(87 days)
Not Found
No
The document describes image processing and 3D model generation but does not mention AI, ML, or related terms, nor does it describe training or test sets characteristic of AI/ML development.
No.
The device is described as a software interface and image segmentation system for surgical simulation and evaluation, not for treating or curing a disease or condition.
No
The device is intended for simulation and evaluation of surgical treatment options, not for diagnosing medical conditions. It transfers imaging information and creates 3D models for surgical planning and navigation.
Yes
The device description explicitly states "The SNAP is software based medical image management system" and describes its function as a software interface and image segmentation system. While it interacts with external hardware (CT/MR scanners, IGS/Navigation systems), the device itself is presented as a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "simulating and evaluating surgical treatment options both pre-operatively and intra-operatively." This is a surgical planning and navigation tool, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces its role as a "medical image management system" for creating 3D models from medical scans and integrating with surgical navigation systems. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device works with medical images, not biological samples.
The device is a software-based tool for surgical planning and navigation, utilizing medical imaging data. This falls outside the scope of In Vitro Diagnostics.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The SNAP is software based medical image management system. It 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 intraoperatively with validated systems as identified in the device labeling.
The SNAP system is based on the Surgical Theater Surgery Rehearsal Platform (SRP) image management system. The SRP was cleared by FDA on February 12, 2013 under 510(k) Accession Number K 123023.
The SNAP utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices. This provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.
The cleared SRP device interfaces with an input from external 3D mouse device (Omni), which allows the surgeons to navigate the simulated instruments within the said 3D image.
The SNAP system enhances the SRP's capability by adding additional input and allowing the surgeon to connect to an external Image Guided System and Navigation systems (in general: "IGS"; for example Brainlab Kolibri or Brainlab Curve), and to see the incoming navigation data in the SNAP monitor. The incoming navigation data is then displayed to the surgeon inside the generated 3D model, so the surgeon gets a 3D representation of his surgery navigation session.
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 navigation system, in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR medical scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, pre-operatively, intra-operatively, 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)
The Surgical Theater SNAP Software was fully tested, verified and validated by Surgical Theater as part of its' own internal design control requirements. Furthermore, the SNAP was validated by two neurosurgeons based on historical DIOCM cases (of patients' cases who had their surgeries done in the past). Verification and validation results confirm that the SNAP Software meets its' performance requirements. The SNAP was tested with the Brainlab Kolibri 2 and Brainlab Curve systems which had "Brainlab Cranial Version 2.1" with an active license for the "IGT Link" connectivity module.
The SNAP System was tested to and mects the requirements of IEC 60601-1-2 Standard for Electromagnetic Interference and Susceptibility.
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
K140819
Page 1 of 6
Surgical Navigation Advanced Platform
510(K) SUMMARY" AS REQUIRED BY SECTION 807.92(c) Modified May 27, 2014
510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.
Surgical Theater 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806
Contact Person:
Mordechai Avisar CEO/President Surgical Theater, LLC 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806 Email: mavisar@surgicaltheater.net
Date Prepared: March 22, 2014
Name of Device
- Trade Name: Surgical Navigation Advanced Platform (SNAP) .
- Common Name: Image Management Software .
- Classification Name: Medical Image Management System Product Code LLC .
Predicate Device
The Surgical Navigation Advanced Platform (SNAP) substantially equivalent to the Surgical Theater, LLC Surgery Rehearsal Platform (K123023).
Device Description:
The SNAP is software based medical image management system. It 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
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Image /page/1/Picture/1 description: The image shows a logo with a stylized design at the top and text below it. The design at the top appears to be an abstract shape, possibly representing a building or structure. Below the design, there are two lines of text in a small font size. The text is difficult to read due to the image quality, but it seems to be the name of an organization or company.
in simulating and evaluating surgical treatment options both pre-operatively and intraoperatively with validated systems as identified in the device labeling.
The SNAP system is based on the Surgical Theater Surgery Rehearsal Platform (SRP) image management system. The SRP was cleared by FDA on February 12, 2013 under 510(k) Accession Number K 123023.
The SNAP utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices. This provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.
The cleared SRP device interfaces with an input from external 3D mouse device (Omni), which allows the surgeons to navigate the simulated instruments within the said 3D image.
