(38 days)
The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.
The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.
The provided text describes the ANET Electrosurgical Applicator and its substantial equivalence determination to a predicate device (Habib EUS RFA 6700). However, it does not include specific quantitative acceptance criteria or detailed study results (like statistical performance measures, sample sizes, expert qualifications, or ground truth establishment) typically associated with the type of request. The information provided is more general, focusing on the types of tests performed to demonstrate safety and performance.
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Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of specific metrics and target values (e.g., "sensitivity > 90%"). Instead, it states that the device "successfully passed all performance testing" and that its "lesion dimensions...are equivalent to those obtained with the predicate device under the same test conditions and specified power levels."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 requirements. | Biocompatibility verification performed for patient-contacting components in accordance with ISO 10993-1, as well as the Guidance Document "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,' June 2016." (Result: Implied compliance, as the device successfully passed all performance testing.) |
| Sterilization/Shelf-Life: Achieve sterility assurance level (SAL) of 10^-6*; maintain package integrity and sterility; demonstrate specified shelf-life. | Validated to achieve a sterility assurance level of 10^-6* and adopted into a validated EO sterilization cycle. Packaging validation performed to ensure devices maintain package integrity and sterility. (Shelf-life: ANET has 6 months, versus predicate's 3 years; "Real time 1 year shelf life in progress" for ANET, implying 6-month shelf life was verified for market clearance.) |
| Electrical Safety and EMC: Comply with applicable standard requirements (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2). | Electrical safety and EMC testing completed for applicable components. Results demonstrated compliance to all applicable standard requirements. |
| Mechanical and Functional Testing: Conform to pre-determined mechanical, functional, and packaging specifications at baseline and 6 months accelerated aging. | Mechanical and Functional testing completed to confirm that the performance of the ANET device conforms to the pre-determined mechanical, functional, and packaging specifications at baseline (post-sterilization, T=0) and 6 months accelerated aging (T=0.5, including devices subjected to sterilization and accelerated aging). |
| Comparative Bench-Top Validation Testing: Lesion dimensions equivalent to predicate device under same test conditions and specified power levels. | Direct comparative bench top validation testing completed to demonstrate substantially equivalent ablation performance in various tissue types. Results demonstrated that the lesion dimensions achieved by the ANET Applicator are equivalent to those obtained with the predicate device under the same test conditions and specified power levels. (No specific quantitative lesion dimensions or acceptable deviation ranges are provided). |
| Overall: Substantial equivalence to predicate device. | The ANET device successfully passed all performance testing. Spiration believes the data supports a determination of substantial equivalence to the predicate device. |
Detailed Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the performance tests (biocompatibility, sterilization, electrical safety, mechanical/functional, or comparative bench-top). The text only mentions "devices tested."
- Data Provenance: Not specified. These appear to be laboratory bench-top tests conducted by the manufacturer, not clinical studies involving human patients or specific geographic origins.
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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 the reported studies are primarily bench-top validation tests comparing the physical and functional characteristics of the device/ablation lesions, not diagnostic performance studies requiring expert interpretation of medical images or pathologies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the types of engineering and bench-top performance tests described.
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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 MRMC study was mentioned. This device is an electrosurgical applicator used for coagulation/ablation, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm; therefore, this question is not applicable. The performance tests described (e.g., lesion dimensions, mechanical function) are for the physical device itself.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the comparative bench-top validation testing, the "ground truth" for comparison was the performance of the predicate device (Habib EUS RFA 6700) under the same test conditions and specified power levels. The measurement of "lesion dimensions" would be considered the objective outcome being compared, likely measured directly from the tissue (e.g., using calipers or imaging).
- For other tests (biocompatibility, electrical safety, mechanical/functional), the "ground truth" or reference was adherence to established international standards (e.g., ISO, IEC) and the manufacturer's own pre-determined specifications.
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The sample size for the training set:
- Not applicable. This device is a medical instrument, not a machine learning model that undergoes "training."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set 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.