ORTHOSIZE

K120115 · Orthosize, LLC · LLZ · Mar 14, 2012 · Radiology

Device Facts

• Record ID: K120115
• Device Name: ORTHOSIZE
• Applicant: Orthosize, LLC
• Product Code: LLZ · Radiology
• Decision Date: Mar 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.

Device Story

Orthosize is a software application for preoperative orthopedic surgical planning. It accepts radiological images as input and utilizes digital prosthesis templates provided by manufacturers. Users (healthcare professionals) overlay these templates onto images to estimate joint size and shape; tools allow for translation, rotation, and simple measurements to match the implant to the patient's anatomy. The software operates on Windows, Mac OS X, and iOS platforms. By facilitating accurate template sizing, the device assists clinicians in selecting appropriate implants, potentially improving surgical outcomes. It is intended for use in clinical settings where preoperative planning is performed.

Clinical Evidence

Bench testing only. The device underwent software validation in accordance with FDA guidance (General Principles of Software Validation, 2002; Content of Premarket Submission for Software, 2005). Testing included boundary values, stress testing, and safety risk analysis per ISO 14971:2007. A requirements coverage matrix confirmed all software requirements were met with no test faults or variances.

Technological Characteristics

Software-based image processing system for orthopedic template overlay and measurement. Compatible with Windows, Mac OS X, and iOS. Operates as a standalone application. No specific hardware materials or energy sources; relies on standard computing platforms. Software validation performed per FDA guidance.

Indications for Use

Indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. No specific patient population or contraindications defined.

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 2.0, Orthocrat Ltd. (K073714)

Submission Summary (Full Text)

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Paul Beck Orthosize LLC 939 W: Madison St. Unit 306 Chicago, IL 60607 T [phone] [e-mail]

#### 510(k) Summary

Submitter Name and Address:

Paul Beck Orthosize LLC 939 W. Madison St. Unit 306 Chicago, IL 60607

January 10, 2012

Date Summary Prepared:

Telephone:

[phone]

Trade Name Orthosize

Common Name:

Classification and Name:

TraumaCAD 2.0, Orthocrat Ltd. (K073714) Predicate Device:

#### Device Description

Orthosize software uses digital templates, template overlays provided by orthopedic manufacturers, to estimate the size of joints. Orthosize software allows the user to place a template over a radiographic image. The user may then select an overlay that best approximates the size of the joint in the image. The user may also translate and rotate the overlay such that it substantially matches the shape and outline of the ioint in the image. In this way, Orthosize software enables the user to estimate the size and shape of implant that most closely approximates the joint presented in the image. Orthosize also allows the user to make simple measurements.

Image Processing System

Picture and Archiving Communications (PACS) System

Orthosize software can run on computers using the following operating systems: Windows XP or later, Mac OS X, and iOS.

#### Indications for Use

Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.

#### Performance Data

Functional requirements as defined by the Orthosize Software Requirements Specification (SRS) were tested and traceability was performed and documented as defined by FDA's General Principles of Software Validation (January 2002) guidance document. 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 (May 2005) guidance document. Safety requirements were

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tested as identified by a safety risk analysis performed in accordance with ISO 14971:2007. The Orthosize software passed all tests. No test faults were found. Additionally, no test variances were found during testing. Final assessment using a requirements coverage matrix showed that all software requirements were addressed by the tests.

Final evaluation showed that testing of all software requirements was completed with passing results. No software changes were required. Evaluation of the test results demonstrates that the software performs as intended and meets product specifications.

#### Substantial Equivalence

Orthosize is substantially equivalent to the predicate device. Orthosize software has the same intended use and indications, as well as very similar technological characteristics and principles of operation, in comparison to the predicate device. The minor technological differences between the Orthosize software and its predicate device raise no new issues of safety or effectiveness. Thus, the Orthosize software is substantially equivalent.

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Image /page/2/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 symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Orthosize LLC % Ms. Yarmela Pavlovic Attorney Hogan Lovells 1835 Market Street, 29th Floor PHILADELPHIA PA 19103

MAR 1 4 2012

Re: K120115

Trade/Device Name: Orthosize Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2012 Received: January 13, 2012

### Dear Ms. Pavlovic:

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 for ass based or to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered pror to ria) 2011-11-11 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). Tour coosinete revy (10) 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional comicillions (CFR), Parts 800 to 895. 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 r lease oc advised that 1211 block.it to trour device complies with other requirements of the Act that I DA has made a deter regulations administered by other Federal agencies. You must or any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements, and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K120115 510(k) Number (if known):

Device Name: Orthosize

Indications for Use:

Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic Ortholice it included a for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.

Prescription Use × (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 OF NEEDED)

Eorcurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510k

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