VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE

K081076 · Velocity Medical Solutions, LLC · LLZ · Jun 20, 2008 · Radiology

Device Facts

• Record ID: K081076
• Device Name: VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
• Applicant: Velocity Medical Solutions, LLC
• Product Code: LLZ · Radiology
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.

Device Story

VelocityAIS is a stand-alone software application for medical image processing. It ingests DICOM-conformant images from modalities including PET, SPECT, CT, and MR. The software enables image display, annotation, volume rendering, registration, and fusion. It performs automated deformable registration and anatomical atlas-based segmentation. Users can define Regions of Interest (ROI) to calculate and report pixel intensities and Standardized Uptake Values (SUV). Results are exported to radiation treatment planning systems and PACS. Used in clinical settings by physicians (radiologists, oncologists) to facilitate workflow, compare images across modalities/time, and aid in clinical decision-making. The device runs on off-the-shelf computers with Windows, Linux, or MacOSX.

Clinical Evidence

Bench testing only. The manufacturer verified and validated that the software meets its functional specifications and performance requirements.

Technological Characteristics

Stand-alone software application. Compatible with Windows XP/Vista, Linux (CentOS), and MacOSX. Features automated deformable registration and anatomical atlas-based segmentation. Supports DICOM-conformant imaging data (PET, SPECT, CT, MR).

Indications for Use

Indicated for physicians in diagnostic radiology, oncology, radiation therapy planning, and other medical specialties to compare, display, annotate, volume render, register, and fuse DICOM-conformant medical images. Not intended for mammography diagnosis.

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

• Velocity AIS (K070248)
• GE Medical Systems, Advantage Windows CT/PET Fusion (K010336)
• GE Medical Systems, Volume Viewer Plus (K041521)
• MIMvista Corp., MIMVista (K071964)

Submission Summary (Full Text)

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JUN 2 0 2008

### Pre-Market Notification 510(k) Summary

#### 1. Sponsor Information:

2.

| Company Name & Address: | Velocity Medical Solutions, LLC<br>75 Fifth Street, Suite 221, Atlanta, GA 30309 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Timothy Fox, Ph.D. |
| Contact Title: | President |
| Contact Phone Number: | 404-272-9217 |
| Contact Fax Number: | 404-873-8326 |
| Date of Summary: | April 4, 2008 |
| Device Name and Classification: | |
| Common and Usual Name: | Picture Archiving and Communication System<br>(Medical Imaging Software) |
| Proprietary Name: | VelocityAIS or VelocityAI |
| Classification Name: | Image Processing System, Radiology<br>(21 CFR § 892.2050) |
| Performance Standards: | No applicable performance standards have been issued<br>under section 514 or under section 513(b) of the Food<br>Drug and Cosmetic Act. |

#### Predicate Device(s): 3.

Velocity Medical Solutions. Velocity AIS (K070248) GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMVista (K071964)

#### 4. Description of Device:

Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other

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values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices.

Version 2.0 of the product contains the additional features of:

- Automated deformable registration .
- Anatomical atlas based segmentation tools .
- Operating systems compatibility with MicroSoft Windows XP Home and . Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard).

VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.

#### Indications for Use: in

VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.

#### Comparison with Predicate Device(s): 6.

The VelocityAIS (VelocityAI) software is substantially equivalent to the predicate devices identified. It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and does not pose any new issues of safety and effectiveness.

#### Non-Clinical Performance Summary: 7.

Velocity Medical Solutions has verified and validated that the VelocityAIS (VelocityAl) software meets its functional specifications and performance requirements.

#### 8. Conclusions:

In summary, Velocity Medical Solutions, LLC, is of the opinion that the modified VelocityAIS (VelocityAI) does not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market, and concludes that the product is substantially equivalent to the predicate devices.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 0 2008

Velocity Medical Solutions, LLC % Mr. Paul Sumner Vice President of Regulatory Quality & Clinical Systems Arkin Consulting Group, LLC 1733 Canton Lane MARIETTA GA 30062

Re: K081076

Trade/Device Name: VelocityAIS (also "VelocityAI") Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 21, 2008 Received: May 23, 2008

Dear Mr. Sumner:

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 (PMA), 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.

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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/cdrb/industry/support/index.html.

Sincerely vours.

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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# Indications for Use Statement

510(k) Number (if known): K070248 Ko81076

VelocityAIS (also "VelocityAl") Device Name:

Indications For Use:

VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAl) is not intended for mammography diagnosis.

Prescription Use XX (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K 081076