SIMTEC IM-MAXX 2 OPTION

K052315 · Siemens Medical Solutions USA, Inc. · LNH · Sep 22, 2005 · Radiology

Device Facts

• Record ID: K052315
• Device Name: SIMTEC IM-MAXX 2 OPTION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer. The SIMTEC IM-MAXX, software application is an optional software accessory to these devices and is indicated where a specific method of treatment delivery, commercially marketed as Fast Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist. The SIMTEC IM-MAXX 2 software option is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique. The indications for use of this accessory has remained unchanged as a result of the modification.

Device Story

SIMTEC IM-MAXX 2 is an optional software accessory for Siemens PRIMUS and ONCOR Avant-Garde linear accelerators. It facilitates 'Fast Intensity Modulated Radiation Therapy' (FIMRT), a 'step and shoot' static delivery technique. The software manages serial communication between the control console and the Multi-Leaf Collimator (MLC) to optimize jaw movements and delivery speed between treatment segments. It integrates with existing Record and Verify (R&V) systems like COHERENCE Therapist workspace and PRIMEVIEW. Operated by clinicians in a radiation therapy setting, the device automates field sequencing to improve treatment efficiency. It utilizes system interlocks to ensure safety during delivery. The output is a controlled radiation field sequence, enabling faster delivery of prescribed cancer treatments, potentially reducing patient time on the treatment table.

Clinical Evidence

Bench testing only. Evidence includes code review, verification of requirements, and validation of user needs to ensure safe and effective device operation. No clinical data was required or presented.

Technological Characteristics

Software accessory for linear accelerators. Utilizes proprietary serial communication interfaces (DMIP and MLCIP) for MLC control. Operates within existing R&V system architectures (COHERENCE/PRIMEVIEW). Safety features include system interlocks. Software development follows established configuration control and defect management procedures.

Indications for Use

Indicated for patients requiring x-ray radiation therapy for cancer treatment where Fast Intensity Modulated Radiation Therapy (FIMRT) is prescribed by a licensed medical oncologist.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• PRIMUS Linear Accelerator (K993425)
• ONCOR Avant-Garde with COHERENCE Workspaces (K031764)

Reference Devices

• PRIMEVIEW (K972275)

Submission Summary (Full Text)

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SEP 2 2 2005

K052315

## Tab 1 510(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: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| | |
| Establishment Registration Number 2910081 | |
| Proprietary Name: | SIMTEC IM-MAXX 2 Option |
| Common Name: | (Accessory To) - Accelerator, Linear, Medical |
| Classification: | 892.5050 |
| Product Code: | IYE |
| | <span style="float: right;">CD 8-23-05</span> |

#### Substantial Equivalence Claimed To:

- K993425 PRIMUS Linear Accelerator, cleared on Nov. 26, 1999. .
- K031764 ONCOR Avant-Garde with COHERENCE Workspaces, cleared on Sept 5, 2003 .

## Historical Information and Device Description:

The radiation therapy treatment technique known as "Intensity Modulation Radiation Therapy" or "IMRT" The ladiation therapy treathern toonline as the fractionated irradiation of patients in the conventional 2D has to ongine in a troutined applied to controlled conformal (3D) step and shoot or arcradiation therapy.

The Automatic Field Sequencing method is trade-named SIMTEC® (Sequential Intensity Modulated The Addinatic Field Ocquonomy mother 16 transm (K882729) product. A faster version of this rechnology, trade named SIMTEC IM-MAXX® (internal name is East IMRT) was introduced in the PRIMUS™ (K993425) product, which is the predicate for this submission. The IM-MAXX treatment delivery technique is a Static IMRT, also known as "step and shoot" method where nothing moves (MLC leaves or technique is a a Giallo mill s on. This static treatment method has remained unchanged from the IMRT gainly) when the Boun is on This State Risital Mevatron product and later in the PRIMUS and ONCOR products.

The SIMTEC IM-MAXX 2 Option (also called IM-MAXX 2) is to be used in conjunction with Siemens THE SIM LO IM MAXX Z Option (also ballod its accessories and provides a method of delivering Fast radian the application bytions and a modification of the serial communication and jaw movements of the Multi-Leaf Collimator between treatment delivery.

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# Summary of Technological Characteristics Compared to Predicate Devices:

The SIMTEC IM-MAXX 2 software incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option.

