ONEFIT HIP PLANNER

K142671 · Onefit Medical · LLZ · Dec 5, 2014 · Radiology

Device Facts

• Record ID: K142671
• Device Name: ONEFIT HIP PLANNER
• Applicant: Onefit Medical
• Product Code: LLZ · Radiology
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

Device Story

Software for preoperative hip replacement planning; inputs include DICOM radiological images (via EOS Imaging System) and 3D bone reconstructions (STL format via SterEOS Workstation). Surgeon uses hipEOS interface to overlay 3D/2D implant models from a digital library onto images/reconstructions; selects implant size and position. System computes anatomic measurements based on landmarks defined during 3D reconstruction. Accessed via web-based ONEFIT Management System; requires authentication. Output assists surgeon in surgical planning; clinical judgment required for final decisions. Benefits include improved visualization and precision in implant selection/positioning.

Clinical Evidence

Bench testing only. Software verification and validation testing conducted in accordance with FDA guidance for software contained in medical devices.

Technological Characteristics

Cloud-based software; web-accessible via secure interface. Inputs: DICOM radiological images (PNG compression) and 3D bone reconstructions (STL). Features digital implant library. Connectivity: Networked/Cloud-based. Software-only device.

Indications for Use

Indicated for healthcare professionals performing preoperative planning for hip replacement surgery. No specific patient age or gender restrictions provided.

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

• TraumaCAD Release 2.0 (K073714)

Reference Devices

• EOS Imaging System (K071546)
• SterEOS Workstation (K141137)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.

December 5, 2014

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

ONEFIT medical % Mr. Julien Simon Research and Development Manager 18 Rue Alain Savary 25000 Besancon FRANCE

Re: K142671

Trade/Device Name: ONEFIT Hip Planner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 15, 2014 Received: September 26, 2014

Dear Mr. Simon:

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,

Robert A Ochs

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) Unknown K142671

Device Name ONEFIT Hip Planner

# Indications for Use (Describe)

The ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

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

x Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□Over-The-Counter Use (21 CFR 801

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## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY ONEFIT's ONEFIT Hip Planner

#### Submitter

#### ONEFIT medical

18, rue Alain Savary 25000 Besançon France

Phone: [phone] Facsimile: [phone] Contact Person: Julien SIMON - ONEFIT medical - Research and development Manager Date Prepared: December 4, 2014

## Device

Name of Device: ONEFIT Hip Planner Common or Usual Name: Radiological image processing system Classification Name: Picture Archiving and Communication System (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

#### Predicate Devices

TraumaCAD Release 2.0 (K073714) by Orthocrat, Ltd.

## Intended Use/Indications for Use

The ONEFIT Hip Planner software is indicated for assisting healthcare professionals in preoperative planning of hip replacement surgery. The software allows for overlaying of 3D/2D implant models on radiological images and 3D reconstruction of bone, and includes tools for performing measurements on the image and 3D model of bones and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

#### Device Description

The ONEFIT Hip Planner software allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. ONEFIT Hip Planner is accessible on any computer via ONEFIT Management System that provides secure interface through authentication mechanisms, web accessible authentication servers and access for authorized users through secure protocols to web server.

## Comparison of Technological Characteristics with the predicate device

Like TraumaCAD, ONEFIT Hip Planner is accessible on any computer via secure internet interface via ONEFIT Management System. Both software programs are cloud-based networks that provide a secure environment to access, control, and share diagnostic images.

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ONEFIT Hip Planner uses a graphic interface titled hipEOS that displays PNG compressions of DICOM radiological images generated by the EOS Imaging System (K071546) and/or a 3D reconstruction of bones, in STL format, created from EOS images using the SterEOS Workstation (K141137) by radiologists. TraumaCAD Release 2.0 uses the radiological, CT-Scan or RM images in DICOM format or in a JPEG compression. Both programs feature an extensive regularly updated library of digital 3D/2D models of implants from leading implant manufacturers. They allow the overlay of the 3D/2D implant models on the radiological images and, for ONEFIT Hip Planner, on the 3D reconstruction. Both software programs permit the user to select implant size and position.

To use ONEFIT Hip Planner, radiologists select anatomic landmarks on the 3D models during the 3D reconstruction using the SterEOS Workstation. ONEFIT Hip Planner uses these landmarks to compute the pre-planning and the post-planning of the anatomic measurements displayed on the hipEOS interface. With TraumaCad, the surgeon can select the anatomic landmarks during the planning and the software provides pre-planning and post-planning measurements on the radiological images.

The ONEFIT Hip Planner has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ONEFIT Hip Planner and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that ONEFIT Hip Planner is as safe and effective as TraumaCAD Release 2.0 (K073714). Thus, the ONEFIT Hip Planner is substantially equivalent.

## Performance Data

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."

## Conclusions

The device has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate device. The minor differences between the device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the device is as safe and effective as its predicate and, thus, is substantially equivalent.