(133 days)
Not Found
No
The summary describes image processing and 3D model creation from 2D slices, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The testing description focuses on functional verification and validation against requirements and the predicate device, not on performance metrics typically associated with AI/ML models.
No
The device is described as a software interface and image segmentation system intended for transfer of imaging information and pre-operative simulation, not for directly treating a condition or disease.
No
The device is described as a software interface and image segmentation system for transferring imaging information and as pre-operative software for simulating surgical treatment options. It facilitates surgical planning and rehearsal rather than diagnosing a medical condition.
Yes
The device description explicitly states "The Surgery Rehearsal Platform (SRP) is software based medical image management system." and the entire description focuses on the software's capabilities and validation. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for transferring imaging information from CT or MR scanners and for simulating surgical treatment options. This is focused on pre-operative planning and simulation based on medical imaging, not on analyzing biological samples (like blood, urine, tissue) to provide diagnostic information about a patient's health status.
- Device Description: The description reinforces the intended use, focusing on image management, segmentation, and creating 3D models from medical scans for surgical simulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function falls outside of that scope.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR medical scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Surgery Rehearsal Platform has been successfully tested, verified and validated to ensure that it meet specifications.
Results of performance tests conducted on the Surgery Rehearsal Platform clearly demonstrate that the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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 |
| Rehearsal | ||
| 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 | |
| transfer of imaging information from CT or MR medical | ||
| scanner to an output file. Pre-operative software for | ||
| simulating/evaluation surgical treatment options. | Same | |
| Data Transfer Method | CD or USB | Same |
| Preoperative Planning | Yes | Yes |
| Patient Contact | No | No |
| Human Intervention for | ||
| Interpretation of Images | Yes | Yes |
| Capability of creating 3D | ||
| models of patient data | ||
| from 2D scan slices. | Yes | Yes |
| Provides the user with | ||
| ability to input, display, | ||
| color, and manipulate the | ||
| 2D scan slices via a 3D | ||
| representation. | Yes | Yes |
| Image tools such as | ||
| rotation, scaling and | ||
| 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