(89 days)
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.
The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the ENCISION AEM Monitor. The AEM Monitoring System, with compatible electrosurgical instruments, is designed to minimize the likelihood of stray energy injuries caused by active insulation failure or capacitive coupling. The monitor does this by shutting down the ESU when excessive current is returned via the shield circuit which extends to near the tip of the electrode. The electrode has a stainless electrode tip welded onto the distal ID of the active tube. The active tube acts as the suction and irrigation path. The tube assembly has primary and secondary insulation layers which separate the inner active tube from the outer shield tube. The device has a molded body that interfaces with the 30 party trumpet valves or luer valves via the appropriate adapter. The Adapters (sold separately) are attached to the body of the electrode to make a compatible connection with selected suppliers of trumpet valve/tube sets. There is an electrical connector on the body capable of accepting Encision AEM cords, which carry the active and AEM shield conductors. The electrode has various fixed tips at the distal end for surgical manipulation and delivery of electrosurgical energy to the patient. All tip styles are insulated from the end of the active tube to the working portion of the tip. There is a sliding sheath outside of the tube assembly. The sheath in the extended position minimizes risk of injury to tissue from tips when the electrode is inserted into a trocar cannula or reoriented. Holes in the distal end of the tube facilitate suction when the sheath is extended. When the sheath is retracted the electrode tip is exposed for delivery of electrosurgical energy. The sheath can be locked into place in the extended position, and has tactile stops in both the extended and retracted positions. The sheath is required for full protection from stray energy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Suction Irrigation Electrodes, structured according to your request:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Continuity | * Active circuit: Continuity between active connector and tip of electrode is to be ≤ 4 Ohms. |
- Shield circuit: Continuity between shield connector and distal end of shield tube is to be ≤ 2 Ohms. | * Active circuit: The device was found to have an active circuit resistance ≤ 1.618 ohms using a 95% confidence interval with 99% reliability. Pass
- Shield circuit: The device was found to have a shield circuit resistance ≤ 0.830 ohms for a 95% confidence interval with 99% reliability. Pass |
| Capacitance | Capacitance between active connector and shield connector is ≤ 130 pF @ 100 kHz. | The device was found to have a capacitance ≤ 121.49 pF @ 100 kHz using a 95% confidence interval with 95% reliability. Pass |
| Energy Transmission | The device must transmit the full range of HF energy, from 30 to 60 watts of power in all modes from any approved ESU with less than 10% change in voltage. | The device was subjected to all 7 modes on the Conmed System 5000 ESU (4 cut modes, 3 coag modes). For every mode, at each of the 3 different power settings, the device transmitted the full range of high frequency energy with less than 10% change in voltage. Pass |
| Flow | Flow rate from the proximal to distal end of the lumen must be a minimum of 580 mL/min when tested with a fluid head height of 57". | The flow rate was found to be greater than 689.7 mL/min using a 95% confidence interval with 95% reliability. Pass |
| Safety (Standards) | Satisfactory results for all applicable clauses of: - IEC 60601-2-2:2006 (Medical electrical equipment – Part 2-2: Particular requirements for the safety of high frequency surgical equipment.)
- IEC 60601-1:1988 with amendments (Medical Electrical Equipment - Part 1: General Requirements for Safety.)
- AAMI ANSI/ISO 10993-1:2003 (Biological evaluation of medical devices - Part 1: Evaluation and testing). | Satisfactory results for all applicable clauses. |
| Biocompatibility | Non-cytotoxic (AAMI/ANSI/ISO 10993-5:1999)
Non-irritating, non-sensitizing (AAMI/ANSI/ISO 10993-10:2002)
Non-toxic (AAMI/ANSI/ISO 10993-11:2006) | * Tests selected for limited contact external communicating device to tissue. - Non-cytotoxic.
- Non-irritating, non-sensitizing.
- Non-toxic. |
| Sterilization | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL (AAMI/ANSI/ISO 17665-1:2006) was validated. | Recommended Cleaning Method and Moist Heat Sterilization for 10⁻⁶ SAL was validated. |
Study Information
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Sample Size used for the test set and the data provenance:
- The document does not explicitly state a sample size ("n") for the device performance tests (continuity, capacitance, energy transmission, flow). It describes the results in terms of confidence intervals (e.g., "using a 95% confidence interval with 99% reliability"), which implies statistical analysis from a sample, but the size of that sample is not provided.
- Data Provenance: The tests are described as bench testing, meaning they were performed in a laboratory setting. There is no information regarding country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable to the provided document. The study described is non-clinical bench testing for device performance characteristics (electrical, fluid flow, and compliance with general standards) rather than clinical performance requiring expert ground truth.
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Adjudication method for the test set:
- This section is not applicable for the same reason as above. Bench testing results are typically evaluated against pre-defined engineering criteria, not through expert adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument (Suction Irrigation Electrode), not an AI-assisted diagnostic or therapeutic tool for which human reader performance with/without AI would be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is an electrosurgical instrument for direct surgical use, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
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The type of ground truth used:
- For the non-clinical performance tests, the "ground truth" implicitly refers to the pre-defined engineering test criteria and established industry/international standards (e.g., 4 Ohms max for continuity, 580 mL/min min for flow, specific levels for biocompatibility). The results were compared directly to these objective, quantitative criteria.
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The sample size for the training set:
- This section is not applicable as there is no "training set" to speak of. The device is not an AI/ML model requiring a training set. The performance tests are conducted on the final device design.
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How the ground truth for the training set was established:
- This section is not applicable for the same reason as above. There is no training set mentioned in the document.
§ 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.