(13 days)
The PleuraFlow® System with FlowGlide® XDL is indicated for use during cardiothoracic surgical 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® XDL is an extension of the PleuraFlow® System with FlowGlide® (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The PleuraFlow System with FlowGlide XDL includes two (2) models: PFFG-20 XDL, and PFFG-24 XDL. Each model includes a Chest Tube with a cut length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each of these Chest Tubes has 15 eyelets distributed along an Effective Drainage Length of 10 inches (25.4 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. Each Chest Tube has a barium stripe to facilitate visualization in the chest cavity under X-ray. Both models include a Chest Tube with FlowGlide applied to the internal and external surfaces to reduce friction and allow easier sliding of the Clearance Wire assembly. 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 and a PTFE-coated Clearance Wire with a Loop set on its distal end. The Clearance Apparatus is advanced into the PleuraFlow 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 open.
This document describes the 510(k) premarket notification for the ClearFlow, Inc. PleuraFlow® System with FlowGlide® XDL, a device intended to proactively remove clots from chest tubes during cardiothoracic surgical procedures and chest trauma. The submission aims to demonstrate substantial equivalence to a predicate device, the PleuraFlow System with FlowGlide (K163139).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in terms of specific numerical thresholds. Instead, it describes various tests performed to demonstrate that the new models (PFFG-20 XDL and PFFG-24 XDL) are "substantially equivalent to the cleared models (predicate) through bench testing" and "suitable for the intended use." The performance is reported in a pass/fail manner, indicating that the new models met the requirements of these tests to demonstrate equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile strength / Force at break | Performance comparable to predicate device. | Verified (implied: met expectations for equivalence). |
| Kink testing | No unacceptable kinking that would impede function, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Force to actuate Clearance Wire and Loop through coated chest tube | Acceptable force for proper actuation and clot clearance, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Test for actuation and tracking of the Clearance Wire and Loop through the coated chest tube tortuous path | Smooth and effective movement of the clearance wire through complex paths, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Integrity / durability of the FlowGlide coating | Coating remains intact and functional over the expected usage duration, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Simulated use | Device performs as intended under simulated clinical conditions, comparable to predicate. | Verified (implied: met expectations for equivalence). |
| Biocompatibility (FlowGlide coating) | Met ISO 10993-1 standards for biological risk assessment. | Summary of test results provided in K163139 submission. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each bench test performed on the new models (PFFG-20 XDL and PFFG-24 XDL). The tests are described as "bench testing."
- Sample Size for Test Set: Not explicitly stated for the individual bench tests. It refers to "the new models PFFG-20 XDL and PFFG-24 XDL."
- Data Provenance: The data appears to be prospective as it involves new bench testing performed on the "new models" in support of the 510(k) submission. The country of origin for the data is not specified, but the applicant (ClearFlow, Inc.) is based in Anaheim, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study described is a series of bench tests comparing a new device to a predicate, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., in medical image analysis). The "ground truth" for these engineering and performance tests would be the established specifications and performance characteristics of the predicate device and relevant industry standards.
4. Adjudication Method for the Test Set
- This information is not applicable for bench testing. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable as the PleuraFlow System is a medical device (a chest tube and clearance apparatus), not an AI algorithm.
7. The Type of Ground Truth Used
- For the bench testing described, the "ground truth" is based on the established performance specifications and characteristics of the legally marketed predicate device (PleuraFlow System with FlowGlide, K163139) and relevant engineering/performance standards (e.g., for tensile strength, kink resistance, coating integrity, and simulated use). The biological risk assessment for the coating was based on ISO 10993-1 standards.
8. The Sample Size for the Training Set
- This information is not applicable as the described study involves bench testing of a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above (not a 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.