(83 days)
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures.
The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as postprocessing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector.
The Innova 2000 S system is identical to the Innova 2000 system but without the optional features.
The provided document is a 510(k) summary for the GE Medical Systems Innova 2000 and Innova 2000S. It does not contain acceptance criteria or a detailed study proving the device meets specific performance criteria in the way typically expected for novel diagnostic algorithms or AI-driven devices.
Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "Summary of Studies" explicitly states:
- "Not applicable as the digital technology (SSXD, i.e., flat panel detectors) has already been clinically compared in the submission of LCV+ Version 2 (K993037) with the image intensified technology system LC introduced in 1989 (cleared under K890348) and found substantially equivalent."
This indicates that the performance of the core technology (flat panel detectors for fluoroscopic imaging) was established in a prior submission (K993037) by comparing it to an older image intensifier technology. For the current submission (K022322), the manufacturer is asserting that the Innova 2000 and Innova 2000S, utilizing the same digital technology, are substantially equivalent to the LCV+ Version 2.
Therefore, many of the requested details about acceptance criteria and a specific study proving the device meets them cannot be extracted from this document, as this type of study was not the primary focus of this specific 510(k) given its reliance on substantial equivalence to prior art.
However, I can address the points based on the information available and what is explicitly stated as not applicable:
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A table of acceptance criteria and the reported device performance
- Not provided in this document. The submission relies on substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria for this particular device.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in this document. The "Summary of Studies" states "Not applicable," referring to a prior submission (K993037) for the clinical comparison. Details about the test set for that prior comparison are not included here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided in this document. See point 2.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in this document. See point 2.
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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 MRMC study described for this submission. The device (Innova 2000/2000S) is a hardware imaging system, not an AI-driven image analysis tool intended to assist human readers as described in this context. The comparison mentioned is between different imaging technologies (digital flat panel vs. image intensifier).
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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, in the context of standalone performance studies for AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in this document. See point 2. The prior clinical comparison (K993037) would have likely used clinical diagnostic equivalence by expert radiologists as the ground truth.
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The sample size for the training set
- Not applicable/Not provided. This device is an imaging system, and there's no mention of a "training set" in the context of machine learning model development within this submission.
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How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
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Image /page/0/Picture/0 description: The image shows a date, "OCT 08 2002". The month is October, the day is the 8th, and the year is 2002. The text is in a bold, sans-serif font. The image is clear and easy to read.
GE Medical Systems
P.O. Box 414, W-709 Milwaukee. Wi 53201 USA
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 Manager | |
| GE Medical Systems | |
| Tel. (414) 544-3894 | |
| Summary prepared: 5 June, 2002 |
| Identification of Product(s): | Innova 2000 and Innova 2000 S |
|---|---|
| Classification Name: | Solid State X-ray Imaging System |
| Manufacturer: | GE Medical Systems Europe283, rue de la Minière78530 Buc Cedex, France |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
Marketed Devices: The Digital Fluoroscopic Imaging Systems are substantially equivalent to the currently marketed cardiographic system LCV+ Version 2 (K993037) that complies with the same or equivalent standards. -The optional Fast Spin rotational angiography feature in the Innova 2000 system is substantially equivalent to the LCA system (K945375) for this feature.
Device Description: The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as postprocessing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector.
The Innova 2000 S system is identical to the Innova 2000 system but without the optional features.
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New optional features : The offset C-arm permits rotational cardiac angiography over a total 200° at variable speed from 20° to 40°/sec with Cranio/Caudal anqulation.
The SuperFast Gantry (SFG) includes capacitive sensor technology and optimized collision avoidance software that permits an increase of pivot and C-arm speed of up to 20°/sec.
Materials: All construction and materials are compliant with UL 2601.
Design: There are hardware and software redundancies to prevent from single point failures that could cause unintended motion.
Energy Source: 480 VAC 50/60Hz.
Indications for Use: 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.
Comparison with
predicate
These systems are substantially equivalent to the Fluoroscopic system LCV+ Version 2 (K993037). The optional Fast Spin rotational angiography feature in the Innova 2000 system is substantially equivalent to the LCA system (K945375) for this feature.
- Summary of Studies: Not applicable as the digital technology (SSXD, i.e., flat panel detectors) has already been clinically compared in the submission of LCV+ Version 2 (K993037) with the image intensified technology system LC introduced in 1989 (cleared under K890348) and found substantially equivalent.
- Conclusions: GE considers the systems to be equivalent with the predicate devices. The systems provide fluoroscopic images that are equivalent to the diagnostic capabilities of the predicate The potential hazards, e.g., wrong device images. measurements, misdiagnosis and increased gantry speeds are controlled by a risk management plan including:
- · A hazard identification
- · A risk evaluation
- · A Software Development and Validation Process
SumSE Rev D.doc
Ch. 1 - 2/2
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized blue graphic on the left, resembling a human figure, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is aligned horizontally with the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
JULL 30 2012
Re: K022322
Trade/Device Name: Innova 2000 and Innova 2000S Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 16, 2002 Received: July 17, 2002
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of October 8, 2002.
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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STATEMENT OF INTENDED USE
· · 510(k) Number (if known): ________________________________________________________________________________________________________________________________________________
Device Name: Digital Fluoroscopic Imaging System - Innova 2000 and Innova 2000 S
Indications for Use
. .
. •
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use_
David A. Elynn
(Division Simm-Off) Proseers of eproductive, Abdominal, . . cal Devices 11223 . : (Yk) N. .: .. .er .
§ 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.