(142 days)
Not Found
No
The document focuses on integration protocols and displaying information from other cleared devices, with no mention of AI/ML algorithms for image processing or analysis.
No.
The device is an angiographic X-ray system used for generating images for diagnostic and interventional procedures, not for therapeutic treatment.
Yes
The device generates images for "diagnostic and interventional procedures," indicating its use in diagnosing medical conditions.
No
The device is described as a modification of existing angiographic X-ray systems and includes integration with hardware components (angiographic X-ray systems, OR table, Vivid E9 system). While it involves software for communication and display, it is fundamentally tied to and modifies hardware devices.
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 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 analyzing samples outside the body.
- Device Description: The description focuses on angiographic, fluoroscopic X-ray systems and their integration with other imaging/data medical devices. This aligns with imaging modalities, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
The device is an imaging system used for visualizing internal structures during medical procedures.
N/A
Intended Use / Indications for Use
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric 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.
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing:
(1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
(2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
(3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, IZI
Device Description
The basis for this 510(k) submission is a modification of the family of legally marketed GE angiographic, fluoroscopic X-ray systems devices to expand their indications for use regarding the generic integration interfaces for other imaging / data medical devices used in interventional and surgical cathlab environments and cleared/approved for commercial distribution.
Same time with the intended use/indications for use expansion we introduce the Integrated Vivid E9 solution. The Vivid E9 (BT12 version) integrates with Innova IGS 520, Innova IGS 530, and Innova IGS 540 systems, integration consisting in displaying the Vivid E9 system screen on Innova IGS Large Display Monitor solution.
For the Innova IGS Vivid E9 integration we apply the specific qualifications criteria and processes described in the section "Determination of Substantial Equivalence" below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, fluoroscopic
Anatomical Site
human anatomy
Indicated Patient Age Range
newborn to geriatric
Intended User / Care Setting
interventional and surgical cathlab environments
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 Integration has been evaluated for electrical and electromagnetic safety. The GE Angiographic, Fluoroscopic X-ray Systems and its applications and accessories comply with voluntary standards and applicable performance standards for radiation emitting products 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 specific qualification of 3rd party systems integrations:
The criteria to qualify the integration of 3rd party imaging/data medical devices are based on the following aspects:
• Shall be "FDA cleared/approved device"
• Shall comply with one or more generic integration interfaces offered by the GE angiographic, fluoroscopic X-ray systems.
Integration of devices shall be safe and effective and shall not raise different questions of safety and effectiveness than the predicate device(s).
Summary of Clinical Tests:
The subject of this premarket submission, Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions, did not require clinical studies to support substantial equivalence as one of the criteria for integration rely on the fact that they are already cleared /approved devices by FDA. Integration does not introduce any new clinical information and the clinical information is pre-existing on the cleared or approved devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 892.1650 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Ms. Dorai Subramaniam Regulatory Affairs Leader 283, RUE DE LA MINIERE BUC. 78530 FRANCE
Re:K122457
Trade/Device Name: GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: December 12, 2012 Received: December 19, 2012
Dear Ms. Dorai Subramaniam:
This letter corrects our substantially equivalent letter of January 2, 2013.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oaks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K122457
Device Name: GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers Solutions
Indications for Use:
The angiographic X-ray systems are indicated for use for patients from newborn to geriatric 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.
The Cathlab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution.
The Cathlab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing:
- (1) communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices,
- (2) communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface,
- (3) interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.
Prescription Use X AND/OR Over-The-Counter Use. (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Janine M. Morris -S 2013.01.02 17:38:37 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K122457 510(k)
Page 1 of .
