(115 days)
The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor's offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.
The Neptune 2 Waste Management System is a fluid waste management system with smoke evacuation. It collects surgical waste fluid within a closed suction system, then disposes of it through a docking station. The system is comprised of a rover and a docker (also referred to as a docking station).
The Neptune 2 Rover (Model Number: 0702-001-000) is a mobile, AC-powered surgical fluid waste collection device. It is intended to collect waste fluids and evacuate smoke during surgical procedures.
The Neptune 2 Docking Station (Model Number: 0702-014-000) is a stationary device for automated rover cleaning and waste offloading. It provides a fixed connection to the hospital's water supply, sewer, and electricity.
The provided text describes the Stryker® Neptune 2 Waste Management System, a fluid waste management system with smoke evacuation, submitted for 510(k) clearance. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a comparative study with a ground truth established by experts.
Therefore, many of the requested elements (e.g., specific acceptance criteria, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not explicitly detailed in this 510(k) summary. The summary primarily relies on bench testing and comparison to predicate devices to establish safety and effectiveness.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of explicit, quantitative acceptance criteria that the device was tested against and then reports its performance against those criteria in a "study" as one might expect for a new diagnostic or AI-driven insights device. Instead, the "Testing" section states:
"The Neptune 2 Waste Management System meets the specification and performance characteristics as identified in Stryker's internal design control procedures. Bench testing was performed to demonstrate the performance of the device. Testing was completed to verify and validate the device as outlined in the device description. Testing included electrically powered suction safety, electrical safety, vacuum cycling, software, smoke evacuation and filtration. Human factors analysis and usability testing was performed on the user interface, labeling, and training materials."
The "Table 1: Device Comparison Matrix" provides comparative specifications against predicate devices, implying that performance within a similar range or meeting similar functional attributes to the predicates would be considered acceptable. Below is a table summarizing key performance characteristics (rather than explicit acceptance criteria with pass/fail thresholds) of the Neptune 2 and its predicates, as presented in the document.
| Feature / Performance Characteristic | Stryker® Neptune 2 (Reported Performance) | Predicate Device 1 (Stryker® Neptune Waste Management System) | Predicate Device 2 (Dornoch Transposal Ultra System) | Predicate Device 3 (Valleylab OptiMumm Smoke Evacuator System) |
|---|---|---|---|---|
| General | ||||
| Classification | II | II | II | II |
| Product Code | JCX, FYD | FYD, JCX | JCX | FYD |
| Rover Empty Weight | 300 lbs | 230 lbs | 195 lbs or 225 lbs (depending on model) | 230 lbs (from Neptune 1, similar category) |
| Electrical Isolation Type | Class I, Type CF Applied Part | Class I, Type CF Applied Part | Information not available | Class I, Type CF Applied Part (from Neptune 1, similar category) |
| Enclosure Protection | IPXO Ordinary Equipment | IPXO Ordinary Equipment | Information not available | IPXO Ordinary Equipment (from Neptune 1, similar category) |
| 120V Single-phase Electric Power Requirements | 12 A | 16 A | 4.5 A | 3 A |
| Number of Uses Before Docking | Limited by fluid capacity | Limited by fluid capacity | Limited to 2 or 4 procedures | Limited by fluid capacity (from Neptune 1, similar category) |
| User Display | LCD screen | LCD screen | LCD screen | Digital display (smoke evacuator) / LCD screen (from Neptune 1) |
| Suction / Fluid Waste Management | ||||
| Canister Vacuum Level Regulation | Electronic regulator | Mechanical regulator | Electronic regulator | Electronic regulator (from Neptune 1, similar category) |
| Rover Canister Capacity | 24 L | 20 L | 33 L or 52 L (depending on model) | 24 L (from Neptune 1, similar category) |
| Canister Graduation Label | Yes | Yes | Yes | Yes |
| Electronic Canister Overfill Protection | Yes | Yes | Yes | Yes |
| Mechanical Canister Overfill Protection | Float-style shut-off valve in rover | Float-style shut-off valve in rover | Hydrophobic filter located in disposable canister lid | Float-style shut-off valve in rover (from Neptune 1, similar category) |
| Volume Display Accuracy | ±150 mL (20L), ±50 mL (4L) | ±175 mL | ±150 mL | ±150 mL (from Neptune 1, similar category) |
| Volume Display Resolution | 50 mL (20L), 20 mL (4L) | 50 mL | 10 mL | 50 mL (from Neptune 1, similar category) |
| Max Suction Range (100% power) | 67 mm-Hg | 61 mm-Hg | 99 mm-Hg | 61 mm-Hg (from Neptune 1, similar category) |
| Min Suction Range (20% power) | 34 mm-Hg | 0 mm-Hg | 12 mm-Hg | 0 mm-Hg (from Neptune 1, similar category) |
| Smoke Evacuation | ||||
| Filtration Efficiency | ULPA | HEPA | ULPA | HEPA |
| Maximum Flow Rate | 24 CFM | 33 CFM | 20 CFM | 33 CFM (from Neptune 1, similar category) |
| Minimum Flow Rate | 21 CFM | 0 CFM | 3 CFM | 0 CFM (from Neptune 1, similar category) |
| Variable Speed Settings | 9 | Infinite (continuous rotary dial) | 5 | Infinite (from Neptune 1, similar category) |
| Pre-filter | Multi-use disposable | Single-use disposable | Single-use disposable | Single-use disposable (from Neptune 1, similar category) |
| Filter Life Indicator | Yes | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "Bench testing was performed...Testing was completed to verify and validate the device." However, specific sample sizes (e.g., number of test articles, number of test runs) for each component of the bench testing (electrical safety, vacuum cycling, smoke evacuation, filtration, software, human factors) are not detailed.
- Data Provenance: The testing was conducted internally by Stryker. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, as this is a device for fluid and smoke management, not an AI or diagnostic device that typically uses patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the 510(k) summary. This type of detail is typically associated with studies for diagnostic devices or AI algorithms where expert consensus establishes a "ground truth" against which device performance is measured (e.g., presence or absence of a disease). For a waste management system, the "ground truth" is typically defined by engineering specifications and functional testing (e.g., vacuum pressure achieved, fluid volume collected, smoke particles filtered).
4. Adjudication Method for the Test Set
This is not applicable and not provided in the 510(k) summary for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to assess the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often comparing performance with and without AI assistance. This device is a surgical waste management system and does not involve human interpretation of cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm-only study was not done because this is a physical medical device. It does not employ an "algorithm" in the sense of a software component making diagnostic or analytical decisions. Its performance is related to its mechanical and electrical functions.
7. The Type of Ground Truth Used
The "ground truth" for this device would be defined by engineering specifications, regulatory standards (e.g., electrical safety, biocompatibility), and functional performance targets (e.g., flow rates, vacuum levels, filtration efficiency, fluid capacity). The device was tested to verify it met these internal specifications and regulatory requirements. The biocompatibility testing specifically referenced ISO-10993 standards.
8. The Sample Size for the Training Set
This is not applicable and not provided. "Training set" refers to data used to train machine learning algorithms. The Neptune 2 is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm for this device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.