(106 days)
This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation.
The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that:
- The embedding procedure is done immediately following PD . catheter implantation.
- Catheter patency has been completely established. .
- The normally external part of the PD catheter can be embedded. .
- The patient is a candidate for delayed onset of PD treatment. .
- The patient is a candidate for PD. .
The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.
The Medigroup, Inc. Embedding™ Tool (TE-1000) is a device used to temporarily embed the external portion of a peritoneal dialysis catheter subcutaneously following initial implantation, for later retrieval and initiation of peritoneal dialysis.
Here's an analysis of the provided information regarding its acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Integrity | "Functional testing has been performed to demonstrate mechanical integrity." |
| Function as Intended | "Clinical evaluation at a dialysis center showed the Embedding™ Tool functioned as intended." |
Note: The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., minimum tensile strength, specific success rate percentage). The statements are qualitative.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Clinical evaluation at a dialysis center," implying human subject participation, but no numbers are provided for this evaluation.
- Data Provenance: Not explicitly stated. The "clinical evaluation at a dialysis center" suggests prospective clinical use, but the specific country of origin is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not stated.
- Qualifications of Experts: The clinical evaluation was conducted at a "dialysis center," implying involvement of medical professionals familiar with peritoneal dialysis and catheter procedures. The intended users are "physicians familiar with proper catheter tunneling techniques" and "nephrologist." These suggest that the experts involved would likely be nephrologists or surgeons experienced in implanting and managing PD catheters. Specific years of experience or board certifications are not provided.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "clinical evaluation" seems to be a direct assessment of the device's function by the users/medical staff at the dialysis center.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The device's function is mechanical and procedural, not diagnostic or interpretive by multiple readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone Performance Study (Algorithm Only)
- This is not an AI-powered device, and therefore, no standalone algorithm-only performance study was conducted. The device is a physical tool.
7. Type of Ground Truth Used
- For "Functional testing": The ground truth would have been established through engineering specifications, material properties, and mechanical test standards (e.g., assessing strength, durability, fit, and operation as designed).
- For "Clinical evaluation": The ground truth was the direct observation of the device functioning "as intended" during actual clinical use in patients undergoing peritoneal dialysis catheter implantation. This would likely involve physician assessment of successful embedding, ease of use, and absence of immediate complications related to the device.
8. Sample Size for the Training Set
- There is no training set mentioned, as this is a physical medical device, not an AI/machine learning algorithm. Therefore, "sample size for the training set" is not applicable.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 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.