160MLC OPTION

K092145 · Siemens Medical Solutions USA, Inc. · IYE · Sep 18, 2009 · Radiology

Device Facts

• Record ID: K092145
• Device Name: 160MLC OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. The linear accelerator is a high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated. Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485). The syngo® Suite for Oncology Workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

Device Story

160MLC™ is an optional 160-leaf multi-leaf collimator upgrade for Siemens ONCOR™ linear accelerators. Device shapes X-ray photon or electron beams to target volumes while sparing healthy tissue. Operated by radiation oncologists/therapists in clinical settings. Integrates with syngo® Suite for Oncology Workspaces for treatment planning, delivery, and verification. Supports dynamic IMRT and dynamic Arc delivery up to 1,000 MU/minute. Provides edge position accuracy of 0.5mm at isocenter. Enhances precision of radiation delivery, potentially improving therapeutic outcomes by minimizing radiation to critical organs.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and effectiveness are supported by risk analysis, software verification, and validation testing adhering to recognized industry standards.

Technological Characteristics

160-leaf multi-leaf collimator; dynamic IMRT/Arc delivery; 1,000 MU/min max dose rate; 0.5mm edge position accuracy. Integrates with syngo® software architecture. Connectivity via proprietary verify and record system (PRIMEVIEW™) and COHERENCE™/syngo® Workspaces.

Indications for Use

Indicated for patients requiring therapeutic radiation treatment for cancer, lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated. Supports 3D conformal radiation therapy, IMRT, and precision radiation therapy via multi-leaf collimator.

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

• SIEMENS ARTISTE™ (K072485)
• SIEMENS ONCOR™ Expression (K060226)
• SIEMENS PreScision™ Option (K082775)

Submission Summary (Full Text)

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K692145

SEP 1 8 2009

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#### Siemens Medical Solutions USA, Inc. Oncology Care Systems

# Section 5

# 510(k) Summary

| Submitter: | Siemens Medical Solutions USA, Inc.<br>Oncology Care Systems<br>4040 Nelson Avenue<br>Concord, CA 94520 | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------|--|--|
| Contact: | Christine Dunbar<br>Senior Regulatory Affairs Specialist | | | |
| Phone:<br>Fax:<br>Email: | [phone]<br>[phone]<br>[e-mail] | | | |
| Proprietary Name: | 160MLC™ Option | | | |
| Common Name: | | An accessory to: Accelerator, Linear, Medical | | |
| Classification: | 892.5050 | | | |
| Product Code: | IYE | | | |

Substantial Equivalence Claimed To:

| PRODUCT | Clearance | Claim of Equivalence For: |
|-------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SIEMENS ARTISTE™ | K072485 | The Siemens branded Linear Accelerator with the 160<br>leaf MLC and the syngo® Suite for Oncology<br>Workspaces including the syngo® RT Therapist and RT<br>Therapist Express. |
| SIEMENS ONCOR™<br>Expression | K060226 | ONCOR™ linear accelerator families and COHERENCE<br>Workspaces (or the re-branded syngo® Suite for<br>Oncology Workspaces), RT Therapist workspace with<br>the PRIMEVIEW V&R system, the 82 leaf MLC marketed<br>as OPTIFOCUS™, the Flat Panel device marketed as<br>the OPTIVUE™ and the Mega-Voltage Cone Beam<br>technology marketed as MVision™ and Adaptive<br>Targeting™. |
| SIEMENS PreScision™<br>Option | K082775 | Establishes the basic hardware/firmware and software<br>components across all of Siemens branded Linear<br>Accelerators for the purposes SE and conformity to<br>standards testing at the device level. Indicates common<br>features between Siemens branded Linear Accelerators<br>for interchangeability of device accessories and options.<br>Supports increased dose rate and Enhanced Stereotactic<br>Technique (EST) for the delivery of high precision<br>radiation therapy when used with an 82 leaf, 160 leaf or<br>Third Party Multi-Leaf Collimators or stereotactic<br>accessories. |

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510(k) for SIEMENS 160MLCTM Option

-

:有

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#### Slemens Medical Solutions USA, Inc. Oncology Care Systems

The ARTISTE™ and ONCOR™ family of linear accelerators with the 160MLC™ Option as described in this premarket notification has similar intended use and fundamental scientific technical characteristics as the predicate devices listed above.

