(90 days)
The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042.
Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medigroup Key Tube™:
The provided document is a 510(k) summary for the Medigroup Key Tube™, which is an accessory device. The key information is presented as a demonstration of substantial equivalence to a predicate device, rather than a clinical trial proving specific performance metrics against pre-defined acceptance criteria for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
This product is not a diagnostic device, and thus does not have typical performance metrics like sensitivity, specificity, or accuracy. Its "performance" is functional, demonstrating its ability to assist in the implantation of another device (the Ash Advantage™ catheter).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Success: The Key Tube™ successfully assists in the implantation of the Ash Advantage™ catheter as designed. | Clinical Results: All catheters were successfully implanted using the prototype Key Tube™. The Key Tube™ functioned as designed, ensuring the T-junction of the Ash Advantage™ was against the parietal peritoneum and the distal cuff was within the rectus sheath, while avoiding incision of the rectus sheath. |
| Safety: The device does not cause adverse events during implantation. | Implied by "all catheters were successfully implanted" and no mention of complications attributable to the Key Tube™ in the small clinical trial. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 14 catheters implanted in 13 patients.
- Data Provenance: Prospective clinical trials (Ash Advantage™ catheter clinical trials) conducted in three dialysis centers. The country of origin is not explicitly stated but is implied to be the US given the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts: The document states that "All implanting doctors used the prototype version of the Key Tube™." The exact number of doctors is not specified, but it's at least three (one for each of the three dialysis centers).
- Qualifications: The document identifies them as "implanting doctors." Their specific specializations (e.g., surgeons, nephrologists performing insertions) and years of experience are not detailed, but their role implies relevant medical expertise in catheter implantation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document simply reports the clinical results as observed by the implanting doctors. Given the nature of a functional device, the success was likely determined by the operating physician's assessment during and immediately after the procedure. There is no indication of independent blinded adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC Study: This is not a diagnostic imaging device or an AI-assisted diagnostic tool, so an MRMC comparative effectiveness study is not applicable or mentioned. The device is a surgical accessory, and its effectiveness is determined by its functional role in the implantation procedure.
6. Standalone Performance Study
- Standalone Study: Yes, in a way. The "clinical trials" described for the Ash Advantage™ catheter included the observation of the prototype Key Tube™'s performance in isolation as part of its function during the implantation of the Ash Advantage™ catheter. The statement "the Key Tube™ functioned as designed" is an assessment of its standalone performance during the procedure. However, this is not a separate, dedicated standalone study with predefined metrics for only the Key Tube™; it was part of a broader study for the Ash Advantage™ catheter.
7. Type of Ground Truth Used
- Ground Truth: Clinical observation and assessment by "implanting doctors" during the surgical procedure. The "ground truth" was the successful physical placement of the catheter components as intended, as verified by the operating physicians.
8. Sample Size for the Training Set
- Training Set: Not applicable. This is a mechanical accessory device, not an AI/ML algorithm that requires a training set. The "design" of the Key Tube™ would have evolved through engineering and potentially pre-clinical testing, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set in the AI/ML sense, no ground truth was established for it. The development and refinement of the Key Tube™ would have been based on engineering principles, predicate device experience, and possibly bench testing or cadaver studies, leading to the prototype used in the described clinical trials.
§ 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.