(93 days)
Yes
The "QuickPredict" module explicitly states it "Predicts the dose to critical structures based upon models extracted from historical data looking through previous patient data," which is a common characteristic of machine learning models trained on historical datasets.
No.
The device is a treatment planning system, not a device that directly treats or provides therapy to a patient.
No
This device is a treatment planning system that assists in planning radiotherapy treatments. While it predicts a plan and dose estimates, it does not diagnose a disease or condition. Its function is to support the treatment planning process, not to identify or determine a medical condition.
Yes
The device description explicitly states it is an "independent software solution" and does not mention any accompanying hardware components. Its function is solely based on processing data and providing predictions and comparisons.
Based on the provided text, the QuickPlan Treatment Planning System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The QuickPlan system works with medical images acquired from the patient's body (like CT or MRI scans) and historical patient data to plan external beam radiation therapy. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description clearly state its purpose is for planning radiotherapy treatments. This involves predicting dose distributions and comparing treatment modalities based on imaging and historical data, not diagnosing or monitoring a condition through the analysis of biological specimens.
- The device description focuses on software modules for matching structures, predicting dose, and comparing modalities. These are all related to treatment planning based on imaging and data, not laboratory analysis of biological samples.
Therefore, the QuickPlan Treatment Planning System falls under the category of medical devices used for treatment planning, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.
The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.
Product codes
MUJ
Device Description
The new QUICKPLAN Software manufactured by Siris Medical is an independent software solution to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron, and proton beams. The new QUICKPLAN Software is intended for trained medical professionals to use in clinical settings. The new QUICKPLAN software application includes three modules:
- QuickMatch Matches a critical structure-set to the closest match within a database. It is a rapid file locator.
- QuickPredict Predicts the dose to critical structures based upon models extracted from historical data looking through previous patient data.
- QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton.
The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Specifically, knowledge-based planning is the result of using dose and anatomical information from previously treated patients to realize models that can accurately estimate deliverable treatment plans based on the type of external radiation source being utilized.
Input Imaging Modality
After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The QuickPlan software is intended for use by trained medical professionals to use in clinical settings.
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
No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission.
Performance bench testing was conducted to verify that the new QUICKPLAN software device meets all design specifications and demonstrates substantial equivalence to its predicate, the Eclipse Treatment Planning System Rapid Plan module by Varian Medical Systems, Inc. (K141283).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Siris Medical % Ms. Cynthia Pillar Consultant CJP Consulting, Inc. 5831 N Kostner Avenue CHICAGO IL 60646
Re: K151560
Trade/Device Name: QuickPlan Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 29, 2015 Received: July 1, 2015
Dear Ms. Pillar:
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'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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151560
Device Name OuickPlan
Indications for Use (Describe)
The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.
The QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.
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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Image /page/3/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and consists of the word "siris" in a sans-serif font, with the word "MEDICAL" in smaller letters underneath. To the right of the word "siris" is a cluster of blue dots arranged in a cross shape. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.
SECTION 5: TRADITIONAL 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92
Traditional 510(k) Summary
| Date Prepared: | June 29, 2015 |
|---|---|
| Submitter: | SIRIS MEDICAL |
| 257 Castro Street, Suite 224 | |
| Mountain View, CA 94041 | |
| Telephone: 1 (650) 394-5161 | |
| Contact: | Cynthia J. Pillar, RAC |
| Phone: 1 (773) 677-8886 | |
| Trade/Proprietary | |
| Name of Device: | QUICKPLAN (K151560) |
| Common Name | |
| of Device: | Medical charged-particle radiation therapy system |
| Classification: | Class II per 21 CFR 892.5050, System, Planning, Radiation |
| Therapy Treatment, Product Code MUJ | |
| Legally Marketed | |
| Predicate | |
| Device: | Eclipse Treatment Planning System manufactured by Varian |
| Medical Systems Inc., K141283, Class II per 21 CFR | |
| 892.5050, Medical charged-particle radiation therapy | |
| system, Product Code MUJ |
Description of New QUICKPLAN Device:
The new QUICKPLAN Software manufactured by Siris Medical is an independent software solution to plan radiotherapy treatments for patients with malignant or benign diseases. It is used to plan external beam irradiation with photon, electron, and proton beams. The new QUICKPLAN Software is intended for trained medical professionals to use in clinical settings. The new QUICKPLAN software application includes three modules:
- QuickMatch Matches a critical structure-set to the closest match within a ● database. It is a rapid file locator.