The SNAP system enhances the SRP's capability by adding additional input and allowing the surgeon to connect to an external Image Guided System and Navigation systems (in general: "IGS"; for example Brainlab Kolibri or Brainlab Curve), and to see the incoming navigation data in the SNAP monitor. The incoming navigation data is then displayed to the surgeon inside the generated 3D model, so the surgeon gets a 3D representation of his surgery navigation session.
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 navigation system, in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
Device Function
The SNAP device takes 2D medical images (DICOM dataset) and reconstructs a 3D model of a specific patient's anatomy. Using the existing data segmentation and visualization capabilities of the SRP, the SNAP system allows the surgeon to connect to external navigation systems and display navigation data (i.e. pointer from IGS) inside its own 3D model. This provides surgeons with additional navigation feedback during surgery.
The two main differences between the SRP and the SNAP are the input device being the navigation systems in the SNAP Vs the Omni device in the SRP and the use in the Operating Room of the SNAP Vs the Pre-Operating Room use of the SRP.
Except for these two differences, the SRP and the SNAP are identical. They are made from the same code (software) and are manufactured by the same company (Surgical
| For any and any contract concession a consumer of the contributed in the continued and
17
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: Number
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| | The form of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of th |
2
Image /page/2/Picture/0 description: The image shows a logo with the words "SURGICAL THEATER" stacked vertically. Above the text is an abstract graphic. The graphic appears to be a stylized representation of a human head or brain. The logo is simple and uses a sans-serif font.
Theater). They share the same features and performance characteristics utilize the same identical technology and both function in the same identical manner.
The underlying method of connectivity to the external device is the same in the SRP and SNAP; both devices present the external device's movements based on information obtained directly from the external device and it relays on the accuracy of the external device.
Scientific Concepts
The SNAP is based on the concept of transforming stacked medical images (DICOM dataset) to a 3 dimensional model of patient specific anatomy, and applying visualization algorithms and filters on that 3D model, to control its visualization representation to get a better understanding of the case at hand.
Furthermore, the SNAP connectivity to an external IGS (i.e. Navigation System) expands the visual model by displaying the navigation data inside the 3D model.
Significant Physical and Performance Characteristics
Design:
The Surgical Navigation Advanced Platform (SNAP) is a software based device running on "of the shelf" commercial components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process the medical data and user inputs, and an image generator software engine that is used to display a high end 3D model of the medical data (DICOM).
The underlying simulation engine includes a navigation connectivity module that allows external IGS systems (i.e. navigation systems) to send navigation data into the SNAP system. to be displayed within its internal 3D model.
Materials:
The Surgical Navigation Advanced Platform is a software based and commercial off the shelf personal computer system (i.e. PC, keyboard, mouse, touchscreen monitor etc.). Materials used in these systems have been used in offices, homes, hospitals and other applications for many years in both medical and non-medical applications, with no adverse effects.
Physical Properties:
The physical properties of the Surgical Navigation Advanced Platform are the same as any software based, and commercial off the shelf personal computer system (i.e. PC, keyboard, mouse, touchscreen monitor etc.).
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------
MARK CARDER LE LAND & CLAND | 100 - 1000 - L P - 10 - 10 - 10 - - 10 - - 10 - - 10 - - 10 - - 10 - - 10 - - 10 - |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| olume | | |
| | | |
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Image /page/3/Picture/0 description: The image shows a black and white drawing of a scorpion. The scorpion has a segmented body, claws, and a stinger. Below the scorpion are two rows of numbers, the top row contains the numbers 5, 4, 1, 1, 4, and 4. The bottom row contains the numbers 1, 11, 2, 4, 7, 6, and 1.
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 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.
Predicate Device Comparison
The Surgical Theater SNAP is substantially equivalent to the Surgical Theater Surgery Rehearsal Platform (SRP) (K123023).
