Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
Device Facts
| Record ID | K232344 |
|---|---|
| Device Name | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR |
| Applicant | GE Medical Systems SCS |
| Product Code | OWB · Radiology |
| Decision Date | Oct 11, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 nonvascular, 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.
Device Story
Monoplane interventional X-ray systems (Allia IGS 3, 5, 7, 7 OR) designed for minimally invasive interventional and surgical procedures in hybrid ORs or clinics. System components include C-arm positioner, X-ray table, X-ray tube assembly (Performix Pulsar), high-voltage generator (Gaia), and imaging chain with digital detector. Inputs: X-ray radiation passing through patient anatomy. Transformation: X-ray tube generates radiation; digital detector captures signals; image processing unit reconstructs fluoroscopic and rotational images. Output: Real-time fluoroscopic and rotational images displayed for clinicians. Operated by physicians/technicians. Benefits: Provides visualization for image-guided interventions and surgeries. Re-design of X-ray source assembly (Performix Pulsar with liquid metal rotor bearing) is primary change from predicate.
Clinical Evidence
Bench testing only. No clinical data required. Verification and validation included risk management, software testing, and image quality/dose performance assessment using standard IQ metrics and anthropomorphic phantoms.
Technological Characteristics
Monoplane fluoroscopic X-ray system. Components: Performix Pulsar X-ray tube (tri-filament, liquid metal rotor), Gaia high-voltage generator (100 kW), digital detector (NGB20/Dynamic 31). Cooling: Closed-loop remote oil cooler. Standards: IEC 60601-1 Ed 3.1, IEC 60601-1-2 Ed 4.0, IEC 60601-1-3 Ed 2.1, IEC 60601-2-28 Ed 3.0, IEC 60601-2-43 Ed 2.2, NEMA XR-27.
Indications for Use
Indicated for patients from newborn to geriatric requiring fluoroscopic and rotational X-ray imaging for cardiovascular, vascular, nonvascular, diagnostic, interventional, and image-guided surgical procedures.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Innova IGS 5, Discovery IGS 7, Discovery IGS 7 OR (K181403)
Submission Summary (Full Text)
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October 11, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
GE Medical Systems SCS % Hubert Welsch Associate Regulatory Affairs Program Manager 283 Rue De La Miniere Buc, 78530 FRANCE
Re: K232344
Trade/Device Name: Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI and OXO Dated: September 14, 2023 Received: September 15, 2023
Dear Hubert Welsch:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K232344
Device Name
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
Indications for Use (Describe)
The angiographic X-Ray systems are indicated for use for patients from newborn to generating fluoroscopic and rotational images of human anatomy for cardiovascular, 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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 27-September-2023 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE MEDICAL SYSTEMS SCS<br>283 RUE DE LA MINIERE<br>78530 BUC, FRANCE |
| Primary Contact<br>Person: | Hubert WELSCH<br>Associate Regulatory Affairs Program Manager<br>GE HealthCare (GE MEDICAL SYSTEMS SCS)<br>Tel: (+33)-1-3070-3847<br>Email: hubert.welsch@ge.com |
| Secondary Contact<br>Person: | Michelle HUETTNER<br>Regulatory Affairs Director IGT and Oncology<br>GE HealthCare<br>Tel: +1 (901) 558-8035<br>Email: michelle.huettner@ge.com |
| Device Trade Name: | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR |
| Common/Usual<br>Name: | Interventional fluoroscopic x-ray system, angiographic x-ray system |
| Regulation<br>Description: | Image-intensified fluoroscopic x-ray system |
| Regulation Number: | 21 CFR 892.1650 |
| Product Code: | OWB |
| Subsequent Product<br>Codes | JAA, IZI; and OXO for Allia IGS 7 and Allia IGS 7 OR. |
| Classification: | Class II |
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Image /page/4/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized design. The text is also purple and is written in a clean, sans-serif font.
| Predicate Device(s): | K181403: Innova IGS 5, Discovery IGS 7, Discovery IGS 7 OR |
|----------------------|-------------------------------------------------------------------------------------------|
| | Common/Usual Name: Interventional fluoroscopic x-ray system,<br>angiographic x-ray system |
| | Regulation description: Image-intensified fluoroscopic x-ray system |
| | Regulation Number: 21 CFR 892.1650 |
| | Product Code: OWB |
| | Subsequent Product Codes: JAA, IZI; and OXO for Discovery IGS 7 and 7 OR |
| | |
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Image /page/5/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a simple, sans-serif font, also in purple.
