(104 days)
The PleuraFlow® System with FlowGlide® is indicated for use during cardical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent and adolescent patients under clinical settings.
The PleuraFlow® System with FlowGlide(R) PFFG3 iss a modification to our current PleuraFlow® System with FlowGlide(R) (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.
The Clearance Apparatus that is part of the PleuraFlow System with FlowGlide consists of a Guide Tube with a magnetic shuttle and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow with FlowGlide Chest Tube using a magnetic Shuttle. When indicated, the Clearance Wire and Loop is advanced and retracted within the PleuraFlow with FlowGlide Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube patent. The PleuraFlow System with FlowGlide, PFFG3, has a new shuttle design that includes a spring activated button to allow the user to increase the magnetic force when needed. The range of magnetic force is the same as predicate.
This document, a 510(k) summary for the ClearFlow PleuraFlow® System with FlowGlide®, describes the device as a modification of a previously cleared device. Therefore, the information provided focuses on bench testing to demonstrate substantial equivalence to the predicate device, rather than a clinical study with human subjects.
As a result, there is no information to fulfill questions 1-9 regarding acceptance criteria and study proving device meets acceptance criteria in a clinical context, such as:
- A table of acceptance criteria and reported device performance (in a clinical study)
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "No clinical performance was deemed necessary according to Risk Management assessment and evaluation." and "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device."
The acceptance criteria and "study" described are focused on engineering and functional performance bench tests to demonstrate the device performs as intended and is equivalent to the predicate.
Here's an interpretation of the "acceptance criteria" and "study" based only on the provided text, but it's important to understand this is not a clinical study:
Acceptance Criteria and Study for the ClearFlow PleuraFlow® System with FlowGlide® (Based on Bench Testing for Substantial Equivalence)
Since this is a 510(k) submission for a modified device, the "study" conducted for proving the device meets acceptance criteria is primarily bench testing to demonstrate substantial equivalence to a previously cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):
| Acceptance Criterion (Test Performed) | Reported Device Performance (Result) |
|---|---|
| Actuation and Tracking of Clearance Wire and Loop | Demonstrated successful actuation and tracking through the coated chest tube tortuous path. |
| Functional Testing of the Shuttle: | The new shuttle design with a spring-activated button allows the user to increase magnetic force when needed, while maintaining the same range of magnetic force as the predicate. |
| - Coupling Force Testing of Shuttle to Clearance Wire and Loop | Performed and results indicate proper coupling. |
| - Force to Actuate, Force to Move Shuttle along Guide Tube | Performed and results demonstrate appropriate force for actuation and movement while coupled to the Clearance Wire and Loop. |
| Magnetic Flux Testing (Magnetic Field in Proximity to Device) | Performed and results show the magnetic field is within acceptable parameters. |
| Button Cycle Testing (for Button Function after Repeated Uses) | Performed and results demonstrate the button functions effectively after repeated uses. |
| Force to Separate the Shuttle Enclosure | Performed and results indicate appropriate force. |
| Transportation Simulation | Performed and results demonstrate device integrity after simulated transportation. |
| Tensile Strength of Drain Tubing to Drain Barb | Performed and results demonstrate adequate tensile strength. |
| Biocompatibility of Materials | Materials remain the same as the predicate and meet ISO 10993-1 applicable requirements. |
| Sterility (Device Provided Sterile and Single Use) | Meets ISO 11135:2014 requirements. |
| Overall Safety and Effectiveness Comparison to Predicate Device | "Results from performance testing of the new models... demonstrates that these are suitable for the intended use and did not raise new issues of safety and effectiveness when compared to the predicate models." "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device." "Risk assessment, verification and validation... do not raise any additional concerns regarding safety and effectiveness and they are substantially equivalent to the predicate system." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of units tested for each bench test, but implies a sufficient number were tested to validate the design.
- Data Provenance: The tests are described as bench testing done internally by the manufacturer (ClearFlow, Inc.) and are prospective in nature for the modified device. No external or historical data is explicitly mentioned for these specific tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was a series of engineering and functional bench tests, not a clinical study requiring expert review of patient data to establish ground truth. The "ground truth" here is adherence to engineering specifications and performance comparable to the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As per point 3, this was not a clinical study involving human judgment on cases. Test results would likely be adjudicated against pre-defined engineering pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not relevant to this type of device or its premarket notification, which relies on bench testing and substantial equivalence to a predicate. There is no AI or human reader component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a mechanical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is engineering specifications, functional performance requirements, and comparison to the known performance of the predicate device. This includes passing criteria for physical and mechanical tests, and compliance with standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135:2014 for sterilization).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device. The "training" for the device would be its engineering design and manufacturing processes.
9. How the ground truth for the training set was established:
- Not Applicable. (As per point 8.) The design and functionality are based on established engineering principles and the existing predicate device's proven performance over "more than 10 years."
§ 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.