(89 days)
The GE High Impedance Cardiac Gating Cable is designed for MR applications where cardiac gating is desired to reduce motion and flow artifacts. The cable may be used in the presence of surface coils.
The high impedance cardiac gating cable is a four lead ECG patient cable used for gating the MR scanner. The cable has a high distributed impedance to limit any RF currents induced into the cable by the MR scanner.
This document describes a 510(k) submission for a medical device, specifically a "High Impedance Cardiac Gating Cable" manufactured by GE Medical Systems. The assessment focuses on establishing substantial equivalence to existing predicate devices, rather than proving novel performance. Therefore, the information provided relates more to validation against established safety and functionality standards for this type of accessory.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a non-diagnostic accessory, the "acceptance criteria" are primarily related to safety and functional equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria (Indirectly Derived) | Reported Device Performance |
|---|---|
| Absence of significant heating during use | "There was no significant heating of the cables." |
| Proper cardiac gating of the MR system | "The cables gated the MR System properly." |
| Substantial equivalence in mechanical flexibility | "Comparable to the Invivo cable in mechanical flexibility." |
| Substantial equivalence in impedance | "Comparable... with the GE Thin Film cable in regard to impedance." |
| No new indications for use | "These cables do not include any new indications for use." |
| No new potential hazards | "nor does use of this cable result in any new potential hazards." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The summary mentions "in-house as well as volunteer testing." The number of volunteers and the specific sample size for "in-house" testing are not provided.
- Data Provenance: The testing was conducted "in-house" and involved "volunteer testing." This implies prospective data collection, likely within the United States (given GE Medical Systems' address in Milwaukee, WI, USA). Specific country of origin for volunteers is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this device. This device is an accessory cable for MRI machines, not a diagnostic algorithm that requires expert interpretation for ground truth establishment. The "ground truth" here is the physical performance and safety of the cable itself (e.g., whether it heats up, whether it gates correctly).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is about device performance, not diagnostic classification requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an accessory, not an AI diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI algorithm; it's a physical cable. The performance described ("no significant heating," "gated the MR System properly") is the standalone performance of the physical device.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was based on:
- Direct Measurement/Observation for physical properties (e.g., temperature measurements for heating, observation of proper gating by MR system).
- Comparison to predicate devices for characteristics like flexibility and impedance to establish "substantial equivalence."
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.