(119 days)
Not Found
No
The summary describes image processing, segmentation, and 3D rendering for surgical planning and navigation, but there is no mention of AI or ML algorithms being used for these functions. The focus is on transforming existing medical images and integrating with traditional navigation systems.
No.
The device is a software interface and image segmentation system used for surgical planning and navigation, not for directly treating a disease or condition.
No
The device is described as a software interface and image segmentation system used for transferring imaging information and simulating surgical treatment options. It aids in surgical planning and navigation by displaying data in a 3D format. It does not provide a medical diagnosis or interpret patient conditions to identify diseases, which are characteristics of a diagnostic device.
Yes
The device description explicitly states that the SNAP product does not include any custom hardware and is a software-based device that runs on a high performance desktop PC assembled using "commercial off-the-shelf" components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for processing and visualizing medical imaging data (CT, MR, XA) and simulating surgical treatment options. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Device Description: The description focuses on image processing, 3D reconstruction, surgical planning, and intra-operative navigation assistance. It does not describe any components or processes related to in vitro testing of biological specimens.
- Lack of IVD-specific information: The document does not mention any aspects typically associated with IVDs, such as reagents, assays, sample handling, or diagnostic results.
The device is a medical imaging software and surgical planning/navigation tool, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Surgical Navigation Advanced Platform (SNAP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
The Surgical Navigation Advanced Platform (SNAP) transforms medical images into a dynamic, interactive 3D scene, and connects to external 3rd party surgical navigation systems (i.e. "validated systems"), to extract and display intra-operative surgical navigation information (such as the 3D navigation pointer) inside the generated 3D scene. Current navigation systems usually display the navigation data on 2D black and white DICOM imagery within the external navigation system itself. The SNAP displays the same navigation data (pointer position and orientation), as it is received from the external 3rd party navigation system. in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
The SNAP allows surgeons to analyze and plan a specific patient's case before surgery, and then take that plan into the operating room (OR) and use it in conjunction with a validated traditional navigation system during surgery. The SNAP then presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. The surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controls such as rotate, zoom in and zoom out. During pre-operative use a virtual reality (VR) headset further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.
The SNAP product does not include any custom hardware and is a software-based device that runs on a high performance desktop PC assembled using "commercial off-the-shelf" components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR or X-ray 3D Angiography (XA) medical scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Operating Room (OR)
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)
- Electromagnetic Compatibility (EMC): EMC evaluation per IEC 60601-1-2:2007 Third Edition was performed by a 3rd party test laboratory on the modified device and the SNAP was found to be in compliance.
- Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff. "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "medium" level of concern, since a malfunction or latent flaw in the software could delay delivery of appropriate medical care that would likely lead to minor injury. The SNAP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements. A formal verification and validation test plan was executed to confirm that the modified SNAP continues to meet its intended use and performance requirements. The verification and validation report included with this submission summarizes the results of verification and validation activities for the modified device.
- Safety and Effectiveness: Product risk management activities were performed in accordance with ISO 14971:2012 throughout the product development process. Risk management verification and validation consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations for the device.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are black and have a flowing, abstract design. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
Surgical Theater, LLC % Mr. Kevin M. Murrock Director of Project Management 781 Beta Drive MAYFIELD VILLAGE, OH 44143
Re: K160584
Trade/Device Name: Surgical Navigation Advanced Platform (SNAP) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2016 Received: May 24, 2016
Dear Mr. Murrock:
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,
Michael D.'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
2
Indications for Use
510(k) Number (if known) K160584
Device Name Surgical Navigation Advanced Platform (SNAP)
Indications for Use (Describe)
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
| 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) |
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."
3
Image /page/3/Picture/0 description: The image features a logo for "Surgical Theater." The logo consists of a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver or gray, with a section on the right side colored gold. Below the ribbon graphic, the words "SURGICAL" and "THEATER" are stacked vertically, with each word in a sans-serif font and a gold color.
510(K) SUMMARY AS REQUIRED BY SECTION 807.92
Purpose of Submission.
Surgical Theater, LLC hereby submits this 510/k) premarket notification to obtain a determination of substantial equivalence for modifications to our Surgical Navigation Advanced Platform (SNAP) system (K140819). The modifications are to enhance the surgeon's situational awareness during intra-operative use.
510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.
Submitter:
Surgical Theater 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806
Establishment Registration Number: 3010197287
Contact Person:
Kevin M. Murrock Director of Project Management Surgical Theater, LLC 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (330) 472-6520 Fax: (216) 916-3806 Email: kmurrock(@surgicaltheater.net
Date Prepared: May 11, 2016
Name of Device
- Trade Name: ●
- Other Device Trade Names: ●
- Common Name: o
- Classification Name: ●
- o Regulation Number:
- Surgical Navigation Advanced Platform (SNAP) VR SNAP & Endo SNAP System, Image Processing, Radiological Picture Archiving and Communications System 21 CFR 892.2050
4
Image /page/4/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver or gray, with a section on the right side colored gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked vertically, written in a serif font with a gold color.
