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 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.

AI/ML Overview

This 510(k) submission for the SDX - SpiroDynr'X device focuses on its safety and effectiveness through performance testing for physical attributes, rather than on AI performance or clinical diagnostic accuracy. Therefore, many of the requested items related to AI algorithms, expert ground truth, and comprehensive clinical studies are not applicable to this specific submission.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The core of the acceptance criteria and performance evaluation in this document revolves around the physical and electrical safety of the device, and the accuracy of its pulmonary volume measurements.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Pulmonary Volume Measurement	Linearity of pulmonary volume measures	"Well within the required specifications."
	Stability of pulmonary volume measures	"Well within the required specifications."
Electrical Safety	Compliance with IEC 60601-1	"Compliant with IEC 60601-1 Electrical Safety of Medical Electrical Device."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	"Compliant with IEC 60601-1-2 ElectroMagnetic Compatibility of Medical Electrical Device."

Study Details

Given the nature of this 510(k) submission, the "study" is primarily a series of performance tests on the physical device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of patient count or data points. The performance tests were conducted on the device itself, likely using controlled laboratory conditions and calibrated testing equipment to simulate pulmonary volume changes. This is not a study involving human subjects or patient data.
Data Provenance: The tests were conducted internally by the manufacturer (DYN'R SAS). No country of origin for patient data applies here as no patient data was used. The tests are prospective in the sense that they were designed and executed to assess the device's performance against pre-defined specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For linearity and stability tests of a spirometer, the "ground truth" is established by using calibrated scientific instruments (e.g., precision flow/volume calibrators) that have their own traceability to national/international standards. Expert clinical consensus is not typically used for establishing the ground truth of instrument physical performance.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among multiple human readers in interpreting clinical information. This level of adjudication is not relevant for objective performance tests of physical device parameters. The outcome of these tests is typically a direct measurement and comparison against a numerical threshold.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a Spirometer and a patient breathing control system; it does not involve AI for interpretation or decision-making, nor does it involve "human readers" in the context of diagnostic image interpretation. Therefore, an MRMC study and AI-assisted improvement metrics are not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. While the device has "software installed on a dedicated workstation," this software's primary function is to visualize the patient's breathing process and guide breath-holding, not to perform autonomous diagnostic or interpretive functions. There is no "algorithm only" performance reported in the context of diagnostic accuracy, as this is not an AI-driven diagnostic device. Its performance is measured by the accuracy and reliability of its physical measurements and its adherence to safety standards.

7. The type of ground truth used:

For pulmonary volume measures (linearity, stability): Instrumental/Metrological Ground Truth. This would involve precise, calibrated reference instruments to generate known volume changes, against which the SDX - SpiroDynr'X's measurements are compared.
For electrical safety and EMC: Regulatory/Standard Compliance Ground Truth. This is established by testing against the specific requirements and methodologies outlined in the IEC 60601-1 and IEC 60601-1-2 standards.

8. The sample size for the training set:

Not Applicable. This device is hardware with supporting software for visualization and control, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to this submission.

Summary

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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.

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Intended Use :

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:

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

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

Regulation Number and Section

§ 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.