during pre-treatment planning. ●
- Establish benchmark and progress data to demonstrate continuous improvement.
- Audit the Dose Volume Histogram (DVH) from the TPS.
- . Facilitate quantitative review of the estimated dose via a single DVH metric.
- Customize and save a library of non-dosimetric plan parameters and compare ● them against user defined constraints.
- . Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.
3 Intended Use Statement:
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.
ব Technological Characteristics
As with the predicate devices, Model 1216 Quality Reports software runs on a standard PC running a Windows Operating System (OS). The complexity of DICOM data and the sheer data volume in images and DICOM RT objects (notably RT Structure Sets and RT Doses) demands high performance computer processing and memory. The software holds all vital data in memory during each analysis and report generation session to ensure high performance to optimize the user experience, and thus there are special requirements for the machine(s) on which the software is installed.
5
System Recommendations
- . Operating Systems Supported: Windows 7 (32- or 64-bit), Windows 8 (32- or 64bit), and Windows Server 2008, 2008 R2, and 2012
- I CPU: 2.4+ GHz
- l CPU: Multi-core processor (4+ cores, 8+ threads)
- l Hard drive space: Software components fully installed require only ~20 MB, but storage requirements for voluminous 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 DICIOM archives.
- Memory (RAM): 2+ GB x number of cores (e.g. 8+ GB for 4 cores)
- . Display Resolution: 1920 x 1080 screen resolution, 24- or 32-bit color depth.
5 Performance Data and Comparison with Predicate
As with the predicate device, no clinical trials were performed for Model 1216 Quality Reports. Testing was limited to Bench testing using simulated clinical workflows.
Verification tests were written and executed to ensure that the system was working as designed. Pass/fail criteria were used to verify requirements and to ensure that risk mitigations functioned as intended. Regression tests were performed.
6 Summary
Model 1216 Quality Reports is deemed substantially equivalent to the predicate devices due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Quality Reports is as safe, as effective, and performs as well as the predicate device. The minor technological differences between Model 1216 Quality Reports and the predicate devices do not raise new types of safety or effectiveness questions.