Delivery Analysis

K143269 · Accuray Incorporated · MUJ · Apr 14, 2015 · Radiology

Device Facts

• Record ID: K143269
• Device Name: Delivery Analysis
• Applicant: Accuray Incorporated
• Product Code: MUJ · Radiology
• Decision Date: Apr 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Delivery Analysis is intended to be used to assess the measured MLC fluence sinogram with respect to the planned MLC fluence sinogram. The assessment augments, but does not replace, the pre-treatment delivery quality assurance assessments outlined in the TomoTherapy Treatment System Delivery Quality Assurance Guide. Delivery Analysis is intended to be used to assess the dose calculations resulting from using the measured MLC fluence sinogram with respect to the dose calculation resulting from using the original planned MLC fluence sinogram. The assessment augments, but does not replace, the pre-treatment delivery quality assurance assessments outlined in the TomoTherapy Treatment System Delivery Quality Assurance Guide. Delivery Analysis is intended to be used to quantify the consistency of the post-patient detector signal from fraction to fraction over the course of a patient's radiation therapy treatment. Variations in the consistency of the post-patient detector signal can be an indication of patient anatomy change or alignment inconsistency. The determination of the degree of inconsistency that is clinically relevant and any subsequent alterations to the patient treatment are the sole responsibility and discretion of the user. Delivery Analysis does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. It is not intended for diagnostic use.

Device Story

Delivery Analysis is a standalone software tool for radiation therapy quality assurance; used with TomoTherapy Treatment Systems. Input data includes planned radiation treatment data and measured radiation fields from the TomoTherapy fan-line detector array. The software performs quantitative comparisons between planned and measured MLC fluence sinograms; calculates dose implications based on measured fluence; and trends detector signals across treatment fractions. Used in clinical settings by radiation therapy professionals to evaluate MLC performance, patient setup consistency, and anatomical changes. Output is presented as comparative data and metrics for clinician review. The device does not provide clinical conclusions or diagnostic interpretations; clinicians use the output to inform decisions regarding treatment delivery quality and potential adjustments. Benefits include enhanced monitoring of treatment delivery consistency and verification of plan adherence.

Clinical Evidence

No clinical tests were required to establish substantial equivalence. Performance was demonstrated through verification and validation testing confirming conformance to design specifications.

Technological Characteristics

Standalone software workstation application. Operates by processing radiation field data from TomoTherapy fan-line detector arrays. Performs quantitative comparisons and dose calculations. Compatible with TomoTherapy HTM-Series and Hi-Art systems (v2.0.5 or 5.0.5+). Requires DICOM Export Data Services Package.

Indications for Use

Indicated for quantitative comparisons of planned and measured MLC fluence sinograms, quantitative comparisons of planned dose distribution to dose distribution calculated based on measured MLC fluence sinograms, and quantitative comparisons of delivered detector sinograms from one fraction to another.

Regulatory Classification

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.

Predicate Devices

• Dosimetry Check Version 4 Release 1 (K132605)

Reference Devices

• TomoTherapy Treatment System (K121934)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2015

Accuray Incorporated % Mr. Keith Picker Regulatory Affairs Specialist 1209 Deming Way MADISON WI 53717

Re: K143269

Trade/Device Name: Delivery Analysis Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, IYE Dated: April 8, 2015 Received: March 6, 2015

Dear Mr. Picker:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

for

Robert Ochs, PhD Acting 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) K143269

Device Name

Delivery Analysis

Indications for Use (Describe)

Delivery Analysis is indicated for making:

- Quantitative comparisons of planned and measured MLC fluence sinograms

- Quantitative comparisons of the planned dose distribution to the dose distribution

calculated based upon the measured MLC fluence sinogram

- Quantitative comparisons of the delivered detector sinograms from one fraction to another

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Section 7 510(k) Summary

### Applicant

Accuray Incorporated 1209 Deming Way Madison, WI 53717-1954 Phone: [phone] Fax: [phone] Keith Picker Contact: Date Prepared: November 4, 2014 April 8, 2015 Date Revised:

### Device Identification

| Device Name: | Delivery Analysis |
|-------------------------|---------------------------------------------------|
| Trade & Brand Names: | Delivery Analysis |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Name: | Medical charged particle radiation therapy system |
| Regulatory Class: | Class II |
| Primary Product Code: | MUJ |
| Secondary Product Code: | IYE |

### Predicate Device

Dosimetry Check Version 4 Release 1 (K132605)

### Device Description

Delivery Analysis is a software tool that runs on a standalone workstation used to compare radiation therapy pre-treatment and measured in-treatment data with information describing the planned radiation treatment delivery. The pretreatment assessment tools provide a means to confirm whether the multi-leaf collimator (MLC) has performed according to the treatment plan and evaluate any differences in MLC performance that may affect the treatment delivery. The intreatment assessment tools allow comparison of the current radiation treatment fraction as delivered with previous fractions to evaluate the consistency of the treatment delivery with particular sensitivity to variations in patient setup and anatomy.

Delivery Analysis is a computer-based analysis tool for viewing plan and treatment delivery system data, making quantitative comparisons among data sets, trending specific metrics associated with deliveries, and calculating the dose implications for some

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measured quantities from the treatment delivery system. Delivery Analysis is designed for use with the TomoTherapy Treatment System last cleared under 510(k) number K121934. Delivery Analysis uses the radiation fields that are measured with the TomoTherapy fan-line detector array to provide both theoretical calculations and direct comparisons of raw data on a fraction per fraction basis.

