(259 days)
No
The summary describes standard radiation therapy delivery techniques and image-guided workflows, with the addition of Surface Guided Radiation Therapy (SGRT) for patient positioning and motion monitoring. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on tracking and gating based on defined thresholds, not on AI/ML-driven analysis or decision-making.
Yes
The device is indicated for the delivery of radiation therapy to tumors or other targeted tissues, which is a therapeutic intervention.
No
The document explicitly states: "Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use."
No
The device is a radiation therapy delivery system that includes hardware components such as a megavoltage x-ray radiation delivery system and an external optical monitoring system (EMS). While it contains software, it is not solely software.
Based on the provided information, the Radixact Treatment Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "delivery of radiation therapy... to tumors or other targeted tissues anywhere in the body". This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the delivery of radiation and imaging capabilities for guiding that delivery. It explicitly states that the system "neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use."
- Lack of Diagnostic Function: The device does not analyze biological samples (like blood, tissue, etc.) to provide diagnostic information about a patient's health status or disease.
Therefore, the Radixact Treatment Delivery System falls under the category of a therapeutic medical device, specifically a radiation therapy delivery system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensitymodulated (IMRT), or non-modulated (non-INRT/three-dimensional conformal) treatment techniques and using imageguided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient position and motion monitoring, and breath-hold gating.
Product codes
IYE
Device Description
The predicate and modified Radixact Treatment Delivery Systems are radiation therapy delivery systems, that provide megavoltage CT imaging capabilities coupled with x-ray radiation delivery. The system achieves delivery using rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) radiation therapy treatment techniques utilizing image-guided (IGRT) or non-image-guided workflows, to tumors or other targeted tissues anywhere in the body, in accordance with the physician-approved plan.
The additional feature update: VitalHold incorporates an external optical monitoring system (EMS), which is integrated with the Radixact system to enable Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.
Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT imaging, kVCT Imaging, Optical
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner
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)
Non-Clinical Data:
Breath-hold gating is enabled by the integration of Radixact with a Surface Guided Radiotherapy (SGRT) system. The use of an SGRT system with Radixact also provides the clinician with the ability to perform optical setup, and patient surface monitoring during treatment.
Key system performance attributes were evaluated:
-
- Track a moving surrogate
-
- Deliver treatment beam to the surrogate
-
- Pause the treatment beam when the surrogate has moved out of a defined threshold, i.e., gating window
-
- Inform the user to resume the treatment beam when the surrogate moves within the defined threshold
The Verification results show that the design goals and objectives had been met. These summaries along with raw data within our submission support the feature addition and claim that the modified Radixact Treatment Delivery System is as safe and effective as the predicate device.
- Inform the user to resume the treatment beam when the surrogate moves within the defined threshold
Clinical Testing:
No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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June 23, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Accuray Incorporated % Karla Fields Senior Regulatory Affairs Specialist 1209 Deming Way MADISON WI 53717
Re: K223159
Trade/Device Name: Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: May 23, 2023 Received: May 24, 2023
Dear Karla Fields:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is 2023.06.23, and the time is 07:54:07 -04'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223159
Device Name The Radixact Treatment Delivery System
Indications for Use (Describe)
The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensitymodulated (IMRT), or non-modulated (non-INRT/three-dimensional conformal) treatment techniques and using imageguided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient position and motion monitoring, and breath-hold gating.
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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Premarket Notification 510(k) Summary
As required by 21 CFR 807.92
| 510(k) Number: | K223159 |
|---|---|
| Product Name: | Radixact Treatment Delivery System |
| Date Prepared: | June 22, 2023 |
| Submitter: | Accuray Incorporated |
| 1209 Deming Way | |
| Madison, Wisconsin 53717 | |
| Primary Contact Person: | Karla Fields |
| (608) 824-2990 | |
| kfields@accuray.com | |
| Secondary Contact Person: | Michael Preto |
| (608) 405-9427 | |
| mpreto@accuray.com | |
| Common or Usual Name | Medical Linear Accelerator |
| Regulation: | 21 CFR 892.5050 |
| Classification Name: | 892.5050 Medical charged-particle radiation therapy system |
| Regulatory Class: | II |
| Product Code: | IYE |
| Primary Predicate Device: | Radixact Treatment Delivery System, K202412 |
| Reference Device: | Radixact Treatment Delivery System, K182687 |
4
Device Description
The primary predicate Radixact Treatment Delivery System was last cleared on K202412.
