(83 days)
No
The document describes a standard digital fluoroscopic imaging system and mentions postprocessing, but there is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is indicated for diagnostic and interventional cardiac angiography procedures, which are investigative or procedural steps rather than therapeutic treatments themselves.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use in diagnostic and interventional cardiac angiography".
No
The device description explicitly lists hardware components such as a detector, positioner, table, X-RAY system, and digital detector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states that this device is a "Digital Fluoroscopic Imaging System" that performs "fluoroscopic x-ray examinations" of "human anatomy." It directly images the inside of the body using X-rays.
- Intended Use: The intended use is for "diagnostic and interventional cardiac angiography," which involves imaging the heart and blood vessels within the body.
The device operates by imaging the body directly, not by analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy (cardiac)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Europe |
| 283, rue de la Minière | |
| 78530 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
3
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 .