(29 days)
The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies. This process is known as electromyography (EMG).
The disposable monopolar needle electrode is designed for single use only. The stainless steel needle electrode is insulated with a special PTFE coating to ensure minimal friction between the needle and the tissue. The tip of the conically sharpened needle is uninsulated and serves as recording area. The sterile electrode is individually sealed and delivered in sets of 48 pcs. In a hygienic and practical package ready for use package. The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.
Here's an analysis of the provided 510(k) summary for the K990375 device, addressing the requested information:
Device: 13 S Series Disposable Monopolar Needle Electrodes
Description of Device: The device is a disposable, single-use monopolar needle electrode used for electromyography (EMG). It consists of a PTFE-coated stainless steel needle with an uninsulated tip for recording, a larger hub for ergonomic grip, and a connector for electrical signal transfer.
Acceptance Criteria and Study Details
This 510(k) submission is for a Special 510(k) Notification, indicating modifications to a previously cleared predicate device (13 R Series Disposable Monopolar Electrodes, K915741). The primary goal of a Special 510(k) is to demonstrate that the changes do not adversely affect the safety or effectiveness of the device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to the predicate device, rather than establishing novel performance metrics.
The "acceptance criteria" are implied to be that the enhanced device performs at least as well as the predicate device in relevant non-clinical tests and that the changes do not introduce new safety or efficacy concerns.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Feature/Test | Acceptance Criteria (Implied: Substantially Equivalent to Predicate) | Reported Device Performance | Comments |
|---|---|---|---|
| Non-Clinical Performance | Enhanced device performs as the predicate device. This encompasses mechanical, electrical, and material properties relevant to its intended use (recording unit potentials in skeletal muscles, spontaneous activity, interference patterns, and conduction velocity studies). | "Verifications results shows that the enhanced device performs as its predicate device." | This is a general statement indicating the device passed all non-clinical tests designed to show equivalence. Specific numerical performance data is not provided in this summary. |
| Biocompatibility | Materials in contact with the patient (specifically the Whitford PTFE coat, Xylan 8400/3349) must be biocompatible per ISO 10993 standards and USP 23. No cytotoxicity, significant intracutaneous reaction, or delayed contact hypersensitivity. | "The results of these tests shows that the material Whitford PTFE coat, xylan 8400/3349 have passed all tests." | Tests performed: In Vitro Cytotoxicity Test (USP 23/ISO 10993-5 Elution Test), Intracutaneous Test (ISO 10993-10:1995), Guinea Pig Maximization Test. |
| Sterilization | Process consistently achieves predetermined specifications for sterility (EN 556). No compromise in sterility due to product changes. | "It is concluded that the process consistently with predetermined specifications. The specified requirements for sterility (EN 556) are met." | Sterilization method is Ethylene Oxide (ETO) at a vendor plant. |
| Safety/Efficacy Concerns | The changes (e.g., coating material, hub design, connector size, tip exposure process, enhanced assortment of sizes) must not introduce any new safety or efficacy concerns compared to the predicate. | "The changes in the new device doesn't effect any safety or efficacy concerns." | This is a declarative statement based on the overall assessment of the modifications and verification testing. |
| Mechanical Pull Strength | 20 N (same as predicate) | 20 N | Explicitly stated as unchanged. |
| Exposed Length | 0.8 mm (same as predicate) | 0.8 mm | Explicitly stated as unchanged. |
| Recording Area | 0.3 mm sq (same as predicate) | 0.3 mm sq | Explicitly stated as unchanged. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: The submission does not specify numerical sample sizes for non-clinical testing. It generally refers to "Verifications results" and "The results of these tests."
- Data Provenance: The data is generated from laboratory testing (e.g., mechanical testing, biocompatibility studies, sterilization validation) performed by Medtronic Functional Diagnostics A/S and/or its vendors. This is prospective testing conducted specifically for this submission. The country of origin of the data is implicitly Denmark, where the manufacturer is located, and potentially the locations of the testing facilities (e.g., Maersk Medical A/S for sterilization).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This device is not an AI/ML diagnostic or image-based device. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation or diagnosis is not applicable.
- The "ground truth" for the non-clinical tests (e.g., biocompatibility, mechanical strength) is established by the specifications and standards (e.g., ISO 10993, EN 556) themselves and the results of the validated test methods. The "experts" would be the qualified laboratory personnel conducting and interpreting these tests, whose qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study involving human interpretation of data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a medical device (needle electrode) used to facilitate a diagnostic procedure, not to perform the diagnosis itself or interpret complex data.
- The submission explicitly states: "Clinical evaluation not performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used:
- For non-clinical performance (mechanical, electrical, material): Engineering specifications, standardized test methods, and compliance with recognized industry standards (e.g., for pull strength, exposed length, recording area).
- For biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., cytotoxicity, intracutaneous, sensitization tests) as per ISO 10993 and USP 23, where biocompatibility is the 'ground truth'.
- For sterility: Validation of the sterilization process demonstrating a Sterility Assurance Level (SAL) of 10^-6, compliant with EN 556.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).