(49 days)
The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.
The PRONEO Neonatal ECG Electrodes (and also to be sold under various private label trade names; i.e. Multiple Labels) are 22mm in square and consist of a conductive adhesive hydrogel, a Ag/AgCl plated sensor element a non-woven substrate and vinyl label, and a 100cm flexible tinned copper or carbon lead wire terminating in a 1.5mm, 2.0mm standard DIN connector. Electrodes are packaged in pouches of 3, 100 pouches per carton and are supplied non-strerile.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for PRO-NEO NEONATAL ECG ELECTRODE (K053011)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reference Standard | Device Performance | Predicate Device Performance |
|---|---|---|---|
| Electrical Performance | ANSI/AAMI EC12:2000 Disposable ECG Electrodes | Met specifications | Met specifications |
| Biocompatibility (Non-irritating, Non-cytotoxic, Non-sensitizing) | ISO 10993 (FDA Memorandum) | Non-irritating, Non-cytotoxic, Non-sensitizing | Not explicitly stated, but implied to meet standards as the predicate was approved |
| Shelf Life | N/A (Accelerated aging testing) | 24 months | Not explicitly stated |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated for electrical performance tests. For biocompatibility and shelf life, the sample sizes are not detailed in the provided summary.
- Data Provenance: The device was manufactured in the Republic of Korea. The testing was conducted by Bio Protech Inc.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The performance testing for this device (ECG electrodes) involved objective, standardized electrical and biological tests, not human interpretation or expert-established ground truth in the way it would for an AI-powered diagnostic device.
4. Adjudication Method
Not applicable, for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical accessory (ECG electrode) and does not involve AI or human interpretation in its primary function. Therefore, a comparative effectiveness study involving human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an electrode, not an algorithm or AI system.
7. Type of Ground Truth Used
- Electrical Performance: Standardized measurements against the specifications outlined in ANSI/AAMI EC12:2000. These are objective engineering and electrical performance metrics.
- Biocompatibility: Results of laboratory tests (e.g., irritation, cytotoxicity, sensitization tests) against established biological evaluation criteria from ISO 10993.
- Shelf Life: Results from accelerated aging studies extrapolated to real-time shelf life.
8. Sample Size for Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 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.