- LLZ ● Product Code:
- Regulatory Classification: ●
- Device Panel: Radiology ●
Predicate Device
Surgical Theater, LLC Surgical Navigation Advanced Platform (SNAP), 510(k) Number: K140819
II
Device Description:
The Surgical Navigation Advanced Platform (SNAP) is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
The Surgical Navigation Advanced Platform (SNAP) transforms medical images into a dynamic, interactive 3D scene, and connects to external 3rd party surgical navigation systems (i.e. "validated systems"), to extract and display intra-operative surgical navigation information (such as the 3D navigation pointer) inside the generated 3D scene. Current navigation systems usually display the navigation data on 2D black and white DICOM imagery within the external navigation system itself. The SNAP displays the same navigation data (pointer position and orientation), as it is received from the external 3rd party navigation system. in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
The SNAP allows surgeons to analyze and plan a specific patient's case before surgery, and then take that plan into the operating room (OR) and use it in conjunction with a validated traditional navigation system during surgery. The SNAP then presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. The surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controls such as rotate, zoom in and zoom out. During pre-operative use a virtual reality (VR) headset further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.
The SNAP product does not include any custom hardware and is a software-based device that runs on a high performance desktop PC assembled using "commercial off-the-shelf" components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
5
Image /page/5/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape that resembles a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font.
Indications for Use:
The SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT, MR or X-ray 3D Angiography (XA) medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra-operatively with validated systems as identified in the device labeling.
Note: Since the SNAP does not specify a disease, condition (or an anatomical site from which a disease state or population may be inferred), per the FDA Guidance entitled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued on July 28, 2014 it has a general "tool type" indications for use resulting in the intended use and indications for use being the same.
Predicate Device Comparison
The modified SNAP is substantially equivalent to the Surgical Navigation Advanced Platform (SNAP), 510(k) Number: K140819.
| Characteristic | Predicate: Surgical
Navigation Advanced
Platform (SNAP) | Modified: Surgical
Navigation Advanced
Platform (SNAP) | Explanation of
Differences |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) Accession Number | K140819 | K160584 | NA |
| Clearance Date | June 27, 2014 | TBD | NA |
| Computer | PC Workstation | PC Workstation | NA |
| Input Data File Format | DICOM | Same | NA |
| DICOM Image Modality
Types Supported | CT and MR | CT, MR and XA | Refer to Note 1
below. |
| Characteristic | Predicate: Surgical
Navigation Advanced
Platform (SNAP) | Modified: Surgical
Navigation Advanced
Platform (SNAP) | Explanation of
Differences |
| Indications for Use | The SNAP is intended for
use as a software interface
and image segmentation
system for the transfer of
imaging information from
a CT or MR medical
scanner to an output file. It
is also intended for use in
simulating and evaluating
surgical treatment options
both pre-operatively and
intra-operatively with
validated systems as
identified in the device
labeling. | The SNAP is intended for
use as a software interface
and image segmentation
system for the transfer of
imaging information from
a CT, MR or X-Ray 3D
Angiography (XA)
medical scanner to an
output file. It is also
intended for use in
simulating and evaluating
surgical treatment options
both pre-operatively and
intra-operatively with
validated systems as
identified in the device
labeling. | Refer to Note 2
below. |
| Data Transfer Method | CD or USB | Same | NA |
| Preoperative Planning | Yes | Same | NA |
| Patient Contact | No | Same | NA |
| Human Intervention for
Interpretation of Images | Yes | Same | NA |
| Capability of creating 3D
models of patient data from
2D scan slices. | Yes | Same | NA |
| Provides the user with
ability to input, display,
color, and manipulate the
2D scan slices via a 3D
representation. | Yes | Same | NA |
| Image tools such as
rotation, scaling and
coloring. | Yes | Same | NA |
| Characteristic | Predicate: Surgical
Navigation Advanced
Platform (SNAP) | Modified: Surgical
Navigation Advanced
Platform (SNAP) | Explanation of
Differences |
| Capability of connecting to
an external Surgical
Navigation system (e.g.
Brainlab Kolibri or
Medtronic Stealth), and
processing the incoming
navigation data. | Yes | Same | NA |
| Intra-operative Use | Yes | Same | NA |
| Pre-operative Use | Yes | Same | NA |
| Multiple Image
Merge/Overlay/Alignment | Yes | Same | NA |
| Software License to Control
SNAP Functionality | Yes | Same | NA |
| Virtual Reality (VR)
Headset Display for
Pre-Operative Use | No | Yes | Refer to Note 3
below. |
| Virtual Reality (VR)
Headset Display for
Intra-Operative Use | No | Yes | Refer to Note 4
below. |
| Video Capture PCB to
capture video output from a
3rd party endoscopy camera
device. | No | Yes | Refer to Note 5
below. |
| Endo View screen presents
the live endoscopy video
side-by-side with the SNAP
3D scene. | No | Yes | Refer to Note 6
below. |
Comparative Analysis
6
Image /page/6/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver, with a section on the right side colored gold. Below the ribbon is the text "SURGICAL" in a sans-serif font, stacked above the word "THEATER" in the same font.