- QuickPredict Predicts the dose to critical structures based upon models ● extracted from historical data looking through previous patient data.
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Image /page/4/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and consists of the word "siris" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. To the right of the word "siris" is a plus sign made up of small circles.
- . QuickCompare - Provides dose estimates to critical structures with one or more alternative energy modalities, i.e. Photon vs. Proton.
The new QuickPlan software does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.
As with the RapidPlan module of the predicate Eclipse Treatment Planning System by Varian Medical Systems, Inc. (K141283), the new QUICKPLAN software uses GHz microprocessor technology along with clinician guided learning and standardized structured data sets to vield knowledge-based planning. Specifically, knowledge-based planning is the result of using dose and anatomical information from previously treated patients to realize models that can accurately estimate deliverable treatment plans based on the type of external radiation source being utilized.
Historically, radiation treatment planning required a team of specialists working with planning software to deliver a prescribed dose of treatment to the tumor while minimizing the dose to surrounding organs referred to as 'organs at risk', or OARs. Coordination of the team of specialists resulted in a treatment planning process that typically spanned several hours over several days.
The treatment planning process typically involves the following steps:
-
- Import of patient images
-
- Creation of critical structures and tumor volumes
-
- Definition of the 3D volume of the tumor
-
- Definition of the 3D volume of the Organs at Risk
-
- Establishment an estimate of the dose that is desired to the tumor
-
- Establishment of a maximum threshold for the dose to each of the OARs
-
- Generation of a plan beam geometry
-
- Dose calculation
-
- Plan approval
-
- Quality Assurance activities
As with the predicate software, the new QuickPlan software involves the following steps:
-
- Definition of the 3D volume of the tumor
-
- Definition of the 3D volume of the OARs
-
- Establishment an estimate of the dose that is desired to the tumor
-
- Establishment of a maximum threshold for the dose to each of the OARs
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Image /page/5/Picture/1 description: The image shows the logo for Siris Medical. The word "siris" is written in large, bold, blue letters. Below that, the word "MEDICAL" is written in smaller, thinner, blue letters. To the right of the word "siris" is a blue plus sign made up of small circles.
Once these steps have been completed, a software program solves for the 4D positioning of the radiation beam for these constraints. This process can take anywhere from 20 - 40 minutes each iteration. If the specialists decide to change the target delivery volume by a few millimeters to determine the effect on the dose to the tumor and OARs, the treatment planning process must begin again.
The new QUICKPLAN software will enable the physician to see the implications of changing these treatment parameters without needing to involve the whole team. In addition, the new QUICKPLAN software eliminates the need to run the treatment planning optimizer again until the clinician is satisfied with the dose distribution. The new QUICKPLAN includes a manual contour editor that allows the clinician to augment or redact margins as they see fit, and provides nearinstantaneous insight as to how changes affect dose to critical structures, saving valuable time to treatment.
lt is important to note that the new QUICKPLAN software is intended as a tool for the clinician to use in planning radiotherapy treatments for patients. It is not connected to, nor does it control, any other devices. The new QUICKPLAN software does not deliver any energy or treatment to the patient. The new QuickPlan software also does not provide full plan generation; it does not include final dose calculation, final beam geometry, nor does it enable plan approval.
Indications for Use of the New QUICKPLAN Device:
The QuickPlan Treatment Planning System is indicated for use in planning radiotherapy treatments for patients with malignant or benign diseases. After image acquisition, QuickPlan supports the treatment planning process for external beam irradiation with photon, electron, and proton beams by predicting a plan.
The QuickPlan software does not provide full plan generation: it does not include final dose calculation, final beam geometry, nor does it enable plan approval. QuickPlan is not connected to any radiation emitting equipment. The QuickPlan Software is intended for use by trained medical professionals to use in clinical settings. The QuickPlan software is compatible with Treatment Planning Systems that use the DICOM-RT format.
Intended Use of the New QUICKPLAN Device
The QuickPlan Treatment Planning System is intended for use in planning radiotherapy treatments for patients with malignant or benign diseases.
