(157 days)
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, 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.
GE Healthcare IGS interventional x-ray systems are designed to perform monoplane, biplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration). 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.
DiscoveryTM IGS 7 OR, DiscoveryTM IGS 7, InnovaTM IGS 6, InnovaTM IGS 5 are the 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 (monoplane or biplane), an x-ray imaging table or the interface to the radiologic table, an x-ray tube assembly (per plane), an x-ray power unit with its exposure control unit (per plane), an x-ray imaging chain (including a digital detector and an image processing unit, per plane).
DiscoveryTM IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 740 configuration with a square 41cm digital detector or in IGS 730 configuration with a square 31cm digital detector. These product configurations are declined in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE OR table
Discovery™ IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed with a square 41cm digital detector or with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Discovery™ IGS 7 OR includes a flat table top configuration 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.
Innova™ IGS 6 is a biplane system (a dual C-arm positioner, LC and LP gantry) and is provided with an Omega V table. Innova™ IGS 6 is proposed in IGS 630 configuration with a square 31cm digital detector per plane or in IGS 620 configuration with a square 20.5cm digital detector per plane. These product configurations are available in Standard configuration.
Innova™ IGS 5 is a monoplane system (C-arm positioner with LC gantry) and is proposed with a square digital detector of 41cm or 31cm or 20.5cm. These product configurations are available in Standard configuration with Innova-IQ or Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with GE OR table.
The purpose of this Premarket Notification is for 2 changes:
First, a change of the collision management of Discovery™ IGS 7 OR to enable the use of a Neurosurgical head holder (skull clamp). During trauma neck surgery and stereotactic navigation, a gantry collision with the skull clamp could result in patient harm, delayed or halted surgical procedures. The subject of this submission is to introduce a functionality for adapting the collision avoidance model to the geometrical characteristic of the skull clamp and patient position with a guard volume defined and validated by the operator during the procedure preparation phase. During the procedure, the collision avoidance software will slow down and stop gantry and/or table axis to minimize risk of collision of a motorized moving part with the patient head or the skull clamp. In this configuration, the OR table, the Neurosurgical head holder and its support are from third party Medical device manufacturers. As a consequence, there is no mechanical interfaces between these devices and the Discovery™ 7 OR. Those devices are registered and cleared in the US. The Neurosurgical head holder is from Pro Med Instrument manufacturer (K063494). The OR table is the registered Magnus OR
The second change is for a primary technology change, adding an optional wireless footswitch in the examination room to Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7 and Discovery™ IGS 7 OR. It provides identical functionalities as the wired footswitch for the control of X-ray on and off, and for the control of the table top brake release.
Labelling is updated for the enhanced collision management for the use with Neurosurgical head holder and for the wireless footswitch.
This submission describes modifications to existing GE Healthcare IGS interventional X-ray systems (Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™ IGS 7 OR). The changes are primarily:
- Enhanced collision management for Discovery™ IGS 7 OR: This modification allows the use of a Neurosurgical head holder (skull clamp) by dynamically adapting the collision avoidance model.
- Optional wireless footswitch: This change adds a wireless footswitch with identical functionalities to the existing wired footswitch for controlling X-ray on/off and table-top brake release.
The document states that these modifications did not require clinical studies to support substantial equivalence and that the intended use and indications for use remain unchanged from the predicate devices. Therefore, the information typically requested regarding acceptance criteria, device performance, ground truth, and reader studies is not explicitly provided in the context of a new efficacy study. Instead, the study focuses on proving the safety and effectiveness of the modifications through non-clinical means and demonstrating substantial equivalence to the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no new clinical efficacy study was conducted for these modifications, a table of specific clinical acceptance criteria and device performance metrics (e.g., sensitivity, specificity, accuracy) is not applicable or provided. The "acceptance criteria" here are aligned with safety and effectiveness demonstrated through non-clinical testing and adherence to standards.
| Acceptance Criteria (Implied from the study objectives) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Collision Management: | |
| - Avoidance of collision with skull clamp and patient head | - Collision avoidance software successfully slows down and stops gantry/table axis to minimize risk. |
| - Safety and effectiveness with neurosurgical holder | - Identified hazards mitigated; expansion to X-ray and surgical procedures requiring neurosurgical holder is within current indications. |
| Wireless Footswitch: | |
| - Identical functionality to wired footswitch | - Provides identical functionalities as the wired footswitch. |
| - No impact on X-ray imaging performance | - No impact on X-ray imaging performance. |
| - Electrical and software interface unchanged | - Does not change existing electrical or software interface. |
| - No adverse events due to wireless technology (e.g., EMC, coexistence) | - Meets EMC and coexistence testing requirements per "Radio Frequency Wireless Technology in Medical Devices" Guidance. |
| - Compliance with relevant standards (IEC 60601-2-43, IEC 62304, IEC 62366) | - Conformity to 21CFR 1020.30 and 32, and with voluntary standards IEC 60601-2-43:2010, IEC 62304 (2006) and IEC 62366 (2007). |
| - Design inputs, user requirements, and risk mitigations met | - Design verification and validation testing completed with acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set data from patients or images is described in this submission for the modifications. The testing was non-clinical (simulated use, usability validation, product verification, safety testing).