Surgical Navigation Advanced Platform (SNAP)
7
Surgical Navigation Advanced Platform (SNAP)
Discussion of Differences
The primary differences between the predicate and modified device are as follows:
-
- Added input support for X-Ray 3D Angiography (XA) scans. To be usable by the SNAP, the XA scan must be exported by the originating system as a DICOM CT image storage type. During case preparation the SNAP software verifies DICOM data meets the following acceptance criteria; otherwise, data is rejected: 1) Image Modality file type is
8
CT, MR or XA and 2) Media Storage SOP Class and SOP Class UID are CT or MR. X-Ray 3D Angiography (XA) modality support was previously implemented in software release 2.5. The determination that the change could not significantly affect safety or effectiveness and a 510(k) premarket submission was not required was documented in the DHF for software release 2.5. The FDA CDRH guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" was referenced in making this determination.
-
- The change in the Indications for Use (IFU) of the subject device was due to the addition of the support for X-Ray 3D Angiography (XA) scans as described above in Note 1. While the Indications for Use statement of the subject device is not identical to that of the predicate device, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate device share the same intended use for simulating and evaluating surgical treatment options both pre-operatively and intra-operatively.
-
- The addition of the VR headset to display the 3D scene displayed on the LED monitor in a 3D stereoscopic fashion to increase the user's immersion level in the scene was previously implemented in software release 2.6. The determination that the change could not significantly affect safety or effectiveness and a 510(k) premarket submission was not required was documented in the DHF for software release 2.6. The FDA CDRH guidance document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" was referenced in making this determination.
-
- Label the Virtual Reality (VR) Headset Display for Intra-Operative Use. Since the VR headset was not included in the EMC testing of the predicate device, the VR headset was labeled for pre-operative use only. Labeling on the VR headset and in the Operator Manual included the statement "Not Intended for OR Use". The EMC testing for the modified device included the VR headset and since no issues were identified, the VR headset will be available for both pre and intra-operative use with labeling updated accordingly.
-
- Add a COTS (commercial off-the-shelt) video capture PCB to the desktop PC to capture live video from any 3rd party endoscopy camera device capable of generating HD video output (e.g. Stryker HD 1188 HD Endoscope Camera System or Storz Image 1 HD Camera Head). The captured endoscopy video presented on the SNAP monitor is identical to the video currently presented on the operating room monitors. An advantage of the SNAP's display is that the endoscopy video is presented side-by-side with the SNAP 3D scenes in the new Endo View screen (refer to item 6 below).
-
- Add the Endo View GUI and Screen Layout. Updated GUI and screen layout to simultaneously display the synchronized virtual endoscopy camera and live endoscopy camera device views, the 3D scene showing the endoscope device, and virtual / simulated "fly-through" view to provide the surgeon with an enhanced situational awareness during intra-operative use. The Endo View screen presents the live endoscopy video side-by-side with the SNAP 3D scene.
9
Image /page/9/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL THEATER" are written in a serif font, with each letter spaced out evenly.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electromagnetic Compatibility (EMC)
In order to ensure that the use of the SNAP system in the operating room does not adversely affect other devices within the patient environment, EMC evaluation per IEC 60601-1-2:2007 Third Edition was performed by a 3rd party test laboratory on the modified device and the SNAP was found to be in compliance.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff. "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "medium" level of concern, since a malfunction or latent flaw in the software could delay delivery of appropriate medical care that would likely lead to minor injury.
The SNAP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements. A formal verification and validation test plan was executed to confirm that the modified SNAP continues to meet its intended use and performance requirements. The verification and validation report included with this submission summarizes the results of verification and validation activities for the modified device.
Safety and Effectiveness
Product risk management activities were performed in accordance with ISO 14971:2012 throughout the product development process. Risk management verification and validation consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations for the device.
Conclusions
Modifications to the SNAP do not raise new questions of safety and effectiveness.
While the Indications for Use statement of the subject device is not identical to that of the predicate device, the device modifications do not alter the intended use of the device nor do they affect the safety and effectiveness of the device or the fundamental scientific technology relative to the predicate device. Both the subject and predicate devices share the same intended use for simulating and evaluating surgical treatment options both pre-operatively and intra-operatively
Verification and validation results demonstrate the modified SNAP is as safe and effective as the predicate SNAP, and performs as intended in the specified use conditions.
In summary, the SNAP device described in this submission is, in our opinion, substantially equivalent to the predicate device.