(247 days)
The Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings.
The Lilliput APD System is available in one (1) configuration that includes an electromechanical cycler (hereinafter referred to as "Cycler"), disposable set (hereinafter referred to as "Disposable Set''), USB key, and Kinexus Gateway. The Disposable Sets are available in three (3) configurations:
- . Lilliput Disposable Set, One Patient Connector (Low feature)
- Lilliput Disposable Set, One Patient Connector with Extended Drain and Patient Lines (Medium Feature)
- . Lilliput Disposable Set, Two Patient Connectors with Extended Drain and Patient Lines (High Feature)
The Cycler is a software-controlled electromechanical device. The Disposable Sets are single-use Class II devices designed to operate with the Cycler to perform Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Disposable Sets are provided sterile and non-pyrogenic and are sterilized using ethylene oxide (EO).
The provided text describes the acceptance criteria and performance data for the Lilliput™ APD System, but it does not detail a study proving the device meets acceptance criteria in the context of diagnostic performance involving human readers or ground truth established by experts/pathology. Instead, the document focuses on engineering and safety performance criteria typical for a medical device.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text, particularly for AI/diagnostic performance studies.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Essential Performance Specifications/Characteristic" in Table 4 and also describes various performance tests. The reported device performance is generally stated as "verified," "determined," or "acceptable results obtained," without specific numerical outcomes in all cases.
| Feature | Specification (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Dialyzing solution flow rate during inflow | 150-300 mL/min | System essential performance was verified. |
| Dialyzing solution flow rate during outflow | 100-250 mL/min | System essential performance was verified. |
| Dialyzing solution volume balancing (inflow volume) (FILL) | Larger of (at 2X standard deviation): $\leq$ 15 mL or ± 5% | System essential performance was verified. |
| Dialyzing solution volume balancing (outflow volume) (DRAIN) | Larger of (at 2X standard deviation): $\leq$ 15 mL or ± 5% | System essential performance was verified. |
| Volume Balancing (Symmetric Volume Accuracy) | Larger of (at 2X standard deviation): $\leq$ 12 mL or ± 2% | System essential performance was verified. |
| PD dwell time | Dependent on prescription. Dwell time accuracy ± 1 minute for the calculated dwell time | System essential performance was verified. |
| Dialyzing solution temperature | 37°C ± 2°C | System essential performance was verified. |
| EO Residuals (Disposable Sets) |
§ 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.