SURGIMAP

K141669 · Nemaris, Inc. · LLZ · Sep 19, 2014 · Radiology

Device Facts

• Record ID: K141669
• Device Name: SURGIMAP
• Applicant: Nemaris, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Surgimap software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.

Device Story

Surgimap 2.0 is a software application for orthopedic surgical planning and image analysis. It accepts standard image formats (JPEG, TIFF, PNG) and DICOM files. Users perform generic and specialty anatomical measurements, simulate surgical procedures (e.g., osteotomies), and template implants (screws, cages, rods). The software operates on PC/Mac platforms, supporting local and PACS connectivity. It features an online database synchronization tool allowing case sharing among authorized users. Healthcare professionals use the output to guide surgical planning and implant selection; clinical judgment remains mandatory for all interpretations. The device benefits patients by facilitating precise pre-operative planning and implant templating.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted in accordance with IEC 62304:2006 and ANSI/IEEE 829-2008 standards. Software was evaluated at a 'Moderate' level of concern, addressing risks associated with surgical planning errors.

Technological Characteristics

Software-based PACS/orthopedic planning tool. Compatible with Windows and Mac OS. Supports DICOM and standard image formats. Features include generic/specialty measurement modules, implant templating, and online database synchronization. Developed under ISO 14971:2012 risk management and IEC 62304:2006 software lifecycle processes.

Indications for Use

Indicated for healthcare professionals requiring software to view, store, and measure medical images and to plan orthopedic surgical procedures, including anatomical measurements for surgical implant placement.

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

• Surgimap Spine (K111019)
• TraumaCad Release 2.0 (K073714)

Submission Summary (Full Text)

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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other.

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

September 19, 2014

Nemaris, Inc. % Mr. Keith Barritt Attorney Fish and Richardson P.C. 1425 K Street NW WASHINGTON DC 20005

Re: K141669

Trade/Device Name: Surgimap 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 13, 2014 Received: August 14, 2014

Dear Mr. Barritt:

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.

Michael D. O'Hara
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) K141669

Device Name Surgimap

#### Indications for Use (Describe)

The Surgimap software assists healthcare professionals in viewing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.

Type of Use (Select one or both, as applicable)

2 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)

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# 510(k) Summary of Safety and Effectiveness Nemaris Inc. Surgimap

The following information is provided pursuant to 21 CFR 807.92

### 807.92(a)(1)

(i) Submitter

Nemaris Inc 306 East 15th Street | Suite 1R New York, NY 10003 Phone: [phone] Fax: [phone]

(ii) Submitter Contact

Virginie Lafage, PhD Vice President and Chief Technology Officer Nemaris Inc 306 East 15th Street | Suite 1R New York, NY 10003 Phone: [phone] Email: vlafage(@surgimap.com

(iii) Preparation Date May 05, 2014

## 807.92(a)(2)

| Trade Name: | Surgimap |
|---------------|---------------------------------------------------|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Section: | 892.2050 |
| Class | II |
| Product Code: | LLZ |

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## 807.92(a)(3)

●

| • | Surgimap Spine | |
|---|----------------|---------------------------------------------------|
| • | Manufacturer: | Nemaris Inc |
| • | Tradename: | Surgimap Spine |
| • | 510K #: | K111019 (September 30, 2011) |
| • | Common Name | Picture Archiving and Communication System (PACS) |
| • | Class: | II |
| • | Product Code: | LLZ |
| • | Traumacad | |
| • | Manufacturer: | Voyant Health formerly known as Orthocrat |
| • | Tradename: | TraumaCad Release 2.0 |
| • | 510K #: | K073714 (March 19, 2008) |
| • | Common Name | Picture Archiving and Communication System (PACS) |
| • | Class: | II |
| • | Product Code: | LLZ |
| | | |

## 807.92(a)(4)

Surgimap is software developed for the medical community. It is intended to be used to view, store and transport images as well as perform generic or specialty measurements and plan or simulate aspects of surgical procedures. The image formats supported encompasses the standard image formats (jpeg, tiff, png, ....) and also DICOM images. Images can be stored in the Surgimap database and measurements (generic or specialty specific) can be overlaid to each image. Surgimap also offers the ability for the end user to plan, or simulate, aspects of certain surgical procedures such as osteotomies and templating implants (including but not limited to screws, interbody cages, rods). Via internet connection during use of the software application, the database can be synchronized online. An optional feature consists in organizing patient information into cases with the possibility to share these cases among Surgimap users.

## 807.92(a)(5)

The Surgimap software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.

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The Indications for Use statement for Surgimap 2.0 device is not identical to the predicate devices; however, the differences do not affect the safety and effectiveness of the device relative to the predicates. The subject and predicate devices have the same intended use for local images, and in both cases, the mitigation of hazard analysis demonstrates an acceptable level of residual risks.

### 807.92(a)(6)

The tabulated comparison of technological characteristics between Surgimap Spine and its predicated devices is outlined in the table hereafter:

| Feature | TraumaCad 2.0 | Surgimap Spine | Surgimap 2.0 |
|------------------------------------------------------------------------|------------------------------|----------------|------------------------------|
| Computer | PC Compatible | PC Compatible | PC Compatible |
| Operating System | Windows | Windows | Windows + MAC |
| Image Input | Local + PACS<br>connectivity | Local | Local + PACS<br>connectivity |
| Scout feature | Yes | No | Yes |
| Runs on Server | Yes | no | no |
| Trauma Module | Yes | No | No |
| Osteotomy Module | Yes | Yes | Yes |
| Generic Measurements | Yes | Yes | Yes |
| Spine measurements | Yes | Yes | Yes |
| Lower Limbs measurements | Yes | No | Yes |
| Pre-operative planning | Yes | Yes | Yes |
| Templating (custom implant) | Yes | Yes | Yes |
| Templating (vendor specific<br>implant) | Yes | No | Yes |
| Database | Yes | Yes | Yes |
| Online synchronization of<br>database | Yes | No | Yes |
| Case Sharing | Yes | No | Yes |
| Control of life-saving devices | None | None | None |
| Human Intervention for<br>interpretation and<br>manipulation of images | Required | Required | Required |
| Ability to add additional<br>Modules when available | Yes | Yes | Yes |
| Web Content | Yes | Yes | Yes |

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## 807.92(b)

Performance data for Surgimap 2.0 consisted in verification activities. The following guidelines and standards were used throughout the software development process:

| EN ISO 14971:2012 | Medical Devices - Application of risk management to<br>medical devices |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304:2006 | Medical device software - Software life cycle processes |
| ANSI/IEEE Standard 829-2008 | IEEE Standard for Software and System Test Documentation |
| FDA Guidance | Guidance for Industry and FDA Staff - Guidance for the<br>content of premarket submissions for software contained in<br>medical devices (May 11, 2005) |

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be at a "Moderate" level of concern, since a latent design flaw might lead the user to inadequately plan a surgery and thus indirectly injure patients.