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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):

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."

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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.

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).

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The PleuraFlow® System with FlowGlide™ 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™ is an extension of the PleuraFlow® System (predicate). The primary components of the System are the Chest Tube and the Clearance Apparatus. The PleuraFlow System with FlowGlide includes four (4) models: PFFG-20, PFFG-24, PFFG-28 and PFFG-32. Each of the four (4) models 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 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. Each Chest Tube has a barium stripe to facilitate visualization in the chest cavity under X-ray. All 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.

The provided text describes a 510(k) premarket notification for the "PleuraFlow System with FlowGlide" and references a predicate device, the "PleuraFlow Catheter System (K150042)". The current submission is for an enhancement to the predicate device, specifically the addition of a "FlowGlide" coating.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it lists various bench tests performed and concludes that the device's performance was "substantially equivalent" to the predicate. The performance reported is that the modified device "is suitable for its intended use and did not raise new issues of safety and effectiveness when compared to the predicate device."

Summary of Tests Performed (as reported in the document):

Overall Conclusion: "Results from performance testing of the PleuraFlow System with FlowGlide™ demonstrate that the modified device is suitable for its intended use and did not raise new issues of safety and effectiveness when compared to the predicate device." The effectiveness of the modified device is enhanced by the FlowGlide™ coating, which provides a low friction surface.

2. Sample sized used for the test set and the data provenance

The document only mentions "bench testing" and "performance testing" being conducted. It does not specify the sample sizes used for any of the individual tests. The data provenance is implied to be from internal lab studies by ClearFlow, Inc. (the applicant), as this is a premarket notification for a medical device. There is no mention of country of origin for the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of clinical outcomes or diagnostic accuracy, as the testing described is primarily bench testing related to the physical properties and functionality of the device.

4. Adjudication method for the test set

Not applicable, as the document details bench testing, not a clinical trial with human subjects requiring adjudication of outcomes or diagnoses.

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 device described, the PleuraFlow System with FlowGlide, is a physical medical device (chest tube system) for active clot clearance, not an AI or imaging-related diagnostic aid that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the "ground truth" would be established by validated test methods and established engineering specifications for the physical and functional properties of the device components (e.g., specific force values for tensile strength, acceptable flow rate ranges, friction coefficients, etc.). These underlying specifications are not detailed in the provided summary.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as this is a physical medical device, not a machine learning model.

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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.

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.

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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.

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.

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