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed in-house by GE Healthcare.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no external ground truth establishment for a clinical test set was performed. Usability validation involved "representatives of actual users, with knowledge of the customer needs and clinical applications," but this does not constitute establishing a ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states that the changes "did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted in the context of diagnostic accuracy. The collision avoidance functionality is integrated into the system, and its "performance" was assessed via risk management, simulated use, and verification testing to ensure it functions as intended to prevent collisions. The wireless footswitch is a control mechanism, not an algorithm for image interpretation.
7. The Type of Ground Truth Used
- For Collision Management: The ground truth for collision avoidance was based on engineering specifications, physical constraints, and risk analysis to ensure the system prevents physical contact with the skull clamp and patient. This was verified through simulated use and product verification testing against defined requirements and hazard mitigations.
- For Wireless Footswitch: The ground truth for the wireless footswitch was its functional equivalence to the wired footswitch. This was verified by ensuring identical functionalities and confirming that it did not introduce new safety or performance issues through safety testing (EMC, coexistence) and product verification.
8. The Sample Size for the Training Set
Not applicable. This submission concerns modifications to existing devices and does not describe the development of a new artificial intelligence algorithm that would require a "training set" in the conventional machine learning sense. The collision avoidance logic is likely based on deterministic geometric models and sensor inputs.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no "training set" described for a new AI algorithm.
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November 2, 2018
GE Healthcare Michel Genuer Senior Regulatory Affairs Program Manager 283 Rue De La Miniere 78530 Buc, France
Re: K181403
Trade/Device Name: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Codes: OWB, JAA, IZI, OXO Dated: May 17, 2018 Received: May 29, 2018
Dear Michel Genuer:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181403
Device Name
Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™ IGS 7 OR
Indications for Use (Describe)
The angiographic X-ray systems are indicated for use for patients from newborn to geriative in 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and the circle has a decorative border. The logo is simple and recognizable, and it is associated with a well-known company.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 31-October-2018 |
|---|---|
| Submitter: | GE MEDICAL SYSTEMS SCS283 RUE DE LA MINIERE78530 BUC, FRANCE |
| Primary Contact Person: | Michel GENUERSenior Regulatory Affairs Program ManagerGE Healthcare, (GE MEDICAL SYSTEMS SCS)Tel: (+33)-1-3070-4741Email: michel.genuer@ge.com |
| Secondary Contact Persons: | GE Healthcare, (GE MEDICAL SYSTEMS SCS)Philip MalcaRegulatory Affairs DirectorTel: (+33)-6 4637 3852Email: philip.malca@ge.comMaxime CORNIERERegulatory Affairs LeaderTel: (+33)-1-3070-4153Email: maxime.corniere@ge.com |
| Device Trade Name: | Innova™ IGS 5, Innova™ IGS 6, Discovery™ IGS 7, Discovery™IGS 7 OR |
| Common/Usual Name: | interventional fluoroscopic x-ray system, angiographic x-ray system |
| Regulation description: | Image-intensified fluoroscopic x-ray system |
| Regulation Number: | 21CFR 892.1650 |
| Product Code: | OWB |
| Subsequent Product Codes | JAA, IZI and OXO for Discovery™ IGS 7 and Discovery™ IGS 7 OR. |
| Classification: | Class II |
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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are decorative swirls around the perimeter of the circle, adding a touch of elegance to the design.
