(260 days)
The PleurX Peritoneal Catheter System is indicated for intermittent. Iong term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method.
The Pleur X Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the Pleur X Valve.
The Pleur X LP Catheter Mini Kit is intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.
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 Peritoneal Catheter and the PleurX Drainage Kits.
The provided document describes a 510(k) premarket notification for the PleurX Peritoneal Catheter System. This submission is for modifications to an existing device, not a new AI-powered diagnostic system. Therefore, the questions related to AI-specific performance metrics (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable.
The document primarily focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance tests and the standards they adhere to. It does not provide specific numerical acceptance criteria or reported device performance values in a table format. Instead, it indicates that testing was conducted according to these standards to demonstrate substantial equivalence.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Summary) |
|---|---|
| Cuff adherence (BS EN 1617: 1997, BS EN 1618: 1997) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Tensile strength (BS EN 1617: 1997, BS EN 1618: 1997) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Leakage (BS EN 1617: 1997, BS EN 1618: 1997) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Imaging (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Flow rate (BS EN 1617: 1997, BS EN 1618: 1997) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Tissue ingrowth (ISO 10993-06) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Biocompatibility (ISO 10993-1, 10993-5, 10993-06, 10993-10, 10993-17, 10993-18) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Sterilization (ISO 11135, ISO 11138-1, ISO 11737-1, AAMI TIR28) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| EO Residuals (ISO 10993-7) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| Packaging (AAMI / ANSI / ISO 11607-1, AAMI/ANSI/ISO 11607-2, ASTM F1980-07) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
| General Surgical Implants (ISO 14630) | Bench-level testing carried out. Results show the device is as safe, as effective, and performs as well as predicate devices. |
2. Sample size used for the test set and the data provenance
This is not an AI/software device. The "test set" here refers to the samples used in bench testing. The document does not specify the sample sizes for each bench test conducted. The data provenance is from "bench-level testing" and is therefore not country-specific or retrospective/prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical device, not an AI diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the physical and chemical properties of the materials and the functionality of the device as measured by standard laboratory equipment and methodologies.
4. Adjudication method for the test set
Not applicable. The performance testing involves objective measurements against established engineering and biocompatibility standards, not subjective expert adjudication.
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
Not applicable. This is not an AI device, so no MRMC study was conducted related to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is evaluated through bench testing.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established engineering standards for medical devices, material science properties, biocompatibility assays, and sterilization effectiveness.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning.
§ 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.