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510(k) Data Aggregation
(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 % for blood pressure up to -200 mmHg | < 10 % for blood pressure up to -200 mmHg (report indicates meeting stricter tolerance than predicate) |
| Working pressure range (Inlet) | Inlet pressure up to: -500 mmHg | Inlet pressure up to: -500 mmHg (report indicates acceptable) |
| Working pressure range (Outlet) | Max. outlet pressure: +500 mmHg | Max. outlet pressure: +500 mmHg (report indicates acceptable) |
| Heparin pump pumping rate | 0.0 to 10.0 mL/h (0.1 mL/h increment) | 0.0 to 10.0 mL/h (0.1 mL/h increment), with specific bolus rates for 10, 20, 30 mL syringes (report indicates acceptable) |
| Heparin pump flow accuracy | Flow accuracy +/- 10 % | Flow accuracy +/- 10 % (report indicates acceptable) |
| Pressure range (Heparin pump) | 0 to 450 mmHg | 0 to 450 mmHg (report indicates acceptable) |
| Dialysate System | ||
| Flow (dialysate) | 100 to 800 mL/min (100 mL/min increment) | 100 to 800 mL/min (100 mL/min increment) (report indicates acceptable) |
| DF tolerance at dialysis machine | 0 to +10 % from the set value | 0 to +10 % from the set value (report indicates compliance with IEC standard) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Ultrafiltration | ||
| Operating range | 0 to 4,000 mL/h | 0 to 4,000 mL/h (report indicates acceptable) |
| Overall accuracy | Fbal ± 0.15 mL/chamber cycle, FUF Ultrafiltration pump tolerance < 1 % | Fbal ± 0.15 mL/chamber cycle, FUF Ultrafiltration pump tolerance < 1 % (report indicates acceptable) |
| Dialysate Temperature | ||
| Temperature setting range | 34 - 39 °C/93 - 102 °F | 34 - 39 °C/93 - 102 °F (report indicates compliance with IEC standard) |
| Temperature tolerance | -0.5 °C to +31 °F to 33 °F | -0.5 °C to +31 °F to 33 °F (report indicates acceptable) |
| Heating power | 1800 W | 1800 W (report indicates acceptable) |
| Dialysate Conductivity | ||
| Operating range (Bicarbonate) | 2.4 – 7.0 mS/cm | 2.4 – 7.0 mS/cm (report indicates acceptable) |
| Operating range (Total) | 12.5 – 16.5 mS/cm | 12.5 – 16.5 mS/cm (report indicates acceptable) |
| Tolerance | ±0.2 mS/cm or less | ±0.2 mS/cm or less (report indicates acceptable) |
| ABPM Blood Pressure Monitoring | ||
| Cuff pressure range | 0 - 300 mmHg | 0 - 300 mmHg (report indicates acceptable) |
| Accuracy | Within ±3 mmHg | Within ±3 mmHg (report indicates acceptable) |
| Blood pressure determination time | Typical 25 seconds | Typical 25 seconds (report indicates acceptable) |
| Pulse rate determination | 40 – 200 bpm | 40 – 200 bpm (report indicates acceptable) |
| Pulse rate accuracy | The smaller of ±2% or ±2 bpm | The smaller of ±2% or ±2 bpm (report indicates acceptable) |
| Overpressure cut-off | In normal operation: 300 mmHg; In single failure: 330 mmHg | In normal operation: 300 mmHg; In single failure: 330 mmHg (report indicates acceptable) |
| Time of alarm suppression | < 1 second | < 1 second (report indicates acceptable) |
| Deactivation of acoustic signal | 120 seconds | 120 seconds (report indicates acceptable) |
| Transmembrane Pressure | ||
| Alarm limit (max. TMP) | 0 to +700 mmHg | 0 to +700 mmHg (report indicates acceptable) |
| Alarm limit (min. TMP) | -200 to +200 mmHg | -200 to +200 mmHg (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Degassing System | ||
| Tolerance | ± 20 mmHg | ± 20 mmHg (report indicates acceptable, tighter than predicate) |
| Arterial and Venous Pressure Monitoring | ||
| Arterial inlet pressure (PA) measurement tolerance | +/- 10 mmHg | +/- 10 mmHg (report indicates acceptable) |
| Venous return pressure (PV) measurement tolerance | +/- 10 mmHg | +/- 10 mmHg (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Bridging time of protective system (PV) | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm (PA) | 120 seconds | 120 seconds (report indicates acceptable) |
| Deactivation of acoustic alarm (PV) | 120 seconds | 120 seconds (report indicates acceptable) |
| Dialysate Conductivity Monitor | ||
| Limit | ±5 % (of set value) | ±5 % (of set value) (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) |
| Ultrafiltration Controller | ||
| Protection system | Yes | Yes (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Air Detector System | ||
| Sensitivity | Alarms for single bubble > 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.
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