(44 days)
Electro Lube NXT is a single patient use device used in open and minimally-invasive surgery to reduce tissue adhesion and eschar on electrosurgical instruments.
Electro Lube NXT is a single-use sterile electrosurgical accessory device intended to be used on electrosurgical electrodes to prevent sticking. It is intended to be used by professional practitioners of electrosurgery in clinical environments where electrosurgery is performed.
Electro Lube NXT is sterilized by irradiation and provided to the end user in an individual sterile barrier package with one bottle containing 4mL of the anti-stick solution and one foam pad for application of the solution during use included in each pack. The foam pad includes an adhesive backing and barium filament strand of material for radiopacity.
The provided text describes the regulatory filing for a medical device (Electro Lube NXT) and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It is not an AI/ML device, so information like sample size for training set, number of experts for ground truth, or MRMC studies are not applicable. However, I can extract the acceptance criteria and the "study" (non-clinical tests) that proves the device meets the criteria.
Acceptance Criteria and Reported Device Performance
The "study" in this context refers to a series of non-clinical tests performed to demonstrate the safety and effectiveness of the Electro Lube NXT, and its substantial equivalence to the predicate device.
| Test | Acceptance Criterion | Reported Device Performance/Conclusion |
|---|---|---|
| Evaluation of Appearance | The material is clear and homogeneous without any particulate. | Pass |
| Evaluation of Product Odor Profile | Odor profile of Electro Lube NXT is equivalent or better than the odor profile of the predicate. | Pass |
| Evaluation of Product Viscosity and Coating | The material visually coats the electrode as well or superior to the coating applied by the predicate and that Electro Lube NXT does not drip more frequently than the predicate. | Pass |
| Evaluation of Cutting Force and Impedance | The cutting force required for an electrode coated in Electro Lube NXT is not more than the cutting force required for a bare electrode. | Pass |
| Evaluation of Electrode Adherence to Tissue | No greater weight loss when an electrode coated in Electro Lube NXT is removed from the tissue as compared to that which occurs when the bare electrode is removed from tissue. | Pass |
| Evaluation of Ease of Product Removal | Percentage of product removed by wiping is higher or not statistically different from the predicate device removal. | Pass |
| Evaluation of Ease of Eschar Removal | Percentage of eschar removal after tissue burns using a blade electrode is with product is higher or not significantly different from the eschar removed from an uncoated blade. | Pass |
| Evaluation of Potential for the Evolution of Hazardous Scenario | No observance of hazardous situations (fire, ESU fault) resulting from repeated use of product to cut tissue. | Pass |
| Flash Point Determination - Closed Cup Method | Flashpoint greater than 200°F. | Pass |
| Evaluation of Pourability/Dispensing | Pourability equivalent or better than predicate. | Pass |
| Evaluation of Sponge Interaction | Applicator sponge incorporates product, does not become discolored, exhibits no damage and does not leave particulate on electrosurgical instruments. | Pass |
| Reprocessing Validation Testing | Use of product does not prevent cleaning of electrosurgical instruments to accepted thresholds. | Pass |
| Thermal Spread Evaluation | Thermal damage associated with the tested electrosurgery tools (irrigating bipolar forceps and blade electrodes) were not negatively impacted by the use of Electro Lube NXT. | Pass |
| Biocompatibility | Cytotoxicity: MEM Elution | |
| Sensitization: Skin Sensitization Study in Guinea Pigs by Guinea Pig Maximization Test | ||
| Irritation: EL201 Intracutaneous Reactivity Test in New Zealand White Rabbits | ||
| Acute Systemic Toxicity: Acute Systemic Toxicity Test in Wistar Rats | ||
| Hemocompatibility: ASTM Hemolysis Direct Contact and Extract Methods | ||
| Pyrogenicity: Material Mediated Pyrogenicity Test in New Zealand White Rabbits | All Pass |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document does not specify exact sample sizes for each non-clinical test (e.g., number of electrodes tested, number of tissue samples, number of animals for biocompatibility).
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be a pre-market non-clinical validation conducted by the manufacturer (STERIS Corporation, based in Mentor, OH, USA), rather than a clinical trial. The tests are likely performed in controlled laboratory settings. The nature of these tests is prospective in the sense that they are specifically designed experiments to evaluate the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a non-AI/ML device. The "ground truth" for these tests isn't established by human experts interpreting data. Instead, it's determined by objective measurements and standardized protocols for physical and chemical properties, and biological responses.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where inter-reader variability needs to be resolved for establishing ground truth. For non-clinical device performance testing, results are based on direct measurement against defined criteria.
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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 is not an AI/ML device, and no MRMC study or assessment of human reader improvement is mentioned or relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device involving an algorithm. The "performance" is the device's physical, chemical, and biological interaction, not an algorithmic prediction.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's non-clinical performance is defined by established scientific and engineering principles, material science, and biological compatibility standards. For example:
- Physical/Chemical Properties: Measured values (e.g., flash point, viscosity) compared to specified thresholds.
- Functional Performance: Observations of the device's behavior (e.g., coating ability, eschar removal, cutting force) under controlled experimental conditions, often compared to an uncoated or predicate substance.
- Biocompatibility: Standardized in vitro and in vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity) with results compared against acceptable biological response criteria.
- The "ground truth" for this device's non-clinical performance is defined by established scientific and engineering principles, material science, and biological compatibility standards. For example:
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that undergoes a "training" phase.
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How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned for this device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.