(13 days)
This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms that contain the tube and solid state detector (either one or two), x-ray generator and a patient table.
This 510(k) submission (K081624) for the Toshiba America Medical Systems, Inc. INFX-8000F (Infinix CSi and Infinix DPi) is a model number change for an electrostatic fluoroscopic x-ray system. The 510(k) summary explicitly states "Model Number Change" as the reason for submission and refers to existing predicate devices (GE Innova 4100; 510(k) Control # K052412 and Toshiba DFP-8000D/FPD; 510(k) Control # K052884).
When the reason for submission is solely a model number change, or a change that does not introduce new technological characteristics or indications for use, the FDA's typically doesn't require new performance studies. Instead, the manufacturer demonstrates substantial equivalence by showing the device employs similar materials and processes as the predicate device(s) and complies with the same or equivalent standards.
Therefore, the provided document does not contain the acceptance criteria or a study demonstrating device performance against such criteria because it is a model change submission. The focus is on demonstrating that the new model number does not alter the fundamental safety or effectiveness characteristics established by the predicate devices.
Here's a breakdown based on the information provided, explicitly noting what is not applicable (N/A) due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
| Explanation: This submission is a model number change; therefore, specific performance acceptance criteria and associated study results for the INFX-8000F are not presented in this document. The device relies on the established performance of its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): N/A
- Data Provenance: N/A
Explanation: No new performance testing in humans was performed for this model change submission. The device's safety and effectiveness are established by its substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: N/A
- Qualifications of Experts: N/A
Explanation: No new clinical studies requiring expert ground truth were conducted for this model change.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A
Explanation: No new clinical studies requiring adjudication were conducted for this model change.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No
- Effect Size of Human Reader Improvement: N/A
Explanation: This submission does not involve a multi-reader multi-case study; it's a model number change, not a new device with software requiring such evaluation.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No
Explanation: This is a hardware-based x-ray system, not an AI/algorithm-only device, and its submission is for a model number change.
7. Type of Ground Truth Used:
- Type of Ground Truth: N/A
Explanation: No new clinical studies requiring ground truth were conducted for this model change.
8. Sample Size for the Training Set:
- Sample Size (Training Set): N/A
Explanation: As a hardware system with a model number change, there's no "training set" in the context of an algorithm's development.
9. How the Ground Truth for the Training Set Was Established:
- Method for Establishing Ground Truth: N/A
Explanation: Not applicable for a hardware device model number change.
Summary of Device Rationale for Acceptance:
The acceptance of the INFX-8000F is based on its substantial equivalence to legally marketed predicate devices:
The submission states, "The INFX-8000V is of comparable type and substantially equivalent to..." and "Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device." This implies that the safety and effectiveness for the INFX-8000F are effectively "inherited" from the performance demonstrated by these predicate devices, which would have undergone their own rigorous testing and review processes when they were initially cleared. The change to the device is specifically noted as a "Model Number Change," indicating no fundamental alterations in the technology, intended use, or safety/effectiveness profile compared to the predicate.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.