(131 days)
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside.
Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.
The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities.
These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions.
There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger.
This document is a 510(k) premarket notification for the SIMEX Subglottic Aspiration System, not a study report. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets them in a clinical context.
The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical (bench) testing and a feature comparison. It does not present a clinical study with human readers, ground truth established by experts for a test set, or multi-reader multi-case (MRMC) comparative effectiveness.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, or reader improvement. Instead, it details performance characteristics against engineering standards and comparison to predicate device specifications.
| Performance Metric / Acceptance Criteria (Implied) | Reported Device Performance (SIMEX Subglottic Aspiration System cuff M and cuff S) |
|---|---|
| Electrical Safety (IEC 60601-1-2) | Meets requirements for IEC 60601-1-2 including National Differences for the US. |
| Electromagnetic Interference (EMI) | Meets electromagnetic interference requirements of the above standards. |
| Operational Lifetime | Capable of operating for more than 2000 hours. |
| Adequate Performance in Simulated Use Environment | Adequately performs when tested in a simulated use environment across the operating parameters of the pumps. |
| Vacuum Pressure | Max Pressure: 300 mbar (225 mmHg) |
| Flow Rate | 8 liters/min |
| Intermittent Operation Range | Programmed to: 1-60 sec On, 1-60 min Off (Factory setting: 10 sec On, 10 min Off, 100 mbar vacuum) |
| Physical Characteristics (e.g., Weight, Collection Container, etc.) | Comparable to predicate devices, as detailed in the "Feature Comparison Chart". |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in a clinical sense. The testing described is "bench testing" and "simulated use environment," meaning it was conducted on the physical device itself or in a laboratory setup, not on a set of clinical cases or patient data.
- Data Provenance: The testing was non-clinical (bench testing). No country of origin for clinical data is applicable. The data is entirely retrospective technical test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical evaluation, is typically established by medical experts for diagnostic or prognostic tasks. This document describes technical device performance, not a clinical diagnostic aid.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a medical pump, not an AI diagnostic tool that assists human readers in interpreting clinical cases. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is designed for AI/algorithm-based devices. The SIMEX Subglottic Aspiration System is a physical medical device (a pump), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The bench testing of the pump itself can be considered its "standalone" performance, as it operates independently according to its design specifications.
7. The Type of Ground Truth Used
The ground truth for the performance metrics described (electrical safety, EMI, operational lifetime, vacuum pressure, flow rate) is based on engineering standards and design specifications. For example, the "ground truth" that the device meets IEC 60601-1-2 is based on the results of tests conducted against the requirements of that standard. This is not clinical ground truth like pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model.
§ 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.