PROCEDURE REHEARSAL STUDIO

K093269 · Simbionix , Ltd. · LLZ · Aug 20, 2010 · Radiology

Device Facts

• Record ID: K093269
• Device Name: PROCEDURE REHEARSAL STUDIO
• Applicant: Simbionix , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 20, 2010
• Decision: SESE
• Submission Type: Traditional
• 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 is a software-based image processing system. It takes CT scan data as input to create patient-specific 3D anatomical models. Clinicians use the software to segment images, simulate surgical procedures, and evaluate treatment options. The resulting 3D models can be exported to the Simbionix ANGIO Mentor Simulator for training or post-operative debriefing. The device is intended for use by physicians in a clinical setting to assist in pre-operative planning. By providing a virtual environment for rehearsal, the device aims to improve surgical preparation and decision-making, potentially benefiting patients through enhanced procedural planning.

Clinical Evidence

Bench testing only. Performance was validated through bench tests and phantom studies comparing the device to the Mimics predicate device.

Technological Characteristics

Software-based image segmentation and processing system. Operates as a standalone software interface for CT imaging data. Utilizes 3D anatomical modeling and simulation capabilities. No specific hardware materials or energy sources described.

Indications for Use

Indicated for use by clinicians as a software interface and image segmentation system to transfer CT imaging data to an output file 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

• Mimics by Materiallise N.V. (K073468)
• CardioCT by Shina System Ltd. (K070226)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(K) SUMMARY [as required by section 807.92(c)] PROcedure Rehearsal Studio™

# 510(k) Number K_093269

### Applicant's Name:

AUG 2 0 2010

Simbionix Ltd. 6 Hamelacha St. Lod, Northern Industrial Zone, 71520 Israel Tel: [phone] Fax: [phone]

## Contact Person:

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

#### Trade Name:

PROcedure Rehearsal Studio™

Classification Name: Regulation Number: Product Code: Classification: Review Panel:

System, Image Processing, Radiological 892.2050 LLZ Class II Radiology

#### Predicate Devices:

- Mimics® by Materiallise N.V., K073468. .
- CardioCT by Shina System Ltd., K070226 .

#### 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.

ge 1 of 2

{1}------------------------------------------------

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..

## 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 device performance was validated through bench tests and phantom studies in comparison to the Mimics predicate device and was found substantially equivalent.

#### Conclusion:

Simbionix Ltd. believes that, based on the information provided in this submission, the PROcedure Rehearsal Studio™ is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.

PROcedure Rehearsal Studio™ · Page 5-4

page a dt²

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized emblem featuring three abstract shapes resembling waves or ribbons.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 President & CEO Push-Med LLC 1914 J N Pease Pl. CHARLOTTE NC 28262

AUG 2 0 2010

Re: K093269

Trade/Device Name: PROcedure Rehearsal StudioTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II. Product Code: LLZ Dated: June 21, 2010 Received: June 23, 2010

#### Dear Ms. Feiedman:

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

{3}------------------------------------------------

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 5 00() , rims rete notification. The FDA finding of substantial equivalence of your device to a legally wonarketed 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.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 长 693269

Device Name:

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 Devie

---

(Division Sign-Off)

Division of Radiological Devic Office of In Vitro Diagnostic Device Eva

510K K093269

PROcedure Rehearsal Studio™ · Page 4-3