(176 days)
To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.
This 510(k) submission for the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System (henceforth referred to as NEBULAE® SRS) covers the following product codes:
• NEBULAE® SRS Pump (7-700-00)
• NEBULAE® SRS CO₂ Gas Filtration Tubing Sets (7-510-57)
The NEBULAE® SRS is intended to recirculate CO2 gas in the pneumoperitoneum whilst removing surgical smoke during laparoscopic procedures. The system consists of two parts: a Pump and dedicated singleuse, sterile Tubing Sets.
The NEBULAE® SRS Pump is a microprocessor driven, mains-powered device containing a DC motor. The single-use, disposable Tubing Set consists of an integrated cartridge, containing a diaphragm pump, an in-line ultra-low particulate air (ULPA) with activated carbon filter, fluid trap(s), 10 feet of DEHP-free PVC tubing and two connectors for connecting the tubing to the trocars. The NEBULAE® SRS Pump's DC motor drives the pump head in the Tubing Set's cartridge to create the flow of CO2 gas from the patient's pneumoperitoneum, through the fluid trap(s) and filter before re-entering the patient.
The NEBULAE® SRS Pump can be positioned on a level surface (e.g. a surgical trolley in the operating room) or fixed to a vertical IV pole using a dedicated bracket, which is available as an accessory (See VOLUME 011 for further information).
The re-circulating CO2 gas can also be warmed by the addition of an in-line gas warmer, also available as an optional accessory.
The provided text describes the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System. It primarily focuses on the device's design, intended use, and non-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. This document is a 510(k) summary, which is a premarket notification to the FDA. As such, it details non-clinical testing, not necessarily clinical studies involving human performance or diagnostic accuracy.
Therefore, many of the requested details, particularly those related to human-in-the-loop performance, ground truth establishment for a test set, expert consensus, and multi-reader multi-case studies, are not applicable or available in this document, as it concerns a physical medical device for smoke removal, not a diagnostic AI/CADe/CADx system.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Run the NEBULAE® SRS device for two hours, with the two tubing lines connected to flow meters, connected to two standard laparoscopic trocars, inserted into a laparoscopy simulation pressure chamber, insufflated with CO2 gas. Log the flow rate through each side of the Tubing Set. | Design Verification, Software Validation - Functionality; Flow Rate | Verify that the device maintains a minimum flow rate of 10L/min, on each side of the disposable Tubing Set, throughout the two hours. | Pass. |
| Connect the two NEBULAE® SRS tubing lines connected to two standard laparoscopic trocars, and introduce various sources of occlusion to the flow. Test introducing the occlusion before and after starting the flow. | Design Verification, Software Validation - Functionality; Occlusion Detection | Verify that the device detects each of the following sources of occlusion, stops flow, and produces an audiovisual alert: gas blocking moisture accumulations within the tubing line, closure of the trocar valve, obstruction of the trocar cannula, a kink in the tubing line, or a disconnected tubing line. | Pass. |
| Connect the in-line gas warmer to the device, and use a thermal camera to measure the temperature of the in-line gas warmer. Introduce each of the various fault conditions to the warmer. | Design Verification, Software Validation— Functionality, Essential Performance; In-Line Warmer | Verify that the in-line warmer reaches and maintains the set temperature. Verify that the user interface generates the designed audiovisual alert for each warmer fault condition. | Pass. |
| IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) | Electrical Safety | Test procedure: Informative. Standard test methods. | Pass. |
| IEC 60601-1-2:2014 (Emissions) | Electrical Safety – Electromagnetic Compatibility; Emissions: General, Harmonic, Flicker | Class A/ Group 1, IEC 61000-3-2:2014, IEC 61000-3-3:2013 | Pass. |
| IEC 60601-1-2:2014 (Immunity) | Electrical Safety – Electromagnetic Compatibility; Immunity: Electrostatic Discharge, Radiated Electromagnetic, Fast Transient, Surge, Conducted, Magnetic Field, Voltage Dips/ Interruptions/ Variations/fluctuations | IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 | Pass. |
| ISO 10993-1:2018 | Biocompatibility | ISO 10993-5:2009 /(R) 2014: Fluid Extract / L929 Mouse Fibroblast (Preliminary Assessment) and Fluid Extract / L929 Mouse Fibroblast; ISO 10993-10:2010 /(R)2014: Dermal Sensitization Guinea Pig Maximization (Cottonseed Oil and 0.9% NaCl) and Intracutaneous Test; ISO 10993-11:2017: Rabbit Pyrogen Test and Acute Systemic Toxicity Test | Pass. |
