(266 days)
Not Found
No
The description focuses on using generalized correlation factors and pre-measured data for calculations, not on learning from data or adapting its algorithms. There is no mention of AI, ML, or deep learning in the document.
No.
The device is described as a "quality control check purposes only" software solution that "cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment." It is intended for medical physicists, radiation oncologists, and dosimetrists, not directly for patient diagnosis or treatment.
No
Explanation: The device is explicitly stated to be for "quality control check purposes only" and "cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment." This indicates it does not provide diagnostic information for a patient's medical condition or disease.
Yes
The device is described as a "standalone software solution" and its description focuses entirely on software functionalities, data processing, and analysis. While it uses data from hardware (LINACs, EPID, CT), the device itself is the software performing the analysis.
Based on the provided information, the SOFTDISO system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SOFTDISO's Function: SOFTDISO is a software solution used for in-vivo dosimetric analysis during radiation therapy. It analyzes data from EPID systems and treatment planning systems to perform quality control checks on the delivered radiation dose to the patient within their body.
- No Sample Analysis: SOFTDISO does not analyze any biological samples taken from the patient. Its inputs are imaging data (CT, EPID) and treatment planning data.
Therefore, while SOFTDISO is a medical device used in the context of patient treatment, its function falls outside the scope of In Vitro Diagnostics. It is a quality control tool for radiation therapy delivery.
N/A
Intended Use / Indications for Use
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
Product codes
IYE
Device Description
SOFTDISO software permit an IN-VIVO dosimetric analysis (IVD) in patient for 3DCRT, IMRT and VMAT beams using a Si-EPID portal systems.
The dosimetric analysis consists of two tests elaboration, dose reconstruction in the isocenter point and EPID images y-analysis. In case of out of tolerance levels, the system is capable of underline the right type of quality control useful to remove the causes of discrepancy.
SOFTDISO software is based on the usage of generalized correlation factors between transit signals measured by EPID and doses measured in water equivalent solid phantom, along the beam central axis.
SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs. So only a small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration. In particular some of the measurements that the user performs include calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams. The user also performs a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration.
SOFTDISO software can use information coming from record and verify systems through DICOM and DICOM-RT protocols. DICOM protocol is used for transferring images from CT and from EPID and the DICOM-RT protocol is used for transferring information related to the TPS system.
As soon as the treatment plan and the EPID images (fraction images for each day) are imported into the system, the user is able to visualize the comparison results.
At the end of fraction SOFTDISO provides result for two tests:
- Calculation of R ratio between in patient reconstructed dose and the one planned by the TPS
- Gamma analysis between a reference EPID image and a current one with Py
§ 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
October 27, 2017
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Best NOMOS % Vineet Gupta, Ph.D. Director-R&D One Best Drive PITTSBURGH PA 15202
Re: K170345
Trade/Device Name: SOFTDISO Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 5, 2017 Received: October 10, 2017
Dear Dr. Gupta:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.
Robert Oaks
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
Indications for Use
510(k) Number (if known) K170345
Device Name
SOFTDISO
Indications for Use (Describe)
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
| 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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3
Traditional 510(k) Summary
A. SUBMITTERS NAME
Best NOMOS
B. ADDRESS
One Best Drive Pittsburgh, PA 15202
C. CONTACT
| Name: | Vineet Gupta, Ph.D. |
|---|---|
| Phone: | (412) 312-6819 |
| Fax: | (412) 312-6701 |
| Email: | vineet.gupta@nomos.com |
D. DATE PREPARED
Date: 5-Oct-2017
E. ESTABLISHMENT REGISTRATION NUMBER
Corporate Office Registration Number: 2434141 Manufacturing and Packaging Registration Number: 2434141
F. DEVICE NAME
Device Trade Name: SOFTDISO Standalone Software Quality Control System Common Name: Medical Charged Particle Radiation Therapy System (21 CFR Classification Name: 892.5050)
G. DEVICE CLASS
Class II Panel: Radiology Product Code: IYE Regulation Number: 21CFR 892.5050
4
H. STATEMENT OF INDICATIONS FOR USE
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is intended to be used as a quality control check purposes only.
SOFTDISO checks the correctness of the treatment by comparing the planned dose (from a treatment planning system) with the applied dose measured from the Electronic Portal Imaging Device (EPID) during treatment delivery and presents the results. SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
DEVICE DESCRIPTION I.
SOFTDISO software permit an IN-VIVO dosimetric analysis (IVD) in patient for 3DCRT, IMRT and VMAT beams using a Si-EPID portal systems.
The dosimetric analysis consists of two tests elaboration, dose reconstruction in the isocenter point and EPID images y-analysis. In case of out of tolerance levels, the system is capable of underline the right type of quality control useful to remove the causes of discrepancy.
SOFTDISO software is based on the usage of generalized correlation factors between transit signals measured by EPID and doses measured in water equivalent solid phantom, along the beam central axis.
SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs. So only a small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration. In particular some of the measurements that the user performs include calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams. The user also performs a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration.
SOFTDISO software can use information coming from record and verify systems through DICOM and DICOM-RT protocols. DICOM protocol is used for transferring images from CT and from EPID and the DICOM-RT protocol is used for transferring information related to the TPS system.
5
As soon as the treatment plan and the EPID images (fraction images for each day) are imported into the system, the user is able to visualize the comparison results.
At the end of fraction SOFTDISO provides result for two tests:
- Calculation of R ratio between in patient reconstructed dose and the one planned by the TPS
- Gamma analysis between a reference EPID image and a current one with Py