SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

K092479 · Dyn'R · IYE · Jan 11, 2010 · Radiology

Device Facts

• Record ID: K092479
• Device Name: SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
• Applicant: Dyn'R
• Product Code: IYE · Radiology
• Decision Date: Jan 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

SDX - SpiroDynr'X 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 the time when a breath should be held to limit internal motion during treatment.

Device Story

SDX is a spirometer-based patient breathing control system used in radiation therapy. The device consists of a spirometer located in the imaging or treatment room and software on a dedicated workstation in the control room. During voluntary breath-hold, the patient monitors their own breathing pattern via the system to reproduce a specific volumetric breath-hold level. The clinical team supervises the process. By visualizing the breathing process, the patient and staff can optimize the timing of breath-holds to minimize internal organ motion during radiation delivery. This aids in precise treatment delivery and potentially improves clinical outcomes by reducing motion-related errors.

Clinical Evidence

Bench testing only. Performance testing evaluated the linearity and stability of pulmonary volume measurements, confirming the device operates within required specifications. Electrical safety and electromagnetic compatibility were verified against IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Spirometer-based breathing control system. Includes a spirometer unit for the treatment room and a dedicated workstation for the control room. Operates via volumetric measurement of patient respiration. Compliant with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients undergoing radiation therapy requiring breath-hold techniques to limit internal motion. Used by patients and treatment staff to visualize breathing patterns and optimize breath-hold timing.

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

• Active Breathing Coordinator ABC System by Aktina Medical Physics (K003330)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko9a2479

## Premarket Notification [510(k)] Summary

JAN 1,1 2010

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 : _ Ko9 2479

DYN'R SAS Company: 73 ure Louge 31600 MURET France

> + (33) 5 62 23 19 00 Telephone: Fax: + (33) 5 62 23 19 01

Contact Person: Xavier ISNARD

Date Prepared: 12th august 2009

#### Device Names:

Trade/Proprietary Name: Common or Usual Name: Device Class: Classification Name: Product Code:

SDX - SpiroDynr'X Radiotherapy Breathing Control Patient Breathing Control system Class II 21 CFR §892.5050 IYE Accessory to Medical Charged Particle Radiation Therapy system

#### Substantial Equivalence:

The data and information supplied in this submission demonstrates substantial equivalence to the Active Breathing Coordinator ABC System by Aktina Medical Physics (K003330)

#### Description:

SDX is a spirometer located in the imaging or treatment room, with software installed on a dedicated workstation located in the control room.

In the voluntary breath hold technique, the patient is independently monitoring their breathing pattern and reproduces the effective breath hold level. The patient holds their breath at a defined volumetric level whilst imaging or radiation therapy is being carried out t under the Clinical team supervision.

{1}------------------------------------------------

#### Intended Use :

SDX - SpiroDynr'X 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 the time when a breath should be held to limit internal motion during treatment.

#### Discussion of Performance Data:

Performances tests on linearity and stability of the pulmonary volume measures demonstrated that the SDX SpiroDynr'X was found to be well within the required specifications.

SDX SpiroDynr'X is compliant with IEC 60601-1 Electrical Safety of Medical Electrical Device and IEC 60601-1-2 ElectroMagnetic Compatibility of Medical Electrical Device.

### Conclusion for Performance Testing :

The performance testing data 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.

#### () 5 4 11 3

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

FEB 2 2 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Xavier Isnard Regulatory Affairs Manager Dyn'R 73, rue de Louge MURET Haute-Garonne 31600 FRANCE

Re: K092479 Trade/Device Name: SDX - SpiroDynr'X Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 8, 2009 Received: December 11, 2009

Dear Mr. Isnard:

This letter corrects our substantially equivalent letter of January 11, 2010.

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

{3}------------------------------------------------

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 of 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 [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 vours.

Signature

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): _K092479

Device Name: SDX - SpiroDynr'X

Indications for Use:

SDX - SpiroDynr'X 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 the time when a breath should be held to limit internal motion during treatment.

Prescription Use X (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Haldeman

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K092479