(346 days)
The Pleural Catheter Kits are indicated for intermittent, long term drainage of symptomatic, recurrent, pleural effusion, mcluding 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 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 Catheter Access Kit is intended to provide access to the Pleurx Catheter to inject or withdraw fluids
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.
The provided text describes a 510(k) premarket notification for the Pleurx Pleural Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study where the device performance is measured against specific acceptance criteria in a clinical setting.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from this document. The submission relies on non-clinical (bench) testing to support its claims of substantial equivalence for a labeling update.
Here's what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance:
This 510(k) submission updates previously cleared device labeling to include the use of sclerosing agents (Talc and Bleomycin) with the Pleurx Pleural Catheter System. The acceptance criteria for this specific submission relate to the validation of this change through biocompatibility and bench testing. The "performance data" section lists standards and tests conducted, implying that the device "passed" or met the requirements of these standards. However, no specific quantitative acceptance criteria or corresponding reported device performance values are provided for the device's clinical function in this document.
For example, for Biocompatibility, the acceptance criterion would be "meets ISO 10993-1, -3, -4, -5, -6, -10, -11 requirements" and the reported device performance is "passed" or "met." The specific metrics and thresholds for each test are not detailed in this summary.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | Meets requirements of listed ISO 10993 standards | Passed |
| Residuals | Meets requirements of AAMI/ANSI/ISO 10993-7 | Passed |
| Performance (e.g., sterilization, packaging) | Meets requirements of listed EN, ISO, ASTM, AAMI standards | Passed |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not specified. The document refers to "non-clinical tests," which likely involve a number of samples for each bench test conducted according to the standards.
- Data provenance: Non-clinical (bench) testing data. The country of origin is not specified, but the standards cited are international (ISO, EN, ASTM, AAMI).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Given this is a non-clinical (bench) testing submission, expert opinion for establishing a "ground truth" in the clinical sense is not relevant. The "ground truth" for these tests would be the established pass/fail criteria within the cited international standards by which the device was evaluated.
4. Adjudication method for the test set:
Not applicable. This type of adjudication is typically for clinical studies where subjective assessments might be involved. For bench testing, the results are typically objective measurements against a standard.
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 is not an AI/software device and no MRMC study was conducted. The document explicitly states: "N/A – No clinical tests were conducted for this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/software device.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the specific test method and acceptance criteria outlined in the cited international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for ethylene oxide sterilization).
8. The sample size for the training set:
Not applicable. This is not an AI/software device, so there is no training set in that context.
9. How the ground truth for the training set was established:
Not applicable, for the same reason as above.
§ 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).