(44 days)
The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.
This 510(k) summary for the Omega Medical Imaging e-VIEW radiographic/fluoroscopy system does not contain the detailed study information typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards.
Therefore, many of the requested categories regarding acceptance criteria and study particulars cannot be directly answered from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied or stated) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Safety Compliance | Compliance with 21 CFR 1020.30 | The e-VIEW systems will comply with these requirements. |
| Compliance with 21 CFR 1020.31 | The e-VIEW systems will comply with these requirements. | |
| Compliance with 21 CFR 1020.32 | The e-VIEW systems will comply with these requirements. | |
| Compliance with IEC 60601-1 | The e-VIEW systems will comply with this standard. | |
| Compliance with IEC 60101-1-2 | The e-VIEW systems will comply with this standard. | |
| Compliance with IEC 60601-1-3 | The e-VIEW systems will comply with this standard. | |
| Compliance with IEC 60601-2-7 | The e-VIEW systems will comply with this standard. | |
| Compliance with IEC 60601-2-28 | The e-VIEW systems will comply with this standard. | |
| Compliance with IEC 60601-2-32 | The e-VIEW systems will comply with this standard. | |
| Compliance with UL 60601-1 | The e-VIEW systems will comply with this standard. | |
| Compliance with CAN/USA C22.2 No.601.1-M90 | The e-VIEW systems will comply with this standard. | |
| Intended Use Equivalence | Use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. | The e-VIEW systems are intended for use in these applications, demonstrating equivalence to predicate devices which also serve these purposes. |
| Hazard Equivalence | No new indications for use. | Stated: "The Omega e-VIEW systems do not introduce any new indications for use." |
| No new potential hazards. | Stated: "nor does the use of the device result in any new potential hazard." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document is a 510(k) summary focusing on substantial equivalence through technical and regulatory compliance, not a clinical study report with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set with ground truth established by experts is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not done. This device is an X-ray system, not an AI-powered diagnostic tool, and there's no mention of a human-in-the-loop study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not done. This refers to a medical imaging device itself, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There is no mention of ground truth in the context of diagnostic performance studies. The "ground truth" implied for safety and performance is adherence to established engineering standards and equivalence to predicate devices.
8. The sample size for the training set
- Not applicable. No machine learning model or training set is discussed.
9. How the ground truth for the training set was established
- Not applicable. No machine learning model or training set is discussed.
Summary of the Study (as described in the 510k summary):
The "study" presented here is not a clinical trial in the traditional sense, but rather a demonstration of substantial equivalence to previously cleared predicate devices. The methodology relies on:
- Comparative Analysis: The Omega e-VIEW system's design, intended use, and technical specifications are compared to those of the Siemens AXIOM ARTIS U Angiography System (K040675), Philips Integris H5000 Angiography System (K984545), and Omega Medical Imaging B200/C300 Fluoroscopy System (K902005). The conclusion is that the e-VIEW systems "do not introduce any new indications for use, nor does the use of the device result in any new potential hazard."
- Compliance with Recognized Standards: The primary "acceptance criteria" and "proof" presented are commitments to comply with a comprehensive list of FDA regulations (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32) and international safety standards (IEC 60601-1 series, UL 60601-1, CAN/USA C22.2 No.601.1-M90). This compliance serves as evidence that the device meets safety and basic performance expectations.
In essence, the submission asserts that because the e-VIEW system is designed to meet established safety standards and performs functions equivalent to existing, legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.
§ 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.