(28 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on integrated planning, dose calculation, and imaging, without mentioning any AI/ML-driven features.
Yes
The device delivers radiation therapy for treating tumors and other targeted tissues, which is a therapeutic intervention.
No
The Device Description explicitly states: "The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use."
No
The device description explicitly states it is a "radiation therapy system" that integrates planning, dose calculation, imaging, and radiation therapy treatment capabilities, indicating it includes hardware components for radiation delivery and imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for the planning and delivery of radiation therapy. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces its function as a radiation therapy system for treatment. It explicitly states the megavoltage CT imaging functionality is not intended for diagnostic use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions based on such analysis, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Onrad™ Treatment System's purpose is to treat a condition (tumors or targeted tissues) using radiation, not to diagnose it.
N/A
Intended Use / Indications for Use
The Onrad™ Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Product codes
MUJ
Device Description
The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT imaging
Anatomical Site
tumors or other targeted tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 Onrad™ Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm the Onrad™ Treatment System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate the Onrad Treatment System is as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TomoTherapy Treatment System (K121934)
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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2016
Accuray Incorporated % Ms. Erin Daly Senior Regulatory Affairs Associate 1209 Deming Way MADISON WI 53717
Re: K152488 Trade/Device Name: Onrad™ Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: September 1, 2015 Received: September 4, 2015
Dear Ms. Daly:
This letter corrects our substantially equivalent letter of September 28, 2015.
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,
Robert Oels
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) K152488
Device Name Onrad™ Treatment System
Indications for Use (Describe)
The Onrad™ Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 201.321 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 201.63) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Applicant:
Accuray Incorporated 1240 Deming Way Madison, WI 53717-1954 Phone: 608.824.2800 Fax: 608.824.2981 Contact: Erin E Dal
| Contact: | Erin E. Daly |
|---|---|
| Date Prepared: | August 15, 2015 |
Device Identification:
| Device Name: | Onrad™ Treatment System |
|---|---|
| Trade & Brand Names: | Onrad™ Treatment System |
| Common Name: | Radiation Therapy System |
| Classification: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Description: | Medical charged particle radiation therapy system |
Predicate Device:
TomoTherapy Treatment System (K121934)
Description:
The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
Intended Use:
The Onrad™ Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Technological Characteristics:
The technological characteristics of the Onrad™ System are substantially equivalent to the predicate. The physical properties of the device are cosmetic ONLY and do not impact the form, fit or function. The most significant change is the release of a new software version to support the removal of the "helical" treatment.
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Performance Data:
The Onrad™ Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm the Onrad™ Treatment System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate the Onrad Treatment System is as safe, as effective, and performs as well as the predicate device.
Summary:
The Onrad™ Treatment System is substantially equivalent to the predicate device. The intended use, major technological characteristics, and the principles of operation of the Onrad™ Treatment System are substantially equivalent to those of the predicate device. Minor modifications do not raise new types of safety or effectiveness questions. Performance data demonstrate the Onrad™ Treatment System is as safe, as effective, and performs as well as the predicate device.