(232 days)
If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.
The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.
The provided text, K970159, describes a 510(k) premarket notification for the Flex-Neck™ PD Catheter. This document asserts the substantial equivalence of the new device to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study.
Therefore, the information required to populate the fields regarding acceptance criteria and a study demonstrating performance is not present in the provided text. The document is generally focused on comparing the new device's characteristics to existing devices to establish substantial equivalence for regulatory approval.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing physical characteristics (material, dimensions, number of cuffs, hole diameter) to predicate devices, not performance against acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned, as no study demonstrating performance against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study with a test set requiring ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- 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 a medical device (catheter), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study with a test set requiring ground truth is described.
- The sample size for the training set: Not applicable. This is a medical device, and the concept of a "training set" is not relevant here.
- How the ground truth for the training set was established: Not applicable.
§ 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.