(141 days)
Not Found
No
The description focuses on the electro-mechanical aspects and control software for precise positioning, with no mention of AI or ML terms or functionalities.
No
The device is designed for patient positioning during radiotherapy and medical imaging, not for treating a disease or medical condition. Its function is to accurately position the patient for other therapeutic or diagnostic procedures.
No
This device is described as an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging, not for diagnosing medical conditions. Its purpose is to accurately position a patient, not to analyze medical data for diagnostic purposes.
No
The device description explicitly states it is an "electro-mechanical robotic arm" and includes components like the robotic arm unit, a control unit with computers and software, and connecting cables, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the LEONI Orion System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patient positioning in radiotherapy and medical imaging." This involves physically moving and positioning a patient's body, not analyzing biological samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description clearly states it's an "electro-mechanical robotic arm" designed to "position a patient." This aligns with a device used for physical manipulation, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The LEONI Orion System's function is entirely focused on the physical positioning of the patient during medical procedures.
N/A
Intended Use / Indications for Use
The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
Product codes (comma separated list FDA assigned to the subject device)
JAI
Device Description
The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability. The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.
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
Not Found
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 bench tests below were carried out by LEONI in support of the substantial equivalence determination: Payload: 375 kg / 826 lbs. Accurate treatment volume : 400 mm x 1000 mm x 500 mm Accuracy: ± 0.5 mm and ± 0.2° Speed: 0.1 m/s and 6 °/s Safety: collision detection: detection of a 150N force; "overtravel" in case of emergency stop:
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
LEONI CIA Cable System SAS % Ms. Aurelie Genho Quality Engineer 5 Avenue Victor Hugo 28000 Chartres FRANCE
Re: K160518
Trade/Device Name: LEONI Orion System Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II Product Code: JAI Dated: July 5, 2016 Received: July 7, 2016
Dear Ms. Genho:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Indications for Use
510(k) Number (if known) K160518
Device Name LEONI Orion System
Indications for Use (Describe)
The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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005 - 510(K) Summary
LEONI ORION System
LEONI
Traditional 510(k) Notification
510 (K) SUMMARY
This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Applicant | LEONI CIA Cable Systems SAS
5, avenue Victor Hugo
ZAC du Jardin d'Entreprises
28000 CHARTRES
France |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Mrs. Aurélie GENHO
Ph : +33 2 37 91 21 82
Fax : +33 2 37 91 21 81 |
| Preparation Date | January 29, 2016 |
| Device Name | Common Name: LEONI ORION System |
| | Trade Name: LEONI ORION System |
| Classification Name | Powered radiation therapy patient support assembly (21 CFR 892.5770) |
| | Product Code: JAI |
| Substantial Equivalence | Patient Positioning System by Forte Automation Systems (K122413) |
| Device Description | The LEONI ORION System is an electro-mechanical robotic arm capable of
motion in six degrees of freedom. The purpose of the device is to position a
patient during radiotherapy, radiology and other medical applications with a
high degree of accuracy and repeatability.
The LEONI ORION System consists of the electro-mechanical unit that is a 6
axes robot which supports a standard radiotherapy table couch or other
approved patient support device, and a Control Unit that includes computers
and application software. The robot is linked to the Control Unit by cables. |
| Intended Use | The LEONI ORION System is an electro-mechanical robotic arm for patient
positioning in radiotherapy, radiology and other medical applications. It is
designed for positioning a patient with a high degree of accuracy and
repeatability. |
4
LEONI
005 - 510(K) Summary
LEONI ORION System
Traditional 510(k) Notification
| Comparison of Technological Characteristics with the Predicate Device | The LEONI ORION System is identical or similar to the predicate device in regard to:
Intended Use Shape, dimensions and materials Behavior and technology of movement Safety features |
|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The LEONI ORION System has the following technological differences compared with the predicate device:
Rotational axis linked to the floor Greater range of motion thanks to its hybrid kinematic and the length of the axes A higher payload capacity A UPS battery that allows the slow release of the brakes in order to lower the couch into a safe position to remove the patient in case of power failure. |
| Non clinical Tests | The bench tests below were carried out by LEONI in support of the substantial equivalence determination:
Payload: 375 kg / 826 lbs. Accurate treatment volume : 400 mm x 1000 mm x 500 mm Accuracy: ± 0.5 mm and ± 0.2° Speed: 0.1 m/s and 6 °/s Safety: collision detection: detection of a 150N force; "overtravel" in case of emergency stop: Clinical Tests | Not Applicable |
| Testing Conclusions | The results from these performance assessments demonstrated that the LEONI ORION System met the acceptance criteria defined in the product specifications. Moreover these results proved that the subject device is comparable to the predicate device in terms of safety and effectiveness performance. |