| Device Description: | GE HealthCare IGS interventional x-ray systems are designed to perform monoplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration).<br><br>Additionally, in the OR configuration (with an OR Table), these systems allow to perform surgery and X-Ray image guided surgical procedures in a hybrid Operating Room.<br><br>Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR are monoplane GE HealthCare IGS interventional X-Ray system product models. Each product model is designed with a set of components that are combined into different configurations for providing specialized interventional x-ray systems. GE HealthCare IGS interventional x-ray system consists of a C-arm positioner, an x-ray table or the interface to the radiologic table, an x-ray tube assembly, an x-ray power unit with its exposure control unit, an x-ray imaging chain (including a digital detector and an image processing unit).<br><br>Allia IGS 5 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed in IGS 530 configuration with a square digital detector of 31cm (also called 30 cm configuration) or in IGS 520 configuration with a square digital detector of 20.5cm (also called 20 cm configuration). These product configurations are available in Standard configuration with Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with Innova-IQ GE HealthCare OR table.<br><br>Allia IGS 3 is a monoplane system (C-arm positioner with L-shaped gantry) and is proposed with a square digital detector of 31cm. This product is available in Standard configuration with Omega V table. Allia IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 730 configuration with a square 31cm digital detector (also called 30 cm configuration). This product configuration is described in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE HealthCare OR table. Allia IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed in IGS 730 OR configuration with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR |
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| | |
| | table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Allia IGS 7 OR includes flat table top configurations for Interventional X-Ray imaging and surgery procedures, an optional universal table top (table top with articulated joints) to enable expansion to surgical procedures requiring advanced patient positioning and with X-Ray imaging capabilities. A set of Magnus OR table accessories is included in the compatible configuration.<br><br>The purpose of this Premarket Notification is for the re-design of the x-ray source assembly.<br><br>Allia IGS 3, Allia IGS 5 in IGS 520 and IGS 530 configurations, Allia IGS 7 |
| | in IGS 730 configuration, and Allia IGS 7 OR in IGS 730 OR configuration will be improved and will be marketed as Allia IGS 3 Pulse, Allia IGS 5 Pulse, Allia IGS 7 Pulse, and Allia IGS 7 OR Pulse. All these four models may also be designated with the marketing name Allia IGS Pulse. |
| Intended Use /<br>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 nonvascular, diagnostic and interventional procedures.<br><br>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.<br><br>The intended use and indications for use are unchanged from the predicate device. |
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| Subsystem | Innova IGS 5, in IGS 520 and IGS 530 configurations<br>Discovery IGS 7 in IGS 730 configuration<br>Discovery IGS 7 OR in IGS 730 OR configuration<br>(Predicate Devices, K181403) | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR (Proposed Devices) | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| x-ray tube | Performix 160A<br>- Bi-filament cathode<br>- 0.3, 0.6, 1.0 focal spot sizes<br>- Ball bearing | Performix Pulsar<br>- Tri-filament cathode<br>- 0.3, 0.5, 0.8 focal spot sizes<br>- Liquid Metal rotor bearing | |
| Tube cooling unit | Closed-loop remote water chiller | Closed-loop remote oil cooler | |
| High-voltage generator | Jedi 100 VASC 1T<br>Peak power: 100 kW | Gaia<br>Peak power: 100 kW | |
| Collimation | CARD AMP<br>20 cm config<br>2 pairs of collimation blades.<br>0.1, 0.2, 0.3, 0.6 and 0.9 mm of copper Spectral filtration.<br>1 integrated contour filter blades. | AF DSA 01<br>30 cm config<br>2 pairs of collimation blades.<br>0.1, 0.2, 0.3 mm of copper Spectral filtration.<br>3 integrated contour filter blades. | MFD<br>2 pairs of collimation blades.<br>0.1, 0.2, 0.3, 0.6 and 0.9 mm of copper Spectral filtration<br>1 integrated contour filter blades. |
| | | | |