| Predicate Device(s): | Trade Name: | GE Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray systems with Cathlab Frontiers solutions. | |
|---|---|---|---|
| 510(k) Clearance: | K122457 | ||
| Regulation Name: | Image-Intensified fluoroscopic x-ray system | ||
| Regulation Number: | 21CFR 892.1650 | ||
| Classification: | Class II | ||
| Product Code: | Primary product code: OWBSecondary Product codes: IZI, JAA | ||
| Trade Name: | Discovery IGS TM 740 | ||
| 510(k) Clearance: | K133278 | ||
| Regulation Name: | Image-Intensified fluoroscopic x-ray system | ||
| Regulation Number: | 21CFR 892.1650 | ||
| Classification: | Class II | ||
| Product Code: | Primary product code: OWBSecondary Product codes: JAA, OXO | ||
| Device Description: | GE Healthcare IGS interventional x-ray systems are designed to perform monoplane, biplane fluoroscopic x-ray examinations to provide the imaging information needed to perform minimally invasive interventional X-Ray imaging procedures (standard configuration). 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.DiscoveryTM IGS 7 OR, DiscoveryTM IGS 7, InnovaTM IGS 6, InnovaTM IGS 5 are the 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 (monoplane or biplane), an x-ray imaging table or the interface to the radiologic table, an x-ray tube assembly (per plane), an x-ray power unit with its exposure control unit (per plane), an x-ray imaging chain (including a digital detector and an image processing unit, per plane).DiscoveryTM IGS 7 is a monoplane system (C-arm with mobile AGV gantry) and is proposed in IGS 740 configuration with a square 41cm digital detector or in IGS 730 configuration with a square 31cm digital detector. These product configurations are declined in sub configurations: Standard or OR configuration. The Innova-IQ table in the OR configuration is the GE OR table |
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of white, stylized water droplets or flourishes, giving the logo a distinctive and recognizable appearance.
| Discovery™ IGS 7 OR is a monoplane system (C-arm positioner with mobile AGV gantry) and is proposed with a square 41cm digital detector or with a square 31cm digital detector configuration. This is the product model compatible with a qualified configuration of the Maquet Magnus OR table system. This product model is provided with a table integration kit. The Magnus OR table configuration compatible with Discovery™ IGS 7 OR includes a flat table top configuration 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. |
|---|
| Innova™ IGS 6 is a biplane system (a dual C-arm positioner, LC and LP gantry) and is provided with an Omega V table. Innova™ IGS 6 is proposed in IGS 630 configuration with a square 31cm digital detector per plane or in IGS 620 configuration with a square 20.5cm digital detector per plane. These product configurations are available in Standard configuration. |
| Innova™ IGS 5 is a monoplane system (C-arm positioner with LC gantry) and is proposed with a square digital detector of 41cm or 31cm or 20.5cm. These product configurations are available in Standard configuration with Innova-IQ or Omega V table or Omega IV table (IGS 520 configuration only); or in OR configuration with GE OR table. |
| The purpose of this Premarket Notification is for 2 changes:First, a change of the collision management of Discovery™ IGS 7 OR to enable the use of a Neurosurgical head holder (skull clamp). During trauma neck surgery and stereotactic navigation, a gantry collision with the skull clamp could result in patient harm, delayed or halted surgical procedures. The subject of this submission is to introduce a functionality for adapting the collision avoidance model to the geometrical characteristic of the skull clamp and patient position with a guard volume defined and validated by the operator during the procedure preparation phase. During the procedure, the collision avoidance software will slow down and stop gantry and/or table axis to minimize risk of collision of a motorized moving part with the patient head or the skull clamp. In this configuration, the OR table, the Neurosurgical head holder and its support are from third party Medical device manufacturers. As a consequence, there is no mechanical interfaces between these devices and the Discovery™ 7 OR. Those devices are registered and cleared in the US. The Neurosurgical head holder is from Pro Med Instrument manufacturer (K063494). The OR table is the registered Magnus OR |
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. The circle and the letters are blue, and there are white flourishes around the circle.
| The second change is for a primary technology change, adding anoptional wireless footswitch in the examination room to Innova™IGS 5, Innova™ IGS 6, Discovery™ IGS 7 and Discovery™ IGS 7 OR. Itprovides identical functionalities as the wired footswitch for thecontrol of X-ray on and off, and for the control of the table top brakerelease.Labelling is updated for the enhanced collision management for theuse with Neurosurgical head holder and for the wireless footswitch. | |
|---|---|
| Intended Use: | The angiographic X-ray systems are indicated for use for patientsfrom newborn to geriatric in generating fluoroscopic and rotationalimages of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.Additionally, with the OR table, the angiographic X-ray systems areindicated for use in generating fluoroscopic and rotational imagesof human anatomy for image-guided surgical procedures. |
| The OR table is suitable for interventional and surgical procedures. | |
| Indication for Use: | The angiographic X-ray systems are indicated for use for patientsfrom newborn to geriatric in generating fluoroscopic and rotationalimages of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.Additionally, with the OR table, the angiographic X-ray systems areindicated for use in generating fluoroscopic and rotational imagesof human anatomy for image-guided surgical procedures.The OR table is suitable for interventional and surgical procedures. |
