FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The VISICLEAR smoke evacuation system is a self-contained system that is used to remove and filter surgical smoke. The device is intended for general electrosurgical and laser applications for removing smoke generated by electrosurgery and laser procedures.

The device is constructed using the same materials and design specifications commonly found in the predicate devices in the smoke evacuation marketplace. The smoke evacuator is comprised of a vacuum motor, aluminum, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the smoke from the surgical site, through the vacuum tubing and into the VISICLEAR filter where the surgical smoke is processed by a series of filtration stages.

The vacuum flow rate for the VISICLEAR smoke evacuation device ranges from a minimum of 5 liters per minute (LPM) in Laparoscopic Mode to 30 cubic feet per minute in Open Mode. These flow rates are substantially equivalent to the flow range for the predicate devices.

The filter for the VISICLEAR smoke evacuation system, like the filters for the predicate devices, is a replaceable self-contained filter that is completely enclosed to protect health care personnel from potential contamination during filter changes. The VIROSAFE 135 filter ("VS135") is an Ultra Low Penetration Air (ULPA) grade with carbon fitter that has filter efficiency of 99.999% for particle sizes of 0.1 to 0.2 microns or greater. These characteristics are consistent with the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for the VISICLEAR Smoke Evacuation System. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

The document describes bench testing for verification and validation to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving patients or human readers.

Sample size used for the test set and the data provenance:
- The document primarily refers to "bench testing" and does not specify a "test set" in terms of patient data or clinical images. It implies testing of the device itself and its components.
- Data provenance is not explicitly stated in terms of country of origin, but the company, Buffalo Filter LLC, is based in Lancaster, NY, USA. The testing appears to be "retrospective" in the sense that it's based on engineering tests rather than prospective patient recruitment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this device's performance is established through objective engineering measurements (e.g., flow rate, filter efficiency, safety standards compliance) rather than expert interpretation of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this was not a study involving human interpretation or adjudication of results.
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 device is a smoke evacuation system and does not involve AI or human readers for diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical system, not an algorithm. Its performance is inherent to its physical design and operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by established engineering and regulatory standards for air handling devices and smoke evacuator performance. This includes:
  - ULPA efficiency standards: 99.999% for particle sizes of 0.1 to 0.2 microns or greater.
  - Flow rate measurements: Minimum 5 LPM (Laparoscopic Mode) to 30 CFM (Open Mode).
  - Filter life: 35 hours (Laparoscopic Mode), 18 hours (Open Mode).
  - Electrical safety standards: IEC/ANSI/AAMI 60601-1 and IEC/ANSI/AAMI 60601-1-2.
  - Mechanical safety standards: IEC/ANSI/AAMI 60601-1.
  - Software functionality: Verification that the filter life decrementing feature works as intended.
  - Smoke removal effectiveness: Quantified ability to remove smoke aerosols.
The sample size for the training set:
- Not applicable. This refers to a physical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

Regulation Number and Section

§ 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.

Acceptance Criteria / Parameter	Predicate Device (Conmed Aer Defense K091139) Reported Performance	Predicate Device (Buffalo Filter Porta PlumeSafe 601 K924732) Reported Performance	VISICLEAR Smoke Evacuation System Reported Performance
Intended Use	Smoke Evacuation and Filtration	Smoke Evacuation and Filtration	Smoke Evacuation and Filtration
Indications for Use	To remove smoke, aerosols and mitigate odors produced by surgical smoke during electrosurgical procedures	Evacuation of smoke plume and odor generated during laser or electrosurgery procedures	To remove smoke and aerosols from a surgical site; to mitigate odors produced by surgical smoke during electrosurgical and laser procedures.
Target Population	Physicians and trained hospital staff during the use of lasers or electrosurgery	For physicians and trained hospital staff during the use of lasers or electrosurgery	For physicians and trained hospital staff during the use of lasers or electrosurgery
User Interface	Touch Keypad with LED Indicator Lights	Touch Keypad with LED Indicator Lights	Touch Keypad with LED Indicator Lights
Energy Used	Electrical Current	Electrical Current	Electrical Current
Operational Settings	On/Off Switch, Suction level buttons for Motor Control	On/Off Switch, Suction level buttons for Motor Control	On/Off Switch, Suction level buttons for Motor Control
Compatibility with Environment & Other Devices	Compatible, neutral to other devices	Compatible, neutral to other devices	Compatible, neutral to other devices
Materials of Construction	Coated Aluminum Housing and ABS Plastic Fascia, Insulation, Glass micro fiber filter media, coconut shell carbon	Stainless Steel Housing, Insulation, Glass micro fiber filter media, granular activated carbon	Powder-Coated Aluminum Housing, ABS -PC Plastic Fascia, Insulation, Glass micro fiber filter media, granular activated carbon
Maximum Flow Rate	Up to 25 CFM	Up to 60 CFM	Up to 30 CFM
Filter Efficiency	ULPA Filter Efficiency of 99.9995% at 0.12 microns or greater	99.99995% at 0.12 microns	99.999% at 0.1 to 0.2 microns
Device Mechanism of Action	Vacuum source with a mechanical means of filtration	Vacuum source with a mechanical means of filtration	Vacuum source with a mechanical means of filtration
Air Flow Path	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room	Through Vacuum hose or tubing, into a filter, then vacuum motor, and vented into the room
Filter Life	Up to 35 hours	25 Hours filter life	Up to 35 hours (Laparoscopic Mode), 18 hours (Open Mode)
Human Factors	Used by surgeons and trained health care professionals	Used by surgeons and trained health care professionals	Used by surgeons and trained health care professionals
Electrical Safety	IEC 60601-1 tested and compliant	Tested and Compliant to IEC 60601-1:1990	Tested and Compliant to IEC 60601-1 and IEC 60601-1-2
Mechanical Safety	Tested and compliant per IEC60601-1 for mechanical safety	Tested and compliant per IEC60601-1 for mechanical safety	Tested and compliant per IEC60601-1 for mechanical safety
Chemical Safety	Neutral pH, non-patient contact	Neutral pH, non-patient contact	Neutral pH, non-patient contact
Thermal Safety	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1	Operation of the device does not result in harmful temperatures, tested and compliant per IEC60601-1
Radiation Safety	Non-radioactive	Non-radioactive	Non-radioactive
Laparoscopic Smoke Evacuation Verification	Not explicitly detailed, but implied by intended use	Not explicitly detailed, but implied by intended use	Confirmed effectiveness at clearing smoke while not reducing the pneumoperitoneum
Software Verification (for filter life decrementing)	Not explicitly detailed, but implied by predicate filter life	Not explicitly detailed, but implied by predicate filter life	Confirmed the effectiveness of this feature to limit the filter use to only the intended life.