The predicate and modified Radixact Treatment Delivery Systems are radiation therapy delivery systems, that provide megavoltage CT imaging capabilities coupled with x-ray radiation delivery. The system achieves delivery using rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) radiation therapy treatment techniques utilizing image-guided (IGRT) or non-image-guided workflows, to tumors or other targeted tissues anywhere in the body, in accordance with the physician-approved plan.
The additional feature update: VitalHold incorporates an external optical monitoring system (EMS), which is integrated with the Radixact system to enable Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.
Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
Intended Use
The Radixact Treatment Delivery System is intended for the delivery of radiation therapy, stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensity-modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) treatment techniques and using image-guided (IGRT) or nonimage-guided workflows in accordance with the physician-approved plan.
Indication for Use
The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, non-rotational, intensity-modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) treatment techniques and using image-guided (IGRT) or nonimage-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.
Significant Differences
The new functionality added to the modified Radixact Treatment Delivery System provides an enhanced user experience. The primary focus of the additional updates within this submission for the modified Radixact Treatment Delivery System are:
-
To provide integration of a Surface-Guided Radiotherapy (SGRT) system, through an optional interface VitalHold utilized for breath-hold gating capabilities
-
Switching of the intended use and indications for use statements, to their appropriate descriptors (with the feature update included in this submission)
5
The primary function of VitalHold encompasses a licensable feature that integrates a Surface Guided Radiotherapy (SGRT) system through the Accuray Connect - Surface Imaging interface. VitalHold can be used for real-time optical patient setup and to perform breath-hold gating techniques like deep inspirational breath-hold (DIBH) and allows an external system to gate the MV beam during treatment delivery for the purpose of breath-hold gating and/or monitoring of patient positioning during treatment. Note that breath-hold gating can be used to do DIBH, is just one of several clinical techniques that can be delivered by using the breath-hold gating feature. This feature also includes the enhanced ability to turn the MV beam on in under one second.
Summary of Technological Characteristics
The modified Radixact Treatment Delivery System has imaging and treatment capabilities similar to those of the predicate Radixact Treatment Delivery System. It also incorporates a functionally equivalent CT-style gantry and patient couch.
Additionally, the predicate and subject devices have substantially equivalent performance specifications, technological characteristics, and incorporate ClearRT helical kVCT imaging (complementing the feature addition in this submission). Further, the predicate and modified Radixact Treatment Delivery System are comprised of the same fundamental scientific principles and have substantially equivalent principles of operation.
The main difference between the predicate and the subject device is the integration of VitalHold the licensable feature discussed. The Intended Use and Indications for Use have been modified (switching them to their appropriate descriptors) with the Intended Use Statement to be more general and the Indications for Use to be more specific. The feature addition supported by the verification and validation activities, the additional acronyms and specificity added to the Indications for Use are considered minor, as outlined in the table below. Where there are technological differences between the subject and predicate devices, those differences do not raise different questions of safety or effectiveness.
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| Device Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Intended Use | ClearRT Helical kVCT for the | ||
| Radixact Treatment Delivery System | |||
| (K202412) | Radixact Treatment Delivery System | Analysis | |
| Intended Use | The kVCT Imaging Feature is an | ||
| option within the intended use of the | |||
| Radixact Treatment Delivery System. | |||
| The Radixact Treatment Delivery | |||
| System is intended to be used for the | |||
| delivery of radiation therapy, | |||
| stereotactic radiotherapy or stereotactic | |||
| radiosurgery to tumors or other targeted | |||
| tissues. The megavoltage x-ray | |||
| radiation is delivered using rotational, | |||
| non-rotational, intensity modulated | |||
| (IMRT), or non-modulated (non- | |||
| IMRT/three dimensional conformal) | |||
| treatment techniques and using image- | |||
| guided (IGRT) or non-image-guided | |||
| workflows in accordance with the | |||
