(31 days)
To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.
The GE LOGIQ Works Image Analysis and Review Workstation is optimized for ultrasound images that are acquired primarily via the GE LOGIQ family of diagnostic ultrasound systems. It is sold with or without the designated computer hardware.
The GE LOGIQ Works Ultrasound Workstation is a medical image management device designed for retrieving, displaying, and processing diagnostic medical images.
Here's an analysis of its acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Section in Document |
|---|---|---|---|
| System Functionality | Conformance to design specifications | Device has been evaluated for conformance to its design specifications | Section b): 1. Non-clinical Tests |
| Industry Standards | Conformance to applicable industry standards for software development | Device has been evaluated for conformance to applicable industry standards for software development | Section b): 1. Non-clinical Tests |
| System Compatibility | Verification of system compatibility with communicating devices | Device is further verified for system compatibility with the devices with which it communicates | Section b): 1. Non-clinical Tests |
| Hardware Safety | Certification of computer hardware to applicable safety standards | Computer hardware is certified to applicable safety standards | Section b): 1. Non-clinical Tests |
| Quality Systems | Conformance to quality systems | The design and development process conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems | Section b): 3. Conclusion |
| Medical Device Safety | Conformance to applicable medical device safety standards | Device conforms to applicable medical device safety standards and compliance is verified through internal and independent quality system audit | Section b): 3. Conclusion |
| Substantial Equivalence | Equivalence to cleared predicate devices regarding safety and effectiveness | It is the opinion of GE Healthcare that the GE LOGIQ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. | Section b): 3. Conclusion |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for evaluating the functionality or performance of the GE LOGIQ Works Ultrasound Workstation. The submission primarily focuses on non-clinical tests related to design, standards, and compatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No clinical test set or ground truth establishment by experts is mentioned for this device. The submission explicitly states "Clinical Tests: None required to confirm safety and effectiveness."
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a workstation for image management and processing, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is an image processing and review workstation, not an algorithm requiring standalone performance evaluation in a diagnostic context. Its performance is related to its ability to display, process, and manage images as intended, which is covered by non-clinical tests.
7. Type of Ground Truth Used
Not applicable. As clinical tests were not required and no diagnostic claims are being made that would necessitate comparison to a specific ground truth (like pathology or outcomes data), no "ground truth" as typically understood in diagnostic device evaluation was used. The ground for its "effectiveness" is its ability to perform its defined functions (display, process, analyze) in accordance with its specifications.
8. Sample Size for the Training Set
Not applicable. This device, a medical image management workstation, does not utilize machine learning or AI models that would require a "training set" in the conventional sense. Its functionality is based on established software engineering principles and image processing algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, no ground truth for a training set was established.
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Special 510(k) Premarket Notification
GE LOGIQ Works Ultrasound Workstation - Medical Image Management Device September 28, 2006
Attachment B:
NUV - 2 2006
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c),
| GE Healthcare | |
|---|---|
| General Electric CompanyP.O. Box 414, Milwaukee, WI 53201 | |
| Section a): | |
| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care DiagnosticsPO Box 414Milwaukee, WI 53201 |
| Contact Person: | Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-721-3992; Fax: 414-721-3899 |
| Date Prepared: | September 28, 2006 |
| 2. Device Name: | GE LOGIQworks ™ Ultrasound Image WorkstationSystem, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ |
| 3. Marketed Device: | RadWorks Review K963699, Platinum PACS Workstation K981217,Centricity PACS Plus K023557 and Centricity RA 600 K042525; all are 90-LLZ |
| 4. Device Description: | The GE LOGIQworks Image Analysis and Review Workstation is optimized for |
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Device Description: The GE LOGIQ Works Image Analysis and Review Workstation is optimized for ultrasound images that are acquired primarily via the GE LOGIQ family of diagnostic ultrasound systems. It is sold with or without the designated computer hardware.
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Indications for Use: To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, Xray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.
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Comparison with Predicate Device: The GE LOGIQworks™ is of a comparable type and substantially equivalent to the above listed marketed devices with the addition of post acquisition image manipulation and processing capability of the GE LOGIQ 9 Ultrasound. It has equivalent technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has essentially the same intended uses as the predicate device.
Section b):
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Non-clinical Tests: The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Computer hardware is certified to applicable safety standards.
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Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability and compatibility within the intended network environment.
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Oonclusion: Intended uses and other key features of the device are consistent with traditional clinical practice, FDA guidelines and established methods of handling patient examination images and data. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems. The device conforms to applicable medical device safety . startans and compliance is verified through internal and independent quality system audit. PACS devices and medical information management systems in general have accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ or is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226
NOV - 2 2006
Re: K063006
Trade/Device Name: GE LOGIQworks" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: September 28, 2006 Received: October 21, 2006
Dear Mr. Schuh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booken overy pro promotially equivalent (for the indications for referenced above and nave accemined arketed predicate devices marketed in interstate commerce ass stated in the encreasury that with in the Medical Device Amendments, or to devices that provide with 20, 1778, the endomical with the provisions of the Federal Food, Drug, and Cosmetic nate been roomsermed in a proval of a premarket approval application (PMA). You may, Act (Act) that ao not require apple ful one general controls provisions of the Act. The general therefore, mailive the detice, sabjoct to envirements 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 If your device is classified (500 above) hits on controls. Existing major regulations affecting your Approval), it thay be sabject to Jack at Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" written below them in a cursive font. Three small dots are arranged in a horizontal line beneath the word "Centennial". The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
ding and Promoting Public S
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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 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/edriv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancv 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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Attachment E
Indications for Use
- Kor 300 6 510(k) Number (if known):
Device Name: GE LOGIQworks ™
Indications For Use: To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound.
Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.
Prescription Use XXX (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)
David Lee Ingram
(Division Sign Off)
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 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).