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The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the perioneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.

The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site.

The Aspira* Luer Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.

The Aspira* Valve Assembly attaches to the Aspira* Drainage Catherer. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.

The Aspira* Peritoneal Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic malignant ascites. The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the system are the Aspira* Periloncal Drainage Catheter and the Aspira* Drainage Bag.

The Aspira* Peritoneal Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the perioncal cavity to relieve symptoms associated with malignant ascites. The fenestrated catheter is placed in the patient's abdominal cavity enabling the patient or caregiver to perform intermittent drainage of their malignant ascites at home.

The Aspira* Drainage Bag is used to collect peritoneal fluid by gravity. The drainage bag attaches to the placed catheter and is activated using an in-line silicone pump.

The Aspira* Luer Adapter is designed to access the Aspira* Drainage Catheter. The lucr adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.

The Aspira* Valve assembly attaches to the proximal end of the Aspira* Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.

The provided document is a 510(k) premarket notification letter and summary for the Aspira Peritoneal Drainage System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for providing acceptance criteria and study results for a new device's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on the device description, its intended use and indications for use, and a technological comparison to a predicate device (PLEURX™ Peritoneal Catheter Kit and PLEURX™ Drainage Kit) to argue for substantial equivalence. It does not detail specific performance studies with quantitative acceptance criteria for the Aspira Peritoneal Drainage System itself.

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