(15 days)
The NeoMedix SupraFlow Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.
The Console contains a roller pump to provide aspiration from the surgical site and a pinch valve to initiate the flow of irrigation fluid simultaneously with the optional foot switch con switch con be used to activate both actions.
This document describes the NeoMedix SupraFlow Console Aspiration Pump (K040239).
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics and their targets (e.g., flow rate must be X L/min +/- Y%). Instead, it states that "Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols."
The "performance" discussed is primarily related to safety and functionality, comparing it to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety compliance | Demonstrated by compliance to applicable requirements defined in consensus standard IEC 60601-1. |
| Functionality (as an aspiration pump in general surgery) | The Console is similar in function to currently marketed aspiration/suction pumps. The aspiration capabilities are similar to those in the predicate devices, with the exception that aspiration is generated via peristaltic action rather than a direct vacuum source. Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols (specific results not provided in this summary). The device is intended for aspiration of irrigation and waste fluid from a surgical site in general surgery applications. It is not indicated for liposuction. |
| Compliance with NeoMedix test protocols for performance specifications | Product testing was performed to demonstrate stated performance specifications and functionality in compliance with NeoMedix test protocols (specific protocols and results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide information regarding a "test set" in the context of clinical data, sample size, or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on engineering and safety testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided in the context of this 510(k) submission, as it focuses on device functionality and safety rather than a clinical study requiring expert ground truth for, e.g., diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable or provided for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed or described in this 510(k) summary. This type of study is typically for evaluating the impact of AI or new diagnostic tools on human reader performance, which is not relevant for an aspiration pump.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone algorithm performance study was not performed or described. This device is a mechanical aspiration pump, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering specifications and test protocols: The device must meet its designed performance specifications (e.g., flow rate, pressure, safety features).
- Compliance with consensus standards: Specifically IEC 60601-1 for electrical safety.
- Comparison to predicate devices: Functionality and aspiration capabilities are shown to be similar to legally marketed predicate devices.
There is no mention of pathology, outcomes data, or expert consensus in the clinical sense for establishing "ground truth" for the device's technical performance.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a physical pump, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided as there is no "training set" 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.