(14 days)
No
The document describes standard digital fluoroscopy and 3D reconstruction techniques, with no mention of AI or ML. The performance studies refer to previously cleared devices and clinical data, not AI/ML model validation.
No
The device is described as generating fluoroscopic images for diagnostic and interventional procedures, and assisting in diagnosis, surgical planning, and treatment follow-up, which are all diagnostic or assistive functions, not direct therapeutic interventions.
Yes
The device's intended use explicitly states "diagnostic and interventional procedures," and the Innova 3D software option is described as assisting "the physician in diagnosis."
No
The device description explicitly states that the system consists of hardware components including a monoplane positioner, a vascular or cardiac table, an X-RAY system, and a digital detector, in addition to the software options.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Innova systems described are imaging devices that generate fluoroscopic images of human anatomy using X-rays. They are used for diagnostic and interventional procedures directly on the patient's body.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device's function is to visualize internal structures through imaging.
Therefore, the Innova systems fall under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography.
It is not intended for mammography applications.
Product codes
OWB, JAA
Device Description
The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 2100''' (2100-IQ) aiready cleared under K050489), Innova 4100''' and Innova 3100'''.
The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.
The Digital Fluoroscopic Imaging Systems Innova 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 positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
- 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.
- Energy Source: 480 VAC 50/60Hz.
Mentions image processing
Yes
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
Physician / 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)
For the Innova 3D option: Clinical data have been submitted been submitted in the Advantage 3D XR 510K (K954355).
For the InnovaSpin option:
Clinical data have been submitted in the LCV+ Version 2 system 510K (K993037), which indications for use is cardiac angiography.
Innova 2000 "Fast Spin Rotational Angiography" option has been submitted in 2002, cleared under K022322, without clinical data based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037).
Innova 4100, Innova 41000, Innova 3100, Innova 310000 and Innova 2100'0 with InnovaSpin and Innova 3D options 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)
K974715, K050489, K033244, K031637
Reference Device(s)
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
K0524/2
SEP 1 6 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 border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol representing the multinational conglomerate corporation.
P.O. Box 414, W-400
GE Healthcare
Milwaukee, WI 53201 USA
1. 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 Healthcare
Tel. (262) 544-3894
Summary prepared: July 11, 2005 |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product:
Classification Name:
Manufacturer:
Distributed by: | Digital Fluoroscopic Imaging System
Fluoroscopic X-ray System
GE Medical Systems SCS.
283, rue de la Minière
78530 Buc Cedex, France
GE Medical Systems, LLC, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 3D option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715). |
| | The GE Healthcare InnovaSpin option for Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ devices is substantially equivalent to the currently marketed InnovaSpin option of the Vascular Angiographic system Innova 2100IQ (2100-IQ) (K050489). |
| | The GE Healthcare Innova 4100IQ and Innova 3100IQ devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637. |
| | This opinion is based on the information contained in the comparison table and the product data sheets. |
| Device Description: | The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under |
1
K031637), Innova 2100''' (2100-IQ) aiready cleared under
K050489), Innova 4100''' and Innova 3100'''.
The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.
The Digital Fluoroscopic Imaging Systems Innova 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 positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
- 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.
- Energy Source: 480 VAC 50/60Hz.
Indications for Use: For Innova 4100, Innova 410019, Innova 3100, Innova 310019, Innova 2100'9 with Innova 3D or InnovaSpin 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 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 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.
It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography.
It is not intended for mammography applications.
2/4
2
Comparison with
The GE Healthcare Innova 3D option for Innova 4100, Innova 410010, Innova 3100, Innova 310010, Innova 210019 devices is substantially equivalent to the currently marketed software option Advantage 3D XR (K974715).
The GE Healthcare InnovaSpin option for Innova 4100, Innova 41000, Innova 3100, Innova 31000 devices is substantially equivalent to the currently marketed InnovaSpin option of the (K050489).
The GE Healthcare Innova 4100'0 and Innova 3100'0 devices are substantially equivalent to the currently marketed devices Innova 4100 device cleared under K033244 and Innova 3100 device cleared under K031637.
The indications of use for the predicative devices are given below:
-
Advantage 3D XR indications for use: The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuroangiographic cases.
-
Innova 21000 (2100-IQ) Indications for Use: The Innova 21000 (2100-1Q) 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.
-
Innova 3100 indications for use: The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended to mammography applications.
-
Innova 4100 indications for use: The Digital Fluoroscopic Imaging System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications.
3
This opinion is based on the information contained in the comparison table and the product data sheets.
Summary of the Studies:
For the Innova 3D option: Clinical data have been submitted been submitted in the Advantage 3D XR 510K (K954355).
For the InnovaSpin option:
Clinical data have been submitted in the LCV+ Version 2 system 510K (K993037), which indications for use is cardiac angiography.
Innova 2000 "Fast Spin Rotational Angiography" option has been submitted in 2002, cleared under K022322, without clinical data based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037).
Innova 4100, Innova 41000, Innova 3100, Innova 310000 and Innova 2100'0 with InnovaSpin and Innova 3D options 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.
Conclusions:
GE Healthcare considers that the Innova 3D and Innova Spin options for Digital Fluoroscopic Imaging Systems Innova 4100,
Innova 41000, Innova 3100, Innova 31000 and Innova 21000 to be equivalent with the predicate devices. The potential hazards, related to the introduction of Innova 3D and InnovaSpin options are controlled by a risk management plan including:
- . A hazard identification
- A risk evaluation .
- A Software Development and Validation Process .
4
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 Healthcare % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K052412
Trade/Device Name: Digital Fluoroscopic Imaging Systems-Innova 4100, Innova 41000 Innova 3100. Innova 310010. Innova 210010 with optional Innova 3D or optional InnovaSpin
Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 31, 2005 Received: September 2, 2005
Dear Mr. Lehtonen:
This letter corrects our substantially equivalent letter of September 16, 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
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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
6
Indications for Use 2.
510(k) Number (if known): Device Name:
K.052412
Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 41000, Innova 3100, Innova 310010, Innova 210019 with optional Innova 3D or optional InnovaSpin.
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 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.
InnovaSpin is a software option that permits fast spin rotational angiography.
It is not intended for mammography applications.
Over-The-Counter-Use AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052417
Posted 13 Nov 2003