(110 days)
If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.
This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.
The provided document is a 510(k) summary for the Medigroup, Inc. Flex-Neck® ARC™ PD Catheter & Accessories. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.
Therefore, many of the requested categories for a new study are not applicable or cannot be extracted directly from this submission. The submission explicitly states: "Because of the longevity and success of the two predicate devices, no further studies have been done for this submission."
However, I can extract the rationale for substantial equivalence which serves as the "study" in this context, demonstrating that the device is believed to meet expected performance criteria based on predicate devices.
Explanation of how this device meets acceptance criteria (implied through substantial equivalence):
The acceptance criteria for the Flex-Neck® ARC™ PD Catheter are implicitly defined by the successful performance and validated design of its predicate devices: the Swan-Neck™ PD Catheter (with a 20-year history) and the Flex-Neck® PD Catheter (with a 10-year history). The new Flex-Neck® ARC™ catheter combines features of both predicate devices which have a long history of safe and effective use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Flex-Neck® ARC™) |
|---|---|
| Safety: Safe for long-term implantation and peritoneal dialysis; no adverse events associated with material or design. | Made of long-term, implantable grade silicone tubing with a radiopaque strip and polyester felt cuffs, materials validated by predicate devices. |
| Effectiveness (Flow Rate): Provides efficient fluid infusion and drainage for peritoneal dialysis. | Incorporates the larger internal diameter of the Flex-Neck® "classic" catheter, which provides faster flow rates. |
| Effectiveness (Catheter Placement/Stability): Maintains proper position within the peritoneum; aids in tunnel/exit site management. | Features a 30° permanent bend, combining the advantage of the Swan-Neck™ catheter for a consistent arcuate tunnel/exit site, and improving upon the "classic" Flex-Neck®'s variable bend if a permanent bend is desired. |
| Compatibility: Compatible with peritoneal dialysis procedures and patient anatomy (adult, pediatric, infant). | Designed for adults, children, and infants; includes stencils for optimal primary and secondary incision sites. |
| Material Biocompatibility: Materials are well-tolerated by the body. | Uses implantable grade silicone, a material well-established in predicate devices. |
| Radiopacity: Observable under imaging for placement verification. | Includes a radiopaque strip. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No new test set was used for a prospective study. The "test set" is the cumulative clinical experience from twenty years of the Swan-Neck™ catheter and ten years of the Flex-Neck® "classic" catheter.
- Data Provenance: Retrospective, derived from the long-term clinical history and usage of the predicate devices. The document also references three articles/studies from 1985, 1995, and 1996 (Appendices F.1, F.2, F.3) that "confirm the benefit of a permanently bent peritoneal dialysis catheter," further validating the design. The specific countries of origin for this long-term data are not specified but would be global, given the widespread use of such medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of a new, controlled study. The "ground truth" is established by the widespread acceptance and successful clinical outcomes experienced by many medical professionals over decades with the predicate devices.
- Qualifications of Experts: Thousands of physicians globally who have implanted and managed patients with the predicate Swan-Neck™ and Flex-Neck® catheters over a 20-year and 10-year period, respectively. These would be experienced nephrologists, surgeons, and other healthcare professionals involved in peritoneal dialysis. The referenced articles also involve expert clinicians and researchers in the field.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new, isolated test set requiring adjudication was used. The validation comes from broad clinical acceptance and published literature over an extended period.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No. No such comparative effectiveness study was performed for this submission. The device's perceived benefit is a combination of known advantages from existing devices (faster flow rates from Flex-Neck®, permanent bend from Swan-Neck™).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used
- Type of Ground Truth: Clinical history and validated performance of legally marketed predicate devices, supported by published literature (Appendices F.1, F.2, F.3, F.4). This constitutes real-world outcomes and expert consensus over an extended period.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this device's design comes from the accumulated knowledge and design iterations based on the predicate devices.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. The "ground truth" that informed the design of the Flex-Neck® ARC™ catheter was the clinical feedback, performance data, and design iterations from the 20-year history of the Swan-Neck™ catheter and the 10-year history of the Flex-Neck® "classic" catheter. This includes physician preferences for specific features (e.g., faster flow rates, permanent bend) derived from their extensive use of these devices.
§ 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.