(143 days)
The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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. The electrodes are for single patient use only.
Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician. Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices. Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor, a hydrogel, and a medical adhesive. The NEO/NEO X electrodes can be used for all pediatric populations (including neonates) The adhesive on the NEO/NEO X electrodes is suitable in the high humidity environment in the incubators and still gentle to the fragile neonatal skin.
The primary document provided is a 510(k) summary for the Ambu® Blue Sensor NEO/NEO X disposable ECG electrodes. The study described focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices, rather than a clinical efficacy study with human subjects.
Here's an analysis based on the provided text, addressing your specific questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Electrical and Mechanical Functionality: Meets ANSI/AAMI EC12:2000 - Disposable ECG Electrodes | All non-clinical tests passed. |
| Biocompatibility: Meets ISO 10993-1 - Biological evaluation of Medical Devices (including ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Intracutaneous reactivity)) | All biocompatibility tests passed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document describes non-clinical laboratory tests. It does not specify the sample size of electrodes used for these tests.
- Data Provenance: The tests are stated as "laboratory tests," implying they were conducted in a controlled environment. The country of origin of the data is not specified, but the manufacturer (Ambu A/S) is based in Denmark. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission.
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 was a non-clinical study evaluating physical and biological properties against established standards, not a study requiring expert interpretation of diagnostic output to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert review or adjudication of diagnostic performance. The tests were objective measurements against predefined standards.
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
No MRMC comparative effectiveness study was done. This device is a disposable ECG electrode, which is a hardware component for acquiring physiological signals. It does not involve AI or human readers for interpretation in the context of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This document pertains to electrodes, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established by recognized industry standards:
- ANSI/AAMI EC12:2000 for electrical and mechanical functionality.
- ISO 10993-1, ISO 10993-5, and ISO 10993-10 for biocompatibility.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.