(142 days)
K 101503
No
The summary describes a software for in-vivo dosimetry using EPID measurements and comparing reconstructed dose to planned dose. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance study sections. The evaluation is described as algorithm evaluation using measured data, not training or testing of an AI/ML model.
No
The device is a software used by radiation oncologists and medical physicists to detect errors in the delivery of high energy X-rays and verify agreement between reconstructed and planned doses. It does not directly provide a therapeutic effect or treat a disease; instead, it is a quality assurance tool for radiation therapy.
No
Explanation: The device is described as software that detects errors in the delivery of high energy X-rays during patient treatment by verifying if the reconstructed dose is in agreement with the planned dose. It does not diagnose medical conditions in patients. Instead, it ensures the accuracy of radiation therapy delivery, which is a quality control/assurance function rather than a diagnostic one.
Yes
The device description explicitly states that EPIgray is "comprehensive software" and is composed of "EPIgray workstation and In-Vivo Manager tool," both described as software components. While it utilizes data from an EPID (a hardware device), the device being submitted for clearance is the software itself, which processes this data.
Based on the provided information, EPIgray is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: 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.
- EPIgray's Function: EPIgray is a software used in radiation therapy to verify the accuracy of dose delivery during patient treatment. It uses measurements from an Electronic Portal Imaging Device (EPID) and compares them to the planned dose. This process does not involve analyzing samples taken from the patient's body.
- Intended Use: The intended use clearly states it's for detecting errors in the delivery of high energy X-rays during treatment, not for diagnosing a disease or condition based on bodily samples.
Therefore, EPIgray falls under the category of medical devices used in treatment delivery and verification, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
EPIgray is a software dedicated for error detection in dose delivery and patient positioning during X-ray high energy radiation therapy. EPIgray uses images acquired from a portal imaging system (EPID) to reconstruct the dose in the patient. The comparison between the reconstructed and the planned dose, activates warnings and allows a follow-up of the dose actually given to the patient.
EPIgray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning svstem. This product in not used to give a prescription of the radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
IYF, MUJ
Device Description
EPIgray is comprehensive software that allows the user to perform an in-vivo dosimetry by means of imaging device such as an Electronic Portal Imaging Device (EPID). The product is composed of: EPIgray workstation and In-Vivo Manager tool. Epigray workstation is an extension of an already cleared product: ISOgray planning system (K103146). It uses only two modules of the previously approved system: Information module and Exacor module. In Vivo manager software is a year application intended for in-vivo measurements management. In particular, it allows to retrieve, on a web browser, the result of dose reconstruction by EPIgray workstation based on EPID.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electronic Portal Imaging Device (EPID)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist and medical physicist
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
Non-Clinical tests: Verification tests were written and executed internally to validate that the system works according to the requirement. The documentation includes system level test pass/fail criteria and a summary of the test results. It is available in the Verification and Validation section from Tab 12, Sub Tab 6.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical tests: Clinical trials were not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. However, algorithm evaluation was performed by Medical Physicists team using measured data in a clinical facility. Evaluation summary is available in tab 13 of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 101503
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DOSIsoft
2002
LAUREAT
CREATION D'ENTREPRISES DE TECHNOLOGIES INNOVANTES
Ministère
jeunesse
éducation
recherche
ministère délégué
recherche et nouvelles
technologies
FEB - 8 2012
Premarket Notification [510(k)] Summary Tab 4
Tuesday, September 6th, 2011
Trade Name: EPIgray
Classification Name: Accelerator, Linear, Medical, IYE (per 21 CFR section 892.5050)
Manufacturer's Name: DOSIsoft SA Address: 45-47 avenue Carnot 94230 CACHAN - France
| Corresponding Official: | Hanna Kafrouni, Ph.D. |
|---|---|
| Title: | CEO |
| Telephone: | 33 1 41 24 26 26 |
| Fax: | 33 1 41 24 26 28 |
Predicate: Dosimetry Check with Exit Dose from Math Resolutions, LLC (K 101503)
Device Description: EPIgray is comprehensive software that allows the user to perform an in-vivo dosimetry by means of imaging device such as an Electronic Portal Imaging Device (EPID). The product is composed of: EPIgray workstation and In-Vivo Manager tool. Epigray workstation is an extension of an already cleared product: ISOgray planning system (K103146). It uses only two modules of the previously approved system: Information module and Exacor module. In Vivo manager software is a year application intended for in-vivo measurements management. In particular, it allows to retrieve, on a web browser, the result of dose reconstruction by EPIgray workstation based on EPID.
Intended Use: EPIgray is a software dedicated for error detection in dose delivery and patient positioning during X-ray high energy radiation therapy. EPIgray uses images acquired from a portal imaging system (EPID) to reconstruct the dose in the patient. The comparison between the reconstructed and the planned dose, activates warnings and allows a follow-up of the dose actually given to the patient.
DOSISOFT SA 45/47, avenue Carnot 94230 CACHAN S.A. capital 500.000 €
.. .
Tél. : 01 41 24 26 26 Fax : 01 41 24 26 28
info@dosisoft.com www.dosisoft.com
1
Image /page/1/Picture/0 description: The image shows the word "DOSI" in bold, followed by a butterfly-like shape with arrows pointing towards it. The word "soft" is written after the butterfly shape. The text and butterfly shape appear to be part of a logo or design.
Image /page/1/Picture/1 description: The image shows a logo with the word "LAUREAT" at the top. Below that is the text "CREATION D'ENTREPRISES ET TECHNOLOGIES INNOVANTES". There is also text that says "Ministere" and "Jeunesse Education recherche". The logo also includes the text "ministre delegue recherche et nouvelles technologies" and the number "2002".
Clinical tests: Clinical trials were not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. However, algorithm evaluation was performed by Medical Physicists team using measured data in a clinical facility. Evaluation summary is available in tab 13 of this submission.
Non-Clinical tests: Verification tests were written and executed internally to validate that the system works according to the requirement. The documentation includes system level test pass/fail criteria and a summary of the test results. It is available in the Verification and Validation section from Tab 12, Sub Tab 6.
DOSISOFT SA 45/47, avenue Carnot 94230 CACHAN SA canital 500 000 €
Tél. : 01 41 24 26 26 Fax : 01 41 24 26 28 info@dosisoft.com www.dosisoft.com
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DOSIsoft SA % Mr. Robert J. Morton President Quality and Regulatory Services, Inc. 1244 Fairway Valley Court LINCOLN CA 95648-8489
FEB - 8 2012
Re: K112723
Trade/Device Name: EPIgray Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: January 18, 2012 Received: January 27, 2012
Dear Mr. Morton:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510(k) Number (if known): Ki l 2723
Device Name: EPIgray
Indications for Use:
EPIgray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning svstem. This product in not used to give a prescription of the radiation therapy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)