Search Results
Found 2 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(144 days)
The PleuraFlow System is indicated for use during cardical procedures and chest trauma. Its active clearance technology proactively removes clots formed inside 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 patients including infant, preadolescent and adolescent patients under clinical settings.
The PleuraFlow System is comprised of a silicone Chest Tube and a Clearance Apparatus. The PleuraFlow Chest Tube is available in four (4) standard sizes (20FR, 24FR, 28FR and 32FR). Each Chest Tube has 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 Clearance Apparatus 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 patent.
The provided text describes a 510(k) premarket notification for the PleuraFlow® System. While it refers to previous demonstrations of safety and effectiveness and mentions a study, it does not provide detailed acceptance criteria or extensive performance data in the structured format requested. Instead, it relies on a previous 510(k) clearance (K093565) and post-market data.
Based on the information provided, here's an attempt to answer the questions, highlighting what is available and what information is missing.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific quantifiable acceptance criteria (e.g., a certain percentage reduction in occlusion or a specific flow rate). The performance claims are qualitative and based on the historical use of the device and a referenced manuscript.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Based on claims in the document) |
|---|---|
| Clinical effectiveness in reducing complications | "Use of the device over the last four (4) years has shown that the product has significantly reduced the complications for patients who have received treatment with PleuraFlow versus other products during and after surgery." |
| Prevention/minimization of chest tube occlusion | "Its active clearance technology proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot." |
| Maintenance of chest tube patency | "A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood." |
| Reduction of Post-Operative Atrial Fibrillation (POAF) | "Studies have linked both chest tube clogging and retained pericardial blood with POAF… demonstrates by adhering to a protocol developed to maximize chest tube patency, POAF can be reduced. Consistent with prior studies, this link appears to be related to reducing RBS [retained blood syndrome]." (Reference to a submitted manuscript: "Reduction in Interventions for Post Operative Effusions and Atrial Fibrillation with Active Clearance of Chest Drainage Catheters" by Sirch J. et al.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "post-market data" and a manuscript to be submitted.
- Sample size: Not explicitly stated for either the post-market data generally or for the specific study referenced.
- Data provenance: For the referenced manuscript, the institutions are:
- Cardiac Surgery, Heart Center, Paracelsus Medical University, Nurenberg, Germany
- St. Charles Medical Center, Bend, Oregon, United States.
This suggests data from both Germany and the United States.
- Retrospective or prospective: Not explicitly stated for any of the performance data. Given it refers to "post-market data" and a study demonstrating "reduced the complications... over the last four (4) years," it could be retrospective analysis of collected data, or could include prospective elements within clinical use. The mention of "adhering to a protocol developed to maximize chest tube patency" suggests a structured approach, which could be part of a prospective study, but this is not confirmed.
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)
This information is not available in the provided text. The performance data relies on clinical outcomes and observations rather than a specific "test set" with expert-adjudicated ground truth as would be common for diagnostic AI algorithms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. The document focuses on clinical outcomes rather than establishing ground truth for a diagnostic test set.
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
The document does not describe an MRMC study. The device is a physical system for active clearance of chest tubes, not primarily a diagnostic AI tool that assists human readers. The performance data relates to the device's impact on clinical outcomes compared to "other products," not an AI-assisted interpretation task.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The PleuraFlow System is a medical device (a chest tube and a clearance apparatus) that performs a physical function (clearing clots), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance appears to be based on clinical outcomes data, specifically:
- Reduction in complications for patients
- Prevention/minimization of chest tube occlusion
- Maintenance of chest tube patency
- Reduction in Post-Operative Atrial Fibrillation (POAF) and Retained Blood Syndrome (RBS).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI algorithm.
Ask a specific question about this device
Page 1 of 1