UNiD Spine Analyzer

K180091 · Medicrea International · LLZ · Feb 8, 2018 · Radiology

Device Facts

• Record ID: K180091
• Device Name: UNiD Spine Analyzer
• Applicant: Medicrea International
• Product Code: LLZ · Radiology
• Decision Date: Feb 8, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Device Story

UNiD Spine Analyzer is a software tool for orthopedic surgical planning. It processes medical images to allow surgeons and service providers to perform generic and spine-specific anatomical measurements. The device includes a database of MEDICREA INTERNATIONAL implants (cages, screws, rods) and supports the design of custom-made patient-specific implants. Operated by clinicians in a clinical setting, the software requires human intervention for image interpretation and manipulation. The output assists in pre-operative planning and surgical implant placement. By providing tools for measurement and implant visualization, the device supports clinical decision-making for surgical procedures. The current update adds a database component for implant selection.

Clinical Evidence

Bench testing only. Software verification and validation were performed in accordance with FDA guidance for software contained in medical devices. No clinical data was required or provided.

Technological Characteristics

PC-compatible software running on Windows and Mac operating systems. Operates on a server. Features include osteotomy module, generic/spine measurement tools, pre-operative planning, and an implant database. Requires human intervention for image interpretation and manipulation. Software level of concern: moderate.

Indications for Use

Indicated for healthcare professionals, including surgeons, to assist in viewing/measuring images and planning orthopedic surgeries, specifically for spine-related procedures and 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

• UNiD SPINE ANALYZER (K170172)

Reference Devices

• SURGIMAP 2.0 (K141669)

Submission Summary (Full Text)

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February 8, 2018

Medicrea International % Mr. David Ryan Chief Operating Officer 5389 Route de Strasbourg-Vancia 69140 Rillieux La Pape FRANCE

Re: K180091

Trade/Device Name: UNiD Spine Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 4, 2018 Received: January 12, 2018

Dear Mr. Ryan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'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

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#### 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 on last page

510(k) Number (if known)

#### K180091

Device Name

#### UNiD Spine Analyzer

Indications for Use (Describe)

The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Type of Use (Select one or both, as applicable)区 Prescription Use (Part 21 CFR 801 Subpart D) CFR 801 Subpart C)

_ Over-The-Counter Use (21

#### 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

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FORM FDA 3881 (8/14) SC Publishing S

Page 1 of 1

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## 510(k) SUMMARY

#### MEDICREA INTERNATIONAL'S UNiD SPINE ANALYZER

In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) summary is submitted to add the UNiD Spine Analyzer.

## 1. Submitter:

MEDICREA INTERNATIONAL 5389 Route de Strasbourg - Vancia 69140 RILLIEUX LA PAPE FR Phone: [phone] Fax: [phone]

## Contact Person:

David RYAN MEDICREA INTERNATIONAL 5389 Route de Strasbourg - Vancia 69140 RILLIEUX LA PAPE FR Phone: [phone]

Date Prepared: January 04, 2018

- 2. Trade name: UNiD Spine Analyzer
## Classification Name:

Class II, Picture archiving and communications system (21 C.F.R. 892.2050)

## Classification and Regulation:

LLZ: system, image processing, radiological

#### 3. Predicate or legally marketed devices which are substantially equivalent:

- . UNiD SPINE ANALYZER (MEDICREA INTERNATIONAL, K170172) (primary predicate)
- SURGIMAP 2.0 (NEMARIS INC, K141669) (reference device) .

#### 4. Description of the new device

The purpose of this submission is to update the UNiD Spine Analyzer with the addition of a new software feature: "Data base of implants". This component will allow a user to draw implants (cages, screws and rods) taken from a range of MEDICREA INTERNATIONAL implants, previously cleared in K08009, K083810, K163595, in addition to the design of custom-made implants specific to a unique patient. A catalog of these implants is provided in this submission.

#### 5. Indication for Use

The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

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# 6. Substantial equivalence claimed to predicate devices

The table below compares the features and technological characteristics of the cleared UNiD Spine Analyzer to the version with the updated software feature, as well as the reference Surgimap 2.0 device.

| Feature | UNiD Spine Analyzer with additional component | UNiD Spine Analyzer ( K170172) | Surgimap 2.0 (K141669) |
|------------------------------------------------------------------|-----------------------------------------------|--------------------------------|---------------------------|
| Computer | PC Compatible | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC | Windows + MAC |
| Image Input | Local | Local | Local + PACS connectivity |
| Runs on Server | Yes | Yes | No |
| Osteotomy Module | Yes | Yes | Yes |
| Generic measurements | Yes | Yes | Yes |
| Spine measurements | Yes | Yes | Yes |
| Pre-operative planning | Yes | Yes | Yes |
| Custom implants | Yes | Yes | Yes |
| Database | Yes (implants) | No | Yes |
| Case sharing | No | No | Yes |
| Human Intervention for interpretation and manipulation of images | Required | Required | Required |
| Web content | Yes | Yes | Yes |

# Table 1: Substantial Equivalence Comparison

## 7. Non-clinical test summary

Performance data for the modified UNiD Spine Analyzer consisted of verification and validation activities. Software verification and validation testing was 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 on Medical Devices". The addition of the database of implants creates additional tools which were also tested, and documentation was provided. The software for this device was considered to be of moderate level of concern.

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# 8. Conclusion

The addition of this new component (i.e., data base of cleared implants) to the UNiD Spine Analyzer does not raise new issues of safety or effectiveness compared to the previously cleared version of the UNiD Spine Analyzer. It is thus substantially equivalent to the company's own legally marketed predicate device.