(76 days)
The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only.
The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural 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 Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage.
The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site.
The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance.
The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space.
The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.
The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Periloneal Catheter and the Pleurx Drainage Kits.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pleurx Peritoneal Catheter System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria with quantitative thresholds alongside reported device performance results in the way commonly seen for AI/ML devices or diagnostic tools. Instead, it lists the types of non-clinical tests performed and states that the device "meets or exceeds all performance requirements."
However, we can infer the "acceptance criteria" were implied by the referenced standards, and the "reported device performance" is a general statement of compliance.
| Acceptance Criterion (Implied by Standard/Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1:2009) | Meets/Exceeds performance requirements |
| Residuals (Ethylene Oxide Sterilization) (ISO 10993-7:2008) | Meets/Exceeds performance requirements |
| Sterile Drainage Catheters (EN 1617:1997) | Meets/Exceeds performance requirements |
| Catheters Other Than Intravascular Catheters - Test Methods for Common Properties (EN 1618:1997) | Meets/Exceeds performance requirements |
| Sterile, Single-use Intravascular Catheters (ISO 11070) | Meets/Exceeds performance requirements |
| Packaging for Terminally Sterilized Medical Devices (ANSI/AAMI/ISO 11607-1,2:2006) | Meets/Exceeds performance requirements |
| Accelerated Aging of Sterile Barrier Systems (ASTM F1980-07) | Meets/Exceeds performance requirements |
| Sterilization of healthcare products - Biological Indicators (ISO 11138-1,2:2006) | Meets/Exceeds performance requirements |
| Sterilization of Medical Devices - Microbiological Methods (ISO 11737-1,2:2006) | Meets/Exceeds performance requirements |
| Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization (ISO 11135:2007) | Meets/Exceeds performance requirements |
| Product Adoption and Process Equivalency for Ethylene Oxide Sterilization (AAMI TIR28:2009) | Meets/Exceeds performance requirements |
| Tensile Strength (Bench-level testing) | Meets/Exceeds performance requirements |
| Leakage (Bench-level testing) | Meets/Exceeds performance requirements |
| Bond Strength (Bench-level testing) | Meets/Exceeds performance requirements |
| Deformation (Bench-level testing) | Meets/Exceeds performance requirements |
| Security of Connections (Bench-level testing) | Meets/Exceeds performance requirements |
2. Sample Size and Data Provenance
The document explicitly states: "N/A - No clinical tests were conducted for this submission".
Therefore, there is no information on:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Sample size for the training set.
3. Number of Experts and Qualifications
Since no clinical studies were performed, there is no mention of experts used to establish ground truth. The device's performance was evaluated through non-clinical, bench-level testing against established standards.
4. Adjudication Method
Not applicable, as no clinical studies with expert review were conducted.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical studies were performed, and this device is a physical medical device (catheter system), not an AI/ML diagnostic tool typically assessed with MRMC studies.
6. Standalone Performance
The device's performance was evaluated in a standalone manner through "bench-level testing" and compliance with referenced standards. The statement "The results of the non-clinical tests show that the CareFusion Pleurx Peritoneal Catheter System meets or exceed all performance requirements" indicates standalone assessment against predefined engineering and material standards. This is not a "standalone algorithm performance" in the context of AI, but rather standalone physical device performance.
7. Type of Ground Truth
The "ground truth" for this device's evaluation was based on:
- Engineering and Material Standards: The various ISO, EN, ANSI/AAMI, and ASTM standards listed (e.g., ISO 10993 for biocompatibility, EN 1617 for drainage catheters, ASTM F1980 for aging).
- Predicate Device Characteristics: The existing predicate devices (e.g., CareFusion Pleurx Catheter Systems: K113854) set the benchmark for technological characteristics.
8. Sample Size for the Training Set
No information is provided, as no clinical studies or machine learning algorithms were involved that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this type of device submission.
§ 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.