K Number
K150042
Manufacturer
Date Cleared
2015-06-02

(144 days)

Product Code
Regulation Number
878.4780
Panel
SU
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

§ 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.