(182 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 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 proposed device, Discovery IGS 740 is an interventional fluoroscopic x-ray system/ x-ray angiographic system with a 41 cm square digital detector.
Discovery IGS 740 is a new product model of the GE Discovery IGS interventional fluoroscopic x-ray system/ x-ray angiographic system platform with a 41cm square digital detector. GE Discovery IGS x-ray angiographic systems are based on the GE laser guided gantry. The 41cm square digital detector of the cleared predicate device Innova IGS 540 K122457 is mounted on the GE Discovery IGS gantry. This gantry is the same gantry as the Discovery IGS 730 predicate device, originally cleared with K113403.
Discovery IGS 740 is proposed in an Interventional configuration and in an OR configuration (with OR table) for the indications for use of surgery.
Discovery IGS 740 has no additional indications for use compared with the predicate device Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions K122457.
Here's a breakdown of the acceptance criteria and study information for the GE Healthcare Discovery IGS 740, based on the provided 510(k) summary:
This device is an interventional fluoroscopic x-ray system, and the provided document indicates it is a modification of an existing device rather than a completely new AI-powered diagnostic tool. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the new configuration remains as safe and effective as the predicate devices, rather than establishing novel clinical performance metrics for a new diagnostic claim.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a modification of an existing device, the "acceptance criteria" revolve around demonstrating that the new configuration meets established safety and performance standards for such X-ray systems, and does not negatively impact existing functionalities. The document refers to compliance with voluntary and mandatory standards as acceptance criteria and summarizes non-clinical tests to confirm performance.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Evidence |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1 (Medical Electrical Equipment – General requirements for basic safety and essential performance) | "Safety testing is performed to confirm that the product meets the requirements of the standards listed in Table 1." (Table 1 includes IEC 60601-1). The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Specific Safety for Interventional X-ray Equipment | Compliance with IEC 60601-2-43 (Particular requirements for the safety of X-ray equipment for interventional procedures) | As above, confirmed through safety testing against standards in Table 1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (General requirements for safety – Collateral standard: Electromagnetic Compatibility – Requirements and tests) | As above, confirmed through safety testing against standards in Table 1. |
| Radiation Protection in Diagnostic X-ray Equipment | Compliance with IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) and FDA Federal Performance Standard (21 CFR 1020.30-32) | "Dose verification... are part of system level verification." Confirmed through safety testing against standards in Table 1. The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Usability | Compliance with IEC 60601-1-6 (General requirements for basic safety and essential performance - Collateral standard : Usability) | "Usability validation testing is conducted to confirm that the product can be used safely and effectively. The participants for these tests are licensed and/or clinically trained healthcare providers or users." The non-clinical testing confirms the Discovery IGS 740 meets user requirements and intended use. |
| Functional Equivalence & Design Input Requirements | The new combination (gantry + detector) does not negatively impact safety and effectiveness compared to predicate devices. System conforms to user needs and intended uses. Design output meets design input requirements. Performance imaging (uniformity, contrast, detail for Innova CT/CA-CBCT). Software reliability. Collision avoidance effectiveness. | "Simulated Use Testing ensures the system conforms to user needs and intended uses through simulated clinical workflow..." "Product verification ensures the system conforms to its requirements including hazard mitigations risk management requirements. The verification tests confirm that design output meets design input requirements. Tests are executed at component, software subsystems and system levels." "Performance imaging of Innova CT (CA-CBCT) has been confirmed with bench testing for uniformity, contrast and detail imaging performances." "Software reliability is verified through intensive cycling of the system. The cycling tests use scenarios that simulate clinical workflow..." The collision avoidance system was adapted and "does not impact the safety and effectiveness." |
| No New Indications for Use | Maintain the same indications for use as the predicate device(s). | "Discovery IGS 740 has no additional indications for use compared with the predicate device Innova/Innova IGS/Discovery IGS/Optima angiographic, fluoroscopic X-ray Systems with Cathlab Frontiers solutions K122457." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation relied entirely on non-clinical tests, including:
- Simulated Use Testing: Ensures conformity to user needs and intended uses through simulated clinical workflow. The number of simulated scenarios or specific "cases" is not provided.
- Usability Validation Testing: Involved licensed and/or clinically trained healthcare providers/users. The number of participants is not provided.
- Product Verification: Tests at component, software subsystems, and system levels, including dose verification, image quality verification, and functional testing.
- Bench Testing: For performance imaging of Innova CT (CA-CBCT) for uniformity, contrast, and detail.
- Software Reliability Cycling Tests: Used scenarios simulating clinical workflow.
Data Provenance: The studies are non-clinical, meaning they don't involve retrospective or prospective human patient data acquisition for this specific submission. The "clinical information" mentioned for substantial equivalence relies on pre-existing data from the cleared predicate device (K023178).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts for Usability Validation Testing: "licensed and/or clinically trained healthcare providers or users." The specific number and exact qualifications (e.g., years of experience, specialty) are not provided.
- Experts for Clinical Ground Truth: No new clinical ground truth was established by experts for this submission. The device relies on the established safety and efficacy of its predicate devices, which would have had expert involvement in their original clearances.
4. Adjudication Method for the Test Set
Since no traditional clinical "test set" with ground truth requiring adjudication was performed for this 510(k) (as it did not require clinical studies), there is no adjudication method described in the document. The evaluations were non-clinical, focusing on compliance with engineering standards, simulated use, and usability.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device itself is an X-ray imaging system, not an AI-powered diagnostic algorithm that assists human readers in lesion detection or diagnosis. This submission focuses on hardware and system changes, not reader performance.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done in the context of an AI algorithm's diagnostic performance. The "algorithm" here refers to the system's operational software and collision avoidance system, which were verified for functionality, safety, and reliability through non-clinical testing, not for standalone diagnostic accuracy.
7. Type of Ground Truth Used
For this specific submission, the "ground truth" used was primarily engineering specifications, established safety standards, and functional requirements (e.g., image quality metrics like uniformity, contrast, detail validated by bench testing; successful operation of the collision avoidance system; adherence to usability principles). No new pathology, expert consensus on patient outcomes, or similar clinical ground truth was generated as part of this submission, as it did not involve new clinical studies.
8. Sample Size for the Training Set
Not applicable. This submission describes an X-ray imaging system, not a machine learning or AI algorithm that requires a "training set" of data for learning diagnostic patterns. The software verification involved "intensive cycling of the system" using "scenarios that simulate clinical workflow," but this is not analogous to training an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not an AI/ML device in the sense of requiring a training set with associated ground truth for diagnostic learning.
§ 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.