(238 days)
Needle Electrodes for neurological purposes are intended for use with recording, monitoring equipment for the recording of biopotential signals including electroencephalograph (EEG), electromyograph (EMG) and nerve potential signals, and are intended for stimulation/recording with stimulation/recording equipment for electromyograph (EMG) and nerve potential signals.
Disposable Subdermal Needle Electrodes, Corkscrew are single-patient use electrodes, delivered Ethylene Oxide (EtO) sterilized. They include a needle at one end which is connected to a lead wire with a 1.5 mm female safety DIN 42802 connector. The needle, which is fabricated using stainless steel, is formed into a corkscrew shape, with a regular bevel tip. The connecting lead wire, which may be supplied in different lengths and colors is terminated with a DIN 42802 connector to enable connection to recording or monitoring / stimulation equipment.
The document provided describes a 510(k) premarket notification for a medical device, specifically a "Disposable Subdermal Needle Electrode, Corkscrew." The purpose of this notification is to demonstrate substantial equivalence to an existing legally marketed predicate device. This type of submission relies on non-clinical testing to show that changes do not raise new questions of safety or effectiveness, rather than a clinical effectiveness study comparing the device to a gold standard.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of diagnostic accuracy, AI, and human reader performance, is not applicable to this submission. This document focuses on demonstrating that a modified version of an existing device is just as safe and effective as its predicate through various engineering and biocompatibility tests.
Here's a breakdown of why many of your questions cannot be answered from this document:
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Acceptance Criteria & Device Performance (Table): While the document lists "tensile strength" and "impedance" as performance metrics with target values (which can be considered acceptance criteria in an engineering sense), these are not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that would be relevant to an AI/diagnostic device study. The reported performance is that the device "passed the tests and meets the set requirements."
Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Impedance | 22N (Predicate) / >25N (New Device) | Passed the tests / Meets requirements |
| Tensile strength needle to hub | >25N (New Device) | Passed the tests / Meets requirements |
| Maximum retraction force protection cap vs hub | Max. 10N (New Device) | Passed the tests / Meets requirements |
| Torsion force Needle to hub | > 15.5 Ncm (New Device) | Passed the tests / Meets requirements |
| Biocompatibility | In accordance with ISO 10993 series | Evaluated to be biocompatible |
| Sterility Assurance Level | 10^-6 | Passed the tests / Meets requirements |
- Sample Size for Test Set & Data Provenance: Not applicable as this is not a diagnostic device study. The "test sets" here refer to batches of devices used for various engineering and biocompatibility tests.
- Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth in this context would be engineering specifications and validated test methods, not expert consensus on diagnostic interpretations.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone Performance: Not applicable. This is not an AI algorithm. Its "performance" relates to its physical and electrical properties, not diagnostic accuracy.
- Type of Ground Truth Used: The ground truth for the non-clinical tests is established by recognized international standards (e.g., ISO, ASTM, IEC) and internal test methods with defined specifications. For sterility, it's a Sterility Assurance Level of 10^-6. For biocompatibility, it's compliance with the ISO 10993 series.
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the machine learning sense.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of Non-Applicable Information and Reasons:
| Information Request | Applicability | Reason |
|---|---|---|
| 1. A table of acceptance criteria and the reported device performance (diagnostic metrics) | Not Applicable | The provided document is for a 510(k) submission of a physical medical device (needle electrode), focusing on demonstrating substantial equivalence through non-clinical engineering and biocompatibility testing. It addresses whether mechanical, electrical, and material properties meet specifications, not diagnostic accuracy or effectiveness in comparison to a gold standard. The table above reflects the engineering-focused criteria. |
| 2. Sample size used for the test set and the data provenance | Not Applicable | The "test set" in this context refers to samples of the device used for various engineering and biocompatibility tests, not a dataset for evaluating diagnostic performance. The document doesn't specify sample sizes for these internal tests, nor is 'data provenance' (e.g., country of origin, retrospective/prospective) relevant to device manufacturing and testing. |
| 3. Number of experts used to establish the ground truth for the test set and their qualifications | Not Applicable | Ground truth for this device is based on established engineering specifications, international standards (ISO, ASTM, IEC), and internal validated test methods, not expert clinical interpretation of images or patient data. |
| 4. Adjudication method | Not Applicable | Adjudication methods (e.g., 2+1) are used for resolving discrepancies in expert interpretation of diagnostic data, which is not relevant to the non-clinical testing of a needle electrode. |
| 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size | Not Applicable | MRMC studies are used to assess the comparative diagnostic performance of readers, usually with and without AI assistance. This device is a physical electrode and does not involve AI or human interpretation of diagnostic results in that manner. |
| 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done | Not Applicable | Standalone performance refers to the diagnostic accuracy of an AI algorithm on its own. This device is not an algorithm. |
| 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc) | Manufacturing/Engineering Specifications, Recognized Standards | The ground truth for this device's evaluation is based on meeting predefined specifications for its physical, electrical, material, and sterility properties as determined by engineering standards, internationally recognized testing methodologies (e.g., ISO, ASTM, IEC), and internal validation protocols. |
| 8. The sample size for the training set | Not Applicable | This device does not utilize machine learning or AI algorithms; therefore, there is no "training set" in the computational sense. |
| 9. How the ground truth for the training set was established | Not Applicable | As there is no training set for an AI algorithm, this question is not applicable. |
The studies performed were non-clinical tests to ensure the device's physical, electrical, and biological safety and performance:
- Performance Testing: Visual, dimensional, electrical (impedance), and mechanical (torsion, pull force) aspects were tested using internal methods.
- Shelf Life (Accelerated Aging): Tested according to ASTM F1980-21, including mechanical, dimensional, electrical, visual, label assessment, and pouch integrity.
- Transit Testing: Electrical and mechanical assessment, label assessment, and pouch integrity after transit simulation (ISTA 3A).
- Electrical, Mechanical and Thermal Safety: Compliance with IEC 60601-1 (Ed. 3.2), specifically section 8.5.2.3.
- Biocompatibility: Extensive testing (Chemical characterization, cytotoxicity, intracutaneous reactivity, acute systemic toxicity, sensitization, pyrogenicity) performed by an external laboratory in accordance with the ISO 10993 series and related standards.
- Sterilization: Validation leveraged from the predicate device (ISO 11135:2014) as the changes did not affect sterilization.
- Pyrogenicity: LAL test performed after sterilization.
- Usability: Applied the "User Interface of Unknown Provenance" (UOUP) principle according to IEC 62366-1, considering the user interface remained unchanged from the predicate.
In conclusion, the document successfully argues for substantial equivalence based on rigorous engineering, material, and safety testing, but it does not contain the type of diagnostic performance data or AI study details you requested.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).