(57 days)
No
The summary describes a standard radiation therapy planning system with image processing and optimization capabilities, but there is no mention of AI or ML being used in the process. The focus is on user-driven planning and calculation based on established physics models.
No.
This device is a treatment planning system, which helps in creating and assessing treatment plans for radiation therapy. It does not directly deliver therapy, but rather aids in the planning process for therapeutic interventions.
No.
The device is a treatment planning system used to create and assess radiation therapy plans, not to diagnose medical conditions.
No
The device description explicitly states it is a "radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems." While the planning system itself is software, its intended use is intrinsically linked to and dependent on hardware radiation delivery systems (CyberKnife® or TomoTherapy® systems) for the actual treatment delivery. It is not a standalone software device performing a medical function independent of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality.
- Device Function: The Accuray Precision™ Treatment Planning System is used for planning and assessing external photon beam irradiation treatment plans for radiation therapy. It uses medical images (CT, MR, PET) of the patient to create a treatment plan, not to analyze biological specimens for diagnostic purposes.
- Intended Use: The intended use clearly states its purpose is for "creation and assessment of external photon beam irradiation treatment plans for radiation therapy...". This is a treatment planning tool, not a diagnostic tool.
- Device Description: The description details how the system uses patient images to define treatment areas and calculate dose distributions for radiation delivery. This process is focused on treatment, not diagnosis.
Therefore, the Accuray Precision™ Treatment Planning System falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
Product codes
IYE, MUJ
Device Description
The Accuray Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS™) Data Management System). The images are imported from the database server into the Accuray Precision™ System and registered/ fused for dose calculation and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.
The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife® or TomoTherapy® systems), treatment delivery mode (e.g. 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.
Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic CT (primary image series) and/or secondary images (MR and PET)
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, medical physicists, and dosimetrists
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)
The performance test data for subject device, Accuray Precision™ Treatment Planning System with modifications, confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device, Accuray Precision™ Treatment Planning System. The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Accuray Incorporated % Shweta Kaushik, Ph.D., RAC Senior Regulatory Affairs Specialist 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K171086
Trade/Device Name: Accuray Precision™ Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: April 10, 2017 Received: April 12, 2017
Dear Dr. Kaushik:
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.
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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
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) K171086
Device Name
Accuray Precision™ Treatment Planning System
Indications for Use (Describe)
The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
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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510(k)SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
Name, Address, Phone and Fax number of the Applicant
Accurav Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Phone: (408) 716-4600 Fax: (408) 789-4249
Contact Person Shweta Kaushik
Date Prepared
April 10, 2017
Device Name
Device Name: Accuray Precision™ Treatment Planning System Marketed Trade or Model Name: Accuray Precision™ Treatment Planning System Common Name: Radiation therapy treatment planning system Regulation Number: 21 CFR 892.5050 Regulatory Classification Name: Medical charged-particle radiation therapy system Requlatory Class: II Regulatory Product Code: IYE, MUJ Classification Panel: Radiology
Device Description
The Accuray Precision™ Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS™) Data Management
4
System). The images are imported from the database server into the Accuray Precision™ System and registered/ fused for dose calculation and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.
The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife® or TomoTherapy® systems), treatment delivery mode (e.g. 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.
Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.
Indications for Use
The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
Intended Use
The Accuray Precision™ Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery
5
system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
The Accuray Precision™ Treatment Planning System is intended to be used by physicians, medical physicists, and dosimetrists to generate radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment plans. Plans may be created with the Accuray Precision™ treatment planning system for delivery using Intensity Modulated Radiation Therapy (IMRT) or 3-D Conformal Radiation Therapy (3DCRT) techniques.
The users will be able to create a plan that satisfies established clinical objectives. For stereotactic radiosurgery, the plan will generally involve delivering a tumoricidal dose to target tissue, while minimizing dose to other tissues. For radiation therapy and stereotactic radiotherapy, the plan will generally involve delivering a damaging dose to diseased tissue at a level that allows healthy tissue in the target volume to recover, while also minimizing dose to tissue outside the target volume.
