(113 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on dose recalculation and dosimetry based on patient position and anatomy changes, which are standard radiotherapy calculations.
No
The device provides comparative dose information and aids in decision-making for treatment plans, but it does not directly treat or cure a disease. It is a tool for monitoring and assessment in radiotherapy.
Yes
The device is described as aiding in determining whether a patient plan should be altered partway through the course of treatment, providing estimates of daily and cumulative dose, and indicating potential clinically relevant deviations, which are all processes to identify or monitor a condition (patient dose/deviation from plan) to guide further medical action.
Yes
The device description explicitly states that Adaptivo is a "stand-alone software product" and the performance studies section focuses solely on software verification and validation, with no mention of associated hardware components.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Adaptivo's Function: Adaptivo is a software product that analyzes medical images (CT scans) and treatment plans to provide information about the dose received by a patient during radiotherapy. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes its function in the context of radiotherapy treatment monitoring and planning adjustments, not diagnostic testing using biological samples.
Therefore, based on the provided information, Adaptivo falls under the category of medical device software used in radiotherapy, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
Aurora Technology Development (ATD) 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 provides: • pre-treatment plan delivery verification; • the ability to monitor daily treatments and indicate potential clinically relevant deviations from the intended plan delivery; • estimates of daily and cumulative dose delivered to the patient, accounting for patient position and anatomy changes; and • an aid in determining whether a patient plan should be altered partway through the course of treatment in order to meet the treatment planning goals. ATD Adaptivo is not a primary treatment planning software, and cannot be used to generate radiotherapy treatment plans. ATD Adaptivo has two (2) primary software modules: (1) the Adaptive Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry (IVD) module. These two (2) modules integrate seamlessly to provide the user full benefit of ATD Adaptivo.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncology licensed medical professional
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
ATD Adaptivo was tested in accordance with internal specifications. Test results indicated that ATD Adaptivo complies with predetermined specifications. Verification and validation activities were conducted to establish the performance and safety characteristics of ATD Adaptivo. The results of these activities demonstrate that ATD Adaptivo is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of a caduceus-like symbol with three figures intertwined, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
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/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 (800) 638-2041 or (301) 796-7100 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
2
4 Indications for Use
3
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.
4
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 ____________________________________________________________________________________________________________________________________________________________________
5
5 510(k) Summary
6
| Submission Date: | 12 October 2015 | |||
|---|---|---|---|---|
| Submitter: | Aurora Technology Development, LLC | |||
| 555 D'Onofrio Drive, Suite 104 | ||||
| Madison, WI 53719 | ||||
| Submitter Contact: | Mr. Gustavo H. Olivera | |||
| Aurora Technology Development, LLC | ||||
| Phone: +1 (608) 831-5419 | ||||
| Fax: +1 (239) 768-5281 | ||||
| Email: Gustavo.Olivera@21co.com | ||||
| Application | ||||
| Correspondent: | Thomas Kroenke | |||
| Speed To Market, Inc. | ||||
| PO Box 3018 | ||||
| Nederland, CO 80466 USA | ||||
| tkroenke@speedtomarket.net | ||||
| 303 956 4232 | ||||
| Manufacturing Site: | Aurora Technology Development, LLC | |||
| 555 D'Onofrio Drive, Suite 104 | ||||
| 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 | ||||
| Regulation: | 21 CFR §892.5050 | |||
| Product Code: | IYE | |||
| Substantially | ||||
| Equivalent Devices: | New ATD Model | Predicate | ||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| ATD Adaptivo | K141800 | Sun Nuclear Corporation Model | ||
| 1215 PerFRACTION | ||||
| K132605 | Math Resolutions Dosimetry | |||
| Check v4.1 |
K140660 Mobius Medical Systems Mobius3D
7
| Device Description: | Aurora Technology Development (ATD) 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 provides: |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • pre-treatment plan delivery verification; |
| | • the ability to monitor daily treatments and indicate potential
clinically relevant deviations from the intended plan delivery; |
| | • estimates of daily and cumulative dose delivered to the patient,
accounting for patient position and anatomy changes; and |
| | • an aid in determining whether a patient plan should be altered
partway through the course of treatment in order to meet the
treatment planning goals. |
| | ATD Adaptivo is not a primary treatment planning software, and
cannot be used to generate radiotherapy treatment plans. |
| | ATD Adaptivo has two (2) primary software modules: (1) the Adaptive
Dose Recalculation (ADR) module; and (2) the In-vivo Dosimetry
(IVD) module. These two (2) modules integrate seamlessly to provide
the user full benefit of ATD Adaptivo. |
| 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 |
8
Technology Comparison:
ATD Adaptivo employs the same technological characteristics as the predicate device.
| Characteristic | Sun Nuclear
PerFraction
(K141800) | Math
Resolution
Dosimetry
Check
(K132605) | Mobius Medical
Systems
Mobius3D plus
FX
(K140660) | ATD Adaptivo |
|----------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------|
| Patient data
input | Automatic | Manual | Manual | Manual or
automatic
retrieval from
ARIA system |
| Workflow once
patient data
are received | Automatic | Manual | Automatic | Automatic |
| Pre-treatment
patient specific
QA | Yes | Yes | Yes | Yes |
| During-
treatment
delivery
monitoring | Yes | No | Yes | Yes |
| Patient setup
error detection | Yes | Yes | No | Yes |
| Interactive
view of dose
distribution on
complete CT
image set | No | Yes | Yes | Yes |
| Comparison
between plan
and daily dose | Partial (plan CT
only) | No | Partial (plan CT
only) | Yes |
| Comparison
between plan
and cumulative
dose | No | No | No | Yes |
9
Summary of Performance Testing:
| Software | ATD Adaptivo contains MODERATE level of concern software.
Software was designed and developed according to a robust software
development process, and was rigorously verified and validated.
Software information is provided in accordance with | | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | • FDA guidance: The content of premarket submissions for software
contained in medical devices, 11 May 05; | | |
| | • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep
99; | | |
| | • FDA guidance: General principles of software validation; Final
guidance for industry and FDA staff, 11 Jan 02; | | |
| | • FDA guidance: Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices, 02 Oct 14; and | | |
| | • IEC 62304: 2006, Medical device software – Software life cycle
processes. | | |
| | Test results indicated that ATD Adaptivo complies with predetermined
specifications and the applicable standard. | | |
| Performance Testing
– Bench | ATD Adaptivo was tested in accordance with internal specifications. | | |
| | Test results indicated that ATD Adaptivo complies with predetermined
specifications. | | |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of ATD Adaptivo. The results of
these activities demonstrate that ATD Adaptivo is as safe, as effective,
and performs as well as or better than the predicate device. | | |
| | Therefore, ATD Adaptivo is considered substantially equivalent to the
predicate device. | | |