PNG · Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Gastroenterology, Urology · 21 CFR 876.5630 · Class 2
Overview
| Product Code | PNG |
|---|---|
| Device Name | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling |
| Regulation | 21 CFR 876.5630 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | Yes |
| Life-Sustaining | Yes |
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.
Classification Rationale
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.
Special Controls
*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.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241278 | ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. | Jan 14, 2025 | SESE |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular, Inc. | Dec 6, 2024 | SESE |
| K230319 | Passio Pump Drainage System | Bearpac Medical | Nov 24, 2023 | SESK |
| K221779 | ASEPT Peritoneal Drainage System | Pfm Medical, Inc. | May 2, 2023 | SESK |
| K212675 | Aspira Peritoneal Drainage System | Merit Medical Systems, Inc. | Dec 14, 2021 | SESK |
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | Oct 21, 2020 | SESK |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit | Rocket Medical Plc | Nov 14, 2016 | SEKD |
| K160437 | PleurX Peritoneal Catheter System | Care Fusion | Nov 3, 2016 | SEKD |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Rocket Medical Plc | Mar 29, 2016 | SESK |
| K122422 | PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER | Care Fusion | Oct 24, 2012 | SESK |
| K113854 | PLEURX PERITONEAL CATHETER SYSTEM | Care Fusion | Mar 19, 2012 | SESK |
| K110396 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | May 6, 2011 | SESE |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | Pfm Medical, Inc. | Feb 26, 2010 | SESK |
| K081288 | ASPIRA PERITONEAL DRAINAGE SYSTEM | C.R. Bard, Inc. | Jul 18, 2008 | SESE |
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | Denver Biomedical, Inc. | Nov 15, 2005 | SESE |
Top Applicants
- Care Fusion — 4 clearances
- Pfm Medical, Inc. — 3 clearances
- C.R. Bard, Inc. — 2 clearances
- Rocket Medical Plc — 2 clearances
- Bard Peripheral Vascular, Inc. — 1 clearance
