(9 days)
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.
The new tilt table will support performing procedures like CO2 studies. Venography.
The new tilt table is offered as an option for Innova 4100, in place of the existing Omega V table, which is part of the Innova 4100 system already cleared under K023178.
The provided text describes a 510(k) summary for the GE Medical Systems Innova 4100 Digital Fluoroscopic Imaging System with an optional Tilt Table. It focuses on establishing substantial equivalence to a predicate device based on product characteristics and safety information, rather than performance against specific acceptance criteria derived from a clinical or technical study for the new tilt table option itself.
Therefore, many of the requested elements regarding acceptance criteria, device performance, and study details are not present in this document. The submission is primarily a declaration of equivalence based on design and safety standards.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission for K033244 is a 510(k) for a modification (new tilt table option) to an already cleared device (Innova 4100). The basis for clearance is substantial equivalence to a predicate device (Siemens Axiom Artis, K021021), not a performance study against specific acceptance criteria for the tilt table's diagnostic performance. The document states:
"The GE Medical System's Innova 4100, with a new Tilt table option for patient positioning, for diagnostic fluoroscopic imaging is substantially equivalent to Siemens Axiom Artis (K021021). This opinion is based on the information contained in the comparison table (Attachment 3), and the product data sheets (Attachment 4 & 5)."
This implies a comparison of specifications and features, not a clinical performance study with predefined acceptance criteria for the new option.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As no such performance study is described, there is no test set, sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. As no such performance study is described, there's no ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided. As no such performance study is described, there's no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a digital fluoroscopic imaging system, not an AI-powered diagnostic tool.
6. If a Standalone Performance Study Was Done
This information is not provided. No standalone performance study (algorithm only) is described, as the submission focuses on hardware equivalence and safety for a new option.
7. The Type of Ground Truth Used
This information is not provided. No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as there's no performance study described for the new tilt table option.
8. The Sample Size for the Training Set
This information is not provided. This document does not describe any machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. This document does not describe any machine learning or AI component for which ground truth would be established for a training set.
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OCT 1 6 2003
GE Medical Systems P.O. Box 414, W-400 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 ManagerGE Medical SystemsTel. (262) 544-3894Summary prepared: 5 September 2003 |
|---|---|
| Identification of Product: | Digital Fluoroscopic Imaging System |
| Classification Name: | Fluoroscopic X-ray system - 21 CFR 892.1650 |
| Manufacturer: | GE Medical Systems Europe283, rue de la Minière78530 Buc Cedex, France |
| Distributed by: | GE Medical Systems, Milwaukee, WI |
| Marketed Devices: | The GE Medical System's Innova 4100, with a new Tilt tableoption for patient positioning, for diagnostic fluoroscopicimaging is substantially equivalent to Siemens Axiom Artis(K021021). This opinion is based on the informationcontained in the comparison table (Attachment 3), and theproduct data sheets (Attachment 4 & 5). |
| Device Description: | The new tilt table is offered as an option for Innova 4100, inplace of the existing Omega V table, which is part of theInnova 4100 system already cleared under K023178. |
| Materials: | All construction and materials are compliant with UL 2601 andIEC 60601-1. |
| Design: | There are hardware and software redundancies to preventfrom single point failures that could cause unintended motion. |
| Energy Source: | 480 VAC 50/60Hz. |
| Indications for Use: | The Digital Fluoroscopic Imaging System with tilt table optionis indicated for use in generating fluoroscopic images ofhuman anatomy for diagnostic and intervention angiographyprocedures in both normal and tilted condition of patient. This |
104 - Au 1 - Summary - SE Rev-Daloc PAGENBPAGES9/16/2003 PAGE
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Image /page/1/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure with outstretched arms, and the text is written in a clear, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems % Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719
JUL 30 2012
Re: K033244
Trade/Device Name: Model Innova 4100 with Tilt Table Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: October 6, 2003 Received: October 7, 2003
Dear Mr. Sherratt:
This letter corrects our substantially equivalent letter of October 16, 2003.
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): K033244
V
Device Name: Digital Fluoroscopic Imaging System – Innova 4100 with optional Tilt Table
Indications for Use
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.
The new tilt table will support performing procedures like CO2 studies. Venography.
(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_
Nancy. C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033244
§ 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.