PQM · Surgical Smoke Precipitator
General, Plastic Surgery · 21 CFR 878.5050 · Class 2
Overview
| Product Code | PQM |
|---|---|
| Device Name | Surgical Smoke Precipitator |
| Regulation | 21 CFR 878.5050 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the Surgical smoke precipitator is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following: (i) Chemical characterization and toxicological risk assessment of the treated surgical smoke. (ii) Demonstration that the elements of the device that may contact the patient are biocompatible. (2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended. (3) Software verification, validation, and hazard analysis must be performed. (4) Performance data must demonstrate the sterility of the patient contacting components of the device. (5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life. (6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use. (ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries. (iii) Device must be demonstrated to be non-damaging to the site of use and animal subject. (7) Labeling must identify the following: (i) Detailed instructions for use. (ii) Electrical safety and electromagnetic compatibility information. (iii) A shelf life.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240868 | Ultravision2 IonPencil | Alesi Surgical Limited | Aug 12, 2024 | SESE |
| K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. | Oct 31, 2023 | SESE |
| K231238 | Ultravision2 System | Alesi Surgical, Ltd. | Oct 31, 2023 | SESE |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | May 4, 2020 | SESE |
| K182053 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | Sep 7, 2018 | SESE |
| K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | May 26, 2017 | SESE |
| DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | Dec 20, 2016 | DENG |
Top Applicants
- Alesi Surgical, Ltd. — 6 clearances
- Alesi Surgical Limited — 1 clearance
