(131 days)
Not Found
No
The document describes image segmentation and 3D model creation based on CT scans for surgical simulation and planning, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The focus is on image processing and software functionality for creating anatomical models.
No.
This device is described as pre-operative software for simulating/evaluating surgical treatment options and for training, not for direct therapeutic intervention on a patient.
No
Explanation: The "Intended Use" states the software is for transferring imaging information and for pre-operative simulation/evaluation of surgical treatment options. It facilitates creating 3D models for planning and training, not for making a medical diagnosis.
Yes
The device description explicitly states "The Simbionix PROcedure Rehearsal Studio software allows clinicians..." and the modifications are described as "Graphic User Interface changes" and "functional change". There is no mention of any hardware component being part of the device itself, only that it receives input from a medical scanner (CT scanner) and exports to a simulator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PROcedure Rehearsal Studio software's intended use and description clearly state its purpose is to:
- Transfer imaging information from a medical scanner (CT).
- Create patient-specific 3D anatomical models based on CT scans.
- Simulate/evaluate surgical treatment options pre-operatively.
- Be used for training and post-operative debriefing.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its input is imaging data (CT scans), not biological specimens.
The device is a software tool used for image processing, 3D modeling, and surgical simulation based on medical imaging data. This falls under the category of medical imaging software and surgical planning/simulation tools, not in vitro diagnostics.
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 (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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ATTACHMENT 2 510(K) SUMMARY
DEC 2 7 2011
PROcedure™ Rehearsal Studio
510(k) Number K_____________
Applicant's Name:
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 . K093269
- Mimics® by Materiallise N.V. cleared for marketing under . K073468.
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.
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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 an EVAR module that allows the software to create 3D models of abdominal scans in addition to the carotid option that was 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.
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 K093269 without raising any new safety and/or effectiveness issue.
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized human figure and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. A line is present underneath the text. The logo is simple and professional in appearance.
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, RAC Regulatory Consultant Push-Med. LLC. 1914 J. N. Pease Place CHARLOTTE NC 28262
DEC 2 7 2011
Re: K112387
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: November 30, 2011 Received: December 2, 2011
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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (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,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 1
INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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___
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE ·CONTINUE ON ANOTHER PAGE IF NEEDED)
Alberto Serta
Division of Radiological De Office of In Vitro Diagnostic Device Evaluation
510K.KU2387
PROcedure Rehearsal Studio™