TRAUMACAD VERSION 2.0

K073714 · Orthocrat, Ltd. · LLZ · Mar 19, 2008 · Radiology

Device Facts

• Record ID: K073714
• Device Name: TRAUMACAD VERSION 2.0
• Applicant: Orthocrat, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The TraumaCAD program 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 template. Clinical judgments and experience are required to properly use the software.

Device Story

TraumaCad Release 2.0 is a software application for orthopedic preoperative surgical planning. It accepts digital radiological images (X-ray, CT, MR) via PACS integration, CD, local workstation, or imported files (JPG, scanner, digital camera). Surgeons use the software to perform complex measurements and overlay digital prosthesis templates from a manufacturer library onto images. The system facilitates film-less orthopedic practice. It operates on a PC in either standalone or client/server configurations. The output assists surgeons in planning operations and positioning prostheses; clinical judgment remains essential for final decision-making. The device aims to improve surgical planning efficiency and accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system. Supports DICOM standard for image import/export. Features include 2D/3D templating, measurement tools, and digital template library. Runs on PC hardware; supports standalone or client/server deployment.

Indications for Use

Indicated for healthcare professionals performing preoperative planning for orthopedic surgery, including foot, knee, hip, spine, and pediatric procedures. Requires clinical judgment and experience.

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 1.0 (K042816)
• Agfa Orthopedic Software for Impax 3 (K071972)

Submission Summary (Full Text)

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## 510(k) Summarv

K073714

MAR 19 ZUU

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

- 1. (a) Submitter's George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726
- 1. (b) Manufacturer Orthocrat, Ltd. Address: 35 Efal St, 12th floor Petach-Tikva Israel, 49511

Mfq. Phone: [phone]

Contact Person: Zeev Glozman, CEO

- Date: December 27, 2007
- 2. Device & Classification Name: Imaging Processing System (Class 2), Product Code LLZ. 21 CFR 892.2050 -- Tradename of device: TraumaCad Release 2.0
- Predicate Device: TraumaCad Release 1.0 (K042816) & Agfa Orthopedic Software for Impax 3. (K071972)
- TraumaCad allows surgeons to evaluate and manipulate digital images while 4. Description: performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute complex measurements in a click, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad supports DICOM and enables the importing and exporting any PACS file (X-ray, CT or MR) from a central PACS system, a CD or from a local workstation. JPG, scanner or digital camera images can also be imported. TraumaCad software is installed and runs locally on a computer (PC) and interacts with a PACS system. Both a standalone and a client/server version of TraumaCad are available.
- The TraumaCAD program is indicated for assisting healthcare professionals in 5. Intended Use: 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 template. Clinical judgments and experience are required to properly use the software.
- 6. Comparison of With respect to technology, TraumaCad Release 2.0 is substantially equivalent to its predicate devices. Besides including 3D templating capability, the main purpose of Technological Characteristics: this 510(k) was to obtain marketing clearance for additional features for aiding foot, knee, hip, spine, and pediatric surgery.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## MAR 1 9 2008

Orthocrat, Ltd. % Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue SOMERSET MA 02726

Re: K073714

Trade/Device Name: TraumaCad Release 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 27, 2007 Received: December 31, 2007

Dear Mr. Hattub:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/1/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle, and the letters "FDA" are in the center. Below the letters, the word "Centennial" is written. The logo is surrounded by a dotted border and some additional text that is difficult to read due to the image quality.

Protecting and Promoting Public Health.

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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); 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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):

510(k) Number (if known):

Device Name: TraumaCad Version 2.0

Indications For Use: The TraumaCAD program 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 template. Clinical judgments and experience are required to properly use the software.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Larry Miller

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi

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510(k) Number