(62 days)
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.
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.
The provided 510(k) summary for the IGROK system does not contain the detailed study information needed to fill out all aspects of your request. This document is a premarket notification for substantial equivalence, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical performance studies with specific statistical acceptance criteria and detailed study designs.
Here's a breakdown of what can and cannot be extracted from the provided text:
Acceptance Criteria and Device Performance:
The document states: "The IGROK system will successfully complete verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." and "In summary, iGrok, LLC, is of the opinion that the IGROK system...performs as well as devices currently on the market, and concludes that the IGROK system is substantially equivalent to the predicate device."
This indicates that internal verification and validation were performed to confirm the system's functionality and that it performs comparably to existing devices. However, no specific numerical acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy, dice score for registration, time savings) are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Performs as well as devices currently on the market" (Implied: Functional equivalence to predicate device VelocityAIS (K070248)) |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Not specified. The document mentions "Beta testing/validation" and "verification testing" but does not provide details on the number of cases or the nature of the test sets used.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe a formal expert-adjudicated ground truth for testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. No mention of expert adjudication methods.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No evidence of an MRMC study. The document focuses on demonstrating substantial equivalence to a predicate device, not on quantifying human reader improvement with the system's assistance. The IGROK system is described as facilitating IGRT by consolidating and organizing data, and providing tools for display, annotation, volume rendering, registration, and fusing of images, implying it's an aid for physicians rather than a standalone AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The primary function described is "providing the physician a means for comparison of medical imaging data" and acting "as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties." This strongly suggests a "human-in-the-loop" design. The document does not describe a standalone performance evaluation of the algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of a PACS-like system with registration capabilities, ground truth for image registration might involve known transformations or anatomical landmarks, but this is not detailed.
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The sample size for the training set:
- Not specified. The document mentions the software was "designed, developed, verified, and validated according to written procedures," but no details on training data are provided. This is typical for device types that are primarily tools for image processing and visualization, rather than AI models needing large training datasets.
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How the ground truth for the training set was established:
- Not applicable / Not specified. Without information on a training set or specific AI algorithms requiring ground truth for learning (beyond basic image processing algorithms), this cannot be addressed.
Summary of Limitations:
This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It confirms internal verification and validation processes were followed and that the device is considered as safe and effective as a predicate device. However, it does not provide the kind of detailed performance study results (with specific metrics, sample sizes, ground truth establishment, and reader studies) that would typically be found in direct clinical performance studies for diagnostic or AI-powered devices aiming to establish novel performance claims.
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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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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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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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 (800) 638-2041 or (240) 276-3150 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
1 - 1
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).