SURGERY REHEARSAL PLATFORM

K123023 · Surgical Theater, LLC · LLZ · Feb 8, 2013 · Radiology

Device Facts

Record IDK123023
Device NameSURGERY REHEARSAL PLATFORM
ApplicantSurgical Theater, LLC
Product CodeLLZ · Radiology
Decision DateFeb 8, 2013
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.2050
Device ClassClass 2
AttributesSoftware as a Medical Device

Intended Use

The Surgical Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating/evaluation surgical treatment options.

Device Story

Surgery Rehearsal Platform (SRP) is a software-based medical image management system used for pre-operative planning. It accepts 2D CT or MR scan slices as input, typically transferred via CD or USB. The software performs image segmentation to transform 2D slices into 3D patient-specific models. Surgeons use the platform to display, color, rotate, scale, and manipulate these 3D representations to simulate and evaluate surgical treatment options. The device is intended for use in a clinical setting by healthcare professionals. By providing a 3D visualization of patient anatomy, the SRP assists surgeons in pre-operative planning, potentially improving surgical preparation and decision-making.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing, functional verification, and validation. Verification confirmed design outputs met input requirements. Validation was performed by surgeons using production-version software to ensure the system met end-user needs and intended use through qualitative and quantitative assessments. Risk management was conducted per ISO 14971.

Technological Characteristics

Software-based medical image management system. Operates on a PC workstation. Inputs: 2D CT/MR scan slices. Outputs: 3D models and output files. Features include image segmentation, 3D representation, rotation, scaling, and coloring tools. Connectivity via CD/USB. Risk management per ISO 14971 (2007).

Indications for Use

Indicated for use as a software interface and image segmentation system for transferring CT or MR imaging data to an output file and as pre-operative software for simulating surgical treatment options. No specific patient population, age, or gender contraindications are defined.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K123023 8 2013 FEB #### 510(k) SUMMARY (Modified February 4, 2013) #### SURGICAL THEATER SURGERY REHEARSAL PLATFORM #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Surgical Theater, LLC 151 Innovation Drive Elyria, Ohio 44035 Contact Person: Mordechai Avisar CEO/President Surgical Theater, LLC Date Prepared: January 26, 2013 #### Name of Device and Name/Address of Sponsor Device Name: Surgery Rehearsal Platform Regulation Name: Picture archiving and communications system Regulation Number: 892.2050 Product Code: LLZ Sponsor: Surgical Theater, LLC 151 Innovation Drive Elyria, Ohio 44035 #### Predicate Device Simbionix PROcedure Rehearsal Studio (K112387) #### Intended Use The Surgical Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating/evaluation surgical treatment options. {1}------------------------------------------------ #### Technological Characteristics and Substantial Equivalence #### A. Device Description The Surgery Rehearsal Platform (SRP) is software based medical image management system. It is intended for use as a software interface and image segmentation system. for the transfer of imaging information from a CT or MR medical scanner, to an output file. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options. The SRP software has the capability of creating 3D models of patient data from 2D scan slices. Additionally, it provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. #### B. Substantial Equivalence The Surgical Theater, LLC Surgery Rehearsal Platform is substantially equivalent to the Simbionix PROcedure Rehearsal Studio (K112387) #### Performance Data The Surgery Rehearsal Platform has been successfully tested, verified and validated to ensure that it meet specifications. #### Testing Summary: Test Plans were written and executed internally which confirmed that the SRP meets specified requirements. Specified requirements include equivalent features and technical characteristics as the predicate device. The test results confirmed that SRP is substantially equivalent to the predicate. The submission includes the comprehensive system test plans, the pass/fail criteria and results. Functional verification testing was conducted to verify that design outputs met design input requirements. The verification effort focused on verifying that design inputs described in system and software requirements specification documents are traceable to design outputs including component specifications, BOMs, and software design documents. Verification activities were performed by Quality personnel. Functional validation testing was conducted to ensure that the SRP meets user needs and intended use. Validation was performed using SRP system and complete production version software. Testing was performed by Quality personnel on each supported system configuration (e.g. 2D vs. 3D Stereoscopic) using documented software test procedures. In addition to the functional validation of the SRP system software, the system was validated by surgeons to ensure the system meets end-user requirements. This validation {2}------------------------------------------------ consisted of both qualitative and quantitative assessments, and confirmed that the SRP meets user needs and intended use. Risk analysis was performed in accordance with ISO 14971 (2007) standard for risk analysis. A risk management file verification and validation was conducted which included a desk audit and, where applicable, system testing. System testing included any mitigation detailed in software test procedures for individual applications. | COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | | |---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | Characteristic | Simbionix PROcedure | Surgery<br>Rehearsal<br>Platform | | 510(k) Accession Number | K112387 | 123023 | | Clearance Date | 12/27/2011 | TBD | | Computer | PC Workstation | Same | | Image Sources | CT and MRI | Same | | Indications for Use | Software interface and image segmentation system for the<br>transfer of imaging information from CT or MR medical<br>scanner to an output file. Pre-operative software for<br>simulating/evaluation surgical treatment options. | Same | | Data Transfer Method | CD or USB | Same | | Preoperative Planning | Yes | Yes | | Patient Contact | No | No | | Human Intervention for<br>Interpretation of Images | Yes | Yes | | Capability of creating 3D<br>models of patient data<br>from 2D scan slices. | Yes | Yes | | Provides the user with<br>ability to input, display,<br>color, and manipulate the<br>2D scan slices via a 3D<br>representation. | Yes | Yes | | Image tools such as<br>rotation, scaling and<br>coloring. | Yes | Yes | ### Comparison of Technological Characteristics {3}------------------------------------------------ #### Conclusions: The Surgery Rehearsal Platform is substantially equivalent to and is as safe and effective as its predicate device. They have the same indications for use, are constructed from the same basic materials and both incorporate the same operational principles. Results of performance tests conducted on the Surgery Rehearsal Platform clearly demonstrate that the device is safe and effective for its intended use. ، {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### February 8, 2013 Surgical Theater, LLC C/O Mordechai Avisar CEO, President and Co-Founder 151 Innovation Drive ELYRIA OH 44035 Re: K123023 Trade/Device Name: Surgical Rehearsal Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: September 28, 2012 Received: December 20, 2012 Dear Mr. Avisar: 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. {5}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Sean My 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 {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: Surgery Rehearsal Platform Indications for Use: Surgery Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating surgical treatment options. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 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 Health Office of In Vitro Diagnostic and Radiological Health K123023 510(k) Page 1 of 1
Innolitics
510(k) Summary
Decision Summary
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