PRESCISION OPTION

K082775 · Siemens Medical Solutions USA, Inc. · IYE · Feb 19, 2009 · Radiology

Device Facts

• Record ID: K082775
• Device Name: PRESCISION OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYE · Radiology
• Decision Date: Feb 19, 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 LINAC 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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the body where radiation therapy is indicated. The syngo® Suite for Oncology Workspaces: The syngo®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

PreScision™ is an optional feature for Siemens ARTISTE™, ONCOR™, and PRIMUS™ linear accelerators (LINACs). It enables high-dose rate (up to 2,000 MU/min) unflattened X-Ray photon beam delivery (7UF energy) for precision stereotactic applications (SRS/SRT). Input includes patient treatment plans managed via syngo®-based workspaces (COHERENCE™/PRIMEVIEW™). The system uses MLCs (58, 82, or 160-leaf) and optional third-party gating/positioning hardware to deliver radiation. Operated by radiation therapists in clinical settings, the device provides high-precision dose delivery for tumors. Output is therapeutic radiation; clinicians use the system to verify patient positioning via EPID (OPTIVUE™) and record treatment delivery. Benefits include reduced treatment times and enhanced precision for stereotactic procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness are supported by risk analysis, software verification, and validation testing of system requirements.

Technological Characteristics

Optional feature for existing LINACs. Delivers 6.67 MV unflattened X-Ray photon energy. Supports 5cm x 5cm to 40cm x 40cm field sizes. Integrates with MLCs (58, 82, 160-leaf), aSi EPID, and third-party gating/fixation devices. Connectivity via syngo®-based RTT/COHERENCE workspaces and PRIMEVIEW™ record and verify systems. Software architecture is syngo®-based.

Indications for Use

Indicated for patients requiring radiation therapy for lesions, tumors, and conditions anywhere in the body. Supports 3D conformal radiation therapy, IMRT, stereotactic radiosurgery (SRS), and stereotactic radiation therapy (SRT).

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 PRIMUSTM (K993425)
• Varian Trilogy™ (K061140)
• TomoTherapy Hi-Art™ (K060912)
• Accuray Cyberknife™ (K052325)

Reference Devices

• SIEMENS ONCOR™ (K031764)
• SIEMENS ModuLeaf MLC (K030609)
• 550 TxT™ patient treatment couch (K050422)
• ZXT™ patient treatment couch (K910971)

Submission Summary (Full Text)

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

KOS2225

FEB 1 9 2009

# Section 5 510(k) Summary

Submitter: Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue Concord, CA 94520 Contact: Christine Dunbar Senior Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Email: [e-mail] Proprietary Name: PreScision™ 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 Stereo mode with the 160 MLC |
| SIEMENS ONCOR™<br>Expression | K060226 | ONCOR™ and PRIMUS™ linear accelerator families<br>with Stereo Mode and COHERENCE Workspaces (or the<br>re-branded syngo® Suite for Oncology Workspaces)<br>and the 82 leaf MLC marketed as OPTIFOCUS. |
| SIEMENS PRIMUSTM | K993425 | PRIMUS™ family of linear accelerators with the Stereo<br>Mode, PRIMEVIEW 3i system, the 58 leaf MLC |
| Varian Trilogy™ | K061140 | Stereotactic (SRT) and Stereotactic Radio-Surgery<br>(SRS) Radiation Therapy with high dose beam rate. |
| TomoTherapy Hi-Art™ | K060912 | Stereotactic (SRT) and Stereotactic Radio-Surgery<br>(SRS) with unflattened beam delivery and extended<br>treatment field for Stereotactic Body Radiation Therapy. |
| Accuray Cyberknife™ | K052325 | Stereotactic (SRT) and Stereotactic Radio-Surgery<br>(SRS) robotic delivery system and increased dose rates<br>for reduced treatment times. |

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

Description Summary:

# 000026

510(k) for PreScision™ Option

CONFIDENTIAL Page Sect. 5/1

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

| Market Name | Internal naming convention |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ARTISTE™ | ARTISTE™ linear accelerator and ACCEL release 4+ |
| ONCOR™ Expression | ONCOR™ linear accelerator and ACCEL release 2+ |
| ONCOR™ Avant-Garde | ONCOR™ linear accelerator and ACCEL release 2+ |
| PRIMUS™ | PRIMUS™ linear accelerator and ACCEL release 2+ |
| 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 | Mega-Voltage Cone Beam - a method of obtaining 3 dimensional<br>data for portal imaging. |
| 160 MLC™ | 160-leaf multi-leaf collimator |
| OPTIFOCUS™ | 82-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 |
| SRT / SRS | Stereotactic Radiation Therapy/ Stereotactic radiosurgery ~ a<br>method of using high energy, X-Ray photon radiation for precision<br>treatment. |
| syngo® Therapist Workspace, RTT<br>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. |

Within the submission the following internal naming conventions are used:

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

# Technological Characteristics:

# The PreScision™ Option:

The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™,

ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

The PreScision option supports the delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam for either single-session radiosurgery or hypo-fractionated stereotactic treatment using a calibrated 6.67 MV photon energy spectrum consisting of an unflattened beam geometry, a selectable field size

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of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.

The control console will support the PreScision feature with one unflattened beam energy labeled as "7UF" to differentiate from the previous 6 MV unflattened beam energy used by the predicate Stereo feature. The 7UF option replaces the existing "Stereo" option previously cleared under the PRIMUS™ (K993425) and ONCOR™ (K031764, K060226) and ARTISTE (K072585) devices.

The unflattened X-Ray photon energy spectrum is similar to the 6 MV energy spectrum as used by the PRIMUS™, ONCOR™, ARTISTE Linear Accelerator systems for the predicate Stereo option and is similar to the energy spectrum of the TomoTherapy Hi-Art system as described in Section 11, Design Description.

The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:

A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:

- COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
- PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
- 58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
- Stereotactic Radiotherapy 0
- Stereotactic Radiosurgery o
- Fixed fields, 0
- o Auto-sequenced,
- 0 Arc (Rotation) and
- Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
- . MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
- . Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
- . Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
- An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
- patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971). �

Refer to Section 11 Design Description, for the Product Specification regarding these specific product features.

#### 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 mitigations. These potential hazards are controlled by software development, verification of

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requirements and validation testing. To minimize electrical 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 LINAC 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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

#### The syngo@ Suite for Oncology Workspaces:

The syngo@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 PreScision option for enhanced stereotactic radiation therapy and stereotactic radiosurgery (SRT / SRS ) does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 9 2009

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

Re: K082775 .

> Trade/Device Name: PreScision™ Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 19, 2008 Received: September 22, 2008

#### 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 such 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.

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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; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 laceling regulation (21) . CFR Part 801) ), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Lain B. Morris

anine 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): _ K082775

#### Device Name: PreScision™ 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 LINAC.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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

# The syngo Suite for Oncology Workspaces:

The syngo@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 | K082775 |
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block;"><img alt="[X]" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+bAwNDg4OB/YGBgYGBgYABWMAhYAwAAAABJRU5ErkJggg=="/></div> OR Over-the-Counter Use ______ |

510(k) for PreScision™ Option