(305 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on image segmentation and simulation based on CT data, which can be achieved with traditional image processing techniques. There is no mention of training or test sets for AI/ML models.
No.
The device is described as pre-operative software for simulating and evaluating surgical treatment options, and for training and debriefing. It does not directly treat or diagnose a disease or condition.
No
The device is described as pre-operative software for simulating and evaluating surgical treatment options, and for creating 3D anatomical models for simulation, analysis, and evaluation. It is used for training and post-operative debriefing, not for diagnosing a condition or disease.
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 that are part of the regulated device.
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.
- Device Function: The PROcedure Rehearsal Studio software processes medical images (CT scans) to create 3D anatomical models for surgical simulation and planning. It does not analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for transferring imaging information and simulating/evaluating surgical treatment options. This is a pre-operative planning tool, not a diagnostic test performed on a biological sample.
Therefore, the device falls under the category of medical imaging software and surgical planning 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
medical scanner such as a 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 device performance was validated through bench tests and phantom studies in comparison to the Mimics predicate device and was found substantially equivalent.
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).
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: +972-8-921-1177 Fax: +972-8-921-1188
Contact Person:
Name: Shoshana (Shosh) Friedman Telephone: 704-899-0092 Fax: 704-899-0098 Email: shosh@pushmed.com
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:
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 (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.
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