(116 days)
The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
MAXXI GOLD Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
The product is offered in 3 different lenath sizes, 48", 60" or 96". The product is offered in package of 5 or 10 units, with multicolor wires.
The electrode is compatible with any recording device with the DIN 42-802 receptacle which is the gold standard for EEG and EMG recording machines.
This document is a 510(k) submission for a medical device called the "MaxxiGold Electrode," a type of cutaneous electrode used for recording physiological signals (e.g., EEG, biofeedback, sleep studies, evoked potentials).
A 510(k) submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through clinical trials. Therefore, the information provided focuses on the comparison to predicate devices and adherence to manufacturing standards, rather than extensive clinical study data as might be found for novel devices or PMAs.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with specific thresholds that the device must meet, followed by a report of the device's performance against those thresholds. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on Intended Use and Technological Characteristics.
The implicit "acceptance criteria" for a 510(k) in this context are:
- Identical or highly similar Indications for Use.
- Highly similar technological characteristics, or if different, that the differences do not raise new questions of safety and effectiveness.
Implicit Acceptance Criteria (for 510(k) Substantial Equivalence)
| Category | Acceptance Criteria | Reported Device Performance (MaxxiGold Electrode) |
|---|---|---|
| Indications for Use | The device's indications for use must be substantially equivalent to, or the same as, a predicate device, specifically: "intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings." | "The MaxxiGold Electrode is intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings." (Identical to predicates K022197 and K071118) |
| Technological Characteristics | The device's fundamental technological characteristics (design, materials, specifications) should be the same or highly similar to a predicate device, such that any differences do not raise new questions of safety or effectiveness. Key aspects include:Application: Cutaneous ElectrodeContact design: Metallic Disk PlateStructure: Metallic Disk Plate connected to a lead wire and terminated in a DIN touch proof connectorContact Disk Material: Gold platedWire Material: Insulated Teflon wireWire Colors: MulticolorJoint material: Heat shrink tubeConnector: Monopolar DIN 42-802 touch proofPackage: Plastic bag | The MaxxiGold Electrode aligns with all listed technological characteristics of the predicate devices (K022197 and K071118). The table explicitly shows identical specifications across all compared parameters (Application, Contact design, Structure, Contact Disk Material, Wire Material, Wire Colors, Joint material, Connector, Package). The conclusion states the comparison "shows that MaxxiGold Electrode was developed to be substantial equivalent to the predicates, not raising any safety or effectiveness concerns." |
| Safety and Effectiveness | While quantitative performance metrics are not given, the implicit acceptance is that the device, due to its substantial equivalence to legally marketed predicates and compliance with relevant quality standards, is considered safe and effective for its intended use without raising new questions in these areas. | The manufacturer states: "In order to reach high quality and effectiveness the MaxxiGold Electrode is produced in compliance with the quality management standard ISO 13485:2003, 'Medical Devices, Quality Management Systems: Requirements for Regulatory Purposes' and FDA GMP 'Good Manufacturing Practices'." The submission concludes "not raising any safety or effectiveness concerns." This suggests the demonstration of substantial equivalence is the evidence for safety and effectiveness in the context of a 510(k). |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical trial was performed." This indicates that there was no "test set" in the sense of patient data collected for a performance study. The data provenance is therefore not applicable as no clinical data was generated for this 510(k) submission. The basis for the submission is a comparison of design and specifications to predicate devices.
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, as no clinical trial or test set requiring expert ground truthing was performed. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the identified predicate device(s).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical trial or test set requiring adjudication was performed.
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 a passive electrode, not an AI-assisted diagnostic tool.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this 510(k) submission, the "ground truth" is the legally marketed status and established safety and effectiveness of the predicate devices. The submission argues that because the new device is fundamentally the same as these predicates in terms of intended use and technological characteristics, it can also be considered safe and effective without requiring new clinical data.
8. The sample size for the training set
Not applicable, as no algorithm or machine learning model was developed or trained. This is a hardware electrode device.
9. How the ground truth for the training set was established
Not applicable, as no algorithm or machine learning model was developed or trained.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).