After image acquisition, QuickPlan supports the treatment planning process for
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Image /page/6/Picture/1 description: The image shows the logo for Siris Medical. The word "Siris" is in a bold, sans-serif font, with a blue color. To the right of the word "Siris" is a cluster of blue circles arranged in a cross shape. Below the word "Siris" is the word "Medical" in a smaller, sans-serif font, also in blue.
external beam irradiation with photon, electron, and proton beams by predicting a plan.
The intended use of the new QUICKPLAN device and the predicate Eclipse RapidPlan module device are the same. Both devices are intended to plan radiotherapy treatments for patients with malignant or benign diseases. The new QUICKPLAN does not claim to include the additional indications of internal irradiation (brachytherapy) or treatment of neoplasms of the eye that are specifically stated in the predicate Varian Medical Systems - Eclipse (K141283) indications for use statement. This difference is not critical to the intended use of the new QUICKPLAN device for its indications, nor does it affect the safety and effectiveness of the device when used as labeled. In addition, the new QUICKPLAN software device performs only a subset of what a full Treatment Planning System (TPS) does. It functions outside of the full TPS by allowing the user to predict plans using DICOM-RT files imported from the full TPS. The risk to the user or patient is extremely low since the QUICKPLAN software does not control any external treatment delivery equipment. Once the QUICKPLAN treatment plan is predicted, the plan is uploaded into the full TPS for dose calculation, plan approval and quality assurance activities, which is identical to what the TPS-produced plans must go through when used without the new QUICKPLAN software.
Comparison of the Technological Features of the New Device and Predicate Device:
We believe that the new QUICKPLAN device has been shown to be substantially equivalent to the predicate Varian Medical Systems Eclipse Treatment Planning System RapidPlan module (K141283). The new and predicate devices are very similar in overall design and technology, principles of operation, and intended use. Main differences are as follows:
-
- The new QUICKPLAN device is not a full treatment planning system (fTPS) and includes only treatment planning prediction, a subset of an fTPS process.
-
- The new QUICKPLAN device limits its indications to patients with malignant and benign diseases. It does not include internal irradiation (brachytherapy) or treatment of neoplasms of the eye. It specifically excludes functions that the new QUICKPLAN does not provide to distinguish itself from an fTPS.
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Image /page/7/Picture/1 description: The image shows the logo for Siris Medical. The word "siris" is written in a bold, sans-serif font in blue. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font, also in blue. To the right of the word "siris" is a blue symbol that resembles a plus sign made up of small circles.
-
- The new QUICKPLAN device performs simultaneous dose prediction and contouring. The predicate Eclipse performs these steps of the process separately.
-
- The new QUICKPLAN device uses Dose Indices to display predicted doses and the predicate device uses Dose Volume Histograms. .
The differences between the new QUICKPLAN device and the predicate Varian Eclipse Treatment Planning System RapidPlan module device do not raise any new questions of safety or effectiveness. Shown in TABLE 5.1 below are selected properties and characteristics of the new Siris Medical QUICKPLAN software and the predicate Varian Medical Systems Eclipse Treatment Planning System RapidPlan device (K141283) compared side-by-side.
| DESCRIPTIVE
INFORMATION | NEW QUICKPLAN
SOFTWARE | PREDICATE DEVICE:
Varian Eclipse
Treatment Planning
System RapidPlan
module (K141283) |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The QuickPlan
Treatment Planning
System is indicated for
use in planning
radiotherapy treatments
for patients with
malignant or benign
diseases. After image
acquisition, QuickPlan
supports the treatment
planning process for
external beam irradiation
with photon, electron,
and proton beams by
predicting a plan.
