(27 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any training or testing data sets typically associated with AI/ML development. The focus is on real-time subtracted angiography and replacing image intensifier systems.
No
The device is indicated for diagnostic and interventional angiographic procedures, not therapeutic ones. Its purpose is to perform imaging for diagnostic purposes ("for diagnostic purpose").
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "indicated for use in diagnostic and interventional angiographic procedures" and that the Bolus Chasing option is for "diagnostic purpose."
No
The device description explicitly states it is an "option for Innova 4100 and 3100," which are Digital Fluoroscopic Imaging Systems. These are hardware-based imaging systems, and the "Bolus Chasing" is an added feature or software component to these existing hardware devices, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic and interventional angiographic procedures of human anatomy." This involves imaging the inside of the body using X-rays and contrast agents, which is an in vivo (within the living body) procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not perform such tests.
- Device Description: The description confirms it's a "Digital Fluoroscopic Imaging System," which is an imaging modality used directly on the patient.
Therefore, the device described is an imaging system used for in vivo diagnostic and interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications.
The two Digital Fluoroscopic Imaging Systems are 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. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
Product codes
OWB, JAA
Device Description
The new Bolus Chasing is offered as an option for Innova 4100 and 3100, already cleared under K033244 and K031637.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
human anatomy, lower limbs
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 Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters and the border are black, while the background is white. The logo is simple and recognizable, representing the well-known multinational conglomerate.
K042053
Page 2
GE Healthcare 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 Manager
GE Healthcare
Tel. (262) 544-3894
Summary prepared: 5 July 2004 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of Product: | Digital Fluoroscopic Imaging System |
| Classification Name: | Fluoroscopic X-ray system - 21 CFR 892.1650 |
| Manufacturer: | GE Medical Systems Europe
283, rue de la Miniere
78530 Buc Cedex, France |
| Distributed by: | GE Healthcare, Milwaukee, WI |
| Marketed Devices: | The GE Healthcare Innova 4100 and Innova 3100, with the
new Bolus Chasing option for angiography of lower limbs are
substantially equivalent to GE Advantx LCV+ (K960575). This
opinion is based on the information contained in the
comparison table, and the product data sheets. |
| Device Description: | The new Bolus Chasing is offered as an option for Innova
4100 and 3100, already cleared under K033244 and
K031637. |
| Materials: | All construction and materials are compliant with UL 2601 and
IEC 60601-1. |
| Design: | Controls of operation of XRAY, injection and table motion are
intended to prevent from useless exposures to XRAY/contrast
agent during a Bolus Chasing sequence in case of failure
from one of these parameters (i.e., XRAY, injection and table
motion). |
| Energy Source: | 380 - 480 VAC; 50/60Hz. |
| Indications for Use: | The Digital Fluoroscopic Imaging System with Bolus Chasing
option is indicated for use in generating fluoroscopic images
of human anatomy for diagnostic and intervention; the option
Bolus enables to perform subtraction angiography of lower |
1
limbs. This device is not intended for mammography applications.
K042053
Page 2 of 2
- Comparison with The GE Healthcare new Bolus Chasing option for Innova 4100, 3100 systems, is substantially equivalent to the GE Health Care Advantx LCV+ Bolus Chasing which is part of the Advantx LCV+ system (K960575).
- GE Healthcare considers that the Bolus Chasing option for Conclusions: their 41 cm and 31 cm Digital Fluoroscopic Imaging Systems Innova 4100 and Innova 3100 to be equivalent with the predicate device. The potential hazards, related to the introduction of new Bolus Chasing option, are controlled by a risk management plan including:
- · A hazard identification
- · A risk evaluation
- · A Software Development and Validation Process
2
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 System, Inc. P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K042053
Trade/Device Name: Innova 4100, Innova 3100 with optional Bolus Chasing Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: July 29, 2004 Received: July 30, 2004
JUL 30 2012
Dear Dr. Kroger:
This letter corrects our substantially equivalent letter of August 26, 2004.
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
4
STATEMENT OF INTENDED USE
510(k) Number (if known): ¼o42e53____________________________________________________________________________________________________________________________________________
Device Name: Digital Fluoroscopic Imaging Systems - Innova 4100, Innova 3100 with optional Bolus Chasing.
Indications for Use
The two Digital Fluoroscopic Imaging Systems are 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. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.
(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 | |
|---|---|---|---|
| --------------------------------------- | --- | ------------------------- | -- |
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K042053 |
|---|---|
| --------------- | --------- |