(165 days)
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 Dialysis Dose Monitor (DDM) is a new optional accessory available with the DBB-06 (under application), which was not available in the predicate DBB-06 (K091978).
The provided text describes Nikkiso Co., Ltd.'s DBB-06 Hemodialysis Delivery System (model under application) and its substantial equivalence to a predicate device (DBB-06 Hemodialysis Delivery System, K091978), and specifically the Dialysis Dose Monitor (DDM) optional accessory to another predicate (Dialog+ Hemodialysis System with Adimea Option, K083460).
The study described primarily focuses on demonstrating the substantial equivalence of the DDM component, rather than establishing acceptance criteria and proving the device meets those criteria with a standalone study. The key performance metric discussed for the DDM is its accuracy in estimating Kt/V and URR.
Here's an attempt to extract and organize the information according to your request, with the caveat that detailed acceptance criteria defined by Nikkiso for this submission are not explicitly stated, but rather performance is compared to a predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (based on predicate Adimea K083460) | Reported Device Performance (DDM of DBB-06) |
|---|---|---|
| Kt/V Accuracy | ||
| Correlation Coefficient*1 | 0.93, 0.80 (from two studies of Adimea) | 0.78 |
| Error*2 | Nonsystematic error 7% | Relative Error 6.26% |
Notes:
- *1 Correlation Coefficient was obtained by comparing Kt/V from UV absorption and measurement from blood. For Adimea, two correlation coefficients were obtained for Study 1 and 2.
- *2 Measurement error in Kt/V values obtained from UV absorption relative to measurement by using blood.
2. Sample size used for the test set and the data provenance
The document refers to "Section 22 Performance Testing-Clinical for details" regarding how the correlation coefficients and errors were obtained for both the predicate Adimea and the DDM. However, Section 22 is not provided in the given text. Therefore, the specific sample size and data provenance (e.g., country of origin, retrospective/prospective) for the DDM's performance evaluation cannot be determined from the provided text.
For the predicate Adimea (K083460), two correlation coefficients (0.93, 0.80) are mentioned, implying at least two studies ("Study 1 and 2"), but specific sample sizes and provenance are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for the DDM performance evaluation (Kt/V and URR) is stated to be derived from "measurement from blood" (e.g., blood urea nitrogen to calculate Kt/V and URR directly from blood samples), not from expert consensus on images or similar modalities. Therefore, experts for ground truth interpretation are not applicable in this context, as the ground truth is a direct physiological measurement.
4. Adjudication method for the test set
Not applicable. The performance evaluation is based on a comparison of a device's physiological estimation against direct physiological measurements, not on subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a hemodialysis delivery system with an optional Dialysis Dose Monitor, not an AI-assisted diagnostic or imaging interpretation tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance of the DDM relates to its standalone capability to estimate Kt/V and URR by optical measurement of spent dialysate fluid. The reported correlation coefficient and relative error describe the algorithm's performance in this standalone capacity, comparing its output to a more direct measurement derived from blood.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the DDM's performance evaluation is "measurement from blood" for Kt/V values. This implies biochemical analyses of blood samples to directly determine Kt/V and URR, which serves as the reference standard.
8. The sample size for the training set
The document does not provide information about a training set for the DDM. The described evaluation appears to be a performance assessment against an existing method, implying that the DDM's algorithm for calculating Kt/V and URR was likely developed and validated prior to this submission using unspecified data.
9. How the ground truth for the training set was established
Not applicable, as no information on a specific training set or its ground truth establishment is provided in the document.
§ 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.”