TraumaCad Mobile Release 1.0

K142923 · Voyant Health, Ltd. · LLZ · Mar 5, 2015 · Radiology

Device Facts

• Record ID: K142923
• Device Name: TraumaCad Mobile Release 1.0
• Applicant: Voyant Health, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The TraumaCad Mobile Release 1.0 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 judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.

Device Story

TraumaCad Mobile Release 1.0 is a web-based software application for preoperative orthopedic surgical planning. It receives digital radiological images from PACS or Quentry systems. Surgeons use the software to overlay prosthesis templates, perform measurements, and position templates on images to facilitate film-less practice. The device is intended for use by healthcare professionals in clinical settings on PCs, Macs, or iPads (3, 4, or Air) when a workstation is unavailable. It provides a subset of features from the predicate TraumaCad 2.0. The output assists surgeons in planning operations; clinical judgment is required for final decision-making. The device benefits patients by enabling precise preoperative planning and template selection.

Clinical Evidence

Bench testing only. Testing included unit, system/integration, and acceptance levels (security, stress, platform, workflow, functional, multi-user, data integrity, compatibility, load, regression, and hazard mitigation). Comparative testing against the predicate device using various medical images confirmed identical results for marker detection, calibration, and template positioning. Usability testing simulated clinical environments with participants performing preoperative planning on Hip X-rays, demonstrating workflow consistency with the predicate.

Technological Characteristics

Web-based software application; supports DICOM; compatible with PCs, Macs, and iPads (3, 4, 5/Air). Features include digital prosthesis template library, interactive template positioning, automatic scaling, and measurement tools. Operates via web browser (Safari, Chrome, Firefox, IE 11). No patient contact. Software-based image processing.

Indications for Use

Indicated for healthcare professionals performing preoperative planning for orthopedic surgery. Not for primary image interpretation. Not for use on mobile phones.

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

• Quentry (Class I device registered by Brainlab AG)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures in profile facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

October 08, 2015

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

Voyant Health Ltd. % Mrs. Yael Guttentag QM&RA Manager 35 Efal Street Petach-Tikva 4951132 ISRAEL

Re: K142923

Trade/Device Name: TraumaCad Mobile Release 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 26, 2015 Received: January 28, 2015

Dear Mrs. Guttentag:

This letter corrects our substantially equivalent letter of March 5, 2015.

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

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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.

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,

ery yours,

Jeff B. Myers

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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## Indications for Use

510(k) Number (if known) K142923

Device Name TraumaCad Mobile Release 1.0

#### Indications for Use (Describe)

The TraumaCad Mobile Release 1.0 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 judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

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

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Image /page/3/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with three petals in green, gray, and orange. To the right of the graphic is the text "Voyant HEALTH" in blue and green, with a trademark symbol after the word "HEALTH".

vant Health Ltd ch-Tikva, 4951132

ww.vovanthealth.com

Phone: [phone] [phone] Fax:

# 510(k) Summary

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

- 1. Submitter's Yael Guttentag (a) Address: Voyant Health, Ltd. 35 Efal Street Petach-Tikva Israel, 4951132
- 1. Manufacturer Voyant Health, Ltd. (b) Address: 35 Efal Street Petach-Tikva Israel, 4951132
- Mfq. Phone: [phone]
- Mfg. Fax: [phone]
- Contact Yael Guttentag, QM&RA Manager Person:
- Date: March 4, 2015
- 2. Device & Imaging Processing System (Class 2), Product Code LLZ, 21 CFR 892,2050 Classification Name: Trade name of device: TraumaCad Mobile Release 1.0
- 3. Predicate TraumaCad Release 2.0 (K073714) Device:
- 4. Description: TraumaCad Mobile Release 1.0 allows surqeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 1.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device

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Image /page/4/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower with three petals in green, gray, and orange, followed by the word "Voyant" in blue. To the right of "Voyant" is the word "HEALTH" in green, with a trademark symbol next to it.

vant Health Ltd ch-Tikva, 4951132

www.vovanthealth.com

Phone: [phone] [phone] Fax:

reqistered by Brainlab AG in the FDA).

TraumaCad Mobile Release 1.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 1.0 has the same basic functionality and intended use as the predicate device, but is now available as a web based version on additional platforms. The differences between the device and the predicate device do not impact on substantial equivalence.

TraumaCad Mobile Release 1.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 1.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile is not intended for use on mobile phones. Use of TraumaCad Mobile for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available.

In order to access TraumaCad Mobile, the user needs to browse to a specific URL and enter the system via username and password. A Web Application will be available in the iTunes store that will automatically open the browser with the correct URL. The application can be downloaded from iTunes for free but cannot be used without receiving a license to ensure the use by appropriate healthcare professionals.

The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile supports DICOM and enables the importing and exporting image files from a central PACS system or from Quentry.

- Intended Use: The TraumaCad Mobile Release 1.0 program is indicated for 5. 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 judgment and experience are required to properly use the software. The software is not for primary

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Image /page/5/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with the text "Voyant HEALTH" to the right. The word "Voyant" is in blue, while "HEALTH" is in green. There is a trademark symbol after the word HEALTH.

vant Health Ltd ch-Tikva, 4951132

ww.vovanthealth.com

Phone: [phone] [phone] Fax:

image interpretation. The software is not for use on mobile phones.

