(57 days)
These disposable noninvasive, hypoallergenic electrodes will be used as a conductive medium between the patient and the diagnostic equipment. Depending on the application, different sizes, shapes and a choice of eigher wet gel or solid hydrogel can be used for better results. These electrodes on be used for short-term or long-term applications, up to 3 days. This product is disposable and should only be used for single use.
These Monitoring Electrodes are non-sterile, hypoallergenic, disposable, adhesive-backed with conductive centers, composed of materials commonly used in this application:
- First Layer: Stainless Steel snap, that works as a connection point for the diagnostic equipment.
- Second Layer: Polypropylene label substrate, used for reinforcement and a printable surface for branding.
- Third Layer: Various materials i.e., medical grade polyester fabric, polyethylene foam and paper, coated with bio-compatible adhesive.
Fourth Layer: Ag/AgCl. coated, 20% carbon filled plastic sensor.
Gel Foam Layer: Polyurethane foam. Only used for conductive wet gel.
Conductive Gel: Bio-compatible conductive solid hydrogel or wet gel
Fifth Layer: Silicone coated release liner to cover the adhesive and conductive media.
The electrodes are disposable and designed for single-patient use. They have a low profile construction that uses soft pliable and conformable materials for patient comfort. Because of the adhesive nature no extra securing materials are required to anchor the device to the patient's skin. The electrodes have one universal contact point which is a stainless steel snap. The equipment manufacturers provide the receptacle to this in the form of cither a snap lead wire or a pinch clip.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shanghai Intco Electrode Manufacturing Co.'s Disposable EKG monitoring electrodes:
Limited Information Provided:
It's important to note that the provided text is a 510(k) summary, which often focuses on substantial equivalence to predicate devices rather than a detailed, standalone clinical study report. Therefore, many of the requested elements (especially those related to human reader studies, training sets, and detailed ground truth establishment) are generally not present in this type of document. The study described is primarily a laboratory-based performance and biocompatibility study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Shanghai Intco electrodes are implicitly based on demonstrating performance equivalent to predicate devices and meeting specific AAMI standards and biocompatibility requirements. The document states that the electrodes are "as safe and effective as Lead-Lok Inc. electrodes" and underwent specific tests.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-1) | Test results attached (implies successful) |
| Sensitization (ISO 10993-1) | Test results attached (implies successful) | |
| Primary Skin Irritation (ISO 10993-1) | Test results attached (implies successful) | |
| Electrical Performance | Bias Current Tolerance (AAMI standards) | Test results attached (implies successful) |
| DC Offset Voltage (AAMI standards) | Test results attached (implies successful) | |
| AC Impedance (AAMI standards) | Test results attached (implies successful) | |
| Combined Offset and Internal Noise (AAMI standards) | Test results attached (implies successful) | |
| Recovery Slope Time (AAMI standards) | Test results attached (implies successful) | |
| AC Impedance after Defib (AAMI standards) | Test results attached (implies successful) |
Note: The document explicitly states "test results attached," indicating that the performance met the thresholds associated with these industry standards, thereby satisfying the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The tests are laboratory-based electrical performance and biocompatibility tests, not clinical studies with patient data. For biocompatibility, tests are typically conducted on material samples using in vitro or animal models, not human patients as a "test set."
- Data Provenance:
- Biocompatibility: The conductive gels (wet gel and solid hydrogel) and adhesive-backed materials underwent testing. The solid hydrogel formula was acquired from Vermont Medical. The origin of the raw materials and testing laboratories is not specified beyond "medical grade."
- Electrical Performance: Tests were run according to AAMI standards. These are laboratory bench tests.
- Retrospective or Prospective: These are laboratory and material-based tests, not human subject studies in the traditional sense. Therefore, the terms retrospective or prospective don't directly apply. The testing was performed on the device materials and finished product before submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this 510(k) summary. The "ground truth" for these types of devices is established by adherence to recognized electrical and biocompatibility standards (AAMI and ISO 10993-1). There is no mention of expert human readers or ground truth established by medical professionals in this context for evaluating the device's fundamental performance.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretative "test set" requiring adjudication in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. The device is a monitoring electrode, and its effectiveness is assessed through its electrical performance and biocompatibility, not by human interpretation of images or signals that would typically involve an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive electrode, not an algorithm or AI system. Its performance is inherent to its physical and electrical properties.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's safety and effectiveness is established by:
- Adherence to recognized industry standards:
- Biocompatibility: ISO 10993-1 requirements for skin contact (Cytotoxicity, Sensitization, Primary Skin Irritation).
- Electrical Performance: AAMI standards for EKG monitoring electrodes (Bias Current Tolerance, DC Offset Voltage, AC Impedance, Combined Offset and Internal Noise, Recovery Slope Time, and AC Impedance after Defib).
- Substantial equivalence to predicate devices: The predicate devices (Lead-Lok Inc. K832877, K911518/D) had previously been determined safe and effective.
In essence, the "ground truth" is that if the device meets these standards and is equivalent to the predicate, then it is considered safe and effective.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or AI/ML algorithm involved.
§ 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.