(174 days)
The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only.
The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve ascites symptoms. The primary components of the PleurX Peritoneal Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.
The provided text primarily details a 510(k) premarket notification for the "PleurX Peritoneal Catheter System" and clarifies its indications for use, rather than presenting a study with specific acceptance criteria and performance data in a quantitative manner. The document asserts that the device is substantially equivalent to a legally marketed predicate device (CareFusion PleurX Peritoneal Catheter System: K160437).
However, I can extract the following information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and states that "Bench-level testing was carried out... to demonstrate substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | Stated to be substantially equivalent to the predicate device K160437. |
| Leak Testing | Performed to evaluate performance of the catheter valve. (Results not quantified in this document) |
| Safety and Efficacy (Non-clinical) | Results of non-clinical tests show the device is "as safe, as effective, and performs as well as the legally marketed predicate device." |
| Safety and Efficacy (Clinical Literature Review) | Demonstrates a history of safety and efficacy in non-malignant refractory ascites and indicates that complication incidence is more related to patient-specific health status than the underlying cause of ascites. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for any bench-level or clinical literature review.
- Data Provenance:
- Bench-level testing: Conducted by the manufacturer (CareFusion).
- Clinical information: Derived from a "clinical literature review." Details on the scope (e.g., country of origin, retrospective/prospective nature of the studies reviewed) are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The document primarily refers to bench testing and a literature review, not a test set requiring expert ground truth establishment in the typical sense of a diagnostic or AI study.
4. Adjudication Method for the Test Set:
Not applicable, as no described test set with expert ground truth establishment is present in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned as having been conducted. The submission relies on non-clinical testing and a clinical literature review to support substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a physical medical device (catheter system), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- For non-clinical testing: Performance against established engineering and design specifications for medical devices, inferred from "predicate devices and leak testing."
- For clinical information: The "clinical literature review" served as the basis for understanding safety and efficacy, implying published clinical data from existing studies constituted the "ground truth" for the claims made regarding the device's performance in managing ascites.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.