- Conclusion The successful non-clinical testing demonstrates the safety and 6. effectiveness of the TraumaCad Mobile Release 1.0 when used for the defined indications for use and demonstrates that these devices for which this 510(k) is submitted perform as well as or better than the legally marketed predicate device.
TraumaCad Mobile contains a subset of the features from TraumaCad 2.0. The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested.

The testing for each release consisted of Unit, System/Integration and Acceptance test levels. Testing included security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing.

In case a test was failed any necessary corrections were made, the relevant test was executed and repeated again until all passed.

- 7. Comparison of TraumaCad Mobile 1.0 has the same intended use and risk Technological control measures as the predicate device TraumaCad 2.0. Characteristics: TraumaCad Mobile contains a limited feature set in comparison to the predicate device TraumaCad. The features in TraumaCad Mobile already exist in the predicate device TraumaCad but have been modified to run on new platforms. Thus we revisited our risk analysis to consider any new potential failure modes and causes for hazards intrinsic to the new mobile environment and implemented new risk control measures as necessary.
Testing was done to compare TraumaCad Mobile with the predicate device TraumaCad using various medical images from a range of cases in parallel and comparing TraumaCad on a PC device and TraumaCad Mobile on an iPad device. Testing included the main functions such as: Marker detection, Calibration result and Templates positioning. The test shows that the predicate device TraumaCad and TraumaCad Mobile

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Image /page/6/Picture/0 description: The image shows the logo for "Voyant HEALTH™". The word "Voyant" is in blue, and the word "HEALTH" is in green. To the left of the word "Voyant" is a graphic of three leaves in the colors orange, gray, and green.

vant Health Ltd ch-Tikva, 4951132

www.vovanthealth.com

Phone: [phone] [phone] Fax:

have the same expected results in all of the tests.

In addition, usability testing was performed using mobile devices and PC environments. The Usability testing simulated a clinical environment and required the test participant to perform preoperative planning on various Hip X-rays in a manner that is almost identical to the planning done on the predicate device. Most of the test participants had used the predicate device TraumaCad in the past and were familiar with the workflow in the predicate device.

The primary operating functions (which exist in the predicate device as well) were tested in a clinical environment and include:

- Select an x-ray image from Quentry/PACS ●
- Calibrate the image
- Select implants
- . Evaluate LLD and offset changes
- Change the implant properties accordingly
- Use measurement tools
- Save the results back to Quentry/PACS ●

Based on the above testing and updated risk analysis, the differences between the device and the predicate device do not impact on substantial equivalence.

| Parameter/Character | Subject Device<br>TraumaCad Mobile<br>1.0 | Predicate Device<br>TraumaCad 2.0 |
|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Operating System | MS Windows 7<br>iOS 6.1 or 7.x<br>Mac OS X | Windows/PC<br>MS Windows 2000 or<br>later |
| Devices supported | PC/MAC<br>iPad 3, 4 and 5 (Air) | PC |
| Parameter/Character | Subject Device<br>TraumaCad Mobile<br>1.0 | Predicate Device<br>TraumaCad 2.0 |
| Browsers supported | Minimum requirements:<br>iOS based browsers:<br>- Safari 7<br>- Chrome 30<br>Mac based browsers:<br>- Firefox 26<br>- Safari 5<br>Windows based<br>browsers:<br>- Chrome 30<br>- Firefox 26<br>- Safari 5<br>- IE 11 | NA |
| Image Input | Can receive digital<br>images from various<br>sources | Can receive digital<br>images from various<br>sources |
| Means of Collecting<br>Data | Obtained from pre-<br>obtained digital images<br>via PACS system or via<br>Quentry | Obtained from pre-<br>obtained digital images<br>via PACS system |
| Number of Images that<br>can simultaneously<br>viewed on screen | One | Up to 4 |
| Runs on Server | Yes | Yes |
| Hip Module | Yes | Yes |
| Trauma Module | No | Yes |
| Knee Module | No | Yes |
| Spinal Module | No | Yes |
| Pediatric Module | No | Yes |
| Foot & Ankle Module | No | Yes |
| Upper Limb Module | No | Yes |
| Input 3D Images | No | Yes |
| Digital Prosthetic<br>Templates | Yes | Yes |
| Interactive template<br>positioning | Yes | Yes |
| Parameter/Character | Subject Device<br>TraumaCad Mobile<br>1.0 | Predicate Device<br>TraumaCad 2.0 |
| Automatic Scaling | Yes | Yes |
| Template support from<br>manufacturers | Yes | Yes |
| Permits template<br>rotation | Yes | Yes |
| Pre-operative Planning | Yes | Yes |
| Patient Contacting | No | No |
| Control of Life-Saving<br>Devices | No | No |
| Healthcare professionals<br>intervention for<br>interpretation and<br>manipulation of images | Yes | Yes |
| 510(k) # | K142923 (Pending) | K073714 |

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Image /page/7/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like symbol on the left, with three petals in orange, gray, and green. To the right of the symbol is the text "Voyant HEALTH" in blue and green, with a trademark symbol next to the word "HEALTH".

Voyant Health Ltd. 35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: [phone]
Fax: [phone]

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Voyant Health Ltd. 35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: [phone]
Fax: [phone]