IGROK

K080325 · Igrok, LLC · LLZ · Apr 8, 2008 · Radiology

Device Facts

• Record ID: K080325
• Device Name: IGROK
• Applicant: Igrok, LLC
• Product Code: LLZ · Radiology
• Decision Date: Apr 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

IGROK is a hardware/software system 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. Certain registration functions and analyses are only applicable in pelvic, head and neck areas. IGROK is not intended for mammography diagnosis.

Device Story

IGROK is a radiation therapy-specific PACS hardware/software system. It ingests DICOM diagnostic images, treatment plans, dose volumes, RT images, and structure sets. The system organizes and consolidates this data to support IGRT review and clinical decision-making. It performs linear and non-linear image registration and volume rendering. Used in clinical settings by oncologists, radiologists, and radiation therapists, the system provides visualization and analysis tools to assist in treatment planning and monitoring. By enabling the fusion and comparison of multi-modality imaging, it aids clinicians in evaluating patient anatomy and radiation dose distribution, potentially improving the accuracy and efficiency of radiation therapy workflows.

Clinical Evidence

Bench testing only. The device underwent software verification and validation according to internal procedures, including hazard analysis and control. No clinical study data was provided.

Technological Characteristics

Hardware/software PACS system. Supports DICOM connectivity. Features include image registration (linear and non-linear), volume rendering, and annotation tools. Software-based processing for radiation therapy data management. No specific materials or energy sources defined beyond standard computing hardware.

Indications for Use

Indicated for use by physicians in diagnostic radiology, oncology, and radiation therapy planning to compare, display, annotate, volume render, register, and fuse DICOM-conformant medical images. Registration and analysis functions are limited to pelvic, head, and neck regions. Contraindicated 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

• VelocityAIS (K070248)

Submission Summary (Full Text)

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K080325

Image /page/0/Picture/1 description: The image shows the logo for "IGROK Image Understanding Solutions". The word "IGROK" is in large, bold, black letters with a textured pattern. Below the logo is the phrase "Image Understanding Solutions" in a smaller, serif font.

APR - 8 2Uuc

# 510(k) Summary

## Sponsor Information

Company Name & Address: iGrok, LLC 234 Graham St, Ste 200, Sewickley, PA 15143

Contact:

Robert Riker, President 412-398-5841 412-741-3238 (shared fax, set up w/ voice call)

Summary Date:

February 1, 2008

### Device Information

Common or Usual Name: Proprietary Name: Classification Name:

Image Processing System, Radiology IGROK PACS, 21 CFR 892,2050

## Predicate Device(s)

VelocityAIS (K070248)

### Description of Device

IGROK is a computer hardware and software system which is intended to facilitate Image-Guided Radiation Therapy (IGRT) by consolidating and organizing a wide array of data pertaining to a patient's course of external beam radiation therapy, and presenting this data, along with relevant analyses, so as to efficiently support typical IGRT review and decision-making tasks. The system functions as a radiation therapy-specific PACS, providing storage and visualization for DICOM diagnostic imaging, treatment plans, dose volumes, RT images, and structure set data. In addition, registration is provided between image volumes using both linear and non-linear techniques.

### Indications for Use

IGROK is a hardware/software system 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. Certain registration functions and analyses are only applicable in pelvic, head and neck areas. IGROK is not intended for mammography diagnosis.

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## Comparison with Predicate Device(s)

IGROK is substantially equivalent to the predicate device VelocityAIS. IGROK 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

The IGROK software was designed, developed, verified, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validation, and maintenance

The IGROK system will successfully complete verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled.

#### Conclusions

In summary, iGrok, LLC, is of the opinion that the IGROK system 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 IGROK system is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## APR - 8 2008

Mr. Robert J. Riker President iGrok, LLC 234 Graham Street, Suite 200 SEWICKLEY PA 15143

Re: K080325

Trade/Device Name: IGROK Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 1, 2008 Received: February 6, 2008

Dear Mr. Riker:

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/2/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal. The word "Centennial" is below the letters "FDA".

Protesting and Promoting Public Health

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#### Page 2

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/cdri/industry/support/index.html.

Sincerely yours,

Nancy Burgdon

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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## 1. Indications for Use

510(k) Number: _ x 080325

Device Name: IGROK

Indications For Use:

IGROK is a hardware/software system 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. Certain registration functions and analyses are only applicable in pelvic, head and neck areas. IGROK is not intended for mammography diagnosis.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off Division of Reproductive, Abd and Radiological Device

510(k) Number K080323

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