| ISO 11137-1:2006, ISO 11137-2:2006 | Sterilization Validation | Microbiological Validation of 25kGy Radiation Sterilization by ANSI/AAMI/ISO 11137-2 Method VDmax25 | Pass. |
| ISO 11607-1: 2006, ISO 11607-2: 2006, ISTA 3A:2018, Dye Penetration Test, Seal Strength Test, Pull strength Test | Packaging Integrity | (Implicitly, to meet these standards) | Pass. |
| Condition the NEBULAE® SRS device per ISTA 3A:2018 and subsequently, per the shipping and storage environmental conditions of IEC 60601-1-11: 2015. | Shipping and Storage | Verify that the device still meets all the functional requirements that were previously verified in manufacturing (FQC). | Pass. |
| Qualitative assessment of users' ability to perform operational tasks and troubleshoot clinical use scenarios in a simulated environment. | Validation- Usability | Greater than 80% successful usability by subjects (clinicians) | Pass. |
| Qualitative evaluation of surgical environment visual clarity while running the NEBULAE® SRS, during monopolar and bipolar electrocautery and ultrasonic coagulation, in a simulated environment. | Validation- Device Performance | ≤ 20% of subjects (surgeons) disagree that the NEBULAE® SRS helped maintain visual clarity by removing smoke and particulates from the field of vision. | Pass. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance and usability testing in simulated environments.
- Performance/Functionality Tests: The sample size for device functionality tests (flow rate, occlusion detection, in-line warmer) is not explicitly stated as a number of distinct units tested, but the results indicate successful verification against stated criteria. These are engineering/device performance tests, not data sets for an algorithm.
- Usability Study: The acceptance criteria mentions "subjects (clinicians)," implying human participants. The specific number of subjects is not provided.
- Device Performance (Visual Clarity) Study: The acceptance criteria mentions "subjects (surgeons)," implying human participants. The specific number of subjects is not provided.
- Data Provenance: The studies are described as "simulated environments" and "non-clinical testing." No information is provided regarding country of origin or whether it's retrospective or prospective, as these are device performance tests, not clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the document describes a physical medical device for smoke removal, not a diagnostic AI/CADe/CADx system that would typically require expert-established ground truth for a test set. The "ground truth" for these tests is based on objective measurements of device performance, adherence to standards, and qualitative user feedback in simulated settings.
For the "Usability" and "Device Performance" (visual clarity) qualitative assessments, the "ground truth" is based on the subjects' (clinicians/surgeons) direct experience and agreement/disagreement with the device's performance in the simulated environment. The number and qualifications of these subjects (clinicians/surgeons) are not specified beyond their professional titles.
4. Adjudication Method for the Test Set
This section is not applicable as the testing described focuses on device functionality and usability in simulated environments, not a diagnostic task requiring adjudication of expert opinions.
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 done. This type of study is typically performed for diagnostic imaging devices or AI algorithms where human readers' performance is evaluated with and without AI assistance across multiple cases. The NEBULAE® SRS is a smoke removal system, not a diagnostic imaging device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This section is not applicable in the context of an AI algorithm. The device itself (NEBULAE® SRS pump and tubing set) has standalone performance characteristics (e.g., flow rate, occlusion detection, in-line warmer function) that were tested. These are device-specific functions, not an "algorithm" in the typical sense of AI/machine learning.
7. The Type of Ground Truth Used
The "ground truth" for the tests is derived from:
- Objective device performance measurements: E.g., maintaining a minimum flow rate, correctly detecting occlusions, maintaining set temperature for the warmer.
- Adherence to recognized industry standards: Such as IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 for biocompatibility, and ISO 11137 for sterilization.
- Qualitative user feedback: For usability (successful task completion) and perceived visual clarity improvement by clinicians/surgeons in simulated settings.
There is no "pathology" or "outcomes data" ground truth as this is a non-diagnostic device.
8. The Sample Size for the Training Set
This section is not applicable. The NEBULAE® SRS is a physical medical device. It is not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for an AI/machine learning algorithm.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.