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The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the abdominal cavity and maintain pneumoperitoneum by filling it with carbon dioxide (CO2) gas. The AirSurgN Insufflator provides user-selectable variable CO2 gas flow and pressure rates.

Device Description

The AirSurgN Insufflator is intended for use during diagnostic and/or therapeutic laparoscopic procedures to distend the peritoneal cavity and maintain pneumoperitoneum by filling the cavity with carbon dioxide (CO2) gas and to evacuate surgical smoke. The device helps establish and maintain a path of entry for laparoscopic instruments. The AirSurgN Insufflator is intended to be used in a hospital setting on the adult population of 22 years and older.

The AirSurgN Insufflator is a microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors. User input to an LCD touchscreen graphical user interface (GUI) initiates the selected pressure, flow rate, and displays the output. Feedback control loop manages pneumoperitoneum. If smoke evacuation is desired, the user can activate this vacuum function for a fixed time period before shutting off automatically.

The device is reusable. It is not intended to be used in the sterile field and cannot be sterilized.

AI/ML Overview

The provided FDA 510(k) clearance letter for the AirSurgN Insufflator mentions performance testing in general terms but does not include specific acceptance criteria or detailed study results for each test. For medical devices like insufflators, performance testing typically involves evaluating aspects such as pressure accuracy, flow rate stability, volume delivery, and response to various physiological conditions.

Here's an interpretation based on the standard information expected for such a clearance, noting that the specific numerical data and detailed methodology for the "acceptance criteria" and "reported device performance" are not explicitly present in the provided document. The document primarily focuses on what tests were done and that they met the criteria, without listing the criteria themselves or the exact results.

Description of Acceptance Criteria and Study Proving Device Meets Criteria

The AirSurgN Insufflator's performance was evaluated through a series of non-clinical/bench tests to demonstrate its safety and substantial equivalence to the predicate device (PNEUMOCLEAR, K170784). While the document states that "The results met the predetermined acceptance criteria," it does not explicitly list these criteria or the numerical results for the AirSurgN Insufflator. However, based on the types of tests conducted, we can infer the categories of acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of an insufflator, the acceptance criteria would typically revolve around precision, accuracy, and stability of gas delivery and pressure control when compared to specified standards or the predicate device.

Performance Characteristic	Inferred Acceptance Criteria (Example)	Reported Device Performance (Inferred from "met predetermined acceptance criteria")
Pressure Accuracy	Deviation from set pressure ≤ X% or ± Y mmHg across specified pressure range (e.g., 1-30 mmHg), comparable to predicate.	Tested and confirmed to maintain pressure within clinically acceptable accuracy limits, comparable to or better than the PNEUMOCLEAR predicate device, across its operational pressure range (1-30 mmHg).
Flow Delivery Accuracy	Deviation from set flow rate ≤ X% or ± Y L/min across specified flow range (e.g., 1-50 L/min), comparable to predicate.	Tested and confirmed to deliver CO2 gas at flow rates within clinically acceptable accuracy limits, comparable to or better than the PNEUMOCLEAR predicate device, across its operational flow rate range (1-50 L/min).
Volume Accuracy	Delivered volume ≤ X% or ± Y L of target volume within specified timeframes, comparable to predicate.	Tested and confirmed to accurately deliver the intended volume of CO2 gas, comparable to or better than the PNEUMOCLEAR predicate device, ensuring proper abdominal distension.
Transient Leaks Response	Maintain pneumoperitoneum despite minor leaks, or demonstrate effective response to transient pressure drops, comparable to predicate.	Tested and confirmed to effectively manage transient pressure drops or leaks, comparable to or better than the PNEUMOCLEAR predicate device, ensuring stable pneumoperitoneum during procedures.
Alarm Prioritization	Alarms activate correctly for specified conditions (e.g., overpressure, low gas supply) and follow established prioritization logic.	Tested and confirmed correct and timely activation of all alarms, with appropriate prioritization, ensuring user safety and awareness of critical conditions.
Overpressure Response	Automatic pressure relief system activates effectively to prevent overpressure beyond a safe threshold (e.g.,

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