LEONI ORION System

K160518 · Leoni Cia Cable System · JAI · Jul 14, 2016 · Radiology

Device Facts

• Record ID: K160518
• Device Name: LEONI ORION System
• Applicant: Leoni Cia Cable System
• Product Code: JAI · Radiology
• Decision Date: Jul 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

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.

Device Story

The LEONI ORION System is a 6-axis electro-mechanical robotic arm designed for patient positioning in radiotherapy and medical imaging. It supports a standard radiotherapy table couch or other approved patient support device. The system consists of the robotic unit and a Control Unit containing computers and application software, linked by cables. It provides motion in six degrees of freedom to achieve high accuracy and repeatability. The system includes a UPS battery for emergency brake release and couch lowering during power failure. It features collision detection (150N force threshold) and emergency stop overtravel limits. The device is operated by clinical staff in medical environments to position patients for treatment or imaging, facilitating precise delivery of radiation or diagnostic procedures.

Clinical Evidence

No clinical data. Bench testing only. Payload capacity: 375 kg. Accuracy: ± 0.5 mm and ± 0.2°. Speed: 0.1 m/s and 6°/s. Safety testing included collision detection (150N) and emergency stop overtravel (< 5 mm). Electromagnetic compatibility (EMC) and electrical/mechanical safety testing performed by third-party organization.

Technological Characteristics

6-axis electro-mechanical robotic arm; hybrid kinematic design; floor-mounted rotational axis; payload capacity 375 kg; UPS battery for emergency brake release; collision detection sensors; electrical and mechanical safety features; connectivity via cables between robot and control unit.

Indications for Use

Indicated for patient positioning during radiotherapy, radiology, and other medical applications requiring accurate and repeatable patient support.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• Patient Positioning System by Forte Automation Systems (K122413)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

### 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<br>5, avenue Victor Hugo<br>ZAC du Jardin d'Entreprises<br>28000 CHARTRES<br>France |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Mrs. Aurélie GENHO<br>Ph : [phone]<br>Fax : [phone] |
| 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<br>motion in six degrees of freedom. The purpose of the device is to position a<br>patient during radiotherapy, radiology and other medical applications with a<br>high degree of accuracy and repeatability.<br>The LEONI ORION System consists of the electro-mechanical unit that is a 6<br>axes robot which supports a standard radiotherapy table couch or other<br>approved patient support device, and a Control Unit that includes computers<br>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<br>positioning in radiotherapy, radiology and other medical applications. It is<br>designed for positioning a patient with a high degree of accuracy and<br>repeatability. |

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

# LEONI

### 005 - 510(K) Summary

LEONI ORION System

Traditional 510(k) Notification

| <b>Comparison of Technological Characteristics with the Predicate Device</b> | The LEONI ORION System is identical or similar to the predicate device in regard to:<br>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:<br>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. |
| <b>Non clinical Tests</b> | The bench tests below were carried out by LEONI in support of the substantial equivalence determination:<br>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: < 5 mm. Moreover, electromagnetic compatibility (EMC) and electrical and mechanical safety tests were performed by third party test organization. |
| <b>Clinical Tests</b> | Not Applicable |
| <b>Testing Conclusions</b> | 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. |