(151 days)
Not Found
No
The description focuses on a spirometer and software for visualizing breathing and facilitating voluntary breath holds, with no mention of AI or ML technologies.
No
The device aids in optimizing breath hold during radiation therapy, but it does not treat or cure a disease or condition itself.
No
The device aids in visualizing a patient's breathing process and optimizing breath hold during radiation therapy. It does not diagnose any disease or condition.
No
The device description explicitly states that SDX is a "spirometer located in the imaging or treatment room," which is a hardware component. The software is installed on a separate workstation, but the overall system includes hardware.
Based on the provided information, the SDX - SpiroDynr'X is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: 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.
- SDX Function: The SDX - SpiroDynr'X is a spirometer used to measure and visualize a patient's breathing process in vivo (within the living body). It aids in optimizing breath-holding during radiation therapy.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures a physiological parameter (lung volume/breathing pattern).
Therefore, the SDX - SpiroDynr'X falls under the category of a medical device used for monitoring and aiding in a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
IYE
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiation therapy
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
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.
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.
Key Metrics
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
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
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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
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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 (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 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
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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