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
Section 5: 510(k) Summary
GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions
5.1 510(k) Summary
5-2
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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: | 10 August 2012 |
|---|---|
| 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 Healthcare, (GE Medical Systems, SCS) | |
| 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: | GE Innova/Innova IGS/Discovery IGS/Optima angiographic, |
| fluoroscopic X-ray systems with Cathlab Frontiers solutions | |
| Innova 4100-IQ, Innova 3100-IQ, Innova 2100-IQ, Innova 2121- | |
| IQ, Innova 3131-IQ, Innova IGS 540, Innova IGS 530, Innova | |
| IGS 520, Innova IGS 620, Innova IGS 630, Discovery IGS 730, | |
| Optima CL320i, Optima CL323i. | |
| Common/Usual Name: | Interventional fluoroscopic x-ray system, angiographic x-ray system |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Regulation number: | 892.1650 |
| Product Code: | OWB, JAA and IZI |
| Class: | II |
| Predicate Device(s): | K113034 : GE Innova Solid State X-ray Imager Fluoroscopic X- |
| ray System | |
| K111209 : Integrated Innova - S5i System Option | |
| K113403 : GE Discovery IGS angiographic, fluoroscopic X-Ray | |
| System | |
| Device Description: | The basis for this 510(k) submission is a modification of the |
| family of legally marketed GE angiographic, fluoroscopic X-ray | |
| systems devices to expand their indications for use regarding the | |
| generic integration interfaces for other imaging / data medical | |
| devices used in interventional and surgical cathlab environments | |
| and cleared/approved for commercial distribution. | |
| Same time with the intended use/indications for use expansion we | |
| introduce the Integrated Vivid E9 solution. The Vivid E9 (BT12 | |
| version) integrates with Innova IGS 520, Innova IGS 530, and | |
| Innova IGS 540 systems, integration consisting in displaying the | |
| Vivid E9 system screen on Innova IGS Large Display Monitor | |
| solution. | |
| For the Innova IGS Vivid E9 integration we apply the specific | |
| qualifications criteria and processes described in the section | |
| "Determination of Substantial Equivalence" below. | |
| Intended Use: | The angiographic X-ray systems are indicated for use for patients |
| from newborn to geriatric 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. | |
| The Cathlab Frontiers solutions are indicated for use in | |
| conjunction with single plane and biplane GE angiographic X-ray | |
| systems and imaging / data medical devices used in interventional | |
| and surgical Cathlab environments and cleared for commercial | |
| distribution. | |
| The Cathlab Frontiers solutions are integrated GE angiographic | |
| X-ray and imaging / data medical devices that simplify the end- | |
| to-end clinical workflow in the Cathlab by implementing: | |
| (1) communication protocols for exchanging and automatically | |
| synchronizing patient, exam, system, and image information | |
| between the angiographic X-ray systems and the imaging / data | |
| medical devices, | |
| (2) communication protocols for the control of imaging / data | |
| medical device functions from the angiographic X-ray systems | |
| user interface, | |
| (3) interfaces for displaying the imaging / data medical device | |
| output on the monitor display solutions of the GE angiographic | |
| X-ray systems. | |
| Technology: | The GE Angiographic, Fluoroscopic X-ray Systems employs the |
| same Solid State X-ray Imaging and Digital Flat-Panel Detector | |
| technology as its predicate devices. | |
| Determination of | Summary of Non-Clinical Tests: |
| Substantial Equivalence: | The Integration has been evaluated for electrical and |
| electromagnetic safety. The GE Angiographic, Fluoroscopic X- | |
| ray Systems and its applications and accessories comply with | |
| voluntary standards and applicable performance standards for | |
| radiation emitting products 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 specific qualification of 3rd party systems | |
| integrations: | |
| The criteria to qualify the integration of 3rd party imaging/data | |
| medical devices are based on the following aspects: | |
| • Shall be "FDA cleared/approved device" | |
| • Shall comply with one or more generic integration | |
| interfaces offered by the GE angiographic, fluoroscopic | |
| X-ray systems. | |
| Integration of devices shall be safe and effective and shall not raise different questions of safety and effectiveness than the predicate device(s). | |
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions, did not require clinical studies to support substantial equivalence as one of the criteria for integration rely on the fact that they are already cleared /approved devices by FDA. Integration does not introduce any new clinical information and the clinical information is pre-existing on the cleared or approved devices. | |
| Conclusion: | GE Healthcare considers the GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |
Section 5
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6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in blue, with the letters and the frame having the same shade of blue.
GE Healthcare 510(k) Premarket Notification Submission
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