(380 days)
The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
The PleuraFlow Catheter System is comprised of a silicone drainage tube and a shuttle assembly and guide tube. The PleuraFlow drainage tube is 20 inches in length with graduated measurements in inches from the first side hole and will be available in standard sizes from 20Fr to 32Fr versions. There is a barium stripe in the tube to facilitate visualization. A connector at the proximal end of the device connects to a commercially available drainage system. Within the catheter is a tube clearance apparatus to facilitate clearing of the drainage tube. The tube clearance apparatus is composed of a PTFE-coated guide wire that has a loop set on its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.
The PleuraFlow Catheter System is described in a 510(k) summary, which outlines its design, indications for use, and the basis for its substantial equivalence to predicate devices. The performance data section describes a "User Preference Study" to demonstrate the device's safety and effectiveness.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal, quantitative acceptance criteria in the typical sense (e.g., "Device must achieve X% successful clearance"). Instead, it presents qualitative findings from a user preference study as evidence of acceptable performance.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Acceptable time for assembly and ease of placement (by surgeons) | Findings from the study indicated that the time for assembly and ease of placement were acceptable to the surgeons. |
| Acceptable ease of use of the clearance mechanism (by ICU nurses) | Findings from the study indicated that ... ease of use of the clearance mechanism ... were acceptable to the ICU nurses. |
| Adequacy of chest tube clearance (by ICU nurses) | Findings from the study indicated that ... adequacy of chest tube clearance were acceptable to the ICU nurses. |
| Device is helpful and easy to use | It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting. (This is a summary conclusion based on the feedback). |
| Device performs as intended in the clinical setting | It was concluded that the device was helpful and easy to use, and performed as intended in the clinical setting. (This is a summary conclusion based on the feedback, aligning with the indication for use to "prevent fluid accumulation within the operative site after closure of the surgical wound" and "indicated for use in thoracic surgical procedures" by facilitating clearance). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A total of 19 patients were enrolled in the User Preference Study.
- Data Provenance: The study appears to be prospective and conducted within a clinical setting (patients undergoing cardiac surgery through a median sternotomy). The country of origin is not explicitly stated, but given the FDA 510(k) submission, it is likely that the study was conducted in the United States or a country with similar regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe establishing a 'ground truth' in the traditional sense for the device's primary function (e.g., whether fluid accumulation was truly prevented or not, or a quantitative measure of clearance efficiency). Instead, the study focused on user preference and assessment of various aspects of the device's usability and perceived performance.
The "experts" involved were the healthcare professionals interacting with the device:
- Surgeons: Responsible for placing the chest tube.
- Nurses: Responsible for patient care prior to chest tube removal, including using the clearance mechanism.
- Physician Assistants or Residents: Responsible for removing the chest tube.
The number of each type of professional is not specified, beyond the implication that multiple individuals from each group provided feedback through the questionnaire. Their specific qualifications (e.g., years of experience, specialization) are also not detailed.
4. Adjudication Method for the Test Set:
There is no mention of an adjudication method for the "ground truth" or for resolving discrepancies in user feedback. The study involved collecting questionnaire responses from different user groups, and the findings were reported as collective "acceptances" or "conclusions." This was not a study relying on diagnostic accuracy or objective measurements requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study was a user preference study comparing the PleuraFlow system to a "standard chest tube" by placing both in the same patients. It did not assess human readers' diagnostic performance with or without AI assistance, as the device is a medical device for fluid drainage, not an AI-powered diagnostic tool. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done:
Not applicable. The PleuraFlow Catheter System is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant. The study assessed the device's performance in a clinical setting with human interaction and assessment.
7. The Type of Ground Truth Used:
The "ground truth" for this study was primarily based on user feedback and qualitative assessment of the device's usability and perceived performance by healthcare professionals (surgeons, nurses, PAs/residents) in a real-world clinical setting. It was not based on objective clinical outcomes (like reduced incidence of fluid accumulation quantified) or pathology reports. The study concluded that the device was "helpful and easy to use, and performed as intended in the clinical setting" based on this subjective user feedback.
8. The Sample Size for the Training Set:
Not applicable. This study is for a physical medical device and does not involve AI or machine learning, and therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, the establishment of ground truth for a training set is not relevant.
§ 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.