(254 days)
Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.
Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes (8, 13, 18, 22 and 22mm Grooved). They are supplied sterile, are non-pyrogenic, and are intended for single use only. The 8 mm dilators are made of stainless steel and are visible under fluoroscopy, while the remaining sizes are made of aluminum alloy and are radiolucent.
The provided document appears to be a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators." It details various performance tests conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | Impedance of current carrying connections | To have sufficiently low impedance so that they will not interfere with any stimulator signal passed through them. | Met applicable requirements (per IEC 60601-1) |
| Dielectric Strength Test | To be sufficiently separated from the conductive portions to prevent any stimulator signal from reaching any part of the Phantom XL Insulated Dilators except the intended delivery point. | Met applicable requirements (per IEC 60601-1) | |
| Temperature Test | Not to introduce any additional heating to the patient as part of the stimulation process. | Met applicable requirements (per IEC 60601-1) | |
| Waveform capture | Not to significantly alter the waveform of the stimulator output. | Met applicable requirements (per IEC 60601-1) | |
| Electromagnetic Compatibility | Emissions tests | Not to impact the emission profile of electrical stimulus and medical monitoring equipment. | Met applicable requirements (per IEC 60601-1-2) |
| Immunity tests | Not to increase the sensitivity to adverse conditions of electrical stimulus and medical monitoring equipment. | Met applicable requirements (per IEC 60601-1-2) | |
| Biocompatibility | Cytotoxicity (ISO Elution Method) | Biological reactivity must be less than or equal to a grade 2. | No evidence of causing lysis or toxicity. Reactivity is less than grade 2. (Non-Cytotoxic) |
| ISO Intracutaneous Study (Irritation) | The difference between the test extract overall mean score and corresponding control overall mean score is 1.0 or less. | Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.2. (Non-irritant) | |
| ISO Guinea Pig Maximization Sensitization Test | No evidence of causing delayed dermal contact sensitization. | Showed no evidence of causing delayed dermal contact sensitization. (Non-Sensitizer) | |
| ISO Systemic Toxicity (acute) | No mortality or evidence of systemic toxicity from the extracts. | No mortality or evidence of systemic toxicity from the extracts. (Non-Toxic) | |
| Sterilization & Residuals | Sterilization Validation | A minimum Sterility Assurance Level (SAL) of 1 x 10-6. | Completed to assure a minimum SAL of 1 x 10-6. |
| Bacterial Endotoxin | FDA criteria for medical device: maximum of 20 EU/device. (Also criteria for device contacting cerebrospinal fluid: maximum of 2.15 EU/device, though noted as N/A for this device). | 0.720 EU/Device, 0.880 EU/Device, |
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.