(102 days)
Not Found
No
The document describes image segmentation and 3D model creation for surgical simulation, but there is no mention of AI or ML techniques being used for these processes. The modifications are related to GUI changes and adding a new anatomical module.
No
The Intended Use states it's for transferring imaging information and as pre-operative software for simulating/evaluating surgical treatment options. The Device Description further clarifies its use for creating patient-specific 3D anatomical models for simulating, analyzing, and evaluating pre-operative surgical treatment options, and for creating training modules. This software is a planning and simulation tool, not one that directly treats or diagnoses a disease or condition.
No
The device is intended as a software interface and image segmentation system for transferring imaging information and as pre-operative software for simulating/evaluating surgical treatment options. It is used to create 3D anatomical models for simulation, analysis, and evaluation of surgical options, and for training and debriefing, rather than for diagnosing a disease or condition.
Yes
The device description explicitly states "The Simbionix PROcedure Rehearsal Studio software" and describes its function as a software interface and image segmentation system. There is no mention of accompanying hardware components being part of the device itself, only that it receives input from a medical scanner (CT scanner).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the software is for transferring imaging information, creating 3D anatomical models, and simulating/evaluating surgical treatment options. This is focused on pre-operative planning and simulation, not on analyzing biological samples (like blood, urine, or tissue) to diagnose or monitor a disease or condition.
- Device Description: The description reinforces the use of the software for creating patient-specific 3D models from CT scans for surgical planning and simulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device operates on medical images and is used for surgical planning and simulation, which are in vivo (within the body) or pre-operative activities.
N/A
Intended Use / 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.
Product codes
LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
chest scans, EVAR, carotid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, physician
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
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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
1
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
3
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