(29 days)
The PleuraFlow System 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 is comprised of a silicone Chest Tube and a Clearance Apparatus. Currently the PleuraFlow Chest Tube is available in four (4) models with standard sizes (20FR, 24FR, 28FR and 32FR). The Chest Tubes of currently marketed and above-references PleuraFlow System models include six (6) eyelets distributed along an Effective Drainage Length of 4 inches (10.2 cm). The Effective Drainage Length is defined as the length of the Chest Tube having eyelets for the influx of fluid. The current Chest Tube models are available with a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet. Each Chest Tube has a barium stripe to facilitate visualization. The Chest Tube is connected to a Clearance Apparatus, which is connected to the tubing from the drainage canister.
The new PleuraFlow System model is similar to the current models except for the Chest Tube, which has four eyelets instead of 6 eyelets. The short Effective Drainage length is only available with a 20FR Chest Tube identifies as: Short Effective Drainage Length (SEDL). This model has four (4) eyelets distributed along an Effective Drainage Length of 2 inches (5.1 cm). This Chest Tube model has a Cut Length of 19 inches (48.3 cm) with graduated measurements in centimeters from the distal eyelet and a barium stripe to facilitate visualization, as all of the currently marketed Chest Tubes have. Same as the marketed models, the 20FR SEDL 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 20FR SEDL Chest Tube is same as the predicate. It consists of a Guide Tube and a PTFE-coated Clearance Wire with a Loop set on its distal end, bent at a 105-degree angle. 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 Chest Tube to proactively prevent or break up and clear any tube obstructions or clogging to keep the tube open.
The PleuraFlow System with 20FR Short Effective Drainage Length (SEDL) Chest Tube can be used when the surgeon determines that a chest tube with a shorter length of drainage holes, 2" (5.1 cm) is needed. This includes patients having smaller dimension chests (length of torso) that cannot accommodate Chest Tubes with longer EDLs.
The provided text describes a 510(k) premarket notification for the PleuraFlow® System with Short Effective Drainage Length (SEDL) Chest Tube. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a de novo study proving the device meets specific acceptance criteria through a comprehensive clinical trial with a defined sample size, expert ground truth, or MRMC studies for AI devices.
Instead, this document focuses on demonstrating that a modified PleuraFlow System (with a shorter effective drainage length) is substantially equivalent to a previously cleared PleuraFlow System and its predicate. Therefore, the "acceptance criteria" and "device performance" in this context refer to the demonstration of safety and effectiveness through mechanical testing and reliance on prior clearances, rather than specific performance metrics against clinical endpoints in a novel study for this particular modification.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a modification, the "acceptance criteria" are not explicitly defined as performance targets for a new study, but rather the demonstration of equivalence through mechanical testing and leverage of prior clearances.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated under predicate 510(k) K093565, in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. |
| Flow Rate | Mechanical testing performed to establish substantial equivalence to predicate 510(k) K093565 (in accordance with BS EN 1617:1997). |
| Tensile Strength | Mechanical testing performed to establish substantial equivalence to predicate 510(k) K093565 (in accordance with BS EN 1618:1997). |
| Safety & Effectiveness (Overall) | Previously demonstrated through design validation and verification cleared under K093565 and K150042. Post-market data published in the Journal of Thoracic and Cardiovascular Surgery (Sirch et al. 2015) also cited. |
| Indication for Use | Same as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a new comprehensive study for this 510(k) submission. The testing mentioned (mechanical) would have been performed on a sample of the modified device. The document does not specify the exact number of units tested for mechanical properties.
- Data Provenance: The document refers to mechanical testing standards (BS EN 1617:1997 and BS EN 1618:1997) which are European standards. The post-market data cited (Sirch et al. 2015) is a journal publication, but its specific provenance (country, retrospective/prospective) is not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This submission relies on mechanical testing against established standards and prior regulatory clearances, not expert review of a test set in the same way an AI device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical data.
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
Not applicable. The PleuraFlow System is a medical device for drainage, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The PleuraFlow System is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing mentioned, the "ground truth" would be the specifications and requirements defined by the BS EN 1617:1997 (flow rate) and BS EN 1618:1997 (tensile strength) standards. For the overall safety and effectiveness, the ground truth refers to the previously established clearances for the predicate devices and general medical device standards. The cited post-market data (Sirch et al. 2015) would relate to clinical outcomes data (e.g., "reduces retained blood"), but the details are not described in this 510(k) summary.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. See #8.
§ 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.