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The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

The DBB-06 HEMODIALYSIS DELIVERY SYSTEM is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyzer through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyzer is controlled automatically by adjustment of the ultra filtration amount and UF rate by the dialyzer. Heparinization of the external circulating blood is accomplished with the heparin pump either by continuous or bolus injection before it is passed on to the dialyzer. The DBB-06 HEMODIALYSIS DELIVERY SYSTEM uses both acetate dialysis and bicarbonate dialysis. Utilizing the various functions of the device, the conductivity and UF profile can be programmed. In addition, the device incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis procedures. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with protective systems for patient safety and proper operation. A Blood Volume Monitor (BVM) is an optional accessory available for the DBB-06 HEMODIALYSIS DELIVERY SYSTEM, and was not available with the predicate device, the DBB-05 Hemodialysis Delivery System. The BVM monitors blood volume to assist in the prevention of excessive removal of fluid.

The Acceptance Criteria and the study proving the device meets these criteria for the NIKKISO DBB-06 HEMODIALYSIS DELIVERY SYSTEM, specifically focusing on its new optional accessories, the Blood Volume Monitor (BVM) and the Non-Invasive Blood Pressure (NIBP) measurement module, are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Blood Volume Monitor (BVM):

  • Test Set Sample Size: Not explicitly stated as a number of subjects. The document mentions "Clinical Test was performed." for the DBB-06 BVM. For the predicate CRIT-LINE Monitor III (K972470), "Comparison testing was performed on blood bank blood under simulated conditions" without specifying a sample size.
  • Data Provenance: Not specified for the DBB-06 BVM clinical test (e.g., country, specific demographics). For the predicate, "blood bank blood" suggests in-vitro testing. Whether the BVM clinical test was prospective or retrospective is not explicitly stated.

• Non-Invasive Blood Pressure (NIBP) measurement module (M2500):

  • Test Set Sample Size: Not specified. The comparison relies on compliance with international standards (IEC, EN, ANSI/AAMI) and documented specifications that match the predicate devices. Performance tests of these blood pressure monitors were conducted, but the sample size for these tests is not provided in the summary.
  • Data Provenance: Not specified. The manufacturer for both the M2100 and M2500 is "Omron Colin Co., Ltd., 1-12-14 Koishikawa, Bunkyo-ku, Tokyo Japan," suggesting Japanese origin for the device's development and potentially testing data. The nature of these "performance tests" (e.g., clinical, bench, simulated) and their provenance is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Blood Volume Monitor (BVM): Not applicable. Ground truth for BVM accuracy is stated as "compare well with other methods such as centrifuge." This implies a gold standard measurement method rather than expert consensus on interpretation.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Not applicable. The ground truth for blood pressure measurement accuracy is typically established against validated reference devices (e.g., intra-arterial measurements) or through compliance with recognized standards (e.g., ANSI/AAMI SP-10). Expert interpretation of NIBP readings against a gold standard is generally not how NIBP accuracy is assessed in regulatory submissions.

4. Adjudication Method for the Test Set

Not applicable for either the BVM or NIBP module, as the assessments are based on objective measurements and compliance with technical specifications and standards rather than subjective expert review requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The devices are objective measurement tools, not systems that rely on human interpretation of complex data (like diagnostic imaging). Therefore, an MRMC study to measure improvement in human reader performance with AI assistance is not relevant to this type of device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Blood Volume Monitor (BVM): Yes. The BVM's performance, including its accuracy of approximately +/-2%, operates independently to calculate blood volume based on light absorption. The "Clinical Test was performed" for the BVM would assess this standalone performance.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Yes. The M2500 NIBP module's performance, including its measuring range and accuracy (0 to 300mmHg, within +/-3mmHg), is an inherent function of the device itself. Performance tests (referenced but not detailed) would evaluate its standalone accuracy against an appropriate reference.

7. Type of Ground Truth Used

• Blood Volume Monitor (BVM): "Comparison well with other methods such as centrifuge." This refers to established laboratory methods for measuring hematocrit, which is then used to calculate blood volume.
• Non-Invasive Blood Pressure (NIBP) measurement module (M2500): Compliance with international standards (IEC60601-2-30, EN1060-1, EN1060-3, ANSI/AAMI SP-10) which define accuracy requirements, often referencing invasive blood pressure measurements or other validated non-invasive methods as the "ground truth."

8. Sample Size for the Training Set

No training set information is provided as the devices described (BVM and NIBP module) are based on established physical principles and algorithms, not machine learning models that require training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set is described for these devices.

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