(1491 days)
2008K@home Indications for Use:
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Wireless Wetness Detector Indications for Use:
The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home hemodialysis machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
The Fresenius 2008K@home machine is a modified version of the 2008K 3stream hemodialysis machine. Modifications to the device interface are designed to improve and simplify the training and process of performing hemodialysis. This modified user interface is intended to make it easier for patients and/or their caregivers to deliver hemodialysis safely and effectively in the home environment.
Additionally, the wireless wetness detector (WetAlert), an optional accessory to the 2008K@home, is a disposable device that detects leaks. During treatment, the WetAlert device transmits radio signals to the corresponding 2008K@home hemodialysis machine and alerts the machine if it detects a blood or water leak. During a wetness alarm, the 2008K@home hemodialysis machine will automatically stop the blood pump, close the venous clamp, and sound an alarm.
The provided text describes the acceptance criteria and the study that proves the device meets them for the Fresenius 2008K@home with Wireless Wetness Detector.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Evaluations | Reported Device Performance |
|---|---|---|
| Non-clinical Performance | Software validation and regression testing | "all modifications functioned as intended and met pre-determined acceptance criteria." |
| Electromagnetic compatibility (EMC) testing | "all modifications functioned as intended and met pre-determined acceptance criteria." | |
| Electrical safety testing | "all modifications functioned as intended and met pre-determined acceptance criteria." | |
| Full system validation | Ensured "that the modifications did not negatively impact the overall 2008K@home hemodialysis machine system" and "all modifications functioned as intended and met pre-determined acceptance criteria." | |
| Clinical Performance | Safety Data Collection (in-center and home hemodialysis) | Collected and evaluated safety data from "over 500 in-center and 500 home hemodialysis treatments." Conclusion: "the 2008K@home can be used as safely and effectively at home as in the dialysis clinic." |
| Treatment Adequacy and Safety (transitional subjects) | Conducted an evaluation from "29 subjects who transitioned from in-center to home hemodialysis." Implied satisfactory outcome given the conclusion of safety and effectiveness. | |
| Usability Testing (clinic and home settings) | Conducted to "confirm the safe and effective use of the modified device." Implied satisfactory outcome given the conclusion of safety and effectiveness. | |
| Overall Comparison | Substantial Equivalence to Predicate Device (Fresenius 2008K) | non-clinical and clinical data demonstrate that the 2008K@home is as safe and effective, and performs as well, as the cleared 2008K." The modifications were made to the user interface and the Wireless Wetness Detector was added as an optional accessory to facilitate the device's use by home patients. The performance data...demonstrate that the modified Fresenius 2008K@home with Wireless Wetness Detector is substantially equivalent to the Fresenius 2008K." |
2. Sample Size Used for the Test Set and the Data Provenance
- Clinical Safety Data: Over 500 in-center and 500 home hemodialysis treatments were evaluated for safety. The provenance (country of origin) is not explicitly stated, but the submission is from "Fresenius Medical Care North America," suggesting the data is likely from North America. The data is retrospective, as it mentions "collected and evaluated safety data."
- Clinical Treatment Adequacy and Safety: 29 subjects who transitioned from in-center to home hemodialysis were evaluated. The provenance is not explicitly stated. The study type (retrospective/prospective) is not specified.
- Usability Testing: Conducted in "clinic and home settings." The sample size for usability testing is not specified. The provenance is not explicitly stated.
- Non-clinical Testing (Software, EMC, Electrical Safety, Full System): The sample size for these tests is not quantified in terms of units tested, but rather refers to the comprehensive nature of the testing. The data provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for any of the clinical or non-clinical studies. The clinical studies evaluated "safety data" and "treatment adequacy," implying clinical assessment by qualified medical professionals, but this is not detailed.
4. Adjudication Method
The adjudication method for any of the test sets (clinical or non-clinical) is not specified in the provided text.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of AI assistance or human reader improvement with/without AI. This device is a hemodialysis machine with a wetness detector, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
The document describes non-clinical performance (software, EMC, electrical safety, full system validation) and clinical performance studies, which involve the device functioning. The Wireless Wetness Detector functions "automatically stop the blood pump, close the venous clamp, and sound an alarm" during a wetness alarm. This indicates a standalone algorithmic function for detection and response.
7. The Type of Ground Truth Used
- Non-clinical Data: The ground truth for non-clinical tests (software validation, EMC, electrical safety, full system validation) would be based on engineering specifications, regulatory standards, and pre-determined functional requirements. "Pre-determined acceptance criteria" are explicitly mentioned.
- Clinical Safety Data: The ground truth for safety would be based on clinical outcomes, adverse event reporting, and standard medical safety assessments.
- Clinical Treatment Adequacy: The ground truth for treatment adequacy would be established by clinical measures of dialysis effectiveness (e.g., clearance rates, patient well-being, lab results), likely compared against established medical standards for hemodialysis.
- Usability Testing: The ground truth for usability would be based on observations of user interaction, task completion rates, error rates, and user feedback, evaluated against pre-defined usability criteria for safe and effective operation in both clinic and home environments.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described does not appear to be an AI/ML-based diagnostic or prognostic tool that would typically involve a separate training set for algorithm development. The "performance data" refers to validation and evaluation of the device as a whole.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" for an AI/ML algorithm, this question is not applicable based on the provided text. The ground truth for the device's intended function and performance was established through the various non-clinical and clinical testing methods described above, against pre-determined acceptance criteria and established medical standards for hemodialysis.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”