ImmersiveTouch3 and MicrovisTouch

K140860 · Immersivetouch · LLZ · Dec 16, 2014 · Radiology

Device Facts

• Record ID: K140860
• Device Name: ImmersiveTouch3 and MicrovisTouch
• Applicant: Immersivetouch
• Product Code: LLZ · Radiology
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.

Device Story

ImmersiveTouch3 and MicrovisTouch are software-based pre-surgical planning systems; operate on PC workstations. Input: 2D CT and MRI scan slices. Transformation: software converts 2D slices into 3D patient models; integrates haptic feedback to simulate tissue-specific sensations; allows user manipulation of 3D representations. Output: 3D visualization and haptic simulation of surgical scenarios. Used in clinical settings by surgeons/clinicians for pre-operative planning. Benefit: enables evaluation of surgical treatment options prior to procedure; enhances surgeon preparation through tactile and visual simulation.

Clinical Evidence

Bench testing only. Device verified and validated against specifications. Compliance with IEC 60950-1:2005, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Software-based pre-surgical planning system; PC workstation platform; CT/MRI image processing; haptic feedback interface for tissue simulation; 3D model reconstruction from 2D slices. Standards: IEC 60950-1, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for pre-operative simulation and evaluation of surgical treatment options using patient-specific imaging data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Surgical Theater Surgery Rehearsal Platform (K123023)
• Simbionix PROcedure Rehearsal Studio (K112387)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Indications for Use | | | |
| | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | | |
| 510(k) Number (if known) | K140860 | | |
| Device Name | ImmersiveTouch3<br>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) | <table><tr><td><label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label></td><td><label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label></td></tr></table> | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | |

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# 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 # [phone]

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.

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## 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<br>Platform | Simbionix<br>PROcedur<br>e |
| 510(k) Accession<br>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<br>are intended as pre-operative<br>software for simulating and<br>evaluating surgical treatment<br>options. | Software interface and<br>image segmentation<br>system for the transfer of<br>imaging information from<br>CT or MR medical scanner<br>to output file. Intended as<br>pre-operative software for<br>simulating and evaluating<br>surgical treatment options | Same as<br>Surgery<br>Rehearsal<br>Platform |
| Patient Contact | No | No | No |

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## 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.