(125 days)
The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.
This document describes a 510(k) premarket notification for the Faller Trocar Catheter Tunneling Device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested data points (like sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in the document for this type of medical device submission.
Here's an analysis of the provided information in relation to your request:
1. Table of acceptance criteria and the reported device performance:
Specific numerical acceptance criteria and reported performance metrics (e.g., sensitivity, specificity, AUC) are not provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through material, design, and functional comparisons, along with a historical safety record of predicate devices.
| Acceptance Criteria (Not Explicitly Stated as Numerical) | Reported Device Performance (as demonstrated by comparison to predicates) |
|---|---|
| Ability to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. | Functions as designed and intended, similar to predicate devices. |
| Separation of tissue as it leads the catheter through to the skin exit-site. | Functions as designed and intended, similar to predicate devices. |
| Safe and effective operation during indicated use. | As safe and effective as predicate devices with a proven record of more than twenty years of successful use. |
| Barbed ends for catheter attachment function correctly. | Barbed ends were tested in-house with acceptable comparisons to predicate devices. |
| Sharp tip for opening tunnel path functions correctly. | Cutting tip was tested in-house with acceptable comparisons to predicate devices. |
| Material compatibility and durability. | Made of the same materials (stainless steel or approved plastic) as predicate devices. |
| Similar shape and bend (for stainless steel version). | Similar to predicate Covidien's Trocar (Faller Stylet). |
| Similar curvature (for plastic version). | Similar to predicate Medigroup's Tunnelor® Tool. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable. The submission does not describe a clinical study with a "test set" in the context of an AI/ML device. Instead, "in-house testing" and "historical data of the predicate devices" are mentioned.
- Data provenance: "In-house" testing for barbed ends and cutting tip. "Journal articles and historical data of the predicate devices" for overall safety and effectiveness. The country of origin for the historical data is not specified, but the predicate devices have been on the market for 20+ years. This would be considered retrospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of experts establishing ground truth for a test set in the context of an AI/ML device. The evaluation relies on comparisons to predicate devices and historical performance.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method is described.
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:
- Not applicable. This is not an AI/ML device, and no MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for this device's performance relies on:
- Functional comparison: Direct comparison of the new device's components (barbed ends, cutting tip) with those of the predicate devices through "in-house testing."
- Historical outcomes data: The safety and effectiveness of the predicate devices are based on their long history of use (more than twenty years) and cited "Journal articles and historical data." The new device is deemed safe and effective due to its "substantial equivalence" to these predicates.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, and no training set is described.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.