(14 days)
The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications.
The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
The provided text is a 510(k) summary for the GE Healthcare Digital Fluoroscopic Imaging System-Innova 2100-IQ. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with quantified results.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details) is not available in this document.
Here's what can be extracted and what is explicitly stated as not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Innova 2100-IQ. The primary focus is on establishing substantial equivalence to previously cleared devices (Innova 3100, Innova 2000/2000S, LCV+ Version 2) based on similar technology, intended use, and complying with equivalent standards.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states that clinical data references from previous products (LCV+ Version 2 and Innova 4100/3100) are being used for comparison. No new study with a dedicated test set for the Innova 2100-IQ to prove specific performance metrics is described.
- Data Provenance: The document refers to "clinical data have been submitted for first digital products in the family introduced by GE Medical Systems-Europe ie LCV+ Version 2 for cardiology diagnostic and interventional procedures, and in Innova 4100 for vascular angiography diagnostic and interventional procedures." This indicates that the data would be retrospective from prior studies on older, related GE devices, likely originating from Europe as mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set or ground truth establishment process is described for the Innova 2100-IQ in this summary. The substantial equivalence argument relies on the performance of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication process is described in this summary.
5. 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:
Not applicable. This device is a digital fluoroscopic imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned, nor is any AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an imaging system, not an algorithm, and its performance is inherently linked to human operation and interpretation. The performance evaluation discussed concerns its equivalence to existing imaging systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As no specific new study to establish performance for the Innova 2100-IQ is detailed, the concept of "ground truth" for this device's performance demonstration is based on the established diagnostic capabilities and image quality of its predicate devices, which were determined through their own clinical evaluations (likely involving expert interpretation of images relative to diagnostic outcomes, though not specified here).
8. The sample size for the training set:
Not applicable. The Innova 2100-IQ is a hardware and software imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of the Study (as described in the document):
The document effectively states that no new clinical study was conducted specifically for the Innova 2100-IQ to demonstrate performance against new acceptance criteria. Instead, the argument for safety and effectiveness, and thus meeting an implicit "acceptance criterion" of being safe and effective for its intended use, is based on substantial equivalence to previously cleared predicate devices:
- Predicate Devices: Innova 3100 (K031637), Innova 2000/Innova 2000S (K022322), and LCV+ Version 2 (K993037).
- Rationale for No New Study: "References in term of clinical data have been submitted for first digital products in the family introduced by GE Medical Systems-Europe ie LCV+ Version 2 for cardiology diagnostic and interventional procedures, and in Innova 4100 for vascular angiography diagnostic and interventional procedures. As Innova 2100-IQ is considered substantially equivalent to Innova 3100 (predicated by Innova 4100), and LCV+ Version 2 in terms of image quality and diagnostic capabilities, it is not applicable."
This indicates that due to the substantial equivalence to existing devices with proven "image quality and diagnostic capabilities," a separate, new clinical study demonstrating specific performance metrics for the Innova 2100-IQ was deemed unnecessary. The "proof" is the established safety and effectiveness of the predicates.
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Tage 1 of 3
MAR í í 2005
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The logo is black and white and has a vintage look.
GE Healthcare
P.O. Box 414, W-400
Milwaukee, WI 53201 USA
4050489
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Identification of Submitter: | Larry A. Kroger, Ph.D.Senior Regulatory Programs ManagerGE HealthcareTel. (262) 544-3894Summary prepared: 07 February 2005 |
|---|---|
| Identification of Product:Classification Name:Manufacturer: | Digital Fluoroscopic Imaging SystemFluoroscopic X-ray SystemGE Medical Systems SCS.283, rue de la Minière |
| Distributed by: | 78530 Buc Cedex, FranceGE Medical Systems, LLC, Milwaukee, WI |
| Marketed Devices: | The Innova 2100-IQ is substantially equivalent to the currentlymarketed Vascular Angiographic system Innova 3100 (K031637)and complies with the same or equivalent standards.Optional feature InnovaSpin and the cardiac imaging modes inthe Innova 2100-IQ are substantially equivalent to the Innova2000/Innova 2000S systems cleared under K022322 and LCV+Version 2 systems cleared under K993037. |
| Device Description: | The Digital Fluoroscopic Imaging System is designed to performfluoroscopic x-ray examinations. The detector is comprised ofamorphous silicon with a cesium iodine scintillator. The resultingdigital image can be sent through a Fiber Channel link to anacquisition system then to network (in using DICOM) forapplications such as post-processing, printing, viewing andarchiving. Digital Fluoroscopic Imaging System consists of an amonoplane positioner, a vascular or cardiac table, an X-RAYsystem and a digital detector. |
| Materials: | All construction and materials are compliant with UL 187 for theexisting parts of the product and with IEC 60601-1 for the newparts. |
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There are hardware and software redundancies to prevent single Design: point failures that could cause unintended motion.
480 VAC 50/60Hz. Energy Source:
The Innova 2100-IQ system is indicated for use in generating Indications for Use: fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures.
It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications.
The Innova 2100-IQ is substantially equivalent to the currently Comparison with marketed Vascular Angiographic system Innova 3100 (K031637) Predicate: and complies with the same or equivalent standards. The optional feature InnovaSpin and cardiac imaging modes in the Innova 2100-IQ are substantially equivalent to the Innova 2000/Innova 2000S systems cleared under K022322 and LCV+ Version 2 systems cleared under K993037.
Innova 2100-IQ combines features from Innova 2000/LCV+ Version 2 and Innova 3100 to enable cardiac and vascular procedures. The indications of use for the predicative devices are given below:
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The Innova 3100 System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology.
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Innova 2000 / Innova 2000S: The Digital Fluoroscopic Imaging Systems are indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography, and optionally, rotational cardiac angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.
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The LCV+ Version 2 is indicated for use in generating fluoroscopic images of human anatomy for cardiology diagnostic / interventional procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology.
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Yage 3rd?
KOSO48 References in term of clinical data have been submitted for first Summary of the Studies: digital products in the family introduced by GE Medical Systems-Europe ie LCV+ Version 2 for cardiology diagnostic and interventional procedures, and in Innova 4100 for vascular angiography diagnostic and interventional procedures. As Innova 2100-IQ is considered substantially equivalent to Innova 3100 (predicated by Innova 4100), and LCV+ Version 2 in terms of image quality and diagnostic capabilities, it is not applicable.
Conclusions:
GE considers the 20 cm Digital Fluoroscopic Imaging System to be equivalent with the predicate devices. The potential hazards, e.q., wrong measurements and misdiagnosis, are controlled by a risk management plan including:
- A hazard identification (Attachment 8) .
- A risk evaluation (Attachment 8) 0
- A Software Development and Validation Process . (Attachment 7)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUL 30 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems, LLC % Mr. Daniel W. Lehtonen Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K050489
Trade/Device Name: Digital Fluoroscopic Imaging System-Innova 2100-IQ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: February 23, 2005 Received: February 25, 2005
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of March 11, 2005.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Digital Fluoroscopic Imaging System - Innova 2100-IQ
Indications for Use:
The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human The innova 2 foo Ta System to the diagnostic and interventional procedures, and optionally. rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images oblained through image intensifier technology. This device is not intended for mammography applications.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter-Use
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Lynn
X
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.