(42 days)
No
The summary describes a digital fluoroscopic imaging system with an option for enhanced connectivity with third-party intravascular ultrasound devices. It mentions image processing but does not mention AI, ML, or related terms, nor does it describe any features or functionalities that are characteristic of AI/ML applications in medical imaging (e.g., automated detection, segmentation, classification, or prediction). The focus is on image acquisition, display, and workflow simplification through data synchronization and remote access.
No
The device is used for generating fluoroscopic images for diagnostic and interventional procedures, not for providing therapy. It explicitly states its purpose is to "replace fluoroscopic images obtained through image intensifier technology," which is an imaging function.
Yes
The "Intended Use / Indications for Use" section explicitly states "diagnostic and interventional procedures" for both fluoroscopic imaging and cardiology. Additionally, the description of the Innova IVUS option mentions the display of IVUS images which are inherently used for diagnostic purposes.
No
The device description clearly states that the Innova Digital Fluoroscopic Imaging Systems consist of hardware components such as a positioner, table, X-RAY system, and digital detectors. The Innova IVUS option is described as an "option" for these hardware systems, providing enhanced connectivity and workflow simplification, but it is not a standalone software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the Innova systems are used for generating fluoroscopic images of human anatomy and displaying intravascular ultrasound (IVUS) images. These are imaging modalities that visualize structures within the body, not analyze samples taken from the body.
- Intended Use: The intended use focuses on diagnostic and interventional procedures using imaging, not on analyzing biological specimens.
- No Mention of Specimen Analysis: There is no mention of collecting or analyzing any biological samples.
The Innova IVUS option enhances the workflow and display of IVUS images, which are also generated in vivo (within the body) using ultrasound technology.
N/A
Intended Use / Indications for Use
For Innova 2121 10, Innova 3131 10, Innova 4100, Innova 4100'9 Innova 3100, Innova 310010, Innova 210010 devices with Innova IVUS option:
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for fluoroscopic images of human anatomy generating for cardiology, diagnostic, and interventional procedures.
They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova IVUS option:
The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by:
(1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system,
(2) providing a remote access to commonly used IVUS functions from the Innova table side user interface.
(3) displaying the IVUS Images on the multi-monitor display of the Innova cathiab system.
Product codes
OWB, JAA, IYO
Device Description
The Innova IVUS is offered as an option for Innova 2121 IQ , Innova 3131 IQ (cleared under K060259), Innova 4100 (cleared under K033244), Innova 3100 (cleared under K031637), Innova 2100 IQ (cleared under K050489), Innova 4100 IQ and Innova 3100 IQ (cleared under K052412).
The Innova Digital Fluoroscopic Imaging Systems are 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 or biplane positioner, a vascular or cardiac table, an X-RAY system and one or two digital detectors.
The Innova IVUS option provides enhanced connectivity with third party intravascular ultrasound devices.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
human anatomy (vascular, cardiology)
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)
Innova 31310, Innova 212119, Innova 4100, Innova 410019 Innova 3100. Innova 31000 and Innova 21000 with Innova IVUS option are considered substantially equivalent to the predicates in terms of image quality and diagnostic capabilities. Therefore, previously submitted clinical data are applicable for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060259, K033244, K052412, K031637, K050489
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
KOGII 63
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
GE Healthcare
P.O. Box 414, W-440
.
Milwaukee, WI 53201 USA
1. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 7 2006
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 Healthcare
Tel. (262) 544-3894
Summary prepared: April 25, 2006 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Digital Fluoroscopic Imaging System |
| Classification Name: | Fluoroscopic X-ray System |
| Manufacturer: | GE Medical Systems SCS.