| physician-approved plan. | The Radixact Treatment Delivery System | ||
| is intended for the delivery of radiation | |||
| therapy, stereotactic body radiotherapy | |||
| (SBRT) or stereotactic radiosurgery (SRS) | |||
| to tumors or other targeted tissues | |||
| anywhere in the body under the direction | |||
| of a licensed medical practitioner. The | |||
| megavoltage x-ray radiation is delivered | |||
| using rotational, non-rotational, intensity- | |||
| modulated (IMRT), or non-modulated | |||
| (non-IMRT/three-dimensional conformal) | |||
| treatment techniques and using image- | |||
| guided (IGRT) or non-image-guided | |||
| workflows in accordance with the | |||
| physician-approved plan. | Addition of acronyms (features), switching | ||
| Intended Use Statement to be more general. | |||
| Device Characteristic | Predicate Device | Subject Device | Comparison |
| Indications for Use | ClearRT Helical kVCT for the | ||
| Radixact Treatment Delivery System | |||
| (K202412) | Radixact Treatment Delivery System | Analysis | |
| Indications for Use | The kVCT Imaging Feature is an option | ||
| within the indications for use of the | |||
| Radixact Treatment Delivery System. | |||
| The Radixact Treatment Delivery System | |||
| is indicated for the delivery of radiation | |||
| therapy, stereotactic radiotherapy or | |||
| stereotactic radiosurgery to tumors or | |||
| other targeted tissues anywhere in the | |||
| body under the direction of a licensed | |||
| medical practitioner. | The Radixact Treatment Delivery System is | ||
| indicated for the delivery of radiation | |||
| therapy, stereotactic body radiotherapy | |||
| (SBRT) or stereotactic radiosurgery (SRS) to | |||
| tumors or other targeted tissues anywhere in | |||
| the body under the direction of a licensed | |||
| medical practitioner. The megavoltage x-ray | |||
| radiation is delivered using rotational, non- | |||
| rotational, intensity-modulated (IMRT), or | |||
| non-modulated (non-IMRT/three- | |||
| dimensional conformal) treatment techniques | |||
| and using image-guided (IGRT) or non- | |||
| image-guided workflows in accordance with | |||
| the physician-approved plan. | |||
| The Radixact Treatment Delivery System | |||
| integrates Surface Guided Radiation Therapy | |||
| (SGRT) for patient setup, patient position | |||
| and motion monitoring, and breath hold | |||
| gating. | Addition of acronyms (features), switching | ||
| Indications for Use Statement to be more specific. | |||
| Addition of SGRT. | |||
| The SGRT statement is supported by the VitalHold | |||
| feature updates: incorporating an external optical | |||
| monitoring system (EMS), integrated with the | |||
| Radixact system for patient setup, patient position | |||
| along with motion monitoring, and breath-hold | |||
| gating. | |||
| The optional feature update does not raise | |||
| additional questions of safety and effectiveness | |||
| supported by the results of the verification and | |||
| validation activities, the additional acronyms and | |||
| specificity. | |||
| Adding to the Indications for Use is considered | |||
| minor. | |||
| Device Characteristic | Predicate Device | Subject Device | Comparison |
| Classification | |||
| Regulation, Product | |||
| Code & System | |||
| Configuration | ClearRT Helical KVCT for the | ||
| Radixact Treatment Delivery System | |||
| (K202412) | Radixact Treatment Delivery System | Analysis | |
| Classification, | |||
| Regulation, Product | |||
| Code | §892.5050 Medical charged-particle | ||
| radiation therapy system, class II, IYE | §892.5050 Medical charged-particle | ||
| radiation therapy system, class II, IYE | Identical | ||
| System Configuration | Stand-alone radiation delivery system | ||
| with kV imaging added (does not | |||
| include data management system or | |||
| planning system) | Stand-alone radiation delivery system with | ||
| ClearRT & kV imaging (does not include | |||
| data management system or planning | |||
| system) with gated motion management. | Administrative updates. kV Radiographs and | ||
| Motion Tracking introduced in K182687. kVCT | |||
| introduced in K202412. Updates to brand | |||
| names. Inclusion of Gated Motion Management. | |||
| Radiation Source | |||
| Nominal Beam | |||
| Energy | 6 MV | 6 MV | Identical |
| Fixed Field Size | 1.0 cm x 40 cm | ||
| 2.5 cm x 40 cm | |||
| 5.0 cm x 40 cm | 1.0 cm x 40 cm | ||
| 2.5 cm x 40 cm | |||
| 5.0 cm x 40 cm | Identical | ||
| Dynamic Field Size | 1.0 - 2.5 cm x 40 cm | ||
| 1.0 - 5.0 cm x 40 cm | 1.0 - 2.5 cm x 40 cm | ||
| 1.0 - 5.0 cm x 40 cm | Identical | ||
| Isocenter Distance | 850 mm | 850 mm | Identical |
| Dose Rate | |||
| (standard) | 850 cGy/min | 850 cGy/min | Identical |
| Dose Rate (optional) | 1000 cGy/min | 1000 cGy/min | Identical |
| Collimation | |||
| Primary Collimation | |||
| Method | Rectangular, fixed tungsten aperture | Rectangular, fixed tungsten aperture | Identical |
| Collimation Size | |||
| (MLC) | 40 cm total width | 40 cm total width | Identical |
| Collimation | |||
| Transition Time | |||
| (MLC) |