(269 days)
The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.
This document is a 510(k) Summary for the NIPRO SURDIAL DX Hemodialysis System, demonstrating its substantial equivalence to a predicate device. It details performance specifications, but it does not describe a study involving a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning (AI/ML) device submissions.
The "performance data" section in this document refers to engineering and quality assurance testing (biocompatibility, electrical safety, software verification, environmental testing, human factors) to ensure the device functions as intended and meets established safety standards for a hemodialysis machine. It does not describe a study that would involve a "test set" and "ground truth" derived from expert consensus in the context of diagnostic accuracy, which is what your questions imply.
Therefore, for aspects related to AI/ML device evaluations (e.g., test set sample size, expert consensus, MRMC studies, standalone performance, training set details), the information is not available in the provided text.
Here's a breakdown of the available information based on your request, focusing on the device's engineering and safety performance rather than diagnostic accuracy:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the comparative table against the predicate device, where "Same" or "Similar" indicates meeting equivalence. Specific quantitative acceptance values are embedded within the "Subject Device: SURDIAL DX" column, and its performance is those reported values, as the testing confirmed it met those specifications.
| Aspect of Device Performance | Acceptance Criteria (from Subject Device Specifications) | Reported Device Performance (from Subject Device Specifications) |
|---|---|---|
| Water Supply | ||
| Pressure range | 0.5 – 7.4 bar | 0.5 – 7.4 bar (report indicates acceptable) |
| Temperature range | 5 - 30 °C / 41- 86 °F | 5 - 30 °C / 41- 86 °F (report indicates acceptable) |
| Alarm "No water" | Internally monitored by pressure sensor and flow regulator | Internally monitored by pressure sensor and flow regulator (report indicates acceptable) |
| Extracorporeal Circulation | ||
| Blood pump pumping rate | 0, 10 to 600 mL/min (5 mL/min increment) | 0, 10 to 600 mL/min (5 mL/min increment) (report indicates acceptable) |
| Tolerance interval (Blood Pressure) | 10 µL or accumulated 0.3 µL+ over 1 min into volume of 1, 10, 50 or 300 µL; Default 10 µL | Specified sensitivity met (report indicates acceptable) |
| Protection system | Ultrasonic transmission method | Ultrasonic transmission method (report indicates acceptable) |
| Bridging time of protective system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Blood Leak Detector | ||
| Measurement | Optical | Optical (report indicates acceptable) |
| Tolerance | +/- 100 ppm | +/- 100 ppm (report indicates acceptable) |
| Alarm threshold | Setting range: 50 to 500 ppm (10 ppm increment); Default: 280 ppm (Ht 32 %) | Specified alarm thresholds met (report indicates acceptable) |
| Bridging time of protective system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Temperature Monitor – Dialysate | ||
| Excessive-temperature protection | Lower limit 33°C/91°F; Upper limit 40°C/104 °F | Lower limit 33°C/91°F; Upper limit 40°C/104 °F (report indicates acceptable) |
| Protection system | Temperature sensor | Temperature sensor (report indicates acceptable) |
| Bridging time of protection system | Cannot be bridged during dialysis | Cannot be bridged during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Fail-safe design (power failure) | ||
| Battery | Power failure backup battery | Power failure backup battery (report indicates acceptable) |
2. Sample Size for Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML diagnostic study with patient data. The "performance data" refers to validation testing of the device itself (e.g., electrical, mechanical, software functionality, biocompatibility). Therefore, there is no sample size of patient data or data provenance (country, retrospective/prospective) relevant to a diagnostic AI model study.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth from experts is not established for this type of device performance testing. The "ground truth" here is the engineering specification that the device must meet, tested through controlled experimental conditions in a lab.
4. Adjudication Method for Test Set
Not applicable. There is no expert adjudication for the engineering performance and safety tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. The SURDIAL DX Hemodialysis System is a treatment device, not a diagnostic AI system, and this document does not refer to any such studies.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a hemodialysis machine. While it contains software, its "performance" is its ability to conduct hemodialysis treatments safely and effectively, not to perform a standalone diagnostic algorithm. The software verification and validation section confirms software functions as intended for controlling the machine.
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing is adherence to engineering specifications, recognized international standards (e.g., ISO, IEC), and documented functional requirements. For biocompatibility, it's the results of specific laboratory tests against established biological safety criteria. For software, it's the functionality of the code against its design specifications and requirements.
8. Sample Size for Training Set
Not applicable. This document does not describe an AI/ML model that would have a "training set" of data.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no AI/ML training set.
§ 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.”