(154 days)
Argyle(TM) Peritoneal Dialysis Catheter and Kits:
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle (TM) Presternal Peritoneal Catheter and Kits:
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.
Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.
Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic peritoneal dialysis to allow consistent bi-directional flow of dialysate into and out of the abdominal cavity. One or more cuffs are bonded on to the catheter tubing, which allows for tissue ingrowth to maintain placement of the catheter. All catheters are made of translucent silicone rubber tubing containing a radiopaque stripe, with felt cuffs available to provide catheter stabilization by virtue of tissue in-growth.
The Argyle™ peritoneal dialysis catheter comes in a variety of lengths and cuff configurations including straight, curled, and Swan Neck catheter styles. The Argyle™ peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a straight or Swan Neck Tenckhoff or Curl Cath catheter with single or double cuff (specified at time of order), a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-Cap™ adapter, cap, clamp, and instructions.
The Argyle™ presternal peritoneal dialysis catheters include the curl catheter and Swan Neck catheter styles. The curl catheter segment contains a felt cuff. The Swan Neck Presternal catheter is a segment of catheter tubing with a Swan Neck bend and two cuffs. It is connected by a double-barbed connector to the intraperitoneal segment of the curl catheter. The Argyle™ presternal peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-CapTM adapter, cap, clamp, titanium connector, and instructions.
The titanium adapter is a two-piece luer-lock system with a barbed end and a threaded cover. The adapter is designed to provide a permanent threaded closure when used with a standard CAPD transfer set.
The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.
Here's an analysis of the provided text regarding the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it indicates that "All performance testing met acceptance criteria." The performance evaluation is primarily focused on biocompatibility and design verification for the expanded indication of laparoscopic insertion.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Tests conducted for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity (AMES, Mouse Micronucleus), Implantation, and Chronic Toxicity. |
| All biocompatibility tests results met ISO 10993 requirements and were deemed acceptable. | |
| Design Verification for Laparoscopic Insertion | Evaluation of insertion through a 7mm/8mm port (trocar). |
| Validation testing by clinicians was performed for laparoscopic insertion. | |
| MR Status Verification | Tests conducted to verify MR Safe or MR Conditional status. |
| Argyle™ peritoneal dialysis catheters with silicone tubing and radiopaque stripe are MR Safe. | |
| Argyle™ presternal peritoneal dialysis catheters plus titanium connectors are MR Conditional. | |
| Overall Performance | No specific quantitative metrics provided. |
| "All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices and accessories." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the PD Catheter" for biocompatibility testing and "the proposed device" for design verification, implying a sufficient number of devices were tested to meet the respective standards, but no specific count is given.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective in the sense that they were conducted for regulatory submission to demonstrate equivalence and safety (i.e., not a new clinical trial generating prospective data on patient outcomes).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: It mentions "validation testing by clinicians" for the laparoscopic insertion and "Good Laboratory Practice (GLP)" for biocompatibility, implying qualified professionals were involved, but specific qualifications (e.g., years of experience, specialty) are not detailed.
4. Adjudication Method for the Test Set
- No specific adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the studies are primarily about device performance against technical standards and benchmarks rather than diagnostic accuracy requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This submission is for a medical device (catheter and accessories), not a diagnostic imaging AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- No standalone performance study for an algorithm was done. This device is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI performance (e.g., expert consensus for image findings, pathology reports) is not directly applicable here. For this medical device, the "ground truth" or reference standards are:
- Biocompatibility: Established international standards (ISO 10993-1) and their associated testing protocols.
- Design Verification (Laparoscopic Insertion): Engineering specifications, validated insertion methods, and clinician feedback on feasibility and safety during simulated use.
- MR Status: Established testing procedures and standards for determining MR compatibility (e.g., ASTM F2503).
8. Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device. There is no AI model involved that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI model, there is no training set or associated ground truth.
§ 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.