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510(k) Data Aggregation
(182 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.
Needle Electrodes are passive devices used for recording, monitoring and stimulation during EEG, EMG, nerve conducting studies and IONM. The Needle Electrodes have different tip shapes for performing different recording and stimulating procedures.
The Needle Electrodes are disposable and designed for single use and are labeled accordingly. The disposable Needle Electrodes are delivered sterile and can be used after opening of the sterile package.
The needles are comprised of a stainless steel or platinum alloy needle, electrically connected to a lead wire. or with a connector for connection to a separate lead wire. Monopolar needles are coated with a polytetrafluoroethylene coating. In case of a pre-connected lead wire the other end is a regular industry standard DIN 42802 safety connector.
The needles are invasive as they are used subcutaneously. Positioning and use is under supervision of a licensed physician.
Here's a breakdown of the acceptance criteria and study information for the Disposable Monopolar and Subdermal Needle Electrodes (K130136), based on the provided 510(k) summary:
This device is a Class II medical device (Needle Electrode, product codes GXZ and IKT) and its approval is based on establishing Substantial Equivalence (SE) to predicate devices, rather than a clinical effectiveness study with strict acceptance criteria often seen in AI/algorithm-driven devices. Therefore, the "acceptance criteria" here refer to meeting the characteristics and performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on predicate K990015 and K072276) | Reported Device Performance (K130136) |
|---|---|---|
| Intended Use | Recording, monitoring equipment for the recording of biopotential signals (EEG, EMG, nerve potential signals), and stimulation/recording with stimulation/recording equipment for EMG and nerve potential signals. (Combined from K990015 and K072276, and narrowed down for K112034) | Same as the combined predicate intended uses, specifically: "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." |
| Device Class | Class II | Same (Class II) |
| Product Code | IKT and GXZ (from K990015) and GXZ (from K072276), IKT (from K112034) | Same (IKT and GXZ) |
| Device Type | Disposable needle electrode, disposable subdermal needle electrode, disposable concentric needle. | Disposable monopolar needle electrode, Disposable subdermal needle electrode. (Encompasses types from predicates) |
| Target Population | All patients | Same (All patients) |
| Anatomical Sites | Peripheral nerves and muscles | Same (Peripheral nerves and muscles) |
| Where Used | Hospital | Same (Hospital) |
| Needle Diameters | Monopolar: 0.30mm to 0.60mm (from K990015), Subdermal: 0.4mm and 0.6mm (from K072276) | Diameters: 0.30mm to 0.60mm (matches K990015 and covers K072276) |
| Needle Lengths | Monopolar: 25 to 75mm (from K990015), Subdermal: 13mm (from K990015 and K072276), corkscrew: 23mm (from K072276) | Lengths: 25 to 75mm (monopolar). 7 to 20 mm (subdermal). 23 mm (corkscrew) (covers and falls within range of predicates, with a slight adjustment for subdermal from 13mm to 7-20mm) |
| Tip Geometry | Front bevel and pencil tip (from K990015), Front bevel (from K072276) | Same (Front bevel and pencil tip) |
| Recording/Stim Area | 0.42mm² - 44.5mm² (from K990015), 16.3mm² - 44.5mm² (from K072276) | Same as K990015 (0.42mm² - 44.5mm²) |
| Electrode Materials | Stainless steel (from K990015, K072276), Pt/Ir or W (from K112034) | Stainless steel, Pt/Ir (matches and encompasses predicate materials, excluding W from K112034 which is not critical for SE) |
| Coatings | PTFE (from K990015) | Same as K990015 (PTFE) |
| Cables | PVC insulated tin plated copper lead wire (from K990015, K072276) | Same as K990015 (PVC insulated tin plated copper lead wire) |
| Connectors | DIN 42802 1.5mm touch proof (from K990015), DIN 42802 Touch proof connector (from K072276) | Same as K990015 and K072276 (DIN 42802 1.5mm touch proof) |
| Electrical Insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection (from K990015, K072276) | Same (Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection) |
| Impedance | <200kΩ (from K990015), <300kΩ (from K112034) | Same as K990015 (<200kΩ) |
| Sterilization Method | EO ethylene oxide (from K990015, K072276, K112034) | Same (EO ethylene oxide) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (from K990015, K112034) | Same as K990015 (10⁻⁶) |
| Biocompatibility | Identical to predicate in formulation, processing, sterilization, no other chemicals (for monopolar); identical to predicate in material (for subdermal). | Met: "The stainless steel monopolar needle with the polytetrafluoroethylene coating is identical to the Technomed Europe disposable hypodermic needles (K062437) in formulation, processing, sterilization, and no other chemicals have been added... The stainless steel or the platinum/iridium material used in the subdermal needle is identical to that of the Technomed Europe needle electrodes (K990015)." |
| Electrical Safety | Verified, including impedance testing consistent with predicates. | Met: "Electrical safety and compatibility was verified, including impedance testing." (Reported as compliant with predicate K990015's <200kΩ) |
| Sterilization Validation | Complies with requirements (for K050325 standard). | Met: "Sterilization validation was confirmed to comply equally as for Technomed Europe devices already released to be legally marketed under K050325, and to conform to all requirements." (Reported as 10⁻⁶ SAL, same as K990015) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of evaluating statistical performance on a test set of data. This submission is for a physical medical device, not an AI/software algorithm.
- Data Provenance: Not applicable. Performance was demonstrated through engineering and manufacturing testing, and comparison of physical and functional characteristics to legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The approval is based on substantial equivalence to existing devices through direct comparison of features and performance tests, not on expert consensus or clinical evaluation of diagnostic interpretations.
4. Adjudication method for the test set:
- Not applicable.
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 is not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" in this context is the established safety and effectiveness of the predicate devices (K990015, K050325, K062437, K112034, K072276). The new device is substantially equivalent if its characteristics and performance fall within acceptable limits or are identical to those predicates. This "ground truth" is established through:
- Direct comparison of technical specifications: Dimensions, materials, coatings, electrical properties, sterilization methods.
- Performance testing: Electrical safety, impedance, and sterilization validation (demonstrating it works as intended and is sterile).
- Biocompatibility assessment: Justification based on identical materials and manufacturing processes to already approved devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-driven device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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