(17 days)
The K.E.P. Connector and Clip is intended to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.
The K.E.P. Connector and Clip comprises three major components: (1) the rightangle barbed tubing connector (outlet), (2) the wire frame, and (3) the suction cup. This device is provided to the user as an assembled device. The K.E.P Connector and Clip enables free flow of waste dialysate in a safe and hygienic manner. The suction cup is designed to adhere to ceramic or any other non-porous surface, unless intentionally released by the "A tab." The K.E.P. Connector and Clip has been designed with an air gap between the distal end of the connector and the discharge site (drain), thereby making it impossible for any fluid to back flow or to be restricted; this air gap is consistent with ASME designs for plumbing fixtures.
The provided text describes a medical device called the "K.E.P. Connector and Clip" and its 510(k) submission to the FDA. However, the document does not contain specific details about acceptance criteria or a study that proves the device meets such criteria.
The text states: "Testing of the K.E.P. Connector and Clip demonstrates that it complies with design and performance specifications." This is a general statement and does not provide quantifiable acceptance criteria, specific performance metrics, or details of how these were tested or achieved.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "complies with design and performance specifications." (general statement, no specific metrics) |
Missing Information (and why):
- Specific Acceptance Criteria: The document mentions "design and performance specifications" but does not define what those specifications are (e.g., tensile strength, flow rate, retention force, material biocompatibility, duration of secure hold, etc.).
- Quantifiable Device Performance: Without specific criteria, there are no reported numerical or descriptive performance outcomes.
The information regarding the study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is entirely absent from the provided 510(k) summary. This type of detail is often found in the full test reports that accompany a 510(k) submission, but it's not present in this high-level summary.
Summary of Missing Information for all other points:
- Sample size for test set and data provenance: Not mentioned.
- Number of experts and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned. The device is a physical connector, not an AI/software device, so this type of study would be highly unlikely.
- Standalone (algorithm only) performance: Not applicable; this is a physical device.
- Type of ground truth used: Not mentioned.
- Sample size for training set: Not applicable and not mentioned.
- How ground truth for training set was established: Not applicable and not mentioned.
In conclusion, while the K.E.P. Connector and Clip received 510(k) clearance based on its submission, the provided summary document lacks the detailed performance testing information required to answer your specific questions about acceptance criteria, study design, and ground truth establishment. This document only states that testing was performed and that the device complies with its specifications.
§ 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.