(116 days)
Not Found
No
The document describes an "Automatic Gating Module" that facilitates the interface and provides recommendations based on the patient's breathing pattern and defined gating levels. However, it explicitly states that operators maintain complete control and the final decision. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance testing focuses on electrical safety, EMC, and conformance to radiotherapy device specifications, not on the performance of an AI/ML algorithm.
No.
The device is used to optimize breathing and synchronize radiation therapy, which aids in the treatment process but does not directly treat a disease or condition itself.
No
The device is described as an aid for visualizing a patient's breathing and for respiratory synchronization during radiation therapy. It is used to optimize breathing and limit internal motion, not to diagnose a condition.
No
The device description explicitly mentions the "Automatic Gating Module is connected, via cabling, to the Radiation Therapy systems via their own 'external interfacing equipment'," indicating a hardware component beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for visualizing and optimizing a patient's breathing process during radiation therapy to limit internal motion. This is a clinical application directly related to patient treatment and imaging, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the device's interaction with radiation therapy systems and its role in respiratory synchronization for imaging and treatment. This aligns with a medical device used in a clinical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.
Therefore, the SDX system with the Automatic Gating Module is a medical device used in the context of radiation therapy, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE, LHN
Device 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. .
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal-thoracic region (for tumor requiring radiation therapy treatment)
Indicated Patient Age Range
pediatric, adolescents & adult patients above the age of 5 years
Intended User / Care Setting
Healthcare Licensed practitioner; Used in the scanner room, simulation room and accelerator room for SDX Module. Control Room for Automatic Gating Module.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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 System
with
Automatic 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 System
with
Automatic Gating Module |
| Common or usual
name | | Radiotherapy breathing control |
| Product Code | IYE
Accelerator, Linear, Medical
LHN
System, Radiation Therapy, Charged-
Particle, Medical | Same |
| 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 RPM Respiratory Gating System is
used to obtain tracking of the
subject respiratory pattern for respiratory
synchronized image
acquisition and radiation therapy
treatment. | The SDX System including the
Automatic Gating Module is used to
provide respiratory synchronization for
radiation therapy imaging & treatment. |
| Gating
requirements | May be gated with radiation therapy
treatment systems possessing an External
System Gating Interface | Same |
| Radiation therapy
treatment systems | Conventional linear accelerators
Proton therapy systems
Radiation therapy simulators
Image acquisition devices | Same
Same
N/A
Same |
| Impact on
Radiation therapy
treatment systems | Does not change the intended diagnostic
or therapeutic effect | Same |
| Approach | Characterize the patients respiratory
motion information
to
synchronize operation with the
respiratory motion | Same |
| Application | Used in image acquisition & radiation
treatment | Same |
| | Triggering the image acquisition | Same |
| | Respiratory motion signal to :
trigger beam-hold
limit the beam-on time | Same |
1
. .
.
.
2
| TABLE 2 | Predicate device (K092479) | New Device |
|---|---|---|
| Device Name | SDX | SDX System |
| with | ||
| Automatic 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 patient | |
| tidal volumes | Same | |
| Patient Population | Patient requiring radiation therapy | |
| treatment of tumour in the abdominal- | ||
| thoracic region influenced by | ||
| respiration | Same | |
| Place of use | ||
| SDX Module | Used in the scanner room, simulation | |
| room and accelerator room | Same | |
| Automatic Gating | ||
| Module | N/A | Control Room |
| Connected between Dedicated | ||
| Workstation & the radiation therapy | ||
| treatment system possessing an External | ||
| System Gating Interface | ||
| Role during | ||
| radiation therapy | ||
| process | Aid the operator to pause patient | |
| breathing at a precisely indicated tidal | ||
| volume and coordinate treatment delivery | ||
| and image acquisition with this pause | Aid the operator to optimize a patient | |
| breathing and to provide respiratory | ||
| synchronization for image acquisition & | ||
| treatment delivery | ||
| Operator | ||
| involvement | ||
| Image acquisition | ||
| process | Operator triggered | |
| N/A | Same | |
| Automatic Gating Module triggered | ||
| Radiation treatment | ||
| process | 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. .
:
:
3
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.
4
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
5
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
6
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