FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Liberty Select Cycler is an electro-mechanical medical device. Software controls the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms. The Liberty Select Cycler is designed as a table-top unit and is prescribed for use in both professional and home treatment settings. 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 Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription. The Liberty Select Cycler accommodates three (3) accessory devices: Cassette and tubing set, IQdrive, Optional wireless modem.

AI/ML Overview

This document describes the Fresenius Liberty Select Cycler, a peritoneal dialysis system. Since the device is a peritoneal dialysis cycler and not an AI/ML powered device, the provided information does not contain details about acceptance criteria, test sets, ground truth, or training sets in the context of AI/ML performance evaluation. These types of details are typically pertinent to the validation of AI/ML algorithms, which is not the subject of this 510(k) summary.

However, the document does list essential performance characteristics and outlines the performance data used to demonstrate substantial equivalence to predicate devices. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document states "The Liberty Select Cycler has the same essential performance characteristics as the predicate device (K123630) as listed in Table 1." It then provides the following table:

Feature	Specification
Inflow	45-316 mL/min
Outflow	Minimum: 30 mL/min
Maximum: 286 mL/min
Temperature	37°C ± 1°C
Volume Accuracy, Fill	± 2% of the fill volume
Volume Accuracy, Drain	± 3% of the drain volume

Note: These specifications serve as the "acceptance criteria" for the device's essential performance characteristics. The document implies that the reported device performance (i.e., the performance of the Liberty Select Cycler) meets these specifications, as it concludes the device is substantially equivalent to the predicate. The document does not provide separate "reported device performance" values if they are identical to the specifications.

2. Sample size used for the test set and the data provenance:

This information is not explicitly provided in the context of AI/ML algorithm evaluation, as the device is not an AI/ML product.
For the described performance parameters (inflow, outflow, temperature, volume accuracy), testing would typically involve a certain number of device units and repeated measurements. However, the specific sample size (e.g., number of cycles tested, number of devices) is not detailed in this summary.
The data provenance (e.g., country of origin, retrospective/prospective) is also not applicable or specified for this type of medical device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable, as this device is not an AI/ML system requiring expert-established ground truth for algorithm performance.
The "ground truth" for the performance characteristics would be established by validated measurement techniques and sensors inherent to the engineering and medical device testing processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the type of device and validation described. Adjudication methods are typically used in clinical studies or AI/ML evaluations where there is subjective interpretation involved.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which the Fresenius Liberty Select Cycler is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional performance in an automated manner, which is what the essential performance characteristics refer to.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the device's essential performance characteristics (Inflow, Outflow, Temperature, Volume Accuracy), the "ground truth" is based on engineering measurements and calibration standards. For example, volume accuracy would be measured against known, accurately measured volumes; temperature against calibrated thermometers; and flow rates against calibrated flow meters.

8. The sample size for the training set:

This information is not applicable, as the device is not an AI/ML system that undergoes a "training set" phase.

9. How the ground truth for the training set was established:

This information is not applicable, as the device is not an AI/ML system with a "training set."

Summary of Study/Testing Methods (as provided in the document):

The performance testing requirements were determined through:

Application of a risk management process.
Applicable FDA guidance documents.
Performance standards (21 CFR 876.5630).

Testing included:

Software Verification and Validation Testing: Unit, integration, and system-level software verification to demonstrate effectiveness of software modifications and confirm machine operation.
Mechanical and Acoustic Testing: Verified that noise level does not exceed 40 dBA during treatment.
Human Factors Testing: Performed on modifications impacting Human Factors, including:
- Selectable drain exit criteria (70% or 85%).
- Selectable additional drain option with alert.
- STAT drain at the end of treatment.
- Implement Soft Alarms.
- The remaining essential and critical user tasks were determined to be equivalent to the predicate devices.

The conclusion states that the four new features tested are safe and effective for the intended users, uses, and use environments, and that the device is substantially equivalent to its predicate.

Summary

Regulation Number and Section

§ 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.