(68 days)
The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent. The electrode is for single patient use only.
Each electrode consists of a foam material with an adhesive to be mounted on the patient. The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point. On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe. The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch. The electrode is non sterile and intended for single use.
This 510(k) summary does not contain the detailed study information needed to fully address all parts of your request. It mainly describes the device and claims substantial equivalence to a predicate device. However, I can extract the available information and highlight what is missing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to a general standard.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K983689) | The MRX electrode is "almost identical with the SUPAtab electrode." The main change is the metal snap on the SUPAtab has been changed to a carbon-filled polymer snap on the MRX. Both electrodes have the same Ag/AgCl sensor material and the same materials except for the snap. The FDA reviewed the 510(k) and "determined the device...is substantially equivalent." This implies the performance is considered comparable enough for its intended use. |
| MR Safety | The choise of materials ensures a non-ferromagnetic electrode which makes it...MR safe. |
| X-ray Translucency | The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent. |
| Adherence to AAMI EC12 2000 standard | Both electrode types meet the AAMI EC12 2000 standard. (This standard likely outlines performance requirements for ECG electrodes, such as impedance, DC offset, amplitude response, etc., but the specific values are not detailed in this document.) |
| Intended Use: Transmit electrical signal for ECG/vectorcardiogram in MR environment (new for MRX) | "The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram." The device is "designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent." The FDA's substantial equivalence determination implies that it performs this function acceptably in the specified environment. |
| Single Patient Use | The electrode is for single patient use only. (This is a design characteristic, not a performance metric per se, but it's part of the product specification.) |
| Shelf Life of 2 years | Both electrode types… have a shelf life of 2 years. (This would typically be confirmed through stability testing, but the details are not provided here.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance evaluation with a numerical sample size. The substantial equivalence argument primarily relies on material changes and adherence to a standard, rather than a clinical trial with a defined test set.
- Sample Size: Not specified for a performance test set.
- Data Provenance: Not applicable in the context of a "test set" for clinical evaluation. The comparison is primarily in vitro based on materials and design, and in silico regarding MR safety and X-ray translucency.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission concerns a medical device accessory (ECG electrode) and relies on technical specifications and substantial equivalence, not a ground truth established by medical experts for a diagnostic performance study.
4. Adjudication Method for the Test Set
Not applicable, as a test set for clinical performance requiring adjudication is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging algorithms where human readers' performance with and without AI assistance is evaluated.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm is not discussed. This device is an electrode, not a standalone diagnostic algorithm. Its performance is tied to its physical properties and ability to reliably transmit an electrical signal according to industry standards.
7. Type of Ground Truth Used
The "ground truth" for this device, implicitly, is:
- Physical and material properties: Ensuring non-ferromagnetic characteristics for MR safety and X-ray translucency.
- Adherence to AAMI EC12 2000 standard: This standard sets performance benchmarks for ECG electrodes (e.g., impedance, offset voltage, noise) which are considered "ground truth" for electrical signal transmission quality.
- Substantial equivalence to the predicate device: The predicate device (SUPAtab) has an established history of safe and effective use, so matching its performance in critical aspects serves as a form of "ground truth."
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this device is not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.