(63 days)
No
The document describes modifications to an existing X-ray system platform to expand its indications for use in surgical procedures. The modifications are primarily hardware-based (new configuration, OR table, accessories) and do not mention any software features related to AI or ML for image processing, analysis, or decision support.
No
The device is an angiographic X-ray system used to generate images for diagnostic and interventional procedures, including image-guided surgery. It is an imaging device, not a device that directly treats or provides therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is indicated for "diagnostic and interventional procedures." It mentions generating fluoroscopic and rotational images for these purposes.
No
The device description explicitly details hardware components like the OR table, user interfaces, UPS, and surgical accessories, indicating it is a hardware-based system with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate fluoroscopic and rotational images of human anatomy for diagnostic and interventional procedures, including image-guided surgical procedures. This involves imaging the inside of the body, not testing samples taken from the body.
- Device Description: The device is an angiographic X-ray system with an OR table. This is an imaging device used on a patient, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an imaging system used directly on the patient.
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. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Product codes
IZI
Device Description
The basis for this submission is a modification of the common platform of a family of legally marketed devices to expand its indications for use to include image-guided surgical procedures and open surgery procedures. The currently cleared devices are indicated for use for interventional and minimally invasive procedures. The subject modification is intended to introduce a new configuration (OR configuration) that will enable the Innova Systems to be additionally indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures.
The modifications mainly consist of introduction of new configuration called OR configuration.
The OR configuration of the product is designed in accordance with the operating table standard (IEC 60601-2-46) with deviation for clause 36.101*, it corresponds to the Innova 4100-IQ, 3100-IQ, 2100-IQ product equipped with:
• OR table (OR table is the Innova-IQ table with specific covers with an "OR" branding)
• IPX4Table side user interface
• Mandatory UPS
• Mandatory surgical accessories
• Dedicated surgery protocols
*Electromagnetic Compatibility tested to cover high power surgical tool up to 300W and as per the Requirements of the IEC 60601-2-46 Edition 2, refer details in section 9.3.1 standards data forms 3654.
To maintain compliance with the operating table safety standard, not all controls are allowed to be mounted on the table rails. The following controls only are allowed:
• IPX4 Table Side Status Control (TSSC)
• IPX4 Smart Box (Smart Box)
• IPX4 Table Panning Device (TPD)
• IPX4 Innova Central touch screen
• IVUS PIM
A table side cart is provided to place any other control (3D mouse, IVUS console and joystick) Table mounted injectors are not allowed with the OR configuration.
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 Innova Systems -OR configuration 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
• Requirements Reviews
• Design Reviews
• 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, Innova Systems -OR configuration, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111209: INTEGRATED INNOVA - S5I SYSTEM OPTION, K090745 : Siemens Artis zee
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 logo is black and white, with the letters and border in black and the background in white.
