(127 days)
If a patient is a suitable adult candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ExxTended ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis. Stencils sold with the device, and marketed separately, will be used to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site for the Flex-Neck® ExxTended™ Catheter.
This device consists of a two-part peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and two cuffs made of polvester felt. The coiled lower catheter section (with one rectus cuff) connects to an arcuate upper catheter section (with one exit cuff) via a tube-to-tube titanium connector (included), secured with a nonabsorbable nylon suture (not included). Also included in the catheter package is a set of stencils (right and left) to assist the physician to locate the optimum primary implantation site and the optimum catheter exit site below the sternum. (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 included in the packaging will be a surgical grade marking pen, a tape measure, a plastic catheter connector and cap, a packet of water-soluble lubricating gel, and an ExxTended™ tunneling tool.
The provided text is a 510(k) summary for a medical device (Flex-Neck® ExxTended™ PD Catheter & Accessories). It focuses on device description, intended use, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a dedicated study proving the device meets those criteria.
510(k) submissions primarily demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study with specific metrics. The "study" in this context refers to the comparison of the new device with existing, legally marketed devices.
Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) cannot be filled with the provided information.
However, based on the information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. 510(k) summaries for devices like this typically focus on demonstrating substantial equivalence to predicate devices, often through material comparisons, design similarities, and sometimes limited bench testing or animal studies, rather than a clinical trial with specific performance metrics and acceptance criteria.
2. Sample size used for the test set and the data provenance
This information is not provided in the given text. There is no mention of a "test set" in the context of a performance study. The 510(k) process for this type of device usually relies on demonstrating equivalence through design and material comparisons to legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. There is no mention of a "test set" or experts establishing a ground truth.
4. Adjudication method for the test set
This information is not provided. There is no mention of a "test set" or adjudication.
5. 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
There is no indication of an MRMC study or any AI component in this device's description. This device is a physical medical implant (peritoneal dialysis catheter and accessories).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
This is not applicable as there is no specific performance study with a "ground truth" described in the provided text. The primary "ground truth" for a 510(k) submission is the pre-market status and clinical use of the predicate devices.
8. The sample size for the training set
This information is not provided. This device is a physical medical device and would not typically have a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
This is not applicable.
Summary of available information related to "study":
The document describes a substantial equivalence comparison study, which is the core of a 510(k) submission.
- Study Goal: To demonstrate that the Flex-Neck® ExxTended™ PD Catheter & Accessories is substantially equivalent to legally marketed predicate devices.
- Predicate Devices:
- Method of comparison: The submission likely compared design, materials, manufacturing processes, and intended use of the new device to the predicate devices. The "Product Description" section details the components and materials (implantable grade silicone tubing, radiopaque strip, polyester felt cuffs, titanium connector, nylon suture). This information, along with the intended use statement, forms the basis of the substantial equivalence argument.
- Conclusion: The FDA determined the device is "substantially equivalent" to the predicate devices, indicating that it is safe and effective for its intended use. This determination serves as the "proof" that the device meets the necessary regulatory standards for market entry, not necessarily against predefined performance acceptance criteria in a clinical trial.
§ 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.