(257 days)
Not Found
No
The description focuses on 3D modeling, haptics, and user manipulation of data, with no mention of AI or ML terms or functionalities.
No
The device is described as pre-operative software for simulating and evaluating surgical treatment options, not actively treating a condition.
No
The device is described as pre-operative software for simulating and evaluating surgical treatment options, and for pre-surgical planning. It does not state that it analyzes, processes, or interprets medical images or data to provide a diagnosis.
No
The device description explicitly states that the 3D models are combined with the use of haptics, which are hardware components providing tactile feedback.
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 "pre-operative software for simulating and evaluating surgical treatment options." This is a planning and simulation tool for surgical procedures, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on displaying and manipulating patient imaging data (CT and MRI) for surgical planning and simulation, including haptic feedback. This aligns with a surgical planning tool, not an IVD.
- Input Data: The input data is medical imaging (CT and MRI), which is used for anatomical visualization and planning, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The device falls under the category of surgical planning and simulation software, which is distinct from in vitro diagnostics. The predicate devices listed (Surgical Theater Surgery Rehearsal Platform and Simbionix PROcedure Rehearsal Studio) also support this classification as they are surgical simulation and planning systems.
N/A
Intended Use / Indications for Use
The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
Product codes
LLZ
Device Description
The ImmersiveTouch is software based pre-surgical planning system. It is intended for use as a software interface. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.
The ImmersiveTouch software has the capability of displaying 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.
The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
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
Not Found
Summary of Performance Studies
The ImmersiveTouch has been successfully tested, verified and validated to ensure that it meets specifications. The ImmersiveTouch was CE certified by Underwriters Laboratories under the standard IEC 60950-1:2005 (2005 (2005); Am 1:2009.
The ImmersiveTouch has also been tested in accordance with IEC 60601-1 and IEC 60601-1-2 standards.
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2014
Immersive Touch, Inc. % Prashant Banerjee, Ph.D. President 708 Kristin Court WESTMONT IL 60559
Re: K140860
Trade/Device Name: ImmersiveTouch3 and MicrovisTouch Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2014 Received: November 21, 2014
Dear Dr. Banerjee:
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.
1
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,
Robert A Ochs
Robert A. Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |||
|---|---|---|---|
| Indications for Use | |||
| Form Approved: OMB No. 0910-0120 | |||
| Expiration Date: January 31, 2017 | |||
| See PRA Statement below. | |||
| 510(k) Number (if known) | K140860 | ||
| Device Name | ImmersiveTouch3 | ||
| MicrovisTouch | |||
| Indications for Use (Describe) | The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | ||
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14)
| Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
|---|---|
| ------------------------------------- | ---------------------------------------- |
3
Chapter 2: Item 2, 3, and 4
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
ImmersiveTouch, Inc. 708 Kristin Court Westmont, Illinois 60559 Phone # 1-630-570-5943
Contact Person:
P. Pat Banerjee CEO ImmersiveTouch Date Prepared: August 12th, 2014
Name of Device and Classification Name.
Device Name: ImmersiveTouch3 Device Name: MicrovisTouch Regulation Name: Picture archiving and communications system Regulation Number: 892.2050 Product Code: LLZ Classification Panel: Radiology
Predicate Device
Surgical Theater Surgery Rehearsal Platform (K123023) Simbionix PROcedure Rehearsal Studio (K112387)
Intended Use
The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
4
Technological Characteristics and Substantial Equivalence
A. Device Description
The ImmersiveTouch is software based pre-surgical planning system. It is intended for use as a software interface. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.
The ImmersiveTouch software has the capability of displaying 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.
The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.
B. Substantial Equivalence
The ImmersiveTouch is substantially equivalent to the Surgery Rehearsal Platform (K123023) and Simbionix PROcedure Rehearsal Studio (K112387). The ImmersiveTouch is substantially equivalent to its predicate devices in that it uses a PC workstation that allows for the viewing of CT and MRI images. These images can be used in pre-operative software for simulating and evaluating surgical treatment options.
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | |||
|---|---|---|---|
| Characteristic | ImmersiveTouch | Surgery Rehearsal | |
| Platform | Simbionix | ||
| PROcedur | |||
| e | |||
| 510(k) Accession | |||
| Number | K140860 | K123023 | K112387 |
| Clearance Date | TBD | 2/8/2013 | 12/27/2011 |
| Computer | PC Workstation | Same | Same |
| Image Sources | CT and MRI | Same | Same |
| Indications for Use | The ImmersiveTouch simulators | ||
| are intended as pre-operative | |||
| software for simulating and | |||
| evaluating surgical treatment | |||
| options. | Software interface and | ||
| image segmentation | |||
| system for the transfer of | |||
| imaging information from | |||
| CT or MR medical scanner | |||
| to output file. Intended as | |||
| pre-operative software for | |||
| simulating and evaluating | |||
| surgical treatment options | Same as | ||
| Surgery | |||
| Rehearsal | |||
| Platform | |||
| Patient Contact | No | No | No |
5
C. Performance Data
The ImmersiveTouch has been successfully tested, verified and validated to ensure that it meets specifications. The ImmersiveTouch was CE certified by Underwriters Laboratories under the standard IEC 60950-1:2005 (2005 (2005); Am 1:2009.
The ImmersiveTouch has also been tested in accordance with IEC 60601-1 and IEC 60601-1-2 standards.
D. Conclusions
ImmersiveTouch, Inc. believes the ImmersiveTouch is substantially equivalent to and is as safe and effective as its predicate devices. While they have different indications for use, all devices are constructed from similar materials and incorporate similar operational principles. Results of performance tests conducted on the pre-operative software clearly demonstrate the device is safe and effective for its intended use.