The SIMTEC IM-MAXX 2 software consists of:

- (1) The original SIMTEC IM-MAXX technology, also referred to as Automatic Field Sequencing (AFS), I he original Silvi EC IM-MAXX technology, also toronodied. The serial communication consists of the software alchillecture and design had not boon weeks Serial Protocol developed by Siemens propretary comminication intenaces based on a Ghivery speed of the FIMRT treatment In accordance to the Arel Esize examinication has been modified in these areas:
- very technique, the Senal Communication had Boom modified the planning systems and the control
- control
b. MLCIP -- The serial communication path between the control console and the 82 Leaf MLCIP = The senal communication patil betwoon the proprietary MLCIP (MLC Interface Protocol).
- (2) The DMIP and MLCIP serial communications design specifications has been used in the previously
(2) The DMIP and MLCIP serial communications and Committee Coursely of Coun i he Divil" and MCGr Senateonined.com/ dosign-of-Schildland-Garde with COHERENCE workspace (K031764) Linear Accelerator systems
- (KUST704) Lifear Accelerator Uyclomo
(3) Setup and delivery of the SIMTEC IM-MAXX 2 (FIMRT) (reatment option) in the Setup and delivery of the SiMTEC IM-MAXX & (1 mirr) (road.nortes) in the same as for
COHERENCE™ Therapist workspace or the PRIMEVIEW 3i works been been COHEHENGE = "Therapist workspace of the Philips hand Record (V & R) systems have been the original Silvi EC INFMAXA option: The Tonly orkspace as part of the ONCOR Avant-Garde proviously cleared f.e. COTIENCE Therepor workepad as par current PRIMEVEW 3i product
(K031764) and the PRIMEVIEW (aka Treatstation, K972275). The current to exisinal V. R (KU31764) and the FrhinLViLW (aka Troduction) Rev LEF S) - The Minor, evolutionary changes to the original V & R has a 5 ro(k) non mining justice remained unchanged in their intended use.
- Fast Intensity Modulation Therapy (1 Mirr) It Sament of the PRIMEVIEW3i (for PRIMUS Systems) record and verify interface. See Figure 1 Block Diagram, Tab 4.
- (5) The safety and control mechanism of system interlocks to stop treatment when the SIMTEC IM-The safety and control mechanism of System inchooks to etop trounny in one minor addition. MAXX 2 remains unchanged as for the onlyind. Only interest message has been added.

See the Modified Device Description, Tab 4 and Comparison Table, Tab 5, for the descriptions of these modifications.

#### General Safety and Effectiveness Concerns:

Labeling: The device labeling contains instructions for use and any necessary caution and/or warings, to Labeling: The device labeling contains instructions for societing i.e. User Manual, remains provide for the sale and enective use of the oction. The oxio.net as a service the series and has been retification update in the form of a User Release Note will be provided to the user.

Risk Management: Risk management has been assured by use of Risk Analysis, which is used to identify Hisk Management. Hisk management has book about a controlled or mitigated in part or in combination by several means:

- by a means of design of the application ●
- eans of design of the application
including the refinement of the product requirements and customer requirements o
- by software means, .
- including best-practice development, adherence to software configuration control and ಂ defect management.
- by documentation means, .

Image /page/1/Picture/20 description: The image shows the number 000004. The numbers are in a simple, bold font. The numbers are all the same size and are evenly spaced. The image is a simple black and white image.

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- user instructions including device description, use instructions, warnings and/or cautions as o necessary.
- necessary.
by means of testing, including, but not limited to, code review, verification of requirements and . by means of testing, including, a see of the intended use of the device.
- validation of user needs and the michdod ass of the safe and effective use of the device. .

#### Design Control:

The Project Development Procedure (GPA02) contains a provision for tailoring smaller projects utilizing a
rmanian and contraction (DCC) at any at which contains soctions for The Project Development Procedure (GPAG2) collians a proviect planning for design Design Change Specification (DS) document which contains section for proposition testing, reporting testing, reporting testing, reporting testing, reporting testing, reportin control, doolyn reviews. Refer to Tab 12.

#### Intended Use:

The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to The intended abo of the therapeutic treatment of cancer.

The SIMTEC IM-MAXX 2, software application is an optional software accessory to these devices The SIMTEC IM-MAXX Z, Soliware applications of treatment of the states of the states as Fast and is Indicated Where a spon Therapy (FIMRT), is desired.

#### Conclusion:

In conclusion, Siemens is of the opinion that the SIMTEC IM-MAXX 2 option does not introduced In conclusion, Slemens is of the opinion that the ended use, similar technical characteristics and is
any new potential safety risks, has the same intended use, similar secur any new polential salety histo, has the same international the predicate devices.

# 0000005

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal or logo. The seal contains the symbol of the U.S. Department of Health & Human Services in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2005

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

#### Re: K052315

Trade/Device Name: SIMTEC IM-MAXX 2 Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LNH Dated: August 23, 2005 Received: August 25, 2005

#### 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 (Premarket Approval), 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.

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 requirements of the Act of any 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 (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.

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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 deviews to legal/y 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 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Actrons (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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### TAB 3

510(k) Number (if known):

Device Name: SIMTEC IM-MAXX 2 Option

Indications for Use:

The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer.

The SIMTEC IM-MAXX, software application is an optional software accessory to these devices and is indicated where a specific method of treatment delivery, commercially marketed as Fast Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist.

The SIMTEC IM-MAXX 2 software option is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique. The indications for use of this accessory has remained unchanged as a result of the modification.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use_

000007

David A. Layson

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

CONFIDENTIAL