| Technology: | The modified GE Healthcare IGS Interventional X-Ray systemsemploy the same fundamental scientific technology as theunmodified predicate devices.The change to enable the dynamic adaptation of the collisionavoidance model with a model fitted to the needs of the operatorand of the procedure, is a software change. The collision avoidancesoftware is the same as with the predicate devices. The change isthe dynamic adaptation of the collision avoidance model. All causesof hazard relative to the use of a Neurosurgical head holder incombination with the Discovery™ IGS 7 OR have been identified andmitigated.The optional wireless footswitch consists of a footswitch containinga transmitter system, a receiver that is installed near the connectionplug of the wired footswitch (at the table base of the Innova-IQtable, of the Omega table or at the Discovery Control Center tableside cart), and a charger. The introduction of this wireless footswitchdoes not change existing electrical or software interface of thepredicate devices. The new option is equivalent to the wiredfootswitch on the predicate in that the functionalities are identical.The communication between the footswitch emitter and the |
| receiver is performed via a proprietary protocol using 2.4 GHz radiofrequency technology.The wireless option provides placement flexibility and reduces cableclutter.Both changes have no impact on x-ray imaging performance.The intended use and indications for use remain unchanged fromthose of the predicate devices. The expansion to x-rayinterventional, minimally invasive surgery and conventional opensurgery procedures requiring the use of a neurosurgical holder incombination with Discovery™ IGS 7 OR is included in Discovery IGS7 OR's indications for use of interventional, image-guided surgicaland surgical procedures. | |
| Determination of SubstantialEquivalence: | The modifications to Discovery™ IGS 7 OR collision managementsoftware and to IGS interventional x-ray systems for the wirelessfootswitch were developed under the GE Healthcare's designcontrols processes and overall quality management system. |
| IGS interventional x-ray systems conform to 21CFR 1020.30 and 32,and with voluntary standards IEC 60601-2-43:2010, IEC 62304(2006) and IEC 62366 (2007). | |
| Risk management activities using risk analysis to identify anypotential issues incorporating the wireless footswitch and the use ofa skull clamp were performed. These issues were assessed andmitigated. | |
| The following testing was used to assess safety and effectivenessand, thus, to establish the substantial equivalence with thepredicate devices. | |
| Summary of Non-Clinical Tests:The following quality management measures were applied to thedevelopment of these modifications:Simulated Use Testing ensured the system conforms to userneeds and intended uses through simulated clinicalworkflow using step-by step procedures that would beperformed for representative clinical applications. Usability validation testing was conducted to confirm thatthe product can be used safely and effectively. Participantswere representatives of actual users, with knowledge of thecustomer needs and clinical applications. Product verification ensured the system conforms to itsrequirements including hazard mitigations riskmanagement requirements. The verification testsconfirmed that design output meet design inputrequirements. Tests were executed at component, softwaresubsystems and system levels. | |
| Safety testing were performed to confirm that the productmeets the requirements of the aforementioned standards.It includes the EMC and coexistence testing per the "RadioFrequency Wireless Technology in Medical Devices"Guidance for Industry and Food and Drug AdministrationStaff issued on August 14, 2013 (Wireless Guidance). | |
| Summary of Clinical Tests:The subject of this premarket submission, change to Discovery™ IGS7 OR collision management to enable the use of a neurosurgicalhead holder and the change to add an optional wireless footswitchin the examination room to GE Healthcare interventional x-raysystems did not require clinical studies to support substantialequivalence. The expansion to x-ray and surgical proceduresrequiring the use of a neurosurgical holder in combination withDiscovery™ IGS 7 OR is included in Discovery IGS 7 OR's indicationsfor use of image-guided surgical and surgical procedures. It does notintroduce new indications for use. Substantial equivalence relies onclinical information that is pre-existing on the cleared predicatedevices.Design verification and validation testing were performed toconfirm that the safety and effectiveness of the devices has not | |
| been affected. The test plans and results have been executed withacceptable results. | |
| Conclusion: | GE Healthcare considers that the Discovery™ IGS 7 OR incorporatingthe enhanced collision management for the use of a skull clamp orthat a GE Healthcare IGS interventional x-ray system incorporatingthe optional wireless footswitch to be as safe and as effective andsubstantially equivalent to the predicate devices.This conclusion is based on the fact that Discovery™ IGS 7 ORincorporating the collision management optimization for the use incombination with the Neurosurgical head holder and that GEHealthcare interventional x-ray systems incorporating the optionalwireless footswitch have: the same indications for use as their predicate devices. The modified devices have the same technologicalcharacteristics as their predicate devices. Verification and Validation testing has demonstrated thatthe design inputs, user requirements, and risk mitigationshave been met. Engineering bench testing per the FDA guidance Radiofrequency wireless technology in medical devices as well asconformance to IEC standards and guidance documentswere provided. |
| The successful completion of the above testing was sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence. |
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§ 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.