Delivery Analysis™ is compatible with any TomoTherapy® System. Prerequisites are:

- · Software version 2.0.5 (TomoTherapy HTM-Series and Tomo HD™; 5.0.5 for TomoTherapy Hi·Art™) or higher
- DICOM Export Data Services Package (standard with all HTM Series systems; . available as an upgrade option for other systems)

Further, Delivery Analysis will not work with any systems that do not meet the above stated prerequisites.

# Intended Use

Delivery Analysis is intended to be used to assess the measured MLC fluence sinogram with respect to the planned MLC fluence sinogram. The assessment augments, but does not replace, the pre-treatment delivery quality assurance assessments outlined in the TomoTherapy Treatment System Delivery Quality Assurance Guide.

Delivery Analysis is intended to be used to assess the dose calculations resulting from using the measured MLC fluence sinogram with respect to the dose calculation resulting from using the original planned MLC fluence sinogram. The assessment augments, but does not replace, the pre-treatment delivery quality assurance assessments outlined in the TomoTherapy Treatment System Delivery Quality Assurance Guide.

Delivery Analysis is intended to be used to quantify the consistency of the post-patient detector signal from fraction to fraction over the course of a patient's radiation therapy treatment. Variations in the consistency of the post-patient detector signal can be an indication of patient anatomy change or alignment inconsistency. The determination of the degree of inconsistency that is clinically relevant and any subsequent alterations to the patient treatment are the sole responsibility and discretion of the user.

Delivery Analysis does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. It is not intended for diagnostic use.

# Indications for Use

Delivery Analysis is indicated for making:

- Ouantitative comparisons of planned and measured MLC fluence sinograms
- Quantitative comparisons of the planned dose distribution to the dose distribution calculated based upon the measured MLC fluence sinogram
- Quantitative comparisons of the delivered detector sinograms from one fraction to another

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While the indications for use for Delivery Analysis are stated differently from those of the predicate, the differences are not critical to the intended use of the devices: the analysis, review, and assessment of radiation fields measured by the TomoTherapy fanline detector array. Both devices provide the same types of data analysis and data comparisons. Neither Delivery Analysis nor the predicate device provide any conclusions regarding the results of the data analysis, nor do they provide criteria to be used for interpreting the results. Experienced clinicians evaluate the data from their patient-specific radiation treatment plans in accordance with their medical training and clinical judgment.

## Technological Characteristics

Delivery Analysis and the predicate device employ the same fundamental scientific principles, and have substantially equivalent technological characteristics and principles of operation.

Both Delivery Analysis and the predicate device use the same types of data to provide the same types of information to the user. Where there are technological differences in implementation, and in the way the information is presented to the user, those differences do not raise different questions of safety or effectiveness. Further, neither device is a required accessory to any system that provides therapy to patients.

A table comparing the predicate cleared on K132605 and Delivery Analysis is presented below:

| Product Characteristics or Features | Predicate Device<br>Dosimetry Check<br>Version 4 release 1<br>(K132605) | Subject Device<br>Delivery Analysis |
|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|
| Type of Therapy Assessed | | |
| Photon Therapy | Yes | Yes |
| Electron Therapy | No | No |
| C-arm-based RT Systems | Yes | No |
| Ring-based RT System (TomoTherapy) | Yes | Yes |
| Pre-Treatment Assessment | | |
| Ability to use TomoTherapy System detector<br>data from a pre-treatment plan without the<br>patient in the treatment bore | Yes | Yes |
| Compute dose in planning CT, and compare<br>computed dose to planned dose | Yes | Yes |
| Provides dose difference or gamma analysis | Yes | Yes |
| In-Treatment Assessment | | |
| Ability to use TomoTherapy System exit<br>detector data from a treatment delivery | Yes | Yes |

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| Product Characteristics or Features | Predicate Device<br>Dosimetry Check<br>Version 4 release 1<br>(K132605) | Subject Device<br>Delivery Analysis |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------|
| Type of Therapy Assessed | | |
| Photon Therapy | Yes | Yes |
| Electron Therapy | No | No |
| C-arm-based RT Systems | Yes | No |
| Ring-based RT System (TomoTherapy) | Yes | Yes |
| Pre-Treatment Assessment | | |
| On a treatment by treatment basis, provide a<br>comparison of delivered dose or fluence to<br>planned or previously delivered dose or<br>fluence | Yes* | Yes* |
| Provide dose/fluence difference or gamma<br>analysis | Yes | Yes |
| *Both devices provide an in-treatment assessment on a treatment-by-treatment basis, using the same<br>detector data as the basis for the comparisons. A minor technological difference is that the predicate<br>device processes the raw data to present results based upon dose, whereas Delivery Analysis<br>presents results based upon the raw data. | | |

# Performance Data

Results of verification and validation testing confirm that Delivery Analysis 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 that Delivery Analysis is as safe and effective, and performs as well as the predicate device.

### Conclusion

Delivery Analysis is substantially equivalent to the predicate device. The intended use, major technological characteristics, and the principles of operation of Delivery Analysis are substantially equivalent to those of the predicate device. Minor differences do not raise different questions of safety and effectiveness of Delivery Analysis in comparison to the predicate device. Further, performance data demonstrate that Delivery Analysis is as safe and effective, and performs as well as the predicate device. Accordingly, Delivery Analysis is substantially equivalent to the predicate device.