(54 days)
Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Nordic Image Control and Evaluation (nICE) Software is a medical imaging manipulation tool, designed to provide a way to optimize the clinician's workflow. It targets activities fundamental to their work: reading, defining, sharing and reporting medical radiographic images. It is designed to work within a Windows™ operating system, and provides the user with the ability to view a wide range of image types.
The provided 510(k) summary for the Nordic Image Control and Evaluation (nICE) Software version 2.1 does not contain specific acceptance criteria or an explicit study proving device performance against such criteria.
Instead, the submission states:
1. Acceptance Criteria and Reported Device Performance:
The document broadly states: "Prospectively defined verification and validation activities for the nICE Software assure that the nICE Software is substantially equivalent to the cleared eFILM Workstation with Modules and meets design and performance specifications as well as user needs when operated according to the operating instructions."
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance is based on demonstrating "substantial equivalence" to the predicate device (eFILM Workstation with Modules, K020995) in terms of intended use, indications for use, technological characteristics, and operational characteristics, as well as meeting general "design and performance specifications" and "user needs."
- Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, processing times, image quality scores) are reported in this summary. The performance is implied to be functionally equivalent to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method:
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned
- Effect Size: Not applicable as no such study is described.
6. Standalone Performance Study:
- No standalone performance study with specific metrics (e.g., sensitivity, specificity) for the algorithm without human interaction is provided. The substance of the submission focuses on verifying and validating the software's functionality and equivalence to existing PACS systems, rather than its performance as a diagnostic AI tool.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not mentioned. Given the nature of the device as an image management and manipulation tool (PACS), the "ground truth" for its verification and validation would more likely relate to proper image display, manipulation functions, data integrity, and adherence to DICOM standards, rather than diagnostic accuracy against a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
- Sample Size: Not mentioned. The nICE Software is described as an "image management and manipulation tool," implying it is not an AI/ML diagnostic algorithm that would typically require a training set in the conventional sense. Its development would involve software engineering and testing against functional requirements.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.
Summary of Findings:
The 510(k) summary for the nICE Software focuses on demonstrating substantial equivalence to a predicate PACS workstation (eFILM Workstation with Modules). It describes the software's intended use as an image management system for acquiring, transmitting, processing, and storing images and data. The "performance testing" section refers to "prospectively defined verification and validation activities" to assure substantial equivalence and meeting design/performance specifications and user needs.
Crucially, this submission does not describe the kind of performance study typically seen for AI-enabled diagnostic imaging devices that would include specific acceptance criteria, test sets, ground truth establishment, and reported sensitivity/specificity/accuracy metrics. This is because the nICE Software, as described, is a Picture Archiving and Communication System (PACS), which is a foundational image management infrastructure, not a diagnostic AI algorithm that independently interprets medical images. The acceptance criteria here would therefore be related to software functionality, reliability, security, interoperability (e.g., DICOM compliance), and proper image display, rather than diagnostic performance.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains handwritten text that appears to be a code or identifier. The text reads "Kol 3534". The numbers are written in a slightly stylized manner, and the overall impression is that of a handwritten label or notation.
JAN | 7 2007
:
SECTION 5
510(K) SUMMARY
NordicIceMedical AS - Traditional 510(k) nICE Software
:
{1}------------------------------------------------
510(k) Summary NordicIceMedical AS Nordic Image Control and Evaluation (nICE) Software
COMPANY NAME AND ADDRESS 1.
1.1 Sponsor
NordicIceMedical AS
Mollendalsvein 61A
5008 Bergen
Norway
| Telephone: | +47 55389977 |
|---|---|
| Fax: | +47 55389971 |
Primary Contact: Tormod Thomsen (tormod@nordicneurolab.com)
Please be advised that effective December 1, 2006, NordicIceMedical AS will change its name to NordicImagingLab AS.
2. DEVICE NAME
| Proprietary Name: | Nordic Image Control and Evaluation (nICE) Software |
|---|---|
| Common/Usual Name: | PACS |
| Device | System, image processing, radiological |
| Classification Name: | Picture archiving and communication system |
| Product Code | LLZ |
| 21 VFR Regulation | 892.2050 |
3. PREDICATE DEVICE
eFILM Workstation with Modules, K020995, Merge eMED. Inc.
DEVICE DESCRIPTION 4.
Nordic Image Control and Evaluation (nICE) Software is a medical imaging manipulation tool, designed to provide a way to optimize the clinician's workflow. It targets activities fundamental to their work: reading, defining, sharing and reporting medical radiographic images. It is designed to work within a Windows™ operating system, and provides the user with the ability to view a wide range of image types.
.
{2}------------------------------------------------
INTENDED USE 5.
Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians. nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The nICE Software is substantially equivalent to the eFILM Workstation with Modules (K020995) in intended use, indications for use, technological characteristics and operational characteristics.
7. PERFORMANCE TESTING
Prospectively defined verification and validation activities for the nICE Software assure that the nICE Software is substantially equivalent to the cleared eFILM Workstation with Modules and meets design and performance specifications as well as user needs when operated according to the operating instructions.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three flowing lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NordicleeMedical AS % Mr. James W. Knox Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
JAN 1 7 2007
Re: K063539
Trade/Device Name: Nordic Image Control and Evaluation (nICE) Software version 2. l Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
Dated: November 22, 2006 Received: November 27, 2006.
Dear Mr. Knox:
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/3/Picture/12 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a cursive font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
{4}------------------------------------------------
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.l1tml.
Sincerely yours.
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): Ku (3539
Device Name: Nordic Image Control and Evaluation (nICE) Software version 2.1
Indications For Use:
Nordic Image Control and Evaluation (nICE) Software is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brygdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
NordiciceMedical AS - Traditional 510(k) nICE Software
510(k) Number .
§ 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).