(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 |
§ 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).