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510(k) Data Aggregation
(210 days)
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.
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.
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., < Z mmHg). | Tested and confirmed the reliable activation of the automatic pressure relief mechanism to prevent potentially dangerous overpressure conditions. |
| Smoke Evacuation Functionality | Manual On/Off function for vacuum/smoke evacuation operates correctly, achieving desired particulate removal within specified timeframe. | Tested and confirmed effective operation of the manual On/Off vacuum/smoke evacuation function, ensuring clear surgical field when activated for the fixed time period. |
| System Durability & Reliability | Withstand simulated operational conditions and expected lifecycle without significant degradation in performance, meet specified MTBF (Mean Time Between Failures) targets. | Tested and found to be robust and reliable under simulated use conditions, demonstrating an expected lifetime and performance stability consistent with safe and effective clinical use. |
| Accessory Compatibility | Compatible with specified standard accessories (e.g., CO2 gas tanks, tubing) without compromise to performance or safety. | Tested and confirmed compatibility with standard CO2 gas sources and the separately sold compatible tubing, without adverse effects on device performance or safety. |
| Electrical Safety & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards regarding electrical safety and electromagnetic compatibility. | Tested and confirmed full compliance with IEC 60601-1:2005/AI: 2012, ANSI/AAMI ES60601-1: 2005(R) 2012 for electrical safety, and IEC 60601-1-2 Edition 4.1 En: 2020-09 for EMC, indicating safe electrical operation and minimal electromagnetic interference. |
| Software Validation | Software functions correctly as designed, meets all requirements, and is free of critical defects based on IEC 62304 and FDA guidance. | Software was rigorously validated in accordance with IEC 62304:2006/A1:2016 and FDA's 2023 guidance for "Enhanced" documentation level, demonstrating proper function, reliability, and safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "Non-Clinical/Bench Testing" and lists categories of tests. It does not specify numerical sample sizes for any of the individual tests performed. For bench testing of a device like an insufflator, the "sample size" would typically refer to the number of devices tested, or the number of test cycles/runs performed on one or more devices to demonstrate reproducibility and robustness. This information is not provided.
- Data Provenance: Not specified. Bench testing typically occurs in a controlled laboratory environment. The document does not mention the country of origin of the data or whether it was retrospective or prospective, as these terms are more typically applied to clinical studies involving patient data rather than device bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For a medical device like an insufflator, "ground truth" is established through engineering and scientific principles, validated test equipment, and established performance standards (e.g., flow meters, pressure transducers traceable to national standards). This type of testing does not typically involve human experts establishing a "ground truth" in the way that image interpretation for AI algorithms would. The "ground truth" (ideal performance) for pressure, flow, etc., is derived from the device's design specifications and regulatory standards.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for subjective data (like medical images). Since this study involves objective bench testing of device physics (pressure, flow, etc.), an adjudication method is not relevant.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. The document explicitly states: "No clinical investigations were required for a determination of substantial equivalence." MRMC studies are typically clinical studies involving multiple human readers interpreting medical cases, often with and without AI assistance, which is not relevant for an insufflator that controls gas flow and pressure.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
- Not Applicable in the traditional sense of AI algorithms. This device is a hardware insufflator with microprocessor control. The "standalone performance" is essentially the device's ability to meet its functional specifications (pressure, flow, etc.) independently. The bench tests described (Pressure Accuracy, Flow Delivery Accuracy, etc.) inherently demonstrate this standalone performance. There isn't an "algorithm" in the typical AI sense that performs interpretation or decision-making that would then be compared to human performance.
7. Type of Ground Truth Used
- Engineering/Physical Measurement Ground Truth. The ground truth for this device's performance is based on accurate, calibrated measurements of physical parameters (e.g., pressure, flow rate, volume) using standardized test equipment and methods. This is guided by the device's design specifications, applicable performance standards (e.g., ISO standards for medical gas systems), and comparison to the predicate device's established performance.
8. Sample Size for the Training Set
- Not Applicable. The AirSurgN Insufflator is described as a "microprocessor-based CO2 insufflator, controlling pneumatic valves, vacuum pump, and pressure sensors." While it has a feedback control loop, the document does not indicate that it uses a machine learning (ML) or artificial intelligence (AI) component that would require a "training set" of data in the typical sense (e.g., for image recognition or predictive analytics). Its control system is likely based on traditional control algorithms rather than learned models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8. No 'training set' is mentioned or implied for a device of this nature in the provided documentation.
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