(141 days)
The Pleurx Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for 1) the palliation of dyspnea due to pleural effusion and 2) providing pleurodesis (resolution of the pleural effusion).
The Pleurx Drainage Kits and Drainage Line Set are indicated for use only with the Pleurx Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Pleural Catheter System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Pleural Catheter and the Pleurx Drainage Kits.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pleurx Pleural Catheter System:
The provided document is a 510(k) summary for the Pleurx Pleural Catheter System, primarily focusing on establishing substantial equivalence to predicate devices. As such, it details non-clinical tests rather than clinical studies with human participants. Therefore, many of the requested points related to clinical studies, ground truth establishment, expert adjudication, and human reader performance will not be applicable.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard / Test | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-1:2009 | Meets or exceeds all performance requirements |
| Residuals: ISO 10993-7:2008 | Meets or exceeds all performance requirements |
| Performance: EN 1617:1997 | Meets or exceeds all performance requirements |
| Performance: EN 1618:1997 | Meets or exceeds all performance requirements |
| Performance: ANSI/AAMI/ISO 11607-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11138-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11737-1,2:2006 | Meets or exceeds all performance requirements |
| Performance: ISO 11135:2007 | Meets or exceeds all performance requirements |
| Specification: ASTM F560-08 | Meets or exceeds all performance requirements |
Study Details
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Sample size used for the test set and the data provenance:
- The document does not describe a test set in the context of a clinical study or a dataset for an AI/algorithm. The tests listed are non-clinical, laboratory-based performance, biocompatibility, and sterilization validation tests on the device itself.
- Data provenance: Not applicable in the context of clinical data. The tests are laboratory-based, not using patient data from specific countries.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" in the sense of clinical diagnoses or interpretations by experts was established for these non-clinical engineering and material tests. The "ground truth" for these tests would be the specifications and requirements defined by the referenced standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no adjudication process described for clinical interpretations or diagnoses.
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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 MRMC study was done. This device is a physical medical device (catheter system), not an AI/software device that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies outlined in the referenced ISO, EN, and ASTM standards (e.g., specific thresholds for chemical residuals, packaging integrity, material properties, sterilization efficacy). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, this question does not apply.
Summary of the Study:
The document describes a submission for a Pleurx Pleural Catheter System, which is a physical medical device. The "study" referenced in the acceptance criteria section consists of a series of non-clinical performance, biocompatibility, and sterilization validation tests. These tests were conducted against established international and national standards (ISO, EN, ANSI/AAMI, ASTM). The purpose of these tests was to demonstrate that the new device meets the necessary safety and performance requirements and is substantially equivalent to existing predicate devices. No clinical studies or studies involving human data, AI algorithms, or expert interpretations were conducted or reported for this 510(k) submission. The conclusion explicitly states: "N/A - No clinical tests were conducted for this submission."
§ 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).