The treatment plan with dose distributions and complete delivered dose value along with the input data will be available through a user display or printed report for user review and evaluation against the treatment prescription and established physics models. The treatment plan will then be saved by the user, approved by the qualified medical practitioner, and subsequently delivered by the treatment delivery system.
Technological Characteristics
There is no significant difference between the subject device (Accuray Precision™ Treatment Planning System with modifications) and the predicate device (Accuray Precision™ Treatment Planning System, last cleared on K161136) in terms of fundamental scientific technology or principles of operation. A brief summary of the technological characteristics of the subject device in comparison to those of the predicate device is provided below:
| Device
Characteristic | Accuray Precision™ Treatment
Planning System (K161136)
(Predicate Device) | Accuray Precision™ Treatment
Planning System with modifications
(Subject Device) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Accuray Precision™ treatment
planning system is indicated for creation
and assessment of external photon beam
irradiation treatment plans for radiation
therapy, stereotactic radiotherapy or
stereotactic radiosurgery for lesions, | Same as predicate |
| Device
Characteristic | Accuray Precision™ Treatment
Planning System (K161136)
(Predicate Device) | Accuray Precision™ Treatment
Planning System with modifications
(Subject Device) |
| | tumors and conditions anywhere in the
body when radiation treatment is
indicated. A treatment plan provides an
estimate of the dose distribution and the
parameters utilized by the radiation
delivery system. Plans must be reviewed
and approved by qualified medical
practitioners prior to delivery. | |
| | The Accuray Precision™ Treatment
Planning System is intended to be used
by physicians, medical physicists, and
dosimetrist to generate radiation therapy,
stereotactic radiotherapy or stereotactic
radiosurgery treatment plans. Plans may
be created with the Precision treatment
planning system for delivery using
Intensity Modulated Radiation Therapy
(IMRT) or 3-D Conformal Radiation
Therapy (3DCRT) techniques. | |
| | The users will be able to create a plan that
satisfies established clinical objectives.
For stereotactic radiosurgery, the plan will
generally involve delivering a tumoricidal
dose to target tissue, while minimizing
dose to other tissues. For radiation
therapy and stereotactic radiotherapy, the
plan will generally involve delivering a
damaging dose to diseased tissue at a
level that allows healthy tissue in the
target volume to recover, while also
minimizing dose to tissue outside the
target volume. | |
| | The treatment plan with dose distributions
and complete delivered dose value along
with the input data will be available
through a user display or printed report for
user review and evaluation against the
treatment prescription and established
physics models. The treatment plan will
then be saved by the user, approved by
the qualified medical practitioner, and
subsequently delivered by the treatment
delivery system. | |
| Hardware | PC class workstation | Same as predicate |
| Associated
Treatment
Delivery
System | Determines treatment planning and dose
distribution for the CyberKnife and
TomoTherapy Systems | Same as predicate with added
support for continued patient
treatment on TomoTherapy system
upgraded to a future configuration |
| Device
Characteristic | Accuray Precision™ Treatment
Planning System (K161136)
(Predicate Device) | Accuray Precision™ Treatment
Planning System with modifications
(Subject Device) |
| Dose
Calculation
Algorithms | Superposition/ Convolution, Ray Tracing,
FSPB and Monte Carlo (only for circular
collimators) | Same as predicate with
modifications to Monte Carlo dose
calculation algorithm to support
InCise™ Multileaf Collimator (MLC) |
| Dosimetry
Tests | Absolute Dose and End-to-End (E2E)
(CyberKnife Systems)
Gamma index (Both CyberKnife and
TomoTherapy Systems) | Same as predicate |
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Performance
The performance test data for subject device, Accuray Precision™ Treatment Planning System with modifications, confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device, Accuray Precision™ Treatment Planning System. The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are equivalent to the predicate device.
Substantial Equivalence
The subject device, Accuray Precision™ Treatment Planning System with modifications, is substantially equivalent to the predicate device, Accuray Precision™ Treatment Planning System, in intended use, technological characteristics and performance. The modifications performed to the predicate device do not raise new questions of safety or efficacy and the subject device is as safe and as effective as the predicate device.