| Characteristic | Surgical Navigation
Advanced Platform
(SNAP) | Surgery Rehearsal
Platform | Explanation of
Differences |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| 510(k) Accession
Number | TBD | K123023 | NA |
| Clearance Date | TBD | 2/12/2013 | NA |
| Computer | PC Workstation | PC Workstation | NA |
| Image Sources | CT and MRI | CT and MRI | NA |
| Indications for Use | 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 preoperatively and
intraoperatively with
interface to external
navigation systems with
OpenIGTLink Capability. | Software interface and
image segmentation
system for the transfer of
imaging information from
CT or MR medical scanner
to an output file. Pre-
operative software for
simulating/evaluation
surgical treatment options. | Unlike the SRP, The
SNAP is also intended to
be used in the OR during
surgery. |
| Data Transfer Method | CD or USB | CD or USB | NA |
| Preoperative Planning | Yes | Yes | NA |
| Patient Contact | No | No | NA |
| Human Intervention
for Interpretation of | Yes | Yes | NA |
SNAP/SRP Comparative Analysis
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| AND AN ANNUAL PRODUCT COLLEGION AR ORDER AND A LA CONTRACT COLLEGION OF CO | AND AND ANNUAL I AL AND |
|---|---|
| v olume . | |
| PARTY CONSULTION CONTROLLERS OF CHARACT PARTY | FOR AND ALL CLAND AND AND ALL |
| Number | |
| 4200 . | |
| g |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
4
Image /page/4/Picture/0 description: The image shows a logo for Surgical Theater. The logo consists of an abstract image of a head with a surgical cap on top. Below the image, the words "SURGICAL THEATER" are written in a small, sans-serif font, with "SURGICAL" on the first line and "THEATER" on the second line.
Surgical Navigation Advanced Platform
| Characteristic | Surgical Navigation
Advanced Platform
(SNAP) | Surgery Rehearsal
Platform | Explanation of
Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Images | | | |
| Capability of creating
3D models of patient
data from 2D scan
slices. | Yes | Yes | NA |
| Provides the user with
ability to input,
display, color, and
manipulate the 2D
scan slices via a 3D
representation. | Yes | Yes | NA |
| Image tools such as
rotation, scaling and
coloring. | Yes | Yes | NA |
| Capability of
connecting to an
external Surgical
Navigation system
(for example Brainlab
Kolibri or Brainlab
Curve), and
processing the
incoming navigation
data. | Yes | No | Unlike the SRP that
connected to a 3D mouse
(Omni), the SNAP is
designed to connect via a
network connection, to an
external navigation
system, and display the
incoming navigation data
on its own 3D model of
the DICOM data.
The underlying method of
connectivity to the
external device is the same
in the SRP and SNAP;
both devices present the
external device's
movements based on
information obtained
directly from the external
device and it relays on the
accuracy of the external
device. |
| Intra-operative Use | Yes | No | Unlike the SRP. The
SNAP is also intended to
be used in the OR during
surgery. |
| Pre-operative Use | Yes | Yes | NA |
Performance Data: (Non-clinical Testing)
.
.
.
| ----------------------------------------------------------------------------------------------------------------------------- | MALARIA MARKA BARA BALLA A BALLA A BALL A BALL A BALL A |
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| olume | 2000 |
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And Antiques (Annual Partic Career Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Com | and and experience of the commend of the commend of the comments of |
5
Image /page/5/Picture/0 description: The image shows a logo with the words "SURGICAL THEATER" stacked vertically. Above the text is a stylized graphic that appears to be an abstract representation of a surgical instrument or tool. The text is in a simple, sans-serif font, and the overall design is minimalist.
The Surgical Theater SNAP Software was fully tested, verified and validated by Surgical Theater as part of its' own internal design control requirements. Furthermore, the SNAP was validated by two neurosurgeons based on historical DIOCM cases (of patients' cases who had their surgeries done in the past). Verification and validation results confirm that the SNAP Software meets its' performance requirements. The SNAP was tested with the Brainlab Kolibri 2 and Brainlab Curve systems which had "Brainlab Cranial Version 2.1" with an active license for the "IGT Link" connectivity module.
The SNAP System was tested to and mects the requirements of IEC 60601-1-2 Standard for Electromagnetic Interference and Susceptibility.
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| . II. II. B. BUSIN BANKARING ANNUSHINGA BARANDA BAR LEWING AND LEWING AND THE OF |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G60 Silver Spring, MD 20993-0002
June 27, 2014
SURGICAL THEATER, LLC MORDECHAI AVISAR 781 BETA DR. MAYFIELD VILLAGE OH 44143
Re: K140819
Trade/Device Name: Surgical Navigation Advanced Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: 11 Product Code: LLZ Dated: May 28, 2014 Received: May 29, 2014
Dear Mr. Avisar:
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 in 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 (sec above) into cither 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.
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
7
Page 2-Mr. Avisar
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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.
l
Sincerely yours,
Sm.h.7.)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
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) K140819
Device Name Surgical Theater. LLC Surgical Navigation Advanced Platform
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 or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
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 (1/14)
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