FJS · Catheter, Peritoneal, Long-Term Indwelling
Gastroenterology, Urology · 21 CFR 876.5630 · Class 2
Overview
| Product Code | FJS |
|---|---|
| Device Name | Catheter, Peritoneal, Long-Term Indwelling |
| Regulation | 21 CFR 876.5630 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| Implant | 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 (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit | Covidien, LLC | Jan 14, 2022 | SESE |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender | Covidien, LLC | Jul 27, 2018 | SESK |
| K130441 | FALLER STYLET | Medionics International, Inc. | Apr 19, 2013 | SESE |
| K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) | Medical Components, Inc. | Sep 5, 2012 | SESK |
| K120130 | FALLER TROCAR | Medigroup, Inc. | May 21, 2012 | SESE |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | Pfm Medical, Inc. | Mar 13, 2012 | SESK |
| K071167 | FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 | Medigroup, Inc. | Aug 31, 2007 | SESK |
| K070730 | FLEX-NECK ARC CATHETER | Medigroup, Inc. | Jul 3, 2007 | SESK |
| K060897 | EMBEDDING TOOL, MODEL TE-1000 | Medigroup, Inc. | Jul 18, 2006 | SESE |
| K053123 | PD CATH | Med-Conduit, Inc. | Mar 29, 2006 | SESE |
| K031351 | FLEX-NECK PD CATHETER, INFANT | Medigroup, Inc. | Sep 17, 2003 | SESE |
| K012502 | MEDIGROUP CATHETER EXTENDER/REPAIR KIT | Janin Group, Inc. | Feb 4, 2002 | SESE |
| K013017 | MEDIGROUP KEY TUBE | Janin Group, Inc. | Dec 6, 2001 | SESE |
| K993149 | PERITONEAL DIALYSIS CATHETERS AND ADAPTERS | Medionics International, Inc. | Apr 28, 2000 | SESE |
| K991042 | ASH ADVANTAGE PERITONEAL CATHETER | Janin Group, Inc. | Jun 25, 1999 | SESE |
| K970159 | FLEX-NECK PD CATHETER | Janin Group, Inc. | Sep 5, 1997 | SESE |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Sil-Med Corp. | Jul 18, 1997 | SESE |
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Accurate Surgical Instruments Co. | Dec 15, 1995 | SESE |
| K934610 | CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS | Tabex Industries, Inc. | Sep 23, 1994 | SESE |
| K930175 | CATH BELT PD CATHETER AND TRANSFER SET HOLDER | Tabex Industries, Inc. | Jun 23, 1994 | SESE |
Top Applicants
- Quinton, Inc. — 8 clearances
- Accurate Surgical Instruments Co. — 7 clearances
- Medigroup, Inc. — 5 clearances
- Janin Group, Inc. — 4 clearances
- Sil-Med Corp. — 3 clearances
