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The Crystal Vision Smoke Evacuator System with Accessories is designed to remove smoke created in surgical procedures. The Crystal Vision Smoke Evacuator System with Accessories can be used to remove smoke produced by lasers, electrosurgical devices, argon beam coagulators, LEEP devices, and other devices that create smoke during surgical procedures.

During internal surgical procedures such as laparoscopy. it helps to maintain the desired internal pressure (pneumoperitoneum). The Crystal Vision Smoke Evacuator System with Accessories removes up to 20 litersper-minute of smoke produced.

The Crystal Vision Smoke Evacuator System with Accessories automatically activates when active (smoke producing) devices that are coupled to the smoke evacuator, with special sensors, are turned on.

The Crystal Vision Smoke Evacuator System with Accessories automatically turns off, at a time predetermined by the operator, after the active device turns off and automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum.

The Crystal Vision Smoke Evacuator System with Accessories can be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures.

The Crystal Vision Smoke Evacuator System with Accessories is intended to be used by trained professionals.

The subject device (Crystal Vision Smoke Evacuator System with Accessories) operates under same technologies, same mechanism of actions as the predicate (Crystal Vision (Model 470) and Accessories) and will use same accessories as the predicate device.

The modifications are: increase dimension of the product chassis to partially enclose the Input ULPA filter and the Output Charcoal filter; replace mechanical controls with push buttons; eliminate Stand By switch; replace flow set display, from bargraph display to 3 digits display; expand flow reading from 2 to 3 digits.

Accessories description:

The ULPA Filter & Water Trap:

The ULPA Filter & Water Trap for the Crystal Vision Smoke Evacuator System with Accessories, like the filters for the predicate device, is a replaceable filter that is completely enclosed to protect health care personnel from potential contamination during filter change. The ULPA Filter & Water Trap has a ULPA (Ultra Low Penetration Air) media.

Charcoal Output Filter:

The Charcoal Output Filter for the Crystal Vision Smoke Evacuator System with Accessories, like the one for the predicate device, is a replaceable filter that is completely enclosed and installed on the back of the Crystal Vision Smoke Evacuator System. The filter contains Granular Activated Charcoal from coconut shell and its life is based on the ability of the charcoal to absorb odors.

Sensor:

The Sensor for the Crystal Vision Smoke Evacuator System with Accessories, like the sensor for the predicate device, is an accessory which activates the Crystal Vision Smoke Evacuator automatically, when a cutting, smoke producing device will activate.

Foot Pedal:

The foot pedal is used for end user convenience as to activate the smoke evacuator when needed. The foot pedal shall be connected through same input connector used by sensor(s).

Intra-Abdominal Tubing Set, Sterile and Non-Sterile:

The I/A tubing is used during laparoscopic procedures, to evacuate the smoke produced. It connects to the trocar at one end and to the smoke evacuator to the other end.

Smoke Tubing, Sterile and Non-Sterile:

The smoke tubing may be used during any surgical procedure where there are smoke producing devices that needs smoke evacuation.

Smoke Tubing with In-Line Filter, Non-Sterile:

The smoke tubing may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation. In addition, the smoke tubing has a HEPA filter

Wand, Sterile and Non-Sterile:

The wand is a hand held device that may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Crystal Vision Smoke Evacuator System with Accessories), not a study proving the device meets specific acceptance criteria based on diagnostic performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through modifications to the form and controls of an existing smoke evacuator system.

Therefore, the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert involvement, MRMC studies, standalone performance, and ground truth establishment for a diagnostic AI/device cannot be extracted from this document, as it is not relevant to the type of device and submission described.

The document discusses performance bench testing against electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2), stating that the device met "Acceptance criteria on all applicable clauses of above mention standards." However, it does not provide a table of these specific acceptance criteria or the reported performance in measurable terms like sensitivity, specificity, or AUC, as these are not relevant for a smoke evacuator's function. No clinical testing (which would involve human or real-world performance data typically associated with diagnostic or AI devices) was performed or required for this submission.

Summary of what can be inferred for this specific device/submission based on the provided text:

Acceptance Criteria & Reported Performance: The document states the device met acceptance criteria for electrical safety and electromagnetic compatibility standards (ANSI/AAMI/ES 60601-1 and IEC 60601-1-2). No specific numerical thresholds or results beyond "met" are provided. This is typical for predicate device submissions focused on substantial equivalence for physical devices, not diagnostic software.
Sample Size for Test Set & Data Provenance: Not applicable, as no diagnostic "test set" in the AI sense was used. Performance was assessed via bench testing on the device itself.
Number of Experts & Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: No. The device is a physical smoke evacuator, not an AI or diagnostic tool where MRMC studies would be relevant.
Standalone Performance: Not applicable.
Type of Ground Truth: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.