| | Solid state<br>digital<br>detector | -Model NGB20 in 20cm<br>Configuration<br>-Model Dynamic 31 in 30cm<br>Configuration, accompanied<br>by a detector conditioner<br>and removable anti-scatter<br>grids | No change. Identical. |
| | Standards | IEC 60601-1 Ed. 3.0 | IEC 60601-1 Ed. 3.1 |
| | | IEC 60601-1-2 Ed 4.0 | IEC 60601-1-2 Ed 4.0 |
| | | IEC 60601-1-3 Ed 2.0 | IEC 60601-1-3 Ed 2.1 |
| | | IEC 60601-2-28 Ed 2.0 | IEC 60601-2-28 Ed 3.0 |
| | | IEC 60601-2-43 Ed. 2.0 | IEC 60601-2-43 Ed. 2.2 |
| | | NEMA XR-27 | NEMA XR-27 |
| Determination<br>of Substantial<br>Equivalence: | The changes described above do not change the fundamental control<br>mechanism, operating principle, energy type, and do not change the intended<br>use from the predicate devices. | | |
| | The Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR has completed testing and<br>is in compliance with IEC60601-1 Ed. 3.1 (FDA Recognition #19-4) and its<br>associated collateral and particular standards, 21 CFR Subchapter J, and<br>NEMA standard XR-27. The devices have successfully completed all applicable<br>testing underthe GE HealthCare quality system and design control. They were<br>designed and are manufactured under the Quality System Regulations of 21<br>CFR 820 and ISO 13485. The following quality assurance measures were<br>applied to the development of the system: | | |
| | • Risk Analysis | | |
| | • Required Reviews | | |
| | • Design Reviews | | |
| | • Testing on unit level (Module verification) | | |
| | • Integration testing (System verification) | | |
| | • Performance testing (Verification) | | |
| | • Safety testing (Verification) | | |
| | • Simulated use testing (Validation) | | |
| | The following FDA guidance documents were utilized in the development of<br>the devices: | | |
| | • Electromagnetic Compatibility (EMC) of Medical Devices (06-Jun-2022) | | |
| | • Off-The-Shelf Software Use in Medical Devices (FDA, 27-Sep-2019) | | |
| | • Cybersecurity for Networked Medical Devices Containing Off-the-Shelf<br>(OTS) Software (14-Jan-2005) | | |
| | • Content of Premarket Submissions for Management of Cybersecurity in<br>Medical Devices (02-Oct-2014) | | |
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Image /page/8/Picture/0 description: The image contains the logo for GE Healthcare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized design. The text is also purple and uses a sans-serif font.
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Image /page/9/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in purple. The text is aligned to the right of the emblem.
| | Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices (11-May-2005) Policy Clarification for Certain Fluoroscopic Equipment Requirements<br>(FDA, 08-May-2019) Pediatric Information for X-ray Imaging Device Premarket Notifications<br>(28-Nov-2017) GE HealthCare believes the Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR<br>systems are of comparable type and substantially equivalent to the cleared<br>predicate systems Innova IGS 5, Discovery IGS 7, Discovery IGS 7 OR<br>(K181403).<br>The substantial equivalence was also based on software documentation for a<br>"Moderate" level of concern device.<br>Summary of Additional Testing:<br><b>Non-Clinical Testing:</b><br>The verification and validation testing have been successfully completed as<br>required by design control procedures under GE HealthCare's quality system.<br>This includes risk management, software verification and validation testing as<br>well as image quality and dose performance using standard IQ metrics and QA<br>phantoms.<br>Additional engineering bench testing was performed to substantiate the<br>quantitative performance claims related to the new x-ray source assembly.<br>Additionally, testing was performed to demonstrate the overall imaging<br>performance of Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR systems using a<br>wide variety of anthropomorphic phantoms.<br><b>Clinical Testing:</b><br>The Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR systems can be fully tested<br>on the engineering bench thus no additional clinical testing was required to<br>support substantial equivalence. |
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| Conclusion: | Based on the conformance to standards, development under the GE<br>HealthCare quality system, and the engineering testing provided, GE<br>HealthCare believes that the Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR are<br>as safe and effective, and perform in a substantially equivalent manner to<br>the predicate devices Innova IGS 5, Discovery IGS 7, Discovery IGS 7<br>OR (K181403). |
