(161 days)
The Baxter AK 98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 dialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis or hospital care environment. The Baxter AK 98 dialysis machine is not intended for Selfcare or home use.
The AK 98 Dialysis Machine is a standalone hemodialysis machine intended for use as a single patient dialysis machine to perform HD treatments of patients with renal failure or fluid overload. The Vantive AK 98 Dialysis Machine is intended to be used in a chronic dialysis or hospitale care environment for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload upon prescription by a physician. The AK 98 Dialysis Machine is intended to be used on patients with a body weight of 25 kg or more.
To perform hemodialysis therapy, the AK 98 system needs a high purity water source and the appropriate consumables for treatment, including but not limited to: cleaning products, ultrafilters, acid and base dialysate concentrates, bloodlines, and dialyzers.
In hemodialysis therapies, the AK 98 is used to pump the blood through the extracorporeal circuit and to monitor the arterial and venous pressure, but the blood directly contacts only the disposable bloodline and dialyzer, not the monitor itself.
The fluid unit of the AK 98 Dialysis Machine is used to produce the dialysis fluid (with the correct temperature, flow, and composition) from reverse osmosis water and concentrates (dry or liquid) and to transport the dialysis fluid through the dialyzer. The fluid unit offers Profiling of Ultrafiltration and/or conductivity, it also offers isolated Ultrafiltration. The fluid unit also includes "Clearance Measurement" (Diascan). The fluid unit maintains the dialysis fluid flow through the dialyzer and controls ultrafiltration. If a fault occurs, the machine enters a patient safe state, which, depending upon the fault, can include actions such as bypassing the dialyzer.
The fluid path of the AK 98 is composed of a variety of different materials, including silicone tubing.
The provided FDA 510(k) clearance letter and summary for the AK 98 Dialysis Machine (K250508) do not contain the details typically associated with Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for AI/ML-driven medical devices.
The document describes a submission for a dialysis machine, and the key changes and testing detailed focus on physical components and performance attributes of a medical device (e.g., changes in silicone tubing curing process, ultrafiltration accuracy, blood flow rate accuracy). It specifically highlights non-clinical tests rather than clinical studies with human subjects or AI-specific validation.
Therefore, many of the requested categories in the prompt (e.g., sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this type of device and submission as described in the provided text.
The information that can be extracted relates to the device's functional performance and how it maintains equivalence to its predicate.
Here's an attempt to address the prompt based only on the provided text, while noting the limitations:
Acceptance Criteria and Device Performance for AK 98 Dialysis Machine
Based on the provided 510(k) summary for the AK 98 Dialysis Machine (K250508), the device is demonstrated to be substantially equivalent to its predicate device (AK 98 Dialysis Machine, K232467). The assessment of differences focuses on ensuring the proposed device maintains similar performance and safety characteristics despite a material change in its silicone tubing.
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to maintaining the performance specifications of the predicate device. The "reported device performance" is implicitly that the proposed device performs identically to the predicate device for all listed features, having passed non-clinical functional testing. The key change evaluated was the transition from peroxide-cured and platinum-cured tubing to solely platinum-cured tubing.
| Feature / Performance Metric | Acceptance Criteria (from Predicate Device K232467) | Reported Device Performance (Proposed Device K250508) |
|---|---|---|
| Intended Use/Indications for Use | Same as predicate (intermittent hemodialysis/isolated ultrafiltration for patients 25 kg+ with renal failure/fluid overload, used by trained operators in chronic care/hospital, not for self-care/home use) | Same |
| Treatment Modalities | Hemodialysis (HD DN/SP, HD SN/SP) | Same |
| Dialysate Conductivity Monitoring | Yes | Same |
| Isolated UF | Yes | Same |
| Ultrafiltration Control | Yes | Same |
| Ultrafiltration Supervision | Yes, in accordance with IEC 60601-2-16, 4th edition | Same |
| Ultrafiltration Accuracy | Between ±50 and ±100 g/h (depending on UF rate); 50 mL or ± 50 mL/h x passed or treatment time (h) or ± 2.5% of accumulated UF volume, whichever is largest. Worst-case accuracy at 4 L/h UF rate is 100 g/h. | Same |
| Air Detector | Yes | Same |
| Blood Leak Detector | Yes | Same |
| Temperature Monitoring | Yes | Same |
| Fail-safe response during power failure | Yes | Same |
| Prescription Profiling | Conductivity profiling (Na, HCO3) | Same |
| Disinfection Programs | Heat, Chemical | Same |
| Anticoagulant Administration Rate | 0 – 10.0 ml/h | Same |
| Anticoagulant Bolus | 0 – 10.0 ml | Same |
| Blood Flow Rate | 20 – 600 ml/min | Same |
| Blood Flow Rate Accuracy | For pre-pump pressure range -200 mmHg to 0 mmHg: ±10 ml/min or ±10% of set point, whichever is largest | Same |
| Dialysate Flow Rate | 300 – 800 ml/min | Same |
| Dialysate Flow Rate Accuracy | ±10% or 50 ml/min, whichever is largest | Same |
| Transmembrane Pressure | -200 – +500 mmHg (calculated value) set of LIMITS | Same |
| Net Fluid Removal Rate | 0 – 4 L/h | Same |
| Dialysate Temperature | 33 – 40 °C | Same |
| Dialysate Conductivity Set Range | 9 – 16 mS/cm | Same |
| Arterial Pressure | -400 - +300 mmHg | Same |
| Venous Pressure | +10 - +500 mmHg | Same |
| Blood Pressure Measurements (BPM) | Yes | Same |
| IT Connectivity | Yes, Integrates with CIS using HL7 protocol | Same |
| Silicone Tubing | Peroxide-cured and Platinum-cured tubing | Platinum-cured tubing |
Note on Silicone Tubing Difference: The crucial "acceptance criteria" here for the tubing change was that "Performance, biocompatibility, and extractables testing demonstrates that the difference in the curing process does not impact the performance or safety of the AK 98 Hemodialysis System." The reported performance is that this testing was successfully conducted, confirming no impact.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical functional performance testing, biocompatibility testing, and extractables and leachables assessment. It does not mention a "test set" in the context of patient data or clinical trials. Therefore, sample sizes for such data are not applicable here. The data provenance would be laboratory testing results from the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission pertains to a physical medical device and primarily relies on engineering and laboratory testing for equivalence, not AI/ML-driven analysis of medical images or patient data requiring expert adjudication. Thus, this information is not applicable.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set requiring human interpretation or AI output evaluation, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done, as this device is a physical hemodialysis machine, not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone algorithm performance study was not done, as this device does not contain a discrete AI/ML algorithm whose performance is being evaluated in isolation. Its "performance" refers to the mechanical and fluid dynamic functions of the dialysis machine itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation lies in established engineering standards, device specifications, and the performance characteristics of the legally marketed predicate device. The change in the silicone tubing's curing process required "Performance, biocompatibility, and extractables testing" to demonstrate continued safety and effectiveness. This testing serves as the "ground truth" method for verifying that the new component does not negatively impact the device's adherence to its established specifications.
8. The Sample Size for the Training Set
This concept is not applicable to the submission of this physical medical device. There is no AI/ML model being trained with a dataset.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable as there is no training set for an AI/ML model.
§ 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.”