(290 days)
The Fresenius Liberty Cycler is indicated for acute and chronic peritoneal dialysis.
The Liberty Cycler is a computer-controlled electro-mechanical medical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Cycler design incorporates software-controlled pumping action for fluid movement. The Liberty Cycler heats the peritoneal dialysate solution prior to user infusion, measures and delivers a pre-determined amount of fluid to the user and monitors the drained volume from the user. The Liberty Cycler is designed as a table-top unit and is prescribed in both professional and home treatment settings. Modifications to the predicate Liberty Cycler include changes to the performance specifications to allow use of a 6-liter dialysate solution bag. The Liberty Cycler can now accommodate a 1 to 6-liter dialysate solution bag configuration. Additional modifications are included in this submission which are intended to enhance performance and data management within predicate specifications.
The provided text describes modifications to an existing medical device, the Fresenius Liberty Cycler, and the testing conducted to ensure its continued safety and effectiveness. It is not an AI/ML device, therefore, some of the information requested in the prompt is not available in the given text.
Here's an analysis of the acceptance criteria and study information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Test results demonstrated that all modifications functioned as intended and met predetermined acceptance criteria" and that "The essential performance of the Liberty Cycler is not affected by the modifications." However, specific numerical acceptance criteria for each test and their corresponding reported performance values are not detailed in the provided text.
The text mentions several types of tests, implying that acceptance criteria were established for each. Here's a general table based on the information provided, noting the lack of specific numerical criteria:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Validation & Regression Testing | All modifications functioned as intended and met predetermined acceptance criteria. |
| System Performance (6L Bag) | The device demonstrated system performance using the 6-liter dialysate solution bag, and all modifications functioned as intended and met predetermined acceptance criteria. The essential performance of the Liberty Cycler is not affected. |
| Human Factors (Usability) Testing | The modified Liberty Cycler met prescribed criteria (according to IEC 62366). |
| Electrical Safety Testing | The modified Liberty Cycler was found to comply with UL 60601-1 (1st Edition, 2006-04-26). |
| Peritoneal Dialysis Device Performance | The modified Liberty Cycler complied with IEC 60601-2-39: 1999 (First Edition) for use in conjunction with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) Testing | The modified Liberty Cycler complied with IEC 60601-1-2 (2007), Class B testing criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the sample size for any of the tests. For example, it doesn't mention how many units were tested for electrical safety or how many participants were involved in human factors testing.
- Data Provenance: The testing was conducted by Fresenius Medical Care North America according to their internal procedures, protocols, and quality system regulations (21 CFR 820). The country of origin of the data is implicitly the United States (Fresenius Medical Care North America is located in Waltham, MA) and is prospective for the modified device, as the testing was done to verify the modifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable and not provided in the document. The device is a medical cycler, not an AI/ML diagnostic tool that requires expert consensus for ground truth establishment. The "ground truth" here is compliance with engineering and safety standards.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of images or data to establish a ground truth, which is not relevant to the performance testing of a peritoneal dialysis cycler.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable and not provided in the document. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this electromechanical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This information is not applicable to this device in the context of an AI algorithm. The device has software control for pumping and other functions, but it's not an AI/ML algorithm being evaluated in isolation. The "standalone performance" of the device refers to its ability to function according to specifications.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance testing is:
- Compliance with established engineering standards and regulations: UL 60601-1, IEC 62366, IEC 60601-2-39, IEC 60601-1-2.
- Meeting pre-determined internal Fresenius Medical Care acceptance criteria for system validation, software functionality, and functional performance (e.g., fluid measurement accuracy, heating capabilities, ability to accommodate a 6-liter bag).
8. Sample Size for the Training Set:
This information is not applicable and not provided in the document, as the device is not an AI/ML model that undergoes a "training set." The software within the device is validated, not trained in the machine learning sense.
9. How Ground Truth for the Training Set Was Established:
This information is not applicable and not provided. As explained above, there is no "training set" in the context of an AI/ML model for this device. The software's functionality is verified against design specifications and industry standards.
§ 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.