(278 days)
The SmartVac is intended to be used for the evacuation of plume from the use of electrocautery, laser or other plume producing devices. It is intended to be used during both open surgery or endoscopic surgical procedures performed in the operating room or procedure room of hospitals, ambulatory surgery centers, clinics or in a physician's office.
The SmartVac Smoke Evacuation System is indicated for the evacuation of plume from electrocautery, laser or other plume generating devices.
The SmartVac operates by collecting air containing smoke/plume from the site of origin, filtering the biological and chemical components, and returning the filtered, odor-free air to the room.
The SmartVac functions by creating a partial vacuum, near the smoke source, which pulls the smoke into a collection accessory and through a filtration system. After filtration, the air moves through the motor/blower and exits the cabinet.
The major components of the SmartVac are:
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- collection devices which consist of plain tubing or tubing with a procedure specific Collection Tip on the distal end;
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- a filtration system which includes a First Filter which is a combination High Efficiency Particulate (HEPA) and carbon filter intended for limited, multiprocedure usage;
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- a second Filter which is a large Ultra Low Penetration Air (ULPA) filter;
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- a pressure sensor monitors the pressure differential across the filter and activates the Change ULPA light when a filter nears occlusion; and
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- a vacuum system which consists of a motor/blower designed to pull a partial vacuum in the Filtration System and its various controls.
In use, the distal end of the Collection Accessory is positioned close to the surgical site. When electrocautery or laser usage produces smoke, the user activates the SmartVac. Air, pulled from in front of the Collection Tip or end of the Tubing, flows through the First Filter which removes most biological particulates and noxious gases. It then passes through the Second Filter for ULPA filtration before it goes through the motor/blower and exits the rear of the cabinet. Pressure sensors monitor the pressure differential across both filters. Those monitoring the First Filter control the three lights of the Filter Status Indicator ULPA light. The sensors on the First Filter also sense any sudden increase in pressure from invagination of either tissue or a foreign object.
The Collection Accessories offered in the SmartVac Evacuation System include corrugated tubing, electrosurgical shrouds, smaller tubing and/or connectors, laser resistant wands, replacement filters and a remote switch.
The provided text is a 510(k) summary for the Niche Medical SmartVac Smoke Evacuation System. It is an application for market clearance for a medical device and describes its function and comparison to a predicate device.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific quantitative acceptance criteria in a dedicated section. However, it implicitly defines "acceptance" as being substantially equivalent to the predicate device, the Niche Medical ECS.01 Plume Evacuation Containment System, and demonstrating superior performance in certain aspects.
| Acceptance Criteria (Implicit from comparison) | Reported Device Performance (SmartVac) |
|---|---|
| Performance related to smoke evacuation efficacy | The SmartVac system demonstrated flow rates and absorption capacity greater than that of the ECS.01. The system effectively filters biological and chemical components, returning filtered, odor-free air to the room. |
| Technological characteristics superiority/equivalence | The SmartVac has: higher flow motor/blower, lower operating sound level, a high flow system ULPA filter, a physically smaller filter canister with more carbon, an electronic rather than mechanical pressure sensing system to determine when the system should shut-off, more rapid pressure relief, and an automatic compensation for a change in tubing size. It uses two filters compared to the ECS.01's one. It also offers a flexible support to hold Collection Tubing in place, reducing the need for manual holding. |
| Safety and efficacy for intended use | The device is considered substantially equivalent to legally marketed predicate devices for the evacuation of plume from electrocautery, laser, or other plume-producing devices in various surgical settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance testing demonstrated that the SmartVac has flow rates and absorption capacity greater than that of the ECS.01." However, it does not provide details on the sample size used, the specific tests conducted (e.g., number of repetitions, volume of smoke), or the provenance (country, retrospective/prospective) of the data.
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)
This information is not applicable/provided. The evaluation is based on technical performance metrics (flow rate, absorption capacity, technological features) of the device itself, rather than expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided. There is no indication of an adjudication method as the testing involves direct measurement of device performance, not interpretation by multiple parties.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or conducted. This device is a smoke evacuation system, not an AI diagnostic or assistive tool, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described implicitly refers to standalone performance of the device (not an algorithm in this context). The "performance testing" evaluated the SmartVac's inherent capabilities (flow rate, absorption capacity) without human-in-the-loop interaction being a primary variable in the performance metrics discussed. The device's features like automatic compensation and electronic pressure sensing also point to its standalone operational capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be the objective, measurable physical properties and functional performance (e.g., actual flow rates, actual absorption capacity determined by standardized tests, actual sound levels, filter efficiency, functional operation of sensors). The comparison is made against the documented performance of the predicate device.
8. The sample size for the training set
This information is not applicable/provided. This device is a mechanical/electronic system, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no training set for this type of device.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.