The QuickPlan software
does not provide full
plan generation; it does
not include final dose
calculation, final beam
geometry, nor does it
enable plan approval. | The Eclipse Treatment
Planning System
(Eclipse TPS) is used to
plan radiotherapy
treatments for patients
with malignant or benign
diseases. Eclipse TPS
is used to plan external
beam irradiation with
photon, electron, and
proton beams, as well as
for internal irradiation
(brachytherapy)
treatments. In addition,
the Eclipse Proton Eye
algorithm is specifically
indicated for planning
proton treatment of
neoplasms of the eye. |
| | QuickPlan is not
connected to any
radiation emitting
equipment. The
QuickPlan Software is
intended for use by
trained medical
professionals to use in
clinical settings. The
QuickPlan software is
compatible with
Treatment Planning
Systems that use the
DICOM-RT format. | |
| Intended Use | The QuickPlan
Treatment Planning
System is intended for
use in planning
radiotherapy treatments
for patients with
malignant or benign
diseases. | Used to plan
radiotherapy treatments
for patients with
malignant or benign
diseases. |
| Product Code | MUJ | MUJ |
| Regulation | | |
| Number | 892.5050 | 892.5050 |
| Regulation Name | Medical charged-particle | Medical charged-particle |
| | radiation therapy system | radiation therapy system |
| Intended Users | Medical Professionals | Medical Professionals |
| Environment of | | |
| Use | Clinical Setting | Clinical Setting |
| Display | Computer, Web Browser | Computer, Web Browser |
| FEATURES | NEW QUICKPLAN
SOFTWARE
APPLICATION | PREDICATE DEVICE:
Varian Eclipse
Treatment Planning
System RapidPlan
module (K141283) |
| Full Treatment
Planning System | No | Yes |
| Ability to import
DICOM-RT | Yes | Yes |
| Structure | Yes | Yes |
| Identification | | |
| Dose Prediction | Yes | Yes |
| Contouring | Yes | Yes |
| Simultaneous
Dose Prediction
& Contouring | Yes | No |
| Axial view | Yes | Yes |
| Zoom
functionality | Yes | Yes |
| Panning
functionality | Yes | Yes |
| Error in patient
loading
displayed to
user | Yes | Yes |
| Contour display
errors displayed
to the user | Yes | Yes |
| Display of dose | Dose Indices | Dose Volume
Histograms |
Device Comparison Table 5.1
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Image /page/8/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and features the word "siris" in a bold, sans-serif font. To the right of the word "siris" is a cluster of blue dots arranged in a circular pattern. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font.
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Image /page/9/Picture/1 description: The image shows the logo for Siris Medical. The logo is blue and features the word "siris" in a bold, sans-serif font. To the right of the word "siris" is a plus sign made up of small circles. Below the word "siris" is the word "MEDICAL" in a smaller, sans-serif font.
Device Comparison Table
Testing:
Non-Clinical Performance Data Testing:
Performance bench testing was conducted to verify that the new QUICKPLAN software device meets all design specifications and demonstrates substantial equivalence to its predicate, the Eclipse Treatment Planning System Rapid Plan module by Varian Medical Systems, Inc. (K141283). In addition, the new QUICKPLAN software device complies with the following standards:
- IEC 62083 - Edition 2.0 - 2009-09 - Medical electrical equipment -Requirements for the safety of radiotherapy treatment planning systems
- IEC 62366 Medical devices Application of usability engineering to ● medical devices
Biocompatibility:
Since the new QUICKPLAN software device is stand alone software, there are no patient contacting parts and therefore no biocompatibility testing has been performed.
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Image /page/10/Picture/1 description: The image shows the logo for Siris Medical. The word "Siris" is in a bold, sans-serif font, with the letters in blue. To the right of the word "Siris" is a graphic of a plus sign made up of blue circles. Below the word "Siris" is the word "Medical" in a smaller, sans-serif font, also in blue.
Software:
The new QUICKPLAN software has been validated and complies with the FDA Guidance for the content of Premarket Submission for Software Contained in Medical Devices as well as IEC 62304: 2006, Medical device software -Software life cycle processes.
Risk Analysis:
Risk management activities were performed throughout development of the new QUICKPLAN software device. Potential individual risks were identified, evaluated, and mitigated to the extent possible. Remaining overall residual risk was assessed and determined that any remaining risk is as low as possible and is outweighed by the benefits of the new QUICKPLAN software.
Clinical Performance Testing:
No clinical testing has been performed in support of this QUICKPLAN software 510(k) submission.
Conclusion:
The conclusions drawn from the specifications and performance testing of the new QUICKPLAN software device demonstrate that the new QUICKPLAN software device is at least as safe and as effective and performs as well as or better than the predicate the Eclipse Treatment Planning System Rapid Plan module by Varian Medical Systems, Inc. (K141283). For these reasons, we believe the new QUICKPLAN software device is substantially equivalent to the predicate device.