(116 days)
SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment.
The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment.
The SDX Systems are intended to be used in conjunction with a Radiation Therapy systems (imaging & treatment) requiring operator intervention to start & stop radiation. The Automatic Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment. The Automatic Gating Module provides the direct interface between the SDX Module and the Imaging / Radiation Treatment equipment; providing channels on : device communication / identification, recommendation to start Patient Imaging / Radiation, order (or recommendation) to stop patient Imaging / Radiation. The Automatic Gating Module is connected, via cabling, to the Radiation Therapy systems via their own "external interfacing equipment". The use of the Automatic Gating Module allows the SDX to optimize breathing to limit internal motion during imaging & treatment independent to the breathing method chosen, Breath Hold, Free Breathing, etc. Thus patients breathing pattern allows the selection of the gating levels, facilitate the starting & stopping of the radiation beam between the two defined levels.
Here's a summary of the acceptance criteria and study information for the SDX System with Automatic Gating Module, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1 | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 |
| Functionality | Conformance to required specifications of Radiotherapy device manufacturers (both safety & functionality criteria) | Performance testing concludes safety and effectiveness are not compromised and meets all acceptance criteria. |
| Substantial Equivalence (General) | Not compromised compared to the initial SDX Module (K092479) | Not compromised. |
| Gating Requirements | Compatible with radiation therapy treatment systems possessing an External System Gating Interface. | Same as predicate (K102024). |
| Impact on Radiation Therapy Treatment Systems | Does not change the intended diagnostic or therapeutic effect. | Same as predicate (K102024). |
| Patient Breathing Control | Aids operator to optimize patient breathing and provide respiratory synchronization for image acquisition & treatment delivery. | Aids operator to optimize patient breathing and to provide respiratory synchronization for image acquisition & treatment delivery (Same as predicate K092479 but with added automatic triggering). |
| Automatic Gating Module Interface | Facilitate interface between operators, ensuring operator control and final decision in imaging & treatment. Provide device communication/identification, recommendation to start/stop imaging/radiation, and orders/recommendations to stop imaging/radiation. | The Automatic Gating Module provides a direct interface with these capabilities. |
Study Information:
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance. The submission refers to "Performance Testing of the Automatic Gating Module" to demonstrate conformance.
- Data Provenance: Not specified. The testing was conducted to demonstrate conformance to specifications of radiotherapy device manufacturers. The context implies bench or engineering testing rather than a clinical study with patient data.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable for the type of testing performed. The "ground truth" for the performance testing cited would be the technical specifications and safety standards (IEC 60601-1, IEC 60601-1-2, and radiotherapy device manufacturer specifications).
-
Adjudication Method for the Test Set:
- Not applicable. The reported performance testing appears to be based on engineering and regulatory compliance rather than expert adjudication of clinical outcomes.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The submission explicitly states: "The addition of the Automatic Gating Module to the SDX System has not resulted in a modification of the systems performance with respect to the elements provided in the initial 510(k) submission : K092479 ; thus no system performance testing has been carried out." Performance testing was specifically for the new Automatic Gating Module's conformance to specifications.
-
Standalone (Algorithm Only) Performance Study:
- A standalone performance study focused on the Automatic Gating Module's conformance to required specifications (safety and functionality criteria set by radiotherapy device manufacturers) was done. However, this is not a standalone clinical performance study of the algorithm without human interaction in the sense of making a diagnosis or clinical decision. Instead, it seems to verify the module's technical operation as an interface.
-
Type of Ground Truth Used:
- The ground truth for the performance testing was based on technical specifications and regulatory standards:
- IEC 60601-1 (Electrical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- Required specifications of Radiotherapy device manufacturers (covering safety & functionality criteria for the interface).
- The ground truth for the performance testing was based on technical specifications and regulatory standards:
-
Sample Size for the Training Set:
- Not applicable. This 510(k) summary describes performance testing for a device (Automatic Gating Module) that acts as an interface for existing technology (SDX System). There is no mention of machine learning or AI algorithms requiring a "training set" in the context of this submission. The device's function is to facilitate synchronization based on predetermined gating levels, not to learn patterns from data.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set was mentioned or implied for this device.
