SDX SYSTEM

K121845 · Dyn'R Sas · IYE · Oct 19, 2012 · Radiology

Device Facts

• Record ID: K121845
• Device Name: SDX SYSTEM
• Applicant: Dyn'R Sas
• Product Code: IYE · Radiology
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

SDX System with Automatic Gating Module (AGM) is a respiratory gating accessory for radiation therapy. Input: patient tidal volume data via spirometer. Operation: system tracks respiratory patterns; AGM interfaces between SDX workstation and radiation therapy equipment to provide respiratory synchronization. Output: signals to trigger beam-hold or limit beam-on time based on defined breathing levels. Used in scanner, simulation, and accelerator rooms; operated by healthcare professionals. AGM facilitates communication between SDX and external radiation therapy systems to optimize breathing and limit internal motion during imaging and treatment. Benefits: improved precision in radiation delivery by synchronizing treatment with patient respiratory cycles; ensures operator maintains final control over imaging/treatment.

Clinical Evidence

No clinical data provided. Performance testing was limited to bench testing, including electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-12) testing, as well as functional verification of the Automatic Gating Module against radiotherapy device manufacturer specifications.

Technological Characteristics

Spirometer-based respiratory tracking system. Components include SDX module and Automatic Gating Module (AGM). Connectivity: wired interface to radiation therapy equipment via external system gating interface. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC). Operation: visual feedback for patient, automated beam-hold/triggering signals for radiation equipment.

Indications for Use

Indicated for pediatric, adolescent, and adult patients (age 5+) undergoing radiation therapy for abdominal-thoracic tumors influenced by respiration, provided the patient can understand and follow therapist instructions.

Regulatory Classification

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.

Predicate Devices

• Varian Medical Systems, Inc RPM Respiratory Gating System (K102024)
• Dyn'R SAS SDX Module (K092479)

Submission Summary (Full Text)

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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: [phone] 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*<br>* Gating part only of the RPM System | SDX System<br>with<br>Automatic Gating Module |
| 510(K) owner | Varian Medical Systems, Inc | Dyn'R SAS |
| TABLE 1 | Predicate device (K102024) | New Device |
| Device Name | RPM*<br>* Gating part only of the RPM System | SDX System<br>with<br>Automatic Gating Module |
| Common or usual<br>name | | Radiotherapy breathing control |
| Product Code | IYE<br>Accelerator, Linear, Medical<br><br>LHN<br>System, Radiation Therapy, Charged-<br>Particle, Medical | Same |
| Intended use | -- | SDX is intended for use in Radiation<br>therapy as an aid in allowing the patient<br>and treatment staff to visualize a patients<br>breathing process and to optimize<br>breathing to limit internal motion during<br>imaging & treatment. |
| | The RPM Respiratory Gating System is<br>used to obtain tracking of the<br>subject respiratory pattern for respiratory<br>synchronized image<br>acquisition and radiation therapy<br>treatment. | The SDX System including the<br>Automatic Gating Module is used to<br>provide respiratory synchronization for<br>radiation therapy imaging & treatment. |
| Gating<br>requirements | May be gated with radiation therapy<br>treatment systems possessing an External<br>System Gating Interface | Same |
| Radiation therapy<br>treatment systems | Conventional linear accelerators<br>Proton therapy systems<br>Radiation therapy simulators<br>Image acquisition devices | Same<br>Same<br>N/A<br>Same |
| Impact on<br>Radiation therapy<br>treatment systems | Does not change the intended diagnostic<br>or therapeutic effect | Same |
| Approach | Characterize the patients respiratory<br>motion information<br>to<br>synchronize operation with the<br>respiratory motion | Same |
| Application | Used in image acquisition & radiation<br>treatment | Same |
| | Triggering the image acquisition | Same |
| | Respiratory motion signal to :<br>trigger beam-hold<br>limit the beam-on time | Same |

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| TABLE 2 | Predicate device (K092479) | New Device |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SDX | SDX System<br>with<br>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<br>tidal volumes | Same |
| Patient Population | Patient requiring radiation therapy<br>treatment of tumour in the abdominal-<br>thoracic region influenced by<br>respiration | Same |
| Place of use | | |
| SDX Module | Used in the scanner room, simulation<br>room and accelerator room | Same |
| Automatic Gating<br>Module | N/A | Control Room<br>Connected between Dedicated<br>Workstation & the radiation therapy<br>treatment system possessing an External<br>System Gating Interface |
| Role during<br>radiation therapy<br>process | Aid the operator to pause patient<br>breathing at a precisely indicated tidal<br>volume and coordinate treatment delivery<br>and image acquisition with this pause | Aid the operator to optimize a patient<br>breathing and to provide respiratory<br>synchronization for image acquisition &<br>treatment delivery |
| Operator<br>involvement | | |
| Image acquisition<br>process | Operator triggered<br>N/A | Same<br>Automatic Gating Module triggered |
| Radiation treatment<br>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. .

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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 [phone]. 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 [phone] or [phone] 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

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(Division Sign Off) Division of Radiological Healt

Office of In Vitre Jiagnostics and Radiological Health

510(k) K121845

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