(51 days)
The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring Procedures. The 2234 & 2266 Radiolucent Monitoring Electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 3 days) monitoring.
The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are a selfadhesive, non-sterile, single use, disposable electrode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a self-adhesive tape backing which holds the conductive elements of the electrode in place on the patient's skin for short or long term (up to 3 days) for ECG monitoring. The 3MTM Red Dot™ 2234 & Radiolucent Monitoring Electrode with Clear Tape is composed of the same materials as the predicate device 3MTM Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the snap which has been modified to include a higher percentage of carbon. The 3M™ Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Backing is composed of the same materials as the predicate device 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the sensing snap which has been modified to include a higher percentage of carbon and the tape backing and adhesive.
The provided text describes the 510(k) summary for the 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes. Below is the requested information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Assured through selection of materials demonstrating appropriate levels of biocompatibility. Tests selected based on ISO 10993-1, "Biological Evaluation of Medical Devices", Part-1. |
| Electrical Performance | Meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes. |
| Intended Use Equivalence (Primary) | The devices are substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 (or reclassified devices), for their stated indications for use in ECG Monitoring Procedures, including short-term and long-term (up to 3 days) monitoring, and can be used in all ECG applications where standard ECG monitoring electrodes are used. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify a distinct "test set" sample size or data provenance for a clinical study. The performance is assessed against recognized standards (ISO 10993-1 and ANSI/AAMI EC12/1991). These standards typically involve a series of tests performed on device samples. The number of samples tested to demonstrate compliance with these standards is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an electrode for ECG monitoring, and its performance is evaluated against established technical and biological standards, not through expert-reviewed diagnostic image/data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods typically apply to studies where expert interpretation of data (e.g., images, clinical records) is required to establish ground truth for a diagnostic device. For this device, compliance is determined by meeting technical specifications and biocompatibility requirements.
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. This device is an ECG monitoring electrode, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is defined by compliance with established voluntary consensus standards:
- Biocompatibility: ISO 10993-1, "Biological Evaluation of Medical Devices".
- Electrical Performance: ANSI/AAMI EC12/1991, "Disposable ECG Electrodes".
- Substantial Equivalence: Comparison to legally marketed predicate devices for stated indications for use.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set for this type of device.
§ 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.