SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE

K042229 · Siemens Medical Solution, Inc. USA · JAK · Sep 1, 2004 · Radiology

Device Facts

• Record ID: K042229
• Device Name: SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
• Applicant: Siemens Medical Solution, Inc. USA
• Product Code: JAK · Radiology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data. For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both hardware and software components) will be offered and provides the following features: - improved gantry tilt accuracy . - reduced table top deflection . - externally adjustable gantry laserlights . - increased tube positioning accuracy . - simplified horizontal positioning of the table . - optimized field coverage using extended Field of View . Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.

Device Story

The SOMATOM Radiation Treatment Planning (RTP) package is a hardware and software upgrade for Siemens SOMATOM Emotion CT systems. It enhances geometric accuracy for radiotherapy planning by reducing table top deflection, improving gantry tilt accuracy, increasing x-ray tube positioning accuracy for Topograms, and providing externally adjustable gantry laserlights. It also enables simplified horizontal table repositioning and extends the Field of View (FOV) to 70 cm. The device is used in clinical settings by radiology or oncology staff to prepare anatomical data. The output is used by physicians to assist in planning external beam radiotherapy, potentially improving the precision of treatment delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardware/software upgrade for CT systems. Features: improved gantry tilt (0.5-degree increments), reduced table top deflection, externally adjustable gantry laserlights, increased x-ray tube positioning accuracy (± 2 degrees), and extended 70 cm FOV. Connectivity includes integration with room RTP lasers. Software manages table positioning memory (± 1mm tolerance).

Indications for Use

Indicated for patients requiring external beam radiotherapy treatment planning where high geometric accuracy of anatomical data is necessary for CT-based planning.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens SOMATOM Emotion 6 (P10) (K023687)

Submission Summary (Full Text)

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**510(K) SUMMARY** Kd42229

## F(){{ SIEMENS RADIATION TREATMENT PLANNING (RTP) PACKAGE

## Submitted by:

Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355

August 17, 2004

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### 1. Contact Person:

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 Malvern, PA 19355 Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Name and Classification 2.

| Product Name: | SOMATOM Radiation Treatment Planning (RTP) |
|-----------------------|--------------------------------------------|
| | package |
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

### 3. Importer/Distributor Establishment:

Registration Number: 2240869 Siemens Medical Solutions, Inc. USA 51 Valley Stream Pkwy Malvern, PA 19355

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### Manufacturing Facility: 4.

Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany

#### Substantial Equivalence 5.

The Radiation Treatment Planning (RTP) Package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:

| Predicate Device Nume | ' FDA Clearance Number FDA Clearance Date | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Siemens SOMATOM Emotion 6 (P10) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>K023687 | 11/22/02 |

#### Device Description 6.

A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following:

- Improved gantry tilt accuracy: . The gantry tilt angle is displayed in 0.5 degree increments.
- Reduced table top deflection: . The tabletop deflection is reduced, by replacing the CT table, allowing for more accurate patient positioning.
- Externally adjustable gantry laserlights: . A position adjustment of the gantry laserlights is possible without opening the gantry thus allowing easier installation and synchronization with room RTP lasers.
- Increased x-ray tube positioning accuracy: . The accuracy of x-ray tube positioning for Topogram scans is improved to a range of ± 2 degrees.
- Simplified horizontal positioning of the table: . During an examination, a table feed position can be stored enabling fast and easy repositioning of a patient back to the previous table position (tolerance of ± 1mm).
- Optimized field coverage using extended Field of View (FOV): . The FOV is extended to 70 cm for maximum anatomical visualization and improved RTP positioning.

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# Ko42229

#### Indications for Use 7.

The use of standard CT scanners in Radiation Treatment Planning environments requires a r it as or banian accuracy of anatomical data. For the Siemens SOMATOM Emotion CTs and all further CT devices a dedicated RTP package (including both hardware and software components) will be offered and provides the following features:

- improved gantry tilt accuracy .
- reduced table top deflection .
- externally adjustable gantry laserlights .
- increased tube positioning accuracy .
- simplified horizontal positioning of the table .
- optimized field coverage using extended Field of View .

Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 1 2004

Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355

Re: K042229

Trade/Device Name: SOMATOM Radiation Treatment Planning (RTP) Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: August 17, 2004 Received: August 17, 2004

Dear Ms. Hartman:

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.

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 (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 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 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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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Indications for Use

510(k) Number (if known): Device Name:

14-229 Radiation Treatment Planning (RTP) package

The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data.

For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both For the Siements SOMA TOM Enion OF Of Systems, a carovides the following features:

- improved gantry tilt accuracy .
- reduced table top deflection .
- externally adjustable gantry laserlights .
- increased tube positioning accuracy .
- simplified horizontal positioning of the table .
- optimized field coverage using extended Field of View .

Radiation Treatment Planning (RTP) Package will be used to prepare geometric and Radiation Treatment Hamiling (NTT ) Packago The Statemal beam radiotherapy treatment planning.

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR \$801.109)

Over-The-CounterUse
(Division Sign-Off)
Division of Reproductive Abdominal
Nancy C. Brogdon

ivision of Reproductive. Abo and Radiological Devices