SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

K141900 · Eckert & Ziegler Bebig GmbH · MUJ · May 20, 2015 · Radiology

Device Facts

• Record ID: K141900
• Device Name: SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
• Applicant: Eckert & Ziegler Bebig GmbH
• Product Code: MUJ · Radiology
• Decision Date: May 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic

Intended Use

SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.

Device Story

SagiPlan is a software-based treatment planning system for HDR brachytherapy. It ingests clinical images and user-entered data to calculate radiation dwell times and dose distributions. Medical professionals use the system to contour target volumes and organs at risk, evaluate dose distributions, and generate treatment plans. The software runs on a Windows-based PC, utilizing peripherals like a mouse, pen tablet, or touch panel for contouring. The final plan is transferred to remote afterloading devices (e.g., SagiNova, MultiSource) to deliver radiation therapy. The system benefits patients by optimizing dose delivery to tumors while sparing healthy tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system running on Windows 7 PC. Hardware includes monitor, keyboard, mouse, optional film scanner, pen tablet, and touch panel. Connectivity via hospital network for image import. Supports HDR brachytherapy isotopes. Operates as a standalone software package for dose calculation and contouring.

Indications for Use

Indicated for medical professionals creating treatment plans for remote afterloader-based HDR brachytherapy, including calculation of treatment courses and evaluation of local/global doses to organs at risk and target volumes.

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

• HDRplus (K123263)

Submission Summary (Full Text)

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

May 20, 2015

Eckert & Ziegler BEBIG GmbH % Mr. Hub van de Bergh Consultant OA & RA Medical Devices Traceability QA & RA Services Muurzwaluw 30 3905 RZ Veenendaal THE NETHERLANDS

Re: K141900

Trade/Device Name: SagiPlan Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide Applicator system Regulatory Class: II Product Code: MUJ Dated: April 24, 2015 Received: April 27, 2015

Dear Mr. van de Bergh:

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

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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. 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,

echon D'Hara For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141900

Device Name SagiPlan

Indications for Use (Describe)

SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals.

SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy.

SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.

Type of Use (Select one or both, as applicable)

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

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Image /page/3/Picture/0 description: The image shows the Eckert & Ziegler logo. The logo consists of a pink oval shape with a white outline, placed between two pink rectangles. To the right of the shapes, the text "Eckert & Ziegler" is written in black.

# 7 510(k) Summary as required by 21 CFR 807.92

#### Submitter of 510(k) 7.1

| 510(k) owner's name<br>address | : | Eckert & Ziegler BEBIG GmbH<br>Robert-Rössle-Strasse 10<br>13125 Berlin<br>Germany |
|--------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------|
| phone | : | [phone] |
| fax | : | [phone] |
| company's contact person | : | Michel Lafuente |
| For this 510(k) submission<br>name of contact person (consultant)<br>e-mail<br>date the summary was prepared | : | Hub van de Bergh<br>[e-mail]<br>June 30, 2014 |

#### Device: SaqiPlan 7.2

name of the device / trade or proprietary name: SagiPlan common or usual name: Brachytherapy Treatment Planning System classification name: Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)

#### 7.3 Legally Marketed Device(s)

SagiPlan can be shown to be substantial equivalent to the legally marketed predicate device cited in the table below.

| Device | Manufacturer | 510(k) # |
|---------|-----------------------------|----------|
| HDRplus | Eckert & Ziegler BEBIG GmbH | K123263 |

#### Description of the Device 7.4

#### 7.4.1 SagiPlan

SagiPlan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input manually entered by the operator.

The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) remote afterloaders.

The main use of SagiPlan is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).

SaqiPlan can reconstruct one or more applicators.

Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device.

The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

Eckert & Ziegler BEBIG GmbH

SagiPlan 510(k) PMN Section 7: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

Phone [phone] [phone] Fax e-mail : [e-mail]

Company Confidential

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Image /page/4/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a maroon rectangle with a maroon oval inside of it. To the right of the shape is the company name, "Eckert & Ziegler".

The SagiPlan System comprises subjoined listed subsystems:

- . Personal Computer to execute the SagiPlan software.
- . Monitor to visualise the treatment planning process.
- . Keyboard to enter treatment data.
- . Mouse to select objects on the screen

The PC is used to execute the SagiPlan software and runs under Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

#### 7.4.2 Accessory: Film Scanner

The Film Scanner allows the user to read an X-Ray image to present it on the screen to visualise the brachytherapy applicator implant.

#### 7.4.3 Accessory: Printer

The Printer allows for hard copy of the patients treatment plan and other stored data.

#### Accessory: Pen Tablet 7.4.4

The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

#### 7.4.5 Accessory: Touch Panel

The Touch Panel acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

#### 7.5 Intended use of the Device

SagiPlan is used for the creation of treatment plans for High Dose Rate remote afterloader based brachytherapy. SagiPlan calculates a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses.

### 7.6 Technological characteristics of device compared to the predicate device

The SagiPlan Brachytherapy Treatment Planning System has the same technological characteristics as the legally marketed predicate device from which it is derived and listed above which is cleared under 510(k) #K123263.

The SagiPlan technology is based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry. A film scanner is used to read available medical images. Optionally a frame grabber may be used with SagiPlan for capturing video images electronically. SagiPlan is designed to run in a Microsoft Windows run-time environment.

#### 7.7 Substantial Equivalence

From the discussion in previous paragraphs it can be concluded that the SagiPlan Brachytherapy Treatment Planning System has the same technological characteristics compared to the legally marketed predicate device indicated in section 7.3.

The differences between SagiPlan and predicate device do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device.

The intended use of SagiPlan and predicate device are the same.

The conclusion is that SagiPlan is substantial equivalent to the legally marketed predicate device.

## Eckert & Ziegler BEBIG GmbH

SagiPlan 510(k) PMN Section 7: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

Phone [phone] Fax [phone] e-mail : [e-mail]

Company Confidential

Doc ID 0011-0008 | Rev 0 | Date June 30, 2014 | page 23 / 62