(30 days)
The Pleurx Pleural Catheter is intended for long-term, intermittent drainage of symptomatic, recurrent, pleural effusions, including malignant pleural effusions and other pleural effusions that do not respond to treatment of the underlying disease.
The Denver® Pleurx Pleural Catheter Kit (#50-7000) and the Denver® Pleurx Drainage Kit (#50-7500) are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond entrailing monagement of the underlying disease. The devices are indicated for 1) the palliation to modiour management effusion and 2) providing pleurodesis (resolution of the pleural effusion.
The Pleurx Pleural Catheter is a silicone tube that is partially implanted in the chest cavity. A cuff is included in the tunneled portion of the catheter. The cuff promotes tissue ingrowth, which helps to anchor the catheter and may provide a barrier against infection. The external portion of the catheter includes a valve that remains closed until it is opened with a specific drainage line. When the drainage line is in place, a vacuum source can be used to drain fluid that builds up in the chest cavity.
The provided text describes a 510(k) premarket notification for a medical device, specifically a modification to the Denver Pleural Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a formal study with quantitative performance metrics.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. This type of information is typically found in design verification and validation reports or clinical study summaries, which are often summarized in a 510(k) but not always presented with full detail on performance metrics.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Material Equivalence | Biocompatibility | Fabric suitable for use in a long-term tissue implant (as reviewed from existing data). |
| Physical and Chemical Specifications | Fabric with similar physical and chemical specifications as the predicate device's fabric. | |
| Bond Strength | Bond strength between tubing and cuff within specification | Testing ensured bond strength remains within specification. |
| Intended Use | Drainage of symptomatic, recurrent, pleural effusions | Maintains established intended use (long-term, intermittent drainage). |
2. Sample size used for the test set and the data provenance
The document does not explicitly mention a "test set" in the context of performance evaluation for the modified device. The evaluation performed was primarily for substantial equivalence based on material properties.
- No specific sample size for a test set is provided.
- Data provenance is not explicitly stated, but the evaluation involves "reviewing biocompatibility data" and "testing." These likely refer to pre-existing data for the alternate fabric and new testing conducted by the manufacturer, respectively. No country of origin for data is mentioned. The study is retrospective for biocompatibility data review and likely prospective for the physical testing of the new material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation focused on material equivalence and bond strength, not on clinical performance requiring expert ground truth establishment for a diagnostic or predictive algorithm.
4. Adjudication method for the test set
Not applicable. The evaluation did not involve a test set requiring adjudication in the context of clinical performance. The review and testing were internal to the manufacturer's quality control/engineering processes.
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. This device is a medical catheter, not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the material and bond strength evaluation:
- Biocompatibility: Established standards and existing data for the alternate fabric material (e.g., ISO 10993).
- Physical and Chemical Specifications: Manufacturer's internal specifications and comparative analysis with the predicate material specifications.
- Bond Strength: Manufacturer's internal specifications for acceptable bond strength.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm-based device.
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).