# Description Summary:

Within the submission the following internal naming conventions are used:

| Market Name | Internal naming convention |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ARTISTE™ | ARTISTE™ linear accelerator and ACCEL release 4.x+ |
| ONCOR™ Expression | ONCOR™ linear accelerator and ACCEL release 2.x+ |
| ONCOR™ Avant-Garde | ONCOR™ linear accelerator and ACCEL release 1.x+ and 2.x+ |
| PRIMEVIEW™ | Siemens proprietary verify and record system. The syngo®based<br>PRIMEVIEW is hosted on the COHERENCE™ Therapist<br>Workspace.<br>The syngo base version is marketed as PRIMEVIEW3i and is used<br>on the PRIMUS™ linear accelerator systems. |
| COHERENCE™ Therapist Workspace | RTT Workspace contains the SIEMENS proprietary verify and<br>record system as well as access to the Oncology Information<br>System and directly connects to the LINAC control console. |
| MVCB - MVision™ | Mega-Voltage Cone Beam - a method of obtalning 3 dimensional<br>data for portal imaging. |
| 160 MLC™ | 160-leaf multi-leaf collimator |
| OPTIFOCUS™ | 82-leaf multi-leaf collimator |
| 58 MLC | 58 leaf multi-leaf collimator |
| OPTIVUE™ | aSi flat panel electronic portal imaging device (EPID) AL7 model |
| OPTIVUE 1000ST | aSi flat panel electronic portal imaging device (EPID) AG9 model |
| syngo® Therapist Workspace,<br>RTT Express™ | RTT Workspace contains the SIEMENS proprietary verify and<br>record system as well as access to the Oncology Information<br>System and directly connects to the LINAC control console on the<br>ARTISTE™ linear accelerator system. |
| syngo® Suite for Oncology<br>Workspaces | Syngo based workstation, re-branded COHERENCE workspaces. |
| syngo® | Siemens proprietary software architecture and hosting SIEMENS<br>software applications organized by task cards on a dedicated<br>workstation. |
| Sys_VB35 | System Software, version VB35 for ONCOR R2.2. |

For further definitions of the terms used in this submission, refer to the Glossary in Section 24.

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510(k) for SIEMENS 160MLC™ Option

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#### Siemens Medical Solutions USA, Inc. Oncology Care Systems

## Technological Characteristics:

#### The 160MLC™ Option:

# The 160MLC™ Option is an integral feature of the currently cleared SIEMENS ARTISTE™ system and is

intended to be marketed as an optional upgrade to the ONCOR™ Klystron class family of medical linear accelerator devices. The basic design, safety features and function of the 160-leaf Multi-Leaf Collimator and the ONCOR Linear Accelerator remain unchanged from their currently cleared intended use and functions. The 160MLC™ supports the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation using the conventional linear accelerator. The 160MLC, in conjunction with the Linear Accelerator and control systems, arrough to delivery of X-Ray photon or electron energy for precise treatment of lesions, turnors and onditions anywhere in the body where radiation therapy is indicated.

The 160MLC™ option supports the dynamic IMRT and dynamic Arc delivery of up to 1,000 (± 2%) MU / Minute X-Ray photon beam using a calibrated MV photon energy spectrum with an edge position acouracy at isocenter of 0.5mm (± 0.5mm) with minimal leakage and penumbra.

Refer to Section 11- Description, for the Product Specification regarding these specific modifications.

## General Safety and Effectiveness:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and miligations. These potential hazards are controlled by software development, vertification of requirements and validation testing. To minimize electrical, mechanical and radiation hazards, SIEMENS adheres to recognized and established industry practice and relevant international standards,

#### Intended Use:

The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

The linear accelerator is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treation ated in the next modulated radiation therapy (IMRT) for lesions, tumors and conditions anywhere in the body when radiation therapy is indicated.

Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multileaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).

510(k) for SIEMENS 160MLC™ Optlon

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#### Siemens Medical Solutions USA, Inc., Oncology Care Systems

# The syngo® Suite for Oncology Workspaces:

The syngo® Suite for Oncology Workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

# Summary:

In summary, it is SIEMENS' belief that the addition of the 160MLC™ option to the ONCOR linear accelerators for high precision radiation therapy does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

510(k) for SIEMENS 160MLC™ Option

CONFIDENTIAL Page Sect. 5/4

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three lines representing the wings and a wavy line representing the body.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 1 8 2009

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

Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue CONCORD CA 94520

Re: K092145

Trade/Device Name: 160MLCTM Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 10, 2009 Received: July 15, 2009

#### Dear Ms. Dunbar:

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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

# Section 4

# Indication For Use Statement

510(k) Number (if known):

## Device Name: 160MLC™ Option

Indications for Use:

The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

The linear accelerator is a high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).

## The syngo® Suite for Oncology Workspaces:

The syngo® Suite for Oncology Workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

| Division of Reproductive, Abdominal, and Radiological Devices | |
|---------------------------------------------------------------|---------------|
| 510(k) Number | K092145 |
| Prescription Use (Per 21 CFR 801.109) | <span></span> |
| OR | |
| Over-the-Counter Use | |

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