(46 days)
The Denver Pleurx Catheter Kit and the Denver Pleurx Drainage Kit/Vacuum Bottle 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 Kit includes a vacuum bottle with drainage line that is connected to the Pleurx catheter for removing fluid that has accumulated in the chest. It also includes a rooedure pack that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
The provided text describes a special 510(k) for a modification to the Denver Pleurx Drainage Kit, focusing on changes to the vacuum bottle/drainage line assembly. The acceptance criteria and the study to prove the device meets these criteria are related to demonstrating substantial equivalence to the currently marketed product, specifically regarding flow rate and other design specifications, and applying risk management techniques.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Key safety-critical performance parameter: Flow rate - (Implicit: within the specification for the currently marketed device). | Not explicitly stated what the specific flow rate was, but the sponsor "verified that the key safety-critical performance parameter, flow rate, was within the specification for the currently marketed device." This indicates successful a meeting of the acceptance criteria. |
| Other aspects of the revised bottle design - (Implicit: met the specifications set for them). | Not explicitly stated what these "other aspects" or their specifications were, but the sponsor "verified that other aspects of the revised bottle design met the specifications set for them." This indicates successful a meeting of the acceptance criteria. |
| Risk management techniques applied to changes - (Implicit: potential impact on device safety assessed, appropriate risk control measures adopted). | The sponsor applied "risk management techniques to assess the potential impact of the changes on device safety, and adopting appropriate risk control measures." This indicates successful a meeting of the acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned appear to be internal verification processes rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for a test set. The verification process seems to be based on engineering specifications and risk management, not expert consensus on patient outcomes or interpretations.
4. Adjudication method for the test set
The document does not describe any adjudication method, as there's no mention of a test set requiring adjudication by experts.
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
The document does not describe an MRMC comparative effectiveness study. The device is a medical drainage kit, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the engineering specifications and safety parameters of the device and its predicate. This is a technical ground truth related to mechanical performance and safety, rather than clinical ground truth (like pathology or outcomes data).
8. The sample size for the training set
The document does not mention a training set, as the described studies are not for machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
§ 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).