HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS

K123263 · Eckert & Ziegler Bebig GmbH · MUJ · Apr 4, 2013 · Radiology

Device Facts

• Record ID: K123263
• Device Name: HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS
• Applicant: Eckert & Ziegler Bebig GmbH
• Product Code: MUJ · Radiology
• Decision Date: Apr 4, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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

Device Story

HDRplus is a software-based brachytherapy treatment planning system (TPS) running on a Windows PC. It ingests medical images and operator-entered data to facilitate contouring of target volumes and organs at risk. The system reconstructs applicators, calculates optimal dwell times and dose distributions for HDR/PDR afterloaders, and provides evaluation tools for treatment qualification. Used in clinical settings by medical professionals; output is a treatment plan transferred to Eckert & Ziegler Multisource or GyneSource afterloading devices. Benefits include precise dose delivery to tumors while sparing healthy tissue. Accessories include film scanners, printers, pen tablets, and touch panels for enhanced contouring accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based TPS running on Windows XP/7 PC. Connectivity via hospital network for image import. Accessories: film scanner, printer, pen tablet, touch panel. Frame grabber optional for video capture. No specific algorithm architecture or material standards cited.

Indications for Use

Indicated for medical professionals creating radiation therapy plans for patients undergoing High Dose Rate (HDR) or Pulsed Dose Rate (PDR) remote afterloader-based brachytherapy.

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

• K091145

Submission Summary (Full Text)

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# 510(k) Summary as required by 21 CFR 807.92 6

## Submitter of 510(k) 6.1

| 510(k) owner's name | : | Eckert & Ziegler BEBIG GmbH |
|-------------------------------|---|-----------------------------|
| address | : | Robert-Rössle-Strasse 10 |
| | : | 13125 Berlin |
| | : | Germany |
| phone | : | [phone] |
| fax | : | [phone] |
| name of contactperson | : | Hub van de Bergh |
| e-mail | : | [e-mail] |
| date the summary was prepared | : | August 10, 2012 |

# 6.2 Device: HDRplus

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

## Legally Marketed Device(s) 6.3

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

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# 6.4 Description of the Device

#### HDRplus 6.4.1

HDRplus 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 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) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus 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).

HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

Eckert & Ziegler BEBIG GmbH

HDRplus 510(k) PMN Section 6: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

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

Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 14 / 45

APR 0 4 2013

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The HDRplus System comprises subjoined listed subsystems:

- Personal Computer . It executes the HDRplus 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 HDRplus software and runs under Windows XP Professional or 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.

#### Accessory: Film Scanner 6.4.2

The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

#### 6.4.3 Accessory: Printer

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

#### 6.4.4 Accessory: Pen Tablet

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.

#### Accessory: Touch Panel 6.4.5

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

# Intended use of the Device 6.5

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

# Technological characteristics of device compared to the 6.6 predicate device

The HDRplus Brachytherapy Treatment Planning System has the same technological characteristics as the legally marketed predicate device listed above which is cleared under 510(k) #K091145.

The HDRplus technology is based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry. Optionally a frame grabber may be used with HDRplus for capturing video images.

# Substantial Equivalence 6.7

From the discussion in previous paragraphs it can be concluded that the HDRplus Brachytherapy Treatment Planning System has the same technological characteristics compared to the legally marketed predicate device indicated in section 6.3.

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

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

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

Eckert & Ziegler BEBIG GmbH

HDRplus 510(k) PMN Section 6: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

Phone : +49:30 941084130 [phone] Fax e-mail : [e-mail]

Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 15 / 45

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

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

April 4, 2013

Hub van de Bergh Consultant ECKERT & ZIEGLER BEBIG GMBH C/O TRACEABILITY OA & RA SERVICES MUURZWALUW 30, 3905 RZ VEENENDAAL NETHERLANDS

Re: K123263

Trade/Device Name: HDRplus & Add in prostate Module for HDRplus Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: MUJ Dated: March 15, 2013 Received: March 20, 2013

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 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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# Page 2-Mr. Bergh

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MichaFDA Hara

for

Janine M. Morris, M.S. 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): K123263

Device Name:_________________ HDRplus

Indications for Use:

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Mishra EOA Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health .

510(k) K123263

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