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Premarket Notification [510(k)] Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : _ ヒ(2 1845
- Company:
DYN'R SAS 74 Cours Gambetta 13100 Aix en Provence France
- 33 4 42 21 07 34 Telephone: +33 4 42 67 30 77 Fax:
Contact Person: Tim LAWTON
Date Prepared: 22nd June 2012
Device Names:
SDX System with Automatic Gating Module Trade/Proprietary Name: Patient Breathing Control system Common or Usual Name: Device Class: Class II 21 CFR §892.5050 Classification Name: Product Code: IYE : Accessory to Medical Charged Particle Radiation Therapy system LHN : System, Radiation Therapy, Charged-Particle, Medical
Substantial Equivalence:
The data and information supplied in this submission demonstrates substantial equivalence to two predicate devices :
- Varian Medical Systems, Inc RPM Respiratory Gating System with respect to the Gating aspects only (Table 1)
- D Dyn'R SAS SDX Module without the Automatic Gating Module (Table 2)
| TABLE 1 | Predicate device (K102024) | New Device |
|---|---|---|
| Device Name | RPM** Gating part only of the RPM System | SDX SystemwithAutomatic Gating Module |
| 510(K) owner | Varian Medical Systems, Inc | Dyn'R SAS |
| TABLE 1 | Predicate device (K102024) | New Device |
| Device Name | RPM** Gating part only of the RPM System | SDX SystemwithAutomatic Gating Module |
| Common or usualname | Radiotherapy breathing control | |
| Product Code | IYEAccelerator, Linear, MedicalLHNSystem, Radiation Therapy, Charged-Particle, Medical | Same |
| Intended use | -- | SDX is intended for use in Radiationtherapy as an aid in allowing the patientand treatment staff to visualize a patientsbreathing process and to optimizebreathing to limit internal motion duringimaging & treatment. |
| The RPM Respiratory Gating System isused to obtain tracking of thesubject respiratory pattern for respiratorysynchronized imageacquisition and radiation therapytreatment. | The SDX System including theAutomatic Gating Module is used toprovide respiratory synchronization forradiation therapy imaging & treatment. | |
| Gatingrequirements | May be gated with radiation therapytreatment systems possessing an ExternalSystem Gating Interface | Same |
| Radiation therapytreatment systems | Conventional linear acceleratorsProton therapy systemsRadiation therapy simulatorsImage acquisition devices | SameSameN/ASame |
| Impact onRadiation therapytreatment systems | Does not change the intended diagnosticor therapeutic effect | Same |
| Approach | Characterize the patients respiratorymotion informationtosynchronize operation with therespiratory motion | Same |
| Application | Used in image acquisition & radiationtreatment | Same |
| Triggering the image acquisition | Same | |
| Respiratory motion signal to :trigger beam-holdlimit the beam-on time | Same |
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| TABLE 2 | Predicate device (K092479) | New Device |
|---|---|---|
| Device Name | SDX | SDX SystemwithAutomatic Gating Module |
| 510(K) owner | Dyn'R SAS | Same |
| Intended Users | Healthcare Licensed practitioner | Same |
| Technology used | Spirometer with visual feedbacks | Same |
| Principle | Measuring and tracking of patienttidal volumes | Same |
| Patient Population | Patient requiring radiation therapytreatment of tumour in the abdominal-thoracic region influenced byrespiration | Same |
| Place of use | ||
| SDX Module | Used in the scanner room, simulationroom and accelerator room | Same |
| Automatic GatingModule | N/A | Control RoomConnected between DedicatedWorkstation & the radiation therapytreatment system possessing an ExternalSystem Gating Interface |
| Role duringradiation therapyprocess | Aid the operator to pause patientbreathing at a precisely indicated tidalvolume and coordinate treatment deliveryand image acquisition with this pause | Aid the operator to optimize a patientbreathing and to provide respiratorysynchronization for image acquisition &treatment delivery |
| Operatorinvolvement | ||
| Image acquisitionprocess | Operator triggeredN/A | SameAutomatic Gating Module triggered |
| Radiation treatmentprocess | Operator triggered | Same |
| N/A | Automatic Gating Module triggered |
Description:
The SDX Systems are intended to be used in conjunction with a Radiation Therapy systems (imaging & treatment) requiring operator intervention to start & stop radiation. .
:
:
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The Automatic Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment.
The Automatic Gating Module provides the direct interface between the SDX Module and the Imaging / Radiation Treatment equipment; providing channels on :
- । device communication / identification
- recommendation to start Patient Imaging / Radiation ।
- order (or recommendation) to stop patient Imaging / Radiation ।
The Automatic Gating Module is connected, via cabling, to the Radiation Therapy systems via their own "external interfacing equipment".
The use of the Automatic Gating Module allows the SDX to optimize breathing to limit internal motion during imaging & treatment independent to the breathing method chosen, Breath Hold, Free Breathing, etc.
Thus patients breathing pattern allows the selection of the gating levels, facilitate the starting & stopping of the radiation beam between the two defined levels.
Intended Use :
SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment.
The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment.
Discussion of Performance Data:
The addition of the Automatic Gating Module to the SDX System has not resulted in a modification of the systems performance with respect to the elements provided in the initial 510(k) submission : K092479 ; thus no system performance testing has been carried out.
The SDX System with the Automatic Gating Module has been tested and is conform to IEC 60601-1 Electrical Safety of Medical Electrical Device and IEC 60601-1-2 Electro-Magnetic Compatibility of Medical Electrical Device
Performance Testing of the Automatic Gating Module has been conducted to demonstrate conformance to the required specifications of the Radiotherapy device manufacturers, covering both safety & functionality criteria.
Conclusion for Performance Testing :
The performance testing conclude that the safety and effectiveness of the devices is not compromised and that it meets all acceptance criteria, demonstrating that the device can be considered substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
OCT 19 2012
Mr. Tim Lawton Regulatory Affaires Manager Dyn'R SAS 74. Cours Gambetta 13100 AIX-EN-PROVENCE FRANCE
Re: K121845
Trade/Device Name: SDX System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, LHN Dated: September 10, 2012 Received: September 12, 2012
Dear Mr. Lawton:
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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Janine M. Morris
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): K121845
Device Name: SDX System
Indications for Use:
SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment.
The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment.
The SDX System may be used for pediatric, adolescents & adult patients above the age of 5 years capable of understanding and following the radiotherapists instructions.
Prescription Use X (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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Michael O'Herin
Page 1 of
(Division Sign Off) Division of Radiological Healt
Office of In Vitre Jiagnostics and Radiological Health
510(k) K121845
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§ 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.