THE VAULT SYSTEM

K124051 · Somersault Orthopedics, Inc. · LLZ · May 17, 2013 · Radiology

Device Facts

• Record ID: K124051
• Device Name: THE VAULT SYSTEM
• Applicant: Somersault Orthopedics, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Device Story

VAULT® System is a web-based surgical planning software for orthopedic and trauma surgeons. Input: DICOM medical images (CT/MRI). Operation: System converts DICOM images to graphical formats (JPEG, BMP, PNG, TIFF) prior to planning; provides tools for image manipulation, measurement of anatomical features/landmarks, and overlaying of implant templates. Output: Surgical plan data files for printing, CAD modeling, or CNC/rapid-prototyping. Usage: Surgeon-directed; accessed via secure web interface. Clinical impact: Facilitates preoperative simulation and implant sizing, aiding surgical decision-making and potentially improving procedural outcomes.

Clinical Evidence

Bench testing only. Validation included objective and subjective testing of functional requirements, anatomical/phantom model digital file testing, DICOM process verification, and image calculation/measurement accuracy. Safety risk/hazard analysis performed per ISO 14971:2007. No clinical data presented.

Technological Characteristics

Web-based software interface; PC compatible. Supports DICOM standard for image input. Performs image manipulation, measurement, and template overlay. Software validation per FDA guidance; risk management per ISO 14971:2007. Connectivity: Web-accessed via secure login.

Indications for Use

Indicated for use by physicians as a preoperative planning tool for orthopedic and trauma surgery. Assists in simulating and evaluating implant placement and surgical treatment options using CT or MRI 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

• Mimics Software (K073468)
• TraumaCAD Software (K073714)

Submission Summary (Full Text)

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K124051

## Section 510(k) Releasable Summary

VAULT® System Surgery Planning Software

# MAY 1 7 2013

Proprietary Name:

Surgery Planning Software

Classification Name

& CFR Reference:

Common Name:

Sec. 892.2050 System, image processing, radiological

(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its' hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

(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). [63 FR 23387. Apr. 29. 1998]

Regulatory Class: Class II

Device Product Code: LLZ

Company Contact:

Mr. David W. Schlerf Somersault Orthopedics, Inc. 142 N. Milpitas Blvd., Suite 262 Milpitas, CA 95035-4401 925.768.0247 - Direct

April 12. 2013 Date Prepared:

Predicate Device(s): 1) Mimics Software - K073468 · 2) TraumaCAD Software- K073714

Summary Device Description: The WAULT® System software described here was developed in conformance with reference to the FDA Guidance Document for Industry "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000". Based on the information contained in Section G of that document, a final determination of submission content was developed. A secondary reference entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005 was also used and resulted in a determination of a "MODERATE" level of concern for the software.

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The UAULT® System software is made available to the user via a web-accessed software interface. The program is a surgeon directed surgical planning package primarily but not exclusively directed at trauma and orthopedic indications. After secure log-in the user requests, creates, reviews and finally authorizes their desired surgical plan. When authorizing, the surgeon/user may choose additional options such as implant sizing and/or various file output options.

Discussion of Similarities and Differences: The primary and most immediately noticeable difference is that the VAULT® Sustem software is Web-based while the predicate devices are local (PC/Laptop/Notebook) or local server based (hospital/clinic/office). Locally installed software presents minor to major complicating factors related to version, hardware, speed, operating system conflicts, etc. Those complicating factors are eliminated or reduced by direct company control of single edition server based web-portal program access. All users access the same optimized revision level software.

A second apparent difference in the basic operation of the Vault System and the predicate(s) software is the initial mass conversion and use of graphical images such as JPEG, BMP, PNG, of TIFF by the Vault System for planning. Both Mimics and TraumaCAD perform their planning on the DICOM images and then save/export files to JPEG file format(s) for presentation and export/import purposes.

