(156 days)
The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ 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 intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
For Pleural Use: The PleurX™ LP Catheter Mini Kit is 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 the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.
For Peritoneal Use: The PleurX™ LP Catheter Mini Kit 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™ Low Profile 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™ Low Profile Catheter is indicated for adults only.
The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.
The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.
For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.
For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.
The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.
The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).
The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.
The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.
The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.
The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.
The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.
The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).
This document is a 510(k) summary for the PeritX™ Peritoneal Catheter System. It describes a medical device, which is a peritoneal dialysis system and accessories. This is a Class II device. The document states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in the context of device acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria for the performance tests conducted. Instead, it lists the types of non-clinical tests performed to evaluate "technological characteristics and performance criteria". The conclusion states that the device's performance is "comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|
| Not explicitly stated as quantitative thresholds for performance metrics. | Technological characteristics and performance criteria are comparable to the predicate device. The device performs as safely and effectively as the legally marketed predicate device. |
The study primarily focuses on demonstrating equivalence through various engineering and functional tests rather than clinical efficacy, given it's a 510(k) submission for a device system with a new accessory.
Details of the Study:
-
1. Table of Acceptance Criteria and the Reported Device Performance:
As noted above, specific quantitative acceptance criteria are not presented in the provided text. The reported device performance is a general statement of comparability and equivalent safety and effectiveness to the predicate device. -
2. Sample Size Used for the Test Set and Data Provenance:
The document lists various non-clinical tests (e.g., Visual Inspection, Tensile Strength, Volume Capacity, Drop Test, Resistance to Leakage). However, it does not specify the sample size used for any of these tests. The data provenance is implied to be from internal testing conducted by Bard Peripheral Vascular, Inc. within the USA. The data is non-clinical, likely from laboratory testing. -
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document, as the testing described is non-clinical (engineering and functional tests), not involving expert-established ground truth in the typical clinical sense. -
4. Adjudication Method for the Test Set:
This information is not provided as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical studies. -
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The document focuses on non-clinical performance testing for substantial equivalence. -
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This question is not applicable as the device is a physical medical device (catheter system and accessories), not a software algorithm with standalone performance metrics. -
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests performed would be defined by engineering specifications, material properties, and functional requirements. For example, a tensile strength test would have a specified minimum strength that the device must meet. This is derived from design requirements and industry standards, not from expert consensus, pathology, or outcomes data in the clinical sense. -
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set." -
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.