← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K123269

# PROCEDURE REHEARSAL STUDIO (K123269)

_Simbionix , Ltd. · LLZ · Jan 29, 2013 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K123269

## Device Facts

- **Applicant:** Simbionix , Ltd.
- **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md)
- **Decision Date:** Jan 29, 2013
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 892.2050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **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

Software interface/image segmentation system; inputs patient CT scan data; transforms data into 3D anatomical models; enables preoperative simulation/evaluation of surgical treatment options. Exportable to ANGIO Mentor Simulator for training/debriefing. Used by clinicians in clinical settings. Modifications include GUI changes and addition of TEVAR module for chest scan 3D modeling (in addition to existing EVAR/carotid options). Facilitates surgical planning and patient-specific anatomical visualization.

## Clinical Evidence

Bench testing only. Verification included functional testing of software features and UI. Validation included high-level integration testing using 10 additional datasets to verify workflow for importing patient data, segmentation, and centerlines. All testing met pass criteria.

## Technological Characteristics

Software-based image processing system. Functions as an interface for CT data transfer and 3D segmentation. Features include GUI, segmentation tools, and centerline generation. Supports TEVAR, EVAR, and carotid module workflows. Operates on standard computing hardware.

## Regulatory 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™ ([K112387](/device/K112387.md))

## Submission Summary (Full Text)

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K123269

# 510(K) SUMMARY

# PROcedure™ Rehearsal Studio

JAN 2 9 2013

510(k) Number K_

## Prepared on:

October 16, 2012

# Applicant's Name:

Simbionix Ltd. Beit Golan Corner of Golan and Hanegev St. Airport City, 70151, Israel Tel: +972-3-9114444 Fax: +972-3-9114455

## Contact Person:

Shoshana (Shosh) Friedman Telephone: 704-899-0092 Fax: 704-899-0098 Email: shosh@pushmed.com

# 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 K112387 .
## 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 

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simulating, analyzing and evaluating for preoperative surgical treatment options.

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 a TEVAR module that allows the software to create 3D models of chest scans in addition to the EVAR and carotid options that were 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. The verification stage of the software consisted of tests performed for each phase of the user work flow, verifying: Correct functionality of each of the software features, which are part of this work phase and Correct UI. The validation stage consisted of a high level integration test of the device module and included a run through of 10 additional datasets, verifying work flow of all software components. The testing activities were conducted according to the following phases of the user work flow: Importing Patient Data, Segmentation and Centerlines. All testing met the Pass criteria.

#### 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 K112387 without raising any new safety and/or effectiveness issue.

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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### January 29, 2013

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

Re: K123269

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: December 21, 2012 Received: December 26, 2012

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 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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#### Page 2 - Ms. Shoshana Friedman

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.

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 Diagnostics and Radiological Health at (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

## Sean M. Boyd -S for

Janine M. Morris 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 STATEMENT

510(k) Number: K123269

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 (Per 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)

# Sean M. Boyd -S

(Division Sign Off)

Division of Radiological He

Office of In Vitro Diagnostics and Ra

510(k)K123069

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