TRAUMACAD 1.2

K042816 · Orthocrat, Ltd. · LLZ · Nov 10, 2004 · Radiology

Device Facts

• Record ID: K042816
• Device Name: TRAUMACAD 1.2
• Applicant: Orthocrat, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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 is a software application for preoperative orthopedic surgical planning. It imports radiological images; allows physicians to overlay digital prosthesis templates; and provides tools for image measurements and template positioning. Used in clinics or hospitals on standalone PCs or workstations; operated by licensed physicians. The surgical plan is stored on the hospital network for access in the Operating Room. The device does not acquire or store images, nor does it define prosthetic template requirements. By facilitating digital templating, it assists surgeons in selecting appropriate implant sizes, potentially improving surgical outcomes and documentation compared to traditional acetate overlays.

Clinical Evidence

Bench testing only. A comparative study of 40 total hip replacement cases (20 using standard acetate overlays, 20 using TraumaCAD) evaluated templating accuracy. Results showed TraumaCAD digital templating achieved 65% exact stem size match (vs 60% acetate) and 47% exact cup size match (vs 40% acetate). No intraoperative or postoperative fractures reported. Digital planning demonstrated comparable accuracy to traditional methods with improved ease of use and documentation.

Technological Characteristics

Software application running on Windows 2000 or Windows XP. Operates on PC/workstation. Features digital prosthetic template overlay, interactive positioning, and measurement tools. Does not control life-sustaining equipment. Developed according to ISO 9001:2000.

Indications for Use

Indicated for healthcare professionals performing preoperative planning for orthopedic surgery. No specific patient population, age, or gender restrictions stated. Contraindications not specified.

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

• Orthoview (K032401)
• Sectra Orthopedic Package (K031590)

Submission Summary (Full Text)

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K042816

NOV 1 0 2004

# 510(k) Summary of Safety and Effectiveness

The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

## 807.92(a)(1) - Submitter Details:

| Submitter name | OrthoCrat Ltd |
|-----------------|------------------------------------------------------------------------------|
| Address: | Bar Kochva 34/3 |
| | Tel Aviv |
| | Israel |
| | Phone: |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact Person: | Adi Ickowicz |
| | MedicSense Ltd |
| | P.O.B 367 |
| | Ramat Hasharon |
| | Israel |
| | Phone: [phone]<br>Fax: + 972 3 923 1274<br>E mail: [e-mail] |
| Date: | August 18, 2004 |

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## 807.92(a)(2) - Device Details:

| Trade Name | TraumaCAD Release 1.00 |
|----------------|-------------------------------------|
| Common Name | Picture Archiving and Communication |
| | (PACS) System |
| Classification | 892.2050 Image Processing System |
| Class | II |
| Product Code | LLZ |

## 807.92(a){3) - Predicate Devices:

| Medical Device<br>Name | Applicant Name | 510(k)<br>Number | Classification |
|------------------------------|------------------------|------------------|-------------------------------|
| Orthoview | Meridian Technique Ltd | K032401 | Class II, Product<br>code LLZ |
| Sectra Orthopedic<br>Package | Sectra Imtec AB | KO31590 | Class II, Product<br>code LLZ |

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

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SEP 28 2004

## 807.92(a)(4) - Device Description:

#### Device Functions:

TraumaCAD is a software application to be used by licensed physicians for preoperative planning of orthopedic surgical procedures. The application can be used in a workstation or in a PC as standalone software.

The system allows the physician to import medical images, and to overlay them with templates of medical prosthesis and to perform measurements to facilitate surgical planning. The surgical plan is available on the hospital network, and can be sent to the Operating Room prior to surgery.

The TarumaCAD does not have any image acquisition or image storage functionality, this is the responsibility of the systems alongside which TraumaCAD. In addition the system does not specify the requirements for the prosthetic template - this is the responsibility of the prosthetic manufacturer.

## 807.92(a)(5) — Device 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.

### Non-Clinical Testing

A study entitled "The Accuracy of Digital (filmless) Templating in Total Hip Replacement" was performed comparing pre-operative planning methods for total hip procedures. 20 cases planned using standard acetate overlays and radiographs were compared with 20 cases using TraumaCAD to perform digital preoperative planning.

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It was found that using standard templating, sixty percent of implanted stems were the same size as templated, 30 percent were within one size, and 10 percent were within 2 sizes. With digital templating 65 percent were the same size, 23 percent were within 1 size and 11 percent were within two sizes. For acetabular components using acetate overlays, 40 percent of implanted cups were the same size as templated, 30 percent were within 2 mm, and 30 percent within 4 mm. Digitally, 47 percent were the identical size, 47 percent were within 2 mm, and 6 percent within 4mm. All postoperative films show good fit of the components and there were no intraoperative or postoperative fractures.

Thus the non-clinical testing of the pre-operative planning using TraumaCAD produces results comparable to planning using acetate overlays with the additional advantages of digital planning including ease of use, improved case documentation, access to a wider arrange of tools, and greater accessibility.

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| Parameter | OrthoView | Sectra Orthopedic<br>Package | TraumaCAD |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------|
| Computer | PC Compatible | Part of workstation<br>and PC compatible | PC Compatible |
| Operating System | Windows | Same | Same |
| Image input | Can receive digital<br>images from<br>various sources | Same | Same |
| Number of<br>images that can<br>be simultaneously<br>viewed on the<br>screen | Four | One | One |
| Runs on server | Yes | Yes | Yes |
| Trauma module | No | No | Yes |
| Osteotomy<br>module | No | No | Yes |
| Digital Prosthetic<br>templates | Template overlay<br>capability<br>Interactive<br>template<br>positioning<br>Automatic Scaling<br>Template support<br>from<br>manufacturers<br>Permits template<br>rotation | Same | Same |
| Pre-operative<br>planning | Allowed | Same | Same |
| Patient contact | None | Same | Same |
| Control of life-<br>saving devices | None | Same | Same |
| Human<br>intervention for<br>interpretation and<br>manipulation of<br>images | Required | Same | Same |
| Ability to add<br>additional<br>modules when<br>available | Yes | Yes | Yes |

## 807.92(a)(6) – Substantial Equivalence Comparison Table:

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## Technological Characteristics

TraumaCAD will run on Windows 2000 or Windows XP.

### Performance Data

The subject device is developed according to IS0 9001 :2000.

### Conclusion

Similar to the predicate devices the TraumaCAD does not control life-sustaining equipment or contact the patient and does not alter the source data and original image. In addition all three require intervention of trained medical for process and interpretation of the images.

Based on the information supplied in this 510(k), we conclude that this device is safe, effective, and substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its body, representing health, human services, and well-being. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Orthocrat, Ltd. 1% Mr. Robert Mosenkis President Citech Medical Device Testing and Consulting 5200 Butler Pike Plymouth Meeting PA 19462-1298 Re: K042816 Trade/Device Name: TraumaCAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and

communications system

Regulatory Class: II Product Code: 90 LLZ Dated: October 28, 2004 Received: October 29, 2004

· Dear Mr. Mosenkis:

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 do not require approvial or wisions 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 n Jour av 100 ho 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.

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 statues 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 / 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 a legal This letter will allow you to begin marketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantial of 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 If you desire specific advice for your device on our laboring regulation (
contact the 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 prematic notification" (21 CFR Also, please note the regulation entitled, "Whisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general manon on Juner Assistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumers of Manufacturers, Division of Small Manufacturers, International and Consulter Particle.
638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrl/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

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

Enclosure

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## 2. STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

TraumaCAD Device Name:

Indication 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _