(170 days)
The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis.
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has associated hardware and software components to allow for data transmission to a healthcare professional.
This system is not intended to provide diagnostic information and is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) is a tabletop passive drainage system used as an attachment during a peritoneal dialysis (PD) treatment and indicated for use by patients with acute and chronic end-stage renal disease undergoing PD. The CloudCath System connects directly to the end of the cycler tubing set drain line in order to enable draining and contains an optical sensor that measures turbidity, reported as a turbidity score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use with validated peritoneal dialysis cyclers in healthcare facilities or home use environments. The optical sensor has associated hardware and software components to allow for remote data transmission by healthcare providers.
The CloudCath System is comprised of three main components: Sensor, Drain Set and Patient Monitoring Software. The Drain Set and the Sensor are components used by the patient. The Patient Monitoring Software is a cloud-based system used by a healthcare professional to view the results from the patient's use of the CloudCath System.
The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines for patients undergoing continuous cycling peritoneal dialysis (CCPD). While this document does not contain an "acceptance criteria" table in the traditional sense for specific performance metrics (e.g., sensitivity, specificity), it outlines the non-clinical performance testing conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to a predicate device.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria (Interpreted from "Results / Conclusions") and Reported Device Performance
The document states that all tests were successfully completed and did not raise any different questions of safety or effectiveness. This implies that the acceptance criteria for each test type were met. The "Results / Conclusions" column effectively serves as the reported device performance against implicitly set acceptance criteria for each non-clinical test.
| Type of Testing Performed | Methods / Standards Used | Results / Conclusions |
|---|---|---|
| Packaging performance and aging testing (Drain Set, Sensor) | ASTM D4332, ASTM D4169, ASTM F1980 | Pass / Did not raise any different questions of safety or effectiveness |
| Functional performance testing (mechanical characteristics and structural integrity testing) | Visual inspection, clamp test, leak test, tensile test, kink test, pressure test | Pass / Did not raise any different questions of safety or effectiveness |
| Maintenance of sterile fluid path (sterility) testing (Drain Set) | Microbial aerosol challenge test per ISO 11607-1 | Pass / Did not raise any different questions of safety or effectiveness |
| Dimensional verification testing (Engineering Analysis and Type Testing) | Verification of device features including inner diameter, outer diameter and durometer | Pass / Did not raise any different questions of safety or effectiveness |
| Complete system performance validation | End-to-end performance testing of complete CloudCath System in simulated-use environment | Pass / Did not raise any different questions of safety or effectiveness |
| Cycler compatibility testing of CloudCath System | Compatibility testing of CloudCath System with compatible cyclers (Force-to-connect test, compatibility testing with and without CloudCath System, backflow, and variety of flow settings test) | Pass / Did not raise any different questions of safety or effectiveness |
| Hardware fatigue/aging testing | Fatigue testing of Sensor and Drain Set | Pass / Did not raise any different questions of safety or effectiveness |
| Electrical safety and EMC testing | Compliance testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Pass / Did not raise any different questions of safety or effectiveness |
| Analytical Performance testing of turbidity measurements | Testing to verify turbidity measurements to ensure limits of detection, bias, and precision. Also included static and dynamic flow testing | Pass / Did not raise any different questions of safety or effectiveness |
| Method Comparison testing using clinical samples | Testing to verify turbidity measurements by comparability to a comparative method using clinical samples | Pass / Did not raise any different questions of safety or effectiveness |
| Reference Intervals/Ranges (Expected Values) testing | Establishing reference intervals/ranges of the CloudCath System Turbidity Score with clinical samples | Pass / Did not raise any different questions of safety or effectiveness |
| Electrical aging testing | Evaluation of aging of the measurement systems of the Sensor | Pass / Did not raise any different questions of safety or effectiveness |
| Human factors / usability testing | Formative and summative evaluations of CloudCath System in accordance with ISO 62366 and FDA Guidance | Pass / Did not raise any different questions of safety or effectiveness |
2. Sample Sizes Used for the Test Set and Data Provenance
The document mentions "clinical samples" for Method Comparison testing and Reference Intervals/Ranges testing. However, it does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on non-clinical performance and comparability.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not provided in the document. The ground truth for the analytical and clinical sample testing would likely be based on established laboratory methods for turbidity measurement, rather than expert interpretation in the same way an imaging AI model would use expert readers.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of turbidity measurement, it's unlikely that an adjudication method for human interpretation would be primarily used for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or described. The device measures turbidity as a supplement to visual examination, and the testing focuses on the instrumental performance and comparability of the turbidity measurements rather than a human-in-the-loop diagnostic improvement.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
The "Analytical Performance testing of turbidity measurements" and "Method Comparison testing using clinical samples" represent evaluations of the device's standalone performance in measuring turbidity. The "algorithm" here refers to the optical sensor's ability to accurately quantify turbidity. The results indicate that the device "Pass[ed]" these tests, implying its standalone performance met the internal criteria for limits of detection, bias, precision, and comparability to a comparative method.
7. Type of Ground Truth Used
The ground truth for the performance testing related to turbidity measurements would be based on:
- Reference laboratory methods: For "Method Comparison testing using clinical samples," the ground truth would be the results from a highly accurate and precise comparative method for measuring turbidity in dialysate effluent.
- Defined solutions/standards: For "Analytical Performance testing," the ground truth would be precise, known turbidity values in control solutions or standards used for calibration and validation.
- Engineering specifications/measurements: For mechanical, electrical, and dimensional testing, the ground truth would be the defined engineering specifications the device is designed to meet, validated by precise measurement tools.
8. Sample Size for the Training Set
This information is not applicable/not provided in the document for the turbidity measurement aspect. The CloudCath System is an optical sensor measuring a physical property (turbidity), not a machine learning model that requires a "training set" in the conventional sense of AI for image interpretation or diagnosis. Its "learning" is based on its optical and electronic design for accurate physical measurement.
9. How the Ground Truth for the Training Set Was Established
As above, this is not applicable for this device in the context of an AI/ML training set. The device's operation is based on established optical measurement principles rather than a trained AI algorithm in the typical machine learning sense. The "ground truth" for its development would be based on physics, engineering, and chemistry principles for accurate turbidity sensing.
§ 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.