The difference between the systems is the fact that the predicate software packages perform DICOM to JPEG conversion as a post-plan individual step. The WAULT® Sustem software performs this activity initially, converting all image files at once before planning and saving or exporting, Functionally there is no significant difference between the program capabilities other than improved performance on the part of the VAULT® System software.

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| Feature | VAULT® System | Mimics<br>K073468 | TraumaCAD<br>K073714 |
|-----------------|-------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|
| Indication for | The VAULT® System is intended for | Mimics software is intended | The TraumaCAD program is |
| Use: | use as a software interface and | for use as a software interface | indicated for assisting healthcare |
| | image manipulation system for the | and image manipulation | professionals in preoperative |
| | transfer of imaging information | system for the transfer of | planning of orthopedic surgery. |
| | from a medical scanner such as | imaging information from a | The device allows for overlaying |
| | Computerized Axial Tomography | medical scanner such as a CT | of prosthesis templates on |
| | (CT) or Magnetic Resonance | scanner or Magnetic | radiological images, and |
| | Imaging (MRI). It is also intended | Resonance Imaging scanner | includes tools for performing |
| | as pre-operative software for | to an output file. It is also | measurements on the image and |
| | simulating/evaluating implant | intended as preoperative | for positioning the template. |
| | placement and surgical treatment | software for simulating / | Clinical judgments and |
| | options. The physician chooses the | evaluating surgical treatment<br>options. Mimics is not | experience are required to<br>properly use the software. |
| | out-put data file for printing and/or<br>subsequent use in CAD modeling | intended for mammography | |
| | or CNC/Rapid-prototyping | imaging. | |
| Classification: | Class II | Class II | Class II |
| ProCode: | LLZ | 1.1.7. | 1.1.7. |
| Computer: | PC Compatible | PC & Workstation | PC Compatible |
| | | Compatible | |
| # of on-Screen | J | ()ne | Onc |
| . Images | | | |
| Runs on | Yes | ا es | Yes |
| Server | | | |
| Elective | | | |
| Procedures | Yes | Yes | Yes |
| Overlav & | | | |
| Templates | Yes | Yes | Yes |
| Preoperative | | | |
| Planning | Yes | Yes | Yes |
| Controls Life | | | |
| Saving Devices | No | No | No |
| Uses DICOM | | | |
| images | Yes | Yes | Yes |
| Expandability | Yes | Yes | Yes |
| | | | |

Summary Non-Clinical Performance Data: Performance data were evaluated by conducting and repeating a defined series of objective and subjective test conditions. Results of this testing demonstrates that the UAULT® System provides an equivalent level of performance and clinical utility to the cited equivalent comparison software systems. Functional requirements as defined by the VAULT® System Software Requirements Specification (SRS) were tested and traceability was performed and documented using FDA's General Principles of Software Validation guidance document.

Safety requirements were developed using a safety risk/hazard analysis based on ISO 14971:2007 approach. Validation included boundary values and stress testing as defined by the FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices guidance document. Software testing addressed the following areas of functionally.

- . Anatomical and phantom model digital file testing demonstrated the required level of accuracy and functionality.
- . Digital file image upload controlled by DICOM process met specifications.

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- Image file integrity, accuracy and suitability following required conversion, save and . transfer operations met all specifications.
- . Image calculations & measurement of anatomic features and landmarks meets specifications.

Indication for Use: The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Conclusion: Substantial equivalence is represented by comparison with the published capabilities of the predicate software devices. The referenced devices have equivalent uses, restrictions, clinical utility, safety and effectiveness to the VAULT® System. It is concluded that the VAULT® System may be reasonably expected to perform in a manner equivalent to the predicate devices. No new issues of either safety or effectiveness are raised.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three wing-like shapes.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2013

Somersault Orthopedics, Inc. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

Re: K124051

Trade/Device Name: Vault® System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ Dated: April 15, 2013 Received: April 19, 2013

Dear Mr. Job:

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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Page 2 - Mr. Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

for

Janine M. Morris 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): K124051

Device Name:

VAULT® System

Indications for Use:

The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as preoperative software for simulating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k): K124051

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