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510(k) Data Aggregation
(212 days)
The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, Minimally Invasive Vessel Harvesting.
The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.
The Nebulae™ I 50 LPM Insufflator is a medical device designed to provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Flow Rates | Bench testing in simulated use environment for all operating modes confirmed device performed within specified flow rates. |
| Fill Time (Abdomen Simulator) | Bench testing in simulated use environment proved the Nebulae™ I could fill an abdomen simulator within the specified time period. |
| Flow Accuracy | Bench testing proved the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes, performing within the specified flow accuracy range. |
| Overpressure Relief | Bench testing proved the Nebulae™ I relieves overpressure conditions of 5mmHg above the preset and returns to the preset within the specified time range. Tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all specified flow rates, the device relieved pressure within the specified time. This also includes the functional requirement of "Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less." |
| Comparative Flow Rate (vs. Predicate) | The Nebulae™ I was tested along with predicate devices using an 11mm trocar with a 10mm laparoscope. Highest flow rates measured were 32 LPM. (Implies satisfactory comparative performance). |
| Pediatric Mode Comparative Testing | Tested along with predicate device in pediatric mode (various weight modes, with Veress needle and trocar, appropriate simulated abdomen sizes). Response times to introduced/removed leaks and over/under pressure conditions were measured. Nebulae™ I performed as well as, or better than, the predicate device. |
| Tissue Desiccation Effect | Cross-comparison test with 40L Abdominal Insufflator at maximum flow rates (5mm trocar, 5mm laparoscopic instrument, moist bovine liver, 30 and 60-second exposures). Results showed negligible change to tissue surface and no perceivable depth of desiccation. Concluded that 50LPM and 40LPM insufflators were identical relative to tissue desiccation and drying. |
| Electrical Safety (IEC 60601-1:2005) | Device shown to conform to standard. |
| EMC (EN 60601-1-2:2007) | Device shown to conform to standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test (e.g., number of units tested, number of simulated abdomens, number of tissue samples). The testing appears to be solely bench testing in a simulated use environment; therefore, the data provenance is not from human subjects/patients, but rather from laboratory/bench testing, typically conducted in the country of manufacture (implied to be the USA, based on the applicant's address). The studies are prospective in nature, as they were conducted to evaluate the performance of the newly developed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. The described studies are purely bench testing and do not involve human interpretation or subjective assessment of results by experts in a clinical context to establish ground truth. Performance was measured objectively against pre-defined specifications or through comparative measurements with predicate devices.
4. Adjudication Method for the Test Set
Not Applicable. As there are no human experts establishing ground truth or making subjective assessments requiring agreement, no adjudication method was used. The performance was determined by direct measurement and comparison with objective criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a hardware insufflator and does not involve human readers interpreting images or data where AI assistance would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes. All reported performance testing was conducted as standalone bench testing, evaluating the algorithm's control of the device's mechanical and gas delivery functions without human intervention in the device's operational performance measurements. The "algorithm" in this context refers to the device's internal microprocessor control logic.
7. The Type of Ground Truth Used
The ground truth used for these studies consisted of:
- Pre-defined engineering specifications/performance ranges: For criteria like flow rates, fill time, flow accuracy, and overpressure relief.
- Objective measurements: Direct quantitative measurements obtained during bench testing.
- Comparative performance against predicate devices: Performance of the Nebulae™ I was measured and directly compared to the performance of legally marketed predicate devices under similar conditions. This established an "equivalency ground truth" for certain aspects.
- Standard conformity: Adherence to recognized electrical safety (IEC 60601-1:2005) and EMC (EN 60601-1-2:2007) standards.
8. The Sample Size for the Training Set
Not Applicable. This is a hardware medical device, and the submission describes verification and validation testing for a solidified design, not the iterative training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The design, however, would have undergone extensive internal development and testing during its engineering phase, which could be considered analogous to "training" in a broad sense, but specific data sets for algorithm training are not relevant here.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As explained above, there is no "training set" in the AI/ML context for this device. The underlying engineering principles and design parameters were established through conventional medical device design and development practices.
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