(57 days)
The New Deantronics Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil, improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator.
The Smoke Evacuation Adapter is a single-use device provided to healthcare professionals. This device is an accessory to an electrosurgical pencil. The Smoke Evacuation Adapter can be attached directly to an electrosurgical pencil improving visibility and capture smoke and odors directly at the surgical site when connected to a smoke evacuator. The device components include a pencil holding clamp, an electrosurgical pencil wire holder, smoke evacuator tubing pathway to the smoke evacuator, and a connector to the smoke evacuator. The clamp secures the smoke evacuation pencil adapter to the bottom of the pencil handle. Suction to remove smoke and odors is created by a smoke evacuator device furnished by the user organization. The smoke evacuator maintains a low pressure condition by a suction pump.
This document is a 510(k) premarket notification for a medical device called the "Smoke Evacuation Adapter." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than presenting a study to prove the device meets acceptance criteria related to its performance in a clinical setting against specific, quantifiable metrics.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as this type of regulatory submission doesn't typically include a clinical study with performance metrics in the way your prompt describes.
However, I can extract information regarding non-clinical testing performed to establish safety and effectiveness for regulatory clearance.
Here's a breakdown of the available information based on your prompt:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria with corresponding performance metrics as one would find in a clinical study for diagnostic accuracy or treatment effectiveness. Instead, it lists harmonized standards and emphasizes a comparison to a predicate device for substantial equivalence.
The "acceptance criteria" here are compliance with the listed standards and demonstrating equivalent performance and safety to the predicate device through non-clinical testing.
| Acceptance Criteria Category (implied by non-clinical tests) | Reported Device Performance (from "Non-clinical testing conclusion" and "Key Features Comparison") |
|---|---|
| Safety and Essential Performance | The device was subjected to and passed non-clinical tests based on IEC 60601-1 (general medical electrical equipment safety), and IEC 60601-2-2 (high frequency surgical equipment safety). The non-clinical tests successfully demonstrated the device is as safe as, as effective as, and performs as well or better than the predicate device. |
| Risk Management | Compliance with ISO 14971 (Application of Risk Management to Medical Devices) is implied, suggesting risks were identified and managed. |
| Biocompatibility | Passed tests for in vitro cytotoxicity (ISO 10993-5), irritation, and skin sensitization (ISO 10993-10), with sampling done according to ISO 10993-12. |
| Sterilization | Adherence to ISO 11137-2 (Establishing the sterilization dose for radiation sterilization). Sterilization method is Gamma radiation, same as predicate. |
| Packaging Integrity | Compliance with ISO 11607 (Packaging for terminally sterilized medical devices) and ISTA 2A (Packaged-Products 150 lb or Less). |
| Usability | Compliance with IEC 62366 (Application of Usability Engineering to Medical Devices) is implied. |
| Technological Characteristics | Equivalent to predicate in use environment (Single Use, hospital, clinic), sterilization method (Gamma radiation), construction design, inlet diameter (Approx. 10 mm), material of suction tube (EVA), and requiring a smoke evacuator with a 10/22 mm port. Materials of pencil adapter (ABS + PC) are different from predicate (Polystyrene). |
Information not available or not applicable based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Provided: This document describes non-clinical engineering and bench testing, not a clinical study involving human or patient data with a "test set" in the context of diagnostic performance. The tests assess compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Provided: Ground truth is not established by clinical experts for this type of non-clinical device testing. Compliance with engineering and safety standards is assessed by appropriate testing methods and validated against those standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Provided: No clinical adjudication method is relevant for this type of non-clinical device testing.
5. 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/Provided: This is a physical accessory device for smoke evacuation during electrosurgery, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Provided: This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Provided (for clinical ground truth): For the non-clinical tests, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601-1 for safety, ISO 10993 series for biocompatibility) and performance equivalent to the predicate device as demonstrated by bench testing.
8. The sample size for the training set
- Not applicable/Provided: This is not an AI/machine learning device that involves training sets.
9. How the ground truth for the training set was established
- Not applicable/Provided: This is not an AI/machine learning 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.