(90 days)
The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.
The Liberty Select Cycler is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Cycler is designed as a table-top unit that can be used to perform peritoneal dialysis (PD) in hospitals, dialysis clinics, and at home. The software has been updated from version 2.9.2 to introduce the Remote Therapy Programming feature. This feature allows the Cycler to securely receive prescription settings remotely from a Fresenius server.
The provided text describes a 510(k) premarket notification for the Fresenius Liberty Select Cycler, focusing on a software modification (Remote Therapy Programming feature). The document emphasizes that there are no changes to the fundamental device characteristics or performance specifications compared to the predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the Liberty Select Cycler has the same essential performance characteristics as the predicate device (K181108). The acceptance criteria are presented as "Specifications" for key features:
| Feature | Specification | Reported Device Performance (Implied) |
|---|---|---|
| Inflow | 45-316 mL/min | Meets specification |
| Outflow | Minimum: 30 mL/min | |
| Maximum: 286 mL/min | Meets specification | |
| Temperature | 37°C ± 1°C | Meets specification |
| Volume Accuracy, Fill | ± 2% of the fill volume | Meets specification |
| Volume Accuracy, Drain | ± 3% of the drain volume | Meets specification |
Note: The document doesn't provide specific "reported device performance" values for these characteristics for the modified device. Instead, it states that the modified device has the "same essential performance characteristics" as the predicate and that "test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness." This implies that the modified device performs within these established specifications.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Unit, software, regression (system verification), and validation testing" and "Human Factors Validation Testing" but does not detail the specifics of these test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned (software verification, human factors) would typically involve engineering and possibly human factors specialists, but no details are given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on a software modification, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a medical cycler, not an AI algorithm for diagnostic purposes. The "Remote Therapy Programming feature" is a software update that allows the device to receive prescription settings remotely. This is a functional update to the device's operational capabilities, not a standalone diagnostic algorithm. Therefore, "standalone" algorithm performance in the typical sense (e.g., for image analysis) is not applicable or discussed. The testing done covers software verification and validation, as well as human factors for the new feature.
7. Type of Ground Truth Used
For the specific performance characteristics listed (inflow, outflow, temperature, volume accuracy), the ground truth would be established by physical measurements and engineering standards against the device's design specifications. The document implies these were the basis for demonstrating equivalence to the predicate device.
For the software verification and validation testing, the "ground truth" would be the expected functional behavior and security requirements of the software, as defined in design documents and specifications, and adherence to relevant standards (e.g., ANSI/AAMI/IEC 62304 for medical device software lifecycle).
For the human factors validation testing, the "ground truth" would be safe and effective use of the device, particularly with the new remote programming feature, as measured against usability metrics and error rates.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. The software modification described involves a new feature for remote programming, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
As no training set for machine learning is mentioned, this information is not applicable.
§ 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.