Adaptivo

K152994 · Aurora Technology Development, LLC · IYE · Feb 3, 2016 · Radiology

Device Facts

• Record ID: K152994
• Device Name: Adaptivo
• Applicant: Aurora Technology Development, LLC
• Product Code: IYE · Radiology
• Decision Date: Feb 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery; to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software and cannot be used to generate radiotherapy treatment plans

Device Story

Adaptivo is stand-alone software for radiotherapy quality assurance; used by radiation oncology professionals in clinical settings. Inputs include patient treatment plan data and daily treatment delivery data (manual or automatic retrieval from ARIA system). Device features two modules: Adaptive Dose Recalculation (ADR) and In-vivo Dosimetry (IVD). It performs pre-treatment plan verification, monitors daily treatment delivery, and calculates daily/cumulative dose estimates accounting for patient position and anatomy changes. Output is comparative dose information displayed to the clinician. This information aids in identifying clinically relevant deviations from the intended plan and supports clinical decision-making regarding potential mid-course treatment plan alterations. Benefits include improved accuracy in dose delivery monitoring and patient-specific quality assurance.

Clinical Evidence

Bench testing only. No clinical data provided. Verification and validation activities were conducted against internal specifications and applicable standards (IEC 62304). Results confirmed compliance with predetermined specifications.

Technological Characteristics

Stand-alone software; modules include Adaptive Dose Recalculation (ADR) and In-vivo Dosimetry (IVD). Connectivity via integration with ARIA system. Software development follows IEC 62304:2006. Moderate level of concern.

Indications for Use

Indicated for use by radiation oncology professionals to verify radiotherapy treatment plan delivery, monitor daily treatments for deviations, estimate daily and cumulative patient dose accounting for anatomical changes, and assist in clinical decisions regarding treatment plan modification.

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

• Sun Nuclear Corporation Model 1215 PerFRACTION (K141800)
• Math Resolutions Dosimetry Check v4.1 (K132605)

Reference Devices

• Mobius Medical Systems Mobius3D (K140660)

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

February 3, 2016

Aurora Technology Development, LLC % Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. Po Box 3018 NEDERLAND CO 80466

Re: K152994

Trade/Device Name: Adaptivo Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 29, 2015 Received: December 30, 2015

Dear Mr. Kroenke:

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/ResourcesforYou/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. 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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4 Indications for Use

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# Indications for Use

510(k) Number (if known): K152994

Device Name: Aurora Technology Development, LLC Adaptivo

Indications For Use: Adaptivo is a stand-alone software product that provides comparative dose information about the daily and cumulative dose received by a radiotherapy patient relative to their treatment plan. It is to be used by a radiation oncology licensed medical professional as a guide to provide pre-treatment plan delivery verification; to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery: to provide estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and to aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans.

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Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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5 510(k) Summary

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| Submission Date: | 12 October 2015 | | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------|--|
| Submitter: | Aurora Technology Development, LLC<br>555 D'Onofrio Drive, Suite 104<br>Madison, WI 53719 | | | |
| Submitter Contact: | Mr. Gustavo H. Olivera<br>Aurora Technology Development, LLC<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | | |
| Application<br>Correspondent: | Thomas Kroenke<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | | |
| Manufacturing Site: | Aurora Technology Development, LLC<br>555 D'Onofrio Drive, Suite 104<br>Madison, WI 53719 | | | |
| Trade Name: | Aurora Technology Development, LLC Adaptivo | | | |
| Common Name: | Quality Assurance Software for Patient Radiation Treatment | | | |
| Classification Name: | Accelerator, Linear, Medical | | | |
| Classification<br>Regulation: | 21 CFR §892.5050 | | | |
| Product Code: | IYE | | | |
| Substantially<br>Equivalent Devices: | New ATD Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model | |
| | ATD Adaptivo | K141800 | Sun Nuclear Corporation Model<br>1215 PerFRACTION | |
| | | K132605 | Math Resolutions Dosimetry<br>Check v4.1 | |

