(88 days)
Not Found
No
The description focuses on workflow simplification and data synchronization between existing systems, with no mention of AI/ML for image analysis, diagnosis, or other functions. The performance studies section details standard software verification and validation, not AI/ML model training or testing.
No
Explanation: The device is described as an angiographic X-ray system that generates images for diagnostic and interventional procedures, and facilitates workflow for an intravascular imaging and pressure system. Its function is image generation and system integration, not direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the angiographic X-ray systems are "indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures." This directly indicates a diagnostic purpose.
No
The device is described as an "integrated system option" that enhances connectivity and provides remote access and display capabilities for an existing angiographic X-ray system and an intravascular imaging and pressure system. While it involves software for synchronization, remote access, and display, it is presented as an option integrated with hardware systems (angiographic X-ray systems and Volcano s5i systems), not as a standalone software device. The description focuses on the interaction and workflow simplification between these existing hardware components.
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 generating and displaying images of human anatomy for diagnostic and interventional procedures using X-ray. This is an in vivo (within the living body) imaging process, not an in vitro (outside the living body) diagnostic test performed on biological samples.
- Device Description: The description focuses on connectivity and integration with an intravascular imaging and pressure system, which are also in vivo procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
The device is an imaging system and an option to enhance the workflow of other imaging systems, all of which operate in vivo.
N/A
Intended Use / Indications for Use
The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems.
The Integrated Innova - s5i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by:
(1) automatically synchronizing the patient demographic and medical exam information (patient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems,
(2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface,
(3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.
Product codes
IZI, MQB
Device Description
The integrated INNOVA - s5i system option provides enhanced connectivity with Volcano's intravascular imaging and pressure system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy
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)
Summary of Non-Clinical Tests:
The integrated Innova - s5i system option complies with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
• Risk Analysis
• Software Requirements Specifications
• Requirements Reviews
• Software design specification document.
• Design Reviews
• Traceability between requirements & hazards towards their associated mitigations as appropriate and V&V
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification) Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, integrated Innova - s5i system option, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K111209
P. 1 of 2
JUL 26 2011
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 shape. The letters and the circle are black, creating a strong contrast against the white background.
GE Healthcare
Integrated Innova - s5i system option - 510(k) Premarket Notification
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: April 27th, 2011 | |
|---|---|
| Submitter: | GE HEALTHCARE |
| GE Medical Systems SCS | |
| 283, rue de la minière | |
| 78530 BUC | |
| FRANCE | |
| Primary Contact Person: | Fayçal KHERRA |
| Regulatory Affairs Leader | |
| GE Medical Systems SCS | |
| 283, rue de la minière | |
| 78530 BUC | |
| FRANCE | |
| T: +33 1 30 70 40 82 | |
| Email: Faycal.kherra@ge.com | |
| Secondary Contact Person: | Carol Alloian |
| Regulatory Affairs Leader | |
| GE Healthcare, QARA Regions - Americas | |
| 9900 W innovation drive | |
| Wauwatosa, WI, USA, 53226-4856 | |
| T: (847) 244-8327 | |
| F: (847) 589-8524 | |
| Email: carol.alloian@ge.com | |
| Device/Trade Name: | Integrated Innova - s5i system option (Formerly known as Innova |
| System with IVUS Option) | |
| Common/Usual Name: | Integrated Innova - s5i system option (Formerly known as Innova |
| System with IVUS Option) | |
| Classification Names: | |
| Product Code: | IZI : SYSTEM, X-RAY, ANGIOGRAPHIC |
| MQB : SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | |
| Predicate Device(s): | K061163 : INNOVA x1x1¹⁰ & X100¹⁰ systems with IVUS option |
| Device Description: | The integrated INNOVA - s5i system option provides enhanced |
| connectivity with Volcano's intravascular imaging and pressure system. | |
| Intended Use: | The angiographic X-ray systems are indicated for use in generating |
| fluoroscopic and rotational images of human anatomy for | |
| cardiovascular, vascular and non-vascular, diagnostic and interventional | |
| procedures. | |
| The Integrated Innova - s5i system option is indicated for use in | |
| conjunction with single plane and biplane angiographic X-ray systems. | |
| The Integrated Innova - s5i system option simplifies the clinical workflow | |
| associated with the use of Volcano s5i systems by: | |
| (1) automatically synchronizing the patient demographic and | |
| medical exam information (patient name, date of birth, etc.) from | |
| angiographic X-ray systems with Volcano s5i systems, | |
| (2) providing a remote access to commonly used Volcano s5i system | |
| functions from the angiographic X-ray systems user interface, | |
| (3) displaying the Volcano s5i systems output on the monitor display | |
| solutions of the angiographic X-ray systems. | |
| Technology: | The integrated Innova - s5i system option employs the same |
| fundamental scientific technology as its predicate devices. | |
| Determination of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The integrated Innova - s5i system option complies with voluntary | |
| standards as detailed in Section 9 of this premarket submission. The | |
| following quality assurance measures were applied to the development | |
| of the system: | |
| • Risk Analysis | |
| • Software Requirements Specifications | |
| • Requirements Reviews | |
| • Software design specification document. | |
| • Design Reviews | |
| • Traceability between requirements & hazards towards their associated | |
| mitigations as appropriate and V&V | |
| • Testing on unit level (Module verification) | |
| • Integration testing (System verification) | |
| • Performance testing (Verification) | |
| • Safety testing (Verification) Simulated use testing (Validation) | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, integrated Innova - s5i system | |
| option, did not require clinical studies to support substantial equivalence. | |
| Conclusion: | GE Healthcare considers the integrated Innova - s5i system option to be |
| as safe and as effective as the predicate devices, and its performance is | |
| substantially equivalent to the predicate devices. |
1
KIII 209
P. 2 of Z
GE Healthcare
Integrated Innova - s5i system option - 510(k) Premarket Notification
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Faycal Kherra Regulatory Affairs Leader GE Healthcare - GE Medical Systems SCS 283, rue de la minière BUC, 78530 FRANCE
JUL 2 6 2311
Re: K111209
Trade/Device Name: Integrated Innova-s5i system option Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: April 27, 2011 Received: April 29, 2011
Dear Mr. Kherra:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales on and 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 conimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have boon roomstiled in assee approval of a premarket approval application (PMA). and Cosmetic (110.) that to hovice, subject to the general controls provisions of the Act. The I ou mayy are sprovisions 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 11 your device to to to stime major regulations affecting your device can be found in Title 21, accitional corners 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 I least be advised hit i Dri i issualite our device complies with other requirements of the Act that I Dri has intate a and regulations administered by other Federal agencies. You must or any I caeral statutes and regencients, 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.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
KI11209
- 510(k) Number (if known): K || | 20 9
- · Device Name: Integrated Innova s5i system option
• Indications for Use:
The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular and non-vascular, diagnostic and interventional procedures.
The Integrated Innova - s5i system option is indicated for use in conjunction with single plane and biplane angiographic X-ray systems.
The Integroted Innova - 55i system option simplifies the clinical workflow associated with the use of Volcano s5i systems by:
(1) automatically synchronizing the patient demographic and medical exam information lpatient name, date of birth, etc.) from angiographic X-ray systems with Volcano s5i systems,
(2) providing a remote access to commonly used Volcano s5i system functions from the angiographic X-ray systems user interface,
(3) displaying the Volcano s5i systems output on the monitor display solutions of the angiographic X-ray systems.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mancy S. Patil
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11209
Prescription Use (Per 21 CFR 801.109)