283, rue de la Minière
78530 Buc Cedex, France |
| Distributed by: | GE Medical Systems, LLC, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 2121 IQ , Innova 3131 IQ , Innova 4100,
Innova 4100 IQ , Innova 3100, Innova 3100 IQ , Innova 2100 IQ
devices with Innova IVUS option are substantially equivalent to
the currently marketed GE Healthcare Innova 2121 IQ , Innova
3131 IQ , Innova 4100, Innova 4100 IQ , Innova 3100, Innova
3100 IQ , Innova 2100 IQ devices (K060259, K033244, K052412,
K031637, K050489) |
| | This opinion is based on the information contained in the
comparison table and the product data sheets. |
| Device Description: | The Innova IVUS is offered as an option for Innova 2121 IQ ,
Innova 3131 IQ (cleared under K060259), Innova 4100 (cleared
under K033244), Innova 3100 (cleared under K031637), Innova
2100 IQ (cleared under K050489), Innova 4100 IQ and Innova
3100 IQ (cleared under K052412). |
| | The Innova Digital Fluoroscopic Imaging Systems are designed
to perform fluoroscopic x-ray examinations. The detector is
comprised of amorphous silicon with a cesium iodine scintillator. |
Attachment 1 Rev 1
1
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 or biplane positioner, a vascular or cardiac table, an X-RAY system and one or two digital detectors.
The Innova IVUS option provides enhanced connectivity with third party intravascular ultrasound devices.
Materials: All construction and materials are compliant with UL 187 and IEC 60601-1 for the existing parts of the product and with UL 2601 and IEC 60601-1 for the new parts.
Design: The design is validated through Failures Modes Effects Analysis (FMEA) process, which allows managing the risks.
480 VAC 50/60Hz. Energy Source:
Indications for Use: For Innova 2121 10, Innova 3131 10, Innova 4100, Innova 4100'9 Innova 3100, Innova 310010, Innova 210010 devices with Innova IVUS option:
The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for fluoroscopic images of human anatomy generating for cardiology, diagnostic, and interventional procedures.
They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova IVUS option:
The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by:
(1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system,
(2) providing a remote access to commonly used IVUS functions from the Innova table side user interface.
(3) displaying the IVUS Images on the multi-monitor display of the Innova cathiab system.
2
Comparison with
The GE Healthcare Innova 2121 19, Innova 3131 19, Innova 4100, Innova 410019, Innova 3100, Innova 310019, Innova 210019 devices with Innova IVUS option are substantially equivalent to the currently marketed GE Healthcare Innova 2121 10, Innova കാശസ്തു അക്കാരം - Ennova 4100", Innova 3100, Innova 3100, Innova
3131 ", Innova 2100" devices (K060259, K033244, K052412, K031637, K050489)
This opinion is based on the information contained in the comparison table and the product data sheets.
Summary of the Studies:
Innova 31310, Innova 212119, Innova 4100, Innova 410019 Innova 3100. Innova 31000 and Innova 21000 with Innova IVUS option are considered substantially equivalent to the predicates in terms of image quality and diagnostic capabilities. Therefore, previously submitted clinical data are applicable for this submission.
GE Healthcare considers that Innova IVUS option for Digital Conclusions: Fluoroscopic Imaging Systems Innova 31319, Innova 21210 Innova 4100, Innova 410019, Innova 3100, Innova 310019 and Innova 21000 to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova IVUS options are controlled by a risk management plan including:
- A hazard identification (Attachment 8)
- A risk evaluation (Attachment 8)
- Software Development and Validation Process A (Attachment 7)
3
Image /page/3/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 is a stylized representation of a human figure, and the text is 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
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems. LLC P.O. Box 414. W-400 MILWAUKEE WI 53201
JUL 30 2012
Re: K061163
Trade/Device Name: Digital Fluoroscopic Imaging Systems-Innova 4100. Innova 41000. Innova 3100, Innova 310010, Innova 210010, Innova 313110, Innova 21210 with Innova IVUS Option
Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. JAA and IYO Dated: April 25, 2006 Received: April 26. 2006
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of June 7, 2006.
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. Iisting 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
4
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
Janine M. Mdrri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
2. Indications for Use
510(k) Number (if known):
Device Name:
Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 4100 °, innova 3100, innova 3100 ° , Innova 2100 ° Innova 3131"0" , Innova 21210 with Innova IVUS option.
Indications for Use:
The Innova systems are Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Innova IVUS option:
The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by:
(1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface.
(3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system.
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 A. Larson
Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061163
Posted 13 Nov 2001
.
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