K140660 Mobius Medical Systems Mobius3D

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| Device Description: | Aurora Technology Development (ATD) Adaptivo is a stand-alone<br>software product that provides comparative dose information about the<br>daily and cumulative dose received by a radiotherapy patient relative to<br>their treatment plan. It provides: |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • pre-treatment plan delivery verification; |
| | • the ability to monitor daily treatments and indicate potential<br>clinically relevant deviations from the intended plan delivery; |
| | • estimates of daily and cumulative dose delivered to the patient,<br>accounting for patient position and anatomy changes; and |
| | • an aid in determining whether a patient plan should be altered<br>partway through the course of treatment in order to meet the<br>treatment planning goals. |
| | ATD Adaptivo is not a primary treatment planning software, and<br>cannot be used to generate radiotherapy treatment plans. |
| | ATD Adaptivo has two (2) primary software modules: (1) the Adaptive<br>Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry<br>(IVD) module. These two (2) modules integrate seamlessly to provide<br>the user full benefit of ATD Adaptivo. |
| Intended Use: | Adaptivo is a stand-alone software product that provides comparative<br>dose information about the daily and cumulative dose received by a<br>radiotherapy patient relative to their treatment plan. It is to be used by a<br>radiation oncology licensed medical professional as a guide to provide<br>pre-treatment plan delivery verification; to monitor daily treatments<br>and indicate potential clinically relevant deviations from the intended<br>plan delivery; to provide estimates of daily and cumulative dose<br>delivered to the patient, accounting for patient position and anatomy<br>changes; and to aid in determining whether a patient plan should be<br>altered partway through the course of treatment in order to meet the<br>treatment planning goals. Adaptivo is not a primary treatment planning<br>software and cannot be used to generate radiotherapy treatment plans |

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#### Technology Comparison:

ATD Adaptivo employs the same technological characteristics as the predicate device.

| Characteristic | Sun Nuclear<br>PerFraction<br>(K141800) | Math<br>Resolution<br>Dosimetry<br>Check<br>(K132605) | Mobius Medical<br>Systems<br>Mobius3D plus<br>FX<br>(K140660) | ATD Adaptivo |
|----------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------|
| Patient data<br>input | Automatic | Manual | Manual | Manual or<br>automatic<br>retrieval from<br>ARIA system |
| Workflow once<br>patient data<br>are received | Automatic | Manual | Automatic | Automatic |
| Pre-treatment<br>patient specific<br>QA | Yes | Yes | Yes | Yes |
| During-<br>treatment<br>delivery<br>monitoring | Yes | No | Yes | Yes |
| Patient setup<br>error detection | Yes | Yes | No | Yes |
| Interactive<br>view of dose<br>distribution on<br>complete CT<br>image set | No | Yes | Yes | Yes |
| Comparison<br>between plan<br>and daily dose | Partial (plan CT<br>only) | No | Partial (plan CT<br>only) | Yes |
| Comparison<br>between plan<br>and cumulative<br>dose | No | No | No | Yes |

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#### Summary of Performance Testing:

| Software | ATD Adaptivo contains MODERATE level of concern software.<br>Software was designed and developed according to a robust software<br>development process, and was rigorously verified and validated.<br>Software information is provided in accordance with | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | • FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; | | |
| | • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep<br>99; | | |
| | • FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02; | | |
| | • FDA guidance: Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices, 02 Oct 14; and | | |
| | • IEC 62304: 2006, Medical device software – Software life cycle<br>processes. | | |
| | Test results indicated that ATD Adaptivo complies with predetermined<br>specifications and the applicable standard. | | |
| Performance Testing<br>– Bench | ATD Adaptivo was tested in accordance with internal specifications. | | |
| | Test results indicated that ATD Adaptivo complies with predetermined<br>specifications. | | |
| Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of ATD Adaptivo. The results of<br>these activities demonstrate that ATD Adaptivo is as safe, as effective,<br>and performs as well as or better than the predicate device. | | |
| | Therefore, ATD Adaptivo is considered substantially equivalent to the<br>predicate device. | | |