(46 days)
The Denver® PLEURX Pleural Catheter Kit and Denver® PLEURX Home Drainage Kit are indicated for intermittent, longterm drainage of symptomatic, recurrent, malignant pleural effusion. The devices are indicated for the palliation of dyspnea due to malignant pleural effusion and for providing pleurodesis.
The Denver® PLEURX Pleural Catheter Kit (#50-7000) is a sterile device, for single use only, and is not to be resterilized. The kit contains the PLTURX Catheter; a specifically matched drainage line that can be configured for either wall suction or a vacuum bottle; and the components needed to place the catheter within the pleural space and to dress the catheter exit site after placement. The PLEURX Catheter contained in the kit is a flexible, fenestrated silicone catheter with a cuff and a valve. The fenestrated portion of the catheter is inserted into the pleural space utilizing a peel-away introducer (Seldinger technique). The portion of the catheter containing the cuff is tunneled subcutaneously, and the remaining portion is left external to the body. A radiopaque stripe runs the entire length of the catheter. The Denver® PLEURX Home Drainage Kit (#50-7500), an accessory to the Denver® PLEURX Pleural Catheter Kit, is a sterile, disposable device designed for single use only, and is not to be resterilized. The kit contains drainage lines, vacuum bottles, and the components needed to drain the effusion and to redress the catheter exit site.
The provided text describes a 510(k) premarket notification for the "Denver® PLEURX Pleural Catheter Kit" and "Denver® PLEURX Home Drainage Kit." This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a de novo clinical study with pre-defined acceptance criteria and statistical analysis to "prove" device performance against those criteria.
Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not present in this document.
The document details clinical testing that was performed under IDE #930085 to evaluate the device's effectiveness, but it does not specify quantitative acceptance criteria or statistical methodologies to prove meeting them in the way a robust performance study would. Instead, it describes observed outcomes related to the indicated uses.
Here's a breakdown of what can be extracted or inferred from the provided text, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (as outcomes) |
|---|---|
| Not explicitly stated as quantitative acceptance criteria for this 510(k). | Effectiveness of PLEURX Catheter for Relief of Dyspnea: Subjects showed a significant improvement in their rating of dyspnea after treatment, as determined by the Friedman test. |
| Effectiveness of PLEURX Catheter for Improving the Quality of Life: Subjects experienced a significant improvement in quality of life, as determined by the t-test, including an improved ability to carry out daily activities. | |
| Effectiveness of PLEURX Catheter for Resulting in Pleurodesis: Approximately half of the subjects achieved pleurodesis. No subjects developed a documented symptomatic recurrence of their effusion. |
Explanation: This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence. While clinical testing was performed and outcomes reported, the text does not present pre-defined numerical "acceptance criteria" against which these outcomes were measured to "prove" device performance in a statistical sense for market clearance. The reported performance refers to the observed results of the clinical evaluation.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this document. The text refers to "subjects" but does not give a number.
- Data Provenance: The clinical evaluation was conducted under IDE #930085. The country of origin is not specified, but the submitter is Denver Biomaterials, Inc. in Golden, Colorado, USA, suggesting the study likely took place in the US. It was a prospective clinical evaluation, as implied by the IDE number and the description of "subjects" receiving treatment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The clinical evaluation describes patient-reported outcomes (dyspnea rating, quality of life) and a clinical outcome (pleurodesis), which would typically be assessed by treating physicians or study investigators, but specific details on "experts" for ground truth establishment are absent.
4. Adjudication method for the test set
- This information is not provided in the document.
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
- This information is not applicable/not provided. The device is a pleural catheter kit, not an imaging analysis AI or diagnostic tool where MRMC studies involving human readers and AI assistance would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/not provided. The device is a physical medical device (catheter kit), not a software algorithm.
7. The type of ground truth used
- The "ground truth" in this context refers to the outcomes measured in the clinical evaluation. These include:
- Patient-reported outcomes: Relief of dyspnea (subjective rating), improvement in quality of life (subjective rating).
- Clinical outcomes: Achievement of pleurodesis (a medical condition that would be diagnosed by a physician based on clinical findings and imaging), and absence of symptomatic recurrence of effusion.
8. The sample size for the training set
- This information is not applicable/not provided. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- This information is not applicable/not provided for the reasons stated 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).