(93 days)
These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.
The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.
Here's a breakdown of the acceptance criteria and study information for the Neonatal ECG Electrodes (KD912744), based on the provided document:
This 510(k) summary does not describe an AI/ML device or a comparative effectiveness study involving human readers with and without AI assistance. The device is a traditional medical device (ECG electrodes) and the testing focuses on its physical and electrical performance against recognized standards. Therefore, many of the requested categories (like MRMC study, standalone algorithm performance, training set details, and expert qualifications for ground truth) are not applicable to this submission.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Performance | ANSI/AAMI EC12:2000/(R) 2005 (for ECG Electrodes) | Meets specifications |
| - AC impedance | (Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005) | Meets specifications |
| - DC offset voltage | (Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005) | Meets specifications |
| - Defibrillation overload recovery | (Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005) | Meets specifications |
| - Combined offset instability and internal noise | (Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005) | Meets specifications |
| - Bias current tolerance | (Implicitly covered by ANSI/AAMI EC12:2000/(R) 2005) | Meets specifications |
| Biocompatibility | ANSI/AAMI EC53:1995/(R) 2008 & "required skin sensitivity testing criteria" | Passed required skin sensitivity testing criteria. Met specifications for skin contact. |
| - Cytotoxicity | (Implicitly covered by biocompatibility testing standards) | Passed |
| - Sensitization | (Implicitly covered by biocompatibility testing standards) | Passed |
| - Primary skin irritation | (Implicitly covered by biocompatibility testing standards) | Passed |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was primarily bench testing to assess electrical characteristics and biocompatibility testing. The submission explicitly states:
- "The Neonatal ECG Electrodes and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008."
- "Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria."
- "Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices."
The conclusion is that "Test results support the conclusion that the electrical output is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the electrical performance bench tests. For biocompatibility, it states "Biocompatibility testing was performed," but does not detail the number of samples or subjects.
- Data Provenance: The data is from bench testing (electrical and physical characteristics) and biocompatibility testing. The country of origin is not explicitly stated, but it would be expected to be from controlled laboratory environments. The nature of these tests is inherently prospective as they are conducted specifically for the device submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a hardware medical device (ECG electrodes). Ground truth in this context refers to established technical standards (ANSI/AAMI EC12 and EC53) and laboratory measurements, not expert review of images or clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this involves technical measurements against standards, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where human interpretation is involved. This device is an electrode.
6. Standalone Performance Study (Algorithm Only)
- No. This is a hardware device; there is no "algorithm" in the sense of AI/ML software for standalone performance evaluation.
7. Type of Ground Truth Used
- Technical Standards and Lab Measurements: The ground truth for this device's performance is defined by the requirements outlined in ANSI/AAMI EC12:2000/(R) 2005 (for ECG electrodes) and ANSI/AAMI EC53:1995/(R) 2008 (for biocompatibility and skin contact). The device's performance was measured against these objective standards.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. 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.