PROCEDURE REHEARSAL STUDIO(TM)

K112387 · Simbionix , Ltd. · LLZ · Dec 27, 2011 · Radiology

Device Facts

• Record ID: K112387
• Device Name: PROCEDURE REHEARSAL STUDIO(TM)
• Applicant: Simbionix , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.

Device Story

PROcedure Rehearsal Studio software processes patient CT scan data to create 3D anatomical models; enables clinicians to simulate, analyze, and evaluate preoperative surgical treatment options. Software includes segmentation tools to generate 3D models; models can be exported to Simbionix ANGIO Mentor Simulator for training and postoperative debriefing. Modifications include updated GUI and addition of EVAR module for abdominal scan modeling alongside existing carotid option. Used by physicians in clinical settings for surgical planning; output assists in preoperative decision-making and procedural rehearsal, potentially improving surgical outcomes.

Clinical Evidence

Bench testing only. Extensive verification and validation activities were performed to ensure the device performs according to its specifications.

Technological Characteristics

Software-based image segmentation and interface system. Operates on CT imaging data. Features 3D anatomical modeling, GUI, and simulation modules (carotid and EVAR). Connectivity includes export to ANGIO Mentor Simulator. No specific hardware materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for use by clinicians as a software interface and image segmentation system to transfer CT imaging data to output files and as pre-operative software for simulating and evaluating surgical treatment options.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• PROcedure Rehearsal Studio (K093269)
• Mimics by Materiallise N.V. (K073468)

Submission Summary (Full Text)

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K112387

## ATTACHMENT 2 510(K) SUMMARY

DEC 2 7 2011

# PROcedure™ Rehearsal Studio

510(k) Number K_____________

## Applicant's Name:

Beit Golan Corner of Golan and Hanegev St. Airport City, 70151, Israel Tel: [phone] Fax: [phone]

#### Contact Person:

Shoshana (Shosh) Friedman Telephone: [phone] Fax: [phone] Email: [e-mail]

### Trade Name:

PROcedure Rehearsal Studio™

| Classification Name: | System, Image Processing, Radiological |
|----------------------|----------------------------------------|
| Regulation Number: | 892.2050 |
| Product Code: | LLZ |
| Classification: | Class II |
| Review Panel: | Radiology |

#### Predicate Device:

- PROcedure Rehearsal Studio™ cleared for marketing under . K093269
- Mimics® by Materiallise N.V. cleared for marketing under . K073468.

Device Description:

The Simbionix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of simulating, analyzing and evaluating for preoperative surgical treatment options.

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Once the 3D segmentation model has been exported to the Simbionix ANGIO Mentor Simulator Practice Environment, the physician can use it to create a library of modules for training and post operative debriefing. The modifications subject to this Special 510(k) submission are: (1) Graphic User Interface changes in various locations; (2) functional change in various locations which include the addition of an EVAR module that allows the software to create 3D models of abdominal scans in addition to the carotid option that was previously cleared.

#### Intended Use:

The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.

#### Performance Data:

The company has performed extensive verification and validation activities to ensure the device performs according to its specifications.

#### Conclusion:

Simbionix Ltd. believes that, based on the information provided in this submission, the modified PROcedure Rehearsal Studio™ is substantially equivalent to the predicate PROcedure Rehearsal Studio previously cleared for marketing under K093269 without raising any new safety and/or effectiveness issue.

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Public Health Service

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

Simbionix, Ltd. % Ms. Shoshana Friedman, RAC Regulatory Consultant Push-Med. LLC. 1914 J. N. Pease Place CHARLOTTE NC 28262

DEC 2 7 2011

Re: K112387

Trade/Device Name: PROcedure™ Rehearsal Studio Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 30, 2011 Received: December 2, 2011

Dear Ms. Friedman:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 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,

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 1

## INDICATIONS FOR USE STATEMENT

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name:

PROcedure™ Rehearsal Studio

Indications for Use:

The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.

Prescription Use _ X___

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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

Alberto Serta

Division of Radiological De Office of In Vitro Diagnostic Device Evaluation

510K.KU2387

PROcedure Rehearsal Studio™