(254 days)
Not Found
No
The document describes image segmentation and 3D model creation for surgical planning and training, but there is no mention of AI or ML techniques being used for these processes. The focus is on software interface, image segmentation, and exporting models.
No.
The device is intended for pre-operative surgical planning and training, not for directly treating a disease or condition.
No
Explanation: The device is described as pre-operative software for surgical planning that creates a patient-specific 3D anatomical model. While it uses imaging information from a medical scanner, its stated purpose is surgical planning and rehearsal, not diagnosis of a disease or condition. The output is for planning and training, not for making a medical diagnosis.
Yes
The device description explicitly states "The PROcedure Rehearsal Studio software" and describes its function as a software interface and image segmentation system. It processes data from a medical scanner but does not include any hardware components itself. The modifications described are also software-based (GUI and functional changes).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "software interface and image segmentation system for the transfer of imaging information from a medical scanner to an output file" and "pre-operative software for surgical planning." This focuses on processing medical images for surgical preparation, not on analyzing biological samples (like blood, urine, or tissue) to diagnose or monitor a disease or condition.
- Device Description: The description emphasizes creating patient-specific 3D anatomical models from CT scans for surgical planning and training. While it uses medical imaging, it doesn't involve the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The device falls under the category of Radiological Image Processing Systems and is used for surgical planning based on medical imaging data. This is distinct from the definition and function of an In Vitro Diagnostic device.
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 to an output file. It is also intended as pre-operative software for surgical planning
Product codes
LLZ
Device Description
The PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of preoperative surgical planning.
The 3D segmentation model produced by the PROcedure Rehearsal Studio may be exported to the Simbionix ANGIO Mentor Simulator Practice Environment and allow the physician to create a library of modules for training and post-operative debriefing. The ANGIO Mentor Simulator Practice Environment is not meant for clinical purposes and is intended to be used for training purposes only.
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 enable the addition of a Neuro module that allows the software to create 3D models for neurological scans in addition to the thoracic (TEVAR), abdominal (EVAR) and Carotid options that were previously cleared.
The Neuro module builds upon the previously cleared PROcedure Rehearsal Studio modules by adding the support for segmentation of the cerebral circulation system in addition to existing carotid, thoracic, and abdominal anatomies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner
Anatomical Site
thoracic (TEVAR), abdominal (EVAR), Carotid, cerebral circulation system
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
Verification was performed using four patients' datasets (Dataset A through Dataset D). Dataset A was of Carotid Type, Dataset B was of EVAR type, Dataset C was of TEVAR type and Dataset D was of Neuro Intervention type.
Summary of Performance Studies
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The testing activities were conducted according to the following phases of the user work flow: Importing Patient Data, Segmentation and Centerlines. Verification was performed using four patients' datasets (Dataset A through Dataset D). Dataset A was of Carotid Type, Dataset B was of EVAR type, Dataset C was of TEVAR type and Dataset D was of Neuro Intervention type.
In addition to the verification testing above, the following tests were completed:
- Segmentation quality testing
- Phantom testing
- Usability testing
All the verification and validation tests passed successfully.
Key Metrics
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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Image /page/0/Picture/1 description: The image shows the 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 circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
3DSystems, Simbionix Products % Ms. Kim Torluemke Vice President, Ouality and Regulatory Affairs, Healthcare 3D Systems, Inc. 5381 South Alkire Circle LITTLETON CO 80127
Re: K153705
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: August 12, 2016 Received: August 15, 2016
Dear Ms. Torluemke:
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Michael O'Hara
For
Robert Ochs, Ph.D. 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
510(k) Number (if known) K153705
Device Name PROcedure Rehearsal Studio
Indications for Use (Describe)
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 to an output file. It is also intended as pre-operative software for surgical planning
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY [as required by section 807.92(c)] PROcedure Rehearsal Studio™ 510(k) Number K
1. SUBMITTER
Applicant's Name:
3DSystems, Simbionix Products Beit Golan Corner of Golan and Hanegev St. Airport City, 70151, Israel Tel: +972-3-9114444 Fax: +972-3-9114455
Contact Person:
Kim Torluemke Vice President, Quality and Regulatory Affairs, Healthcare 5381 South Alkire Circle Littleton, Colorado 80127 Phone: 720-643-1001; Fax: 720-643-1009; kim.torluemke@3dsystems.com Date Prepared: December 22, 2015
2. DEVICE
Trade Name: PROcedure Rehearsal Studio™
Common or Usual Name:
Radiological Image Processing System
Classification: Name: System, Image Processing, Radiological Product Code: LLZ Regulation No: 892.2050 Class: 2 Classification Panel: Radiology
3. PREDICATE DEVICES
Main predicate:
PROcedure Rehearsal Studio™ cleared for marketing under K123269, K112387 and K093269
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4. DEVICE DESCRIPTION
The PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of preoperative surgical planning.
The 3D segmentation model produced by the PROcedure Rehearsal Studio may be exported to the Simbionix ANGIO Mentor Simulator Practice Environment and allow the physician to create a library of modules for training and post-operative debriefing. The ANGIO Mentor Simulator Practice Environment is not meant for clinical purposes and is intended to be used for training purposes only.
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 enable the addition of a Neuro module that allows the software to create 3D models for neurological scans in addition to the thoracic (TEVAR), abdominal (EVAR) and Carotid options that were previously cleared.
The Neuro module builds upon the previously cleared PROcedure Rehearsal Studio modules by adding the support for segmentation of the cerebral circulation system in addition to existing carotid, thoracic, and abdominal anatomies.
ട്. 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 preoperative software for surgical planning.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE
The software uses the same imaging inputs and substantially equivalent segmentation methods as the predicate device to create a 3D model which can be used for pre-operative surgical planning.
7. PERFORMANCE DATA
Below is a list of the tests that have been performed and successfully completed for the PROcedure Rehearsal Studio.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
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The testing activities were conducted according to the following phases of the user work flow: Importing Patient Data, Segmentation and Centerlines. Verification was performed using four patients' datasets (Dataset A through Dataset D). Dataset A was of Carotid Type, Dataset B was of EVAR type, Dataset C was of TEVAR type and Dataset D was of Neuro Intervention type.
In addition to the verification testing above, the following tests were completed:
- Segmentation quality testing ●
- Phantom testing
- Usability testing ●
All the verification and validation tests passed successfully.
8. CONCLUSION:
The PROcedure Rehearsal Studio has the same intended use and technological characteristics as the previously cleared version of the same device (K123269, K112387 and K093269). Consequently, it is clear that the PROcedure Rehearsal Studio is as safe and effective as its predicate devices without raising any new safety and/or effectiveness concerns. Any differences have been addressed by extensive testing and validations and therefore negate any safety or effectiveness concerns.