(114 days)
The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.
The Liberty Cycler is the first model in the next generation of Fresenius peritoneal dialysis cyclers. It incorporates features found on other Fresenius cvclers and also utilizes a cassette design similar to the cassette for Baxter HomeChoice Pro.
The provided document is a 510(k) Premarket Notification for the Fresenius Liberty Cycler and Disposable Cycler Set. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or a comprehensive study proving a device meets specific performance metrics against an established ground truth.
Therefore, the document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance: The submission states that "The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler. The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use." However, specific quantitative acceptance criteria or detailed performance data are not provided.
- Sample size used for the test set and data provenance: No information is available about the sample size or the origin of any test data.
- Number of experts used to establish ground truth and qualifications: No ground truth establishment process or experts are mentioned.
- Adjudication method for the test set: Not applicable as no ground truth establishment is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned as the device is a medical cycler, not an AI diagnostic tool.
- Standalone (algorithm-only) performance: Not applicable as the device is a physical cycler.
- Type of ground truth used: Not applicable as no ground truth is described.
- Sample size for the training set: Not applicable as the device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on establishing substantial equivalence to predicate devices. It states:
- Intended Use: "The intended use for the Liberty Cycler is identical to that for the Fresenius PD* IQcard Cycler" and "The Liberty Cycler is indicated for acute and chronic peritoneal dialysis."
- Technological Characteristics: "The features included in the Liberty Cycler are equivalent to those present on other commercially available peritoneal dialysis cyclers and raise no new types of safety or effectiveness questions."
- Functional and Software Validation: It mentions that "The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler." and "The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use." However, these are general statements and do not include specific performance data against acceptance criteria.
§ 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.