(63 days)
No
The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the description focuses on combining features of existing predicate devices without mentioning novel AI/ML capabilities.
No.
The "Precision™ treatment planning system" is indicated for creation and assessment of treatment plans, not for direct delivery of therapy. It is a planning system for radiation therapy, which is a therapeutic treatment, but the device itself is not a therapeutic device.
No
The device is a treatment planning system used to create and assess radiation treatment plans, not to diagnose medical conditions.
No
The device description explicitly states it is a "radiation therapy planning system" and compares it to predicate devices which are also described as "treatment planning systems." While it processes data (DICOM images) and provides output (treatment plans), the description focuses on its function as a system for planning radiation therapy, which typically involves software but is intrinsically linked to the hardware of the radiation delivery systems it plans for. The description does not limit the device to being solely software and implies a system that interacts with and supports hardware delivery systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Precision™ treatment planning system is used to create and assess radiation treatment plans based on medical images (CT, MR, PET, etc.). It helps determine how radiation will be delivered to a patient's body.
- Lack of Specimen Analysis: The description clearly states the input is DICOM image series, not biological specimens. The system analyzes images of the body, not samples taken from the body.
Therefore, based on the provided information, the 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 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
MUJ, IYE
Device Description
The 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. It includes the planning system features of both the currently marketed predicate devices: CyberKnife MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:
- Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
- Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image series (CT, MR, PET, etc.)
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The 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.
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 Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems. Thus, Precision Treatment Planning System demonstrates similar performance characteristics to the predicate devices.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Accuray Incorporated % Shweta Kaushik, Ph.D., RAC Regulatory Affairs Specialist II 1310 Chesapeake Terrace SUNNYVALE CA 94089
Re: K161136
Trade/Device Name: Precision Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, IYE Dated: June 7, 2016 Received: June 9, 2016
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 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)
Device Name Precision™ Treatment Planning System
Indications for Use (Describe)
The 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
Accuray Incorporated 1310 Chesapeake Terrace Sunnyvale, California 94089 Ph: (408) 716-4600 Fax: (408) 789-4249
Contact Person Shweta Kaushik
Date Prepared April 21, 2016
Device Name
Device Name: Precision™ Treatment Planning System Common Name: Radiation therapy treatment planning system Marketed Trade or Model Name: Precision™ Treatment Planning System Regulatory Classification Name: Medical charged-particle radiation therapy system Regulatory Class: II Regulatory Product Code: MUJ Classification Panel: Radiology Regulation Number: CFR 892.5050
Device Description
The 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. It includes the planning system features of both the currently marketed predicate devices: CyberKnife
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MultiPlan Treatment Planning System (K150873) and the TomoTherapy Planning Station (K121934). Hence, the Precision Treatment Planning System is intended for treatment planning for multiple platforms:
- · Accuray's robotic radiosurgery systems, including but not limited to the CyberKnife® Treatment Delivery System (last cleared K150873).
- · Accuray's ring gantry systems, including but not limited to the Radixact™ Treatment Delivery System which is a next generation TomoTherapy® Treatment System (last cleared K121934).
Indications for Use
The 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 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.
The 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 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
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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 and predicate devices in terms of fundamental scientific technology or principles of operation. During the design of subject device, some modifications or additions were made to the CyberKnife MultiPlan Treatment Planning System to either include the functionality of TomoTherapy Planning Station or to improve the existing functionality/ user interface. A brief summary of the technological characteristics of the subject device in comparison to those of the predicate devices is provided below:
| Device
Characteristic | CyberKnife
MultiPlan
Treatment
Planning System
(K150873)
(Primary
Predicate Device) | TomoTherapy
Planning Station
(K121934)
(Predicate Device) | Precision Treatment Planning
System
(Subject Device) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Associated
Treatment
Delivery System | Determines
treatment planning
and dose
distribution for the
CyberKnife System | Determines
treatment planning
and dose
distribution for the
TomoTherapy
System | Same as predicates as determines
treatment planning and dose
distribution for both CyberKnife and
TomoTherapy Systems |
| Hardware | PC class
workstation | PC class
workstation | Same as predicates (PC class
workstation) |
| Image series
used | DICOM image
series (CT, MR,
PET, etc.) | DICOM image
series (CT) | Same as predicates (CT, MR,
PET, etc.) |
| Image registration | Rigid image
registration | N/A | Same as predicate with added
Deformable Fusion |
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Precise, innovative tumor treatments™
| Device
Characteristic | Cyberknife
MultiPlan
Treatment
Planning System
(K150873)
(Primary
Predicate Device) | TomoTherapy
Planning Station
(K121934)
(Predicate Device) | Precision Treatment Planning
System
(Subject Device) |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Autosegmentation
(VOI contour tool) | Brain, Male Pelvis | N/A | Same as predicate with added
Head and Neck
Autosegmentation tool |
| Treatment
Machine set-up | Default for
CyberKnife System | Default for
TomoTherapy
System | Same as predicates but with
added option to select treatment
delivery system if multiple
machines are available |
| Plan Modes | N/A | IMRT, 3DCRT | Same as predicate with added
Forward Planning mode |
| Optimization and
dose calculation
subsystem | N/A | Separate GPU
processing
hardware | Same as predicate with GPU
integrated into the PC workstation |
Performance
The performance test data for Precision Treatment Planning System demonstrates that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as currently produced by each of the individual predicate treatment planning systems. Thus, Precision Treatment Planning System demonstrates similar performance characteristics to the predicate devices.
Substantial Equivalence
The subject device, Precision Treatment Planning System is substantially equivalent to both predicate devices: CyberKnife MultiPlan Treatment Planning System and TomoTherapy Planning Station in intended use, technological characteristics and performance. The minor differences in technological characteristics raise no new questions of safety or efficacy and the performance data confirms that the Precision Treatment Planning System is as safe and effective as the predicate devices.