DEC 1 3 2011
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 5, 2011 |
|---|---|
| Submitter: | GE Healthcare |
| GE Medical Systems, SCS | |
| 283 rue de la Miniere | |
| Buc, FRANCE, 78530 | |
| T: +33-01-30-70-42-07 | |
| Primary Contact Person: | Dorai.Subramaniam |
| Regulatory Affairs Leader, | |
| GE Medical Systems, | |
| John F. Welch Technology Centre, | |
| Plot #122, EPIP, Phase 5, | |
| Whitefield Road, Bangalore, Karnataka 560066, India | |
| T: +91-80-4088-3769 | |
| Email: Dorai.Subramaniam@ge.com | |
| Secondary Contact Person: | Carol Alloian |
| Regulatory Affairs Leader, | |
| GE Healthcare- 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: | Innova Systems (Innova 4100-IQ, 3100-IQ, 2100-IQ) |
| Common/Usual Name: | Innova Systems (Innova 4100-IQ, 3100-IQ, 2100-IQ) |
| Classification Names: | Angiographic x-ray system |
| Product Code: | IZI, 892.1600. |
| Predicate Device(s): | K111209: INTEGRATED INNOVA - S5I SYSTEM OPTION, |
| K090745 : Siemens Artis zee | |
| Device Description: | The basis for this submission is a modification of the common |
| platform of a family of legally marketed devices to expand its | |
| indications for use to include image-guided surgical procedures and | |
| open surgery procedures. The currently cleared devices are | |
| indicated for use for interventional and minimally invasive | |
| procedures. The subject modification is intended to introduce a new | |
| configuration (OR configuration) that will enable the Innova Systems | |
| to be additionally indicated for use in generating fluoroscopic and | |
| rotational images of human anatomy for image-guided surgical | |
| procedures. | |
| The modifications mainly consist of introduction of new | |
| configuration called OR configuration. | |
| The OR configuration of the product is designed in accordance with | |
| the operating table standard (IEC 60601-2-46) with deviation for | |
| clause 36.101*, it corresponds to the Innova 4100-IQ, 3100-IQ, 2100- | |
| IQ product equipped with | |
| • OR table (OR table is the Innova-IQ table with specific covers | |
| with an "OR" branding) | |
| • IPX4Table side user interface | |
| • Mandatory UPS | |
| • Mandatory surgical accessories | |
| • Dedicated surgery protocols | |
| *Electromagnetic Compatibility tested to cover high power surgical | |
| tool up to 300W and as per the Requirements of the IEC 60601-2-46 | |
| Edition 2, refer details in section 9.3.1 standards data forms 3654. | |
| To maintain compliance with the operating table safety standard, | |
| not all controls are allowed to be mounted on the table rails. The | |
| following controls only are allowed: | |
| • IPX4 Table Side Status Control (TSSC) | |
| • IPX4 Smart Box (Smart Box) | |
| • IPX4 Table Panning Device (TPD) | |
| • IPX4 Innova Central touch screen | |
| • IVUS PIM | |
| A table side cart is provided to place any other control (3D mouse, | |
| IVUS console and joystick) | |
| Table mounted injectors are not allowed with the OR configuration. | |
| 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. | |
| Additionally, with the OR table, the angiographic X-ray systems are | |
| indicated for use in generating fluoroscopic and rotational images of | |
| human anatomy for image-guided surgical procedures. The OR | |
| table is suitable for interventional and surgical procedures. | |
| Technology: | The Innova Systems employs the same fundamental scientific |
| technology as its predicate devices. | |
| Determination of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The Innova Systems -OR configuration 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 | |
| • Requirements Reviews | |
| • Design Reviews | |
| • 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, Innova Systems -OR | |
| configuration, did not require clinical studies to support substantial | |
| equivalence. | |
| Conclusion: | GE Healthcare considers the Innova Systems -OR configuration to |
| be as safe, as effective as its predicates devices, and its | |
| performances substantially equivalent to the predicate devices. |
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are white, set against a black background.
GE Healthcare
510(k) Premarket Notification Submission
2
Image /page/2/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 logo is black and white, with the letters and border in black and the background in white.
. .
GE Healthcare
510(k) Premarket Notification Submission
:
,
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
GE Healthcare Americas Division % Ms. Carol Alloian Regulatory Affairs Leader 9900 W. Innovation Drive WAUWATOSA WI 53226-4856
DEC 1 3 2011
Re: K113034
Trade/Device Name: Innova Systems- OR configuration (Innova 4100-IQ, 3100-IQ, 2100-
IO) Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI Dated: October 5. 2011 Received: October 11, 2011
Dear Ms. Alloian:
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
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/ReportalProblem/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 S. Patil
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
5
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known):
Device Name: Innova Systems- OR configuration (Innova 4100-IQ, 3100-IQ)
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. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
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)
(Division Sign-Off)
Division of Badiologi Office of In Vitro Diagnostic De vice Evaluation and Safety
510K K113034
Prescription Use (Per 21 CFR 801.109)