(454 days)
This dialysis machine can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a physician.
The following types of renal replacement therapy can be carried out with the Dialog+ System:
Hemodialysis (HD) with or without phases of pure ultrafiltration -
- . High flux hemodialysis
- 트 Low flux hemodialysis
The Adimea option to the Dialog* Hemodialysis System provides an alternate means of obtaining effectiveness information on the patient's hemodialysis treatment during a double-needle procedure by continuously measuring the UV absorption in the spent dialysate line. This optional feature includes controlling software, ancillary hardware (a double-beam spectrophotometer) and electronics to operate the Adimea function. Adimea software provides the Kt/V calculation, an online measure of dialysis treatment effectiveness.
This document (K083460) is a 510(k) Premarket Notification for the Dialog+ Hemodialysis System with Adimea Option. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, study details, or performance data for the Adimea option's ability to measure hemodialysis effectiveness.
The document primarily focuses on establishing substantial equivalence based on the Adimea option being an "alternate means of obtaining effectiveness information" that "does not have a significant affect upon the fundamental technology" of the Dialog+ System. It mentions "Software requirements specifications for Adimea have been met and verification and validation testing is complete," but does not provide any details about these tests, the acceptance criteria used, or the results.
Therefore, based solely on the provided text, I cannot fill out the requested table and answer the study-related questions for the Adimea option's performance. The information required for those sections is typically found in a separate performance study report or verification and validation documentation, which is not included in this 510(k) summary.
Here's what I can extract from the provided text, and where I identify missing information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not provided in this document. The document states "Software requirements specifications for Adimea have been met," implying criteria existed, but they are not detailed.
- Reported Device Performance: Not provided in this document. The document states "verification and validation testing is complete," but no performance results are presented.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not provided. The Adimea option measures UV absorption for Kt/V calculation, which is a quantitative measurement, not typically relying on expert interpretation for ground truth establishment in this context. If "ground truth" refers to the accuracy of the Kt/V calculation against a gold standard, that information is missing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not provided. Adjudication methods are typically used for subjective assessments or when multiple human readers interpret data. This device performs automated measurements.
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
- No, an MRMC study was not described or implied. The Adimea option is described as an "alternate means of obtaining effectiveness information," implying it provides direct measurements rather than assisting human readers in interpreting clinical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implied. The description of the Adimea option suggests it operates as a "discreet component / function" that "continuously measuring the UV absorption" and provides a "Kt/V calculation." This indicates a standalone algorithmic function. However, no performance data for this standalone operation is presented.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated, but likely a reference method for Kt/V. For a device measuring Kt/V, the "ground truth" would typically be established by a well-accepted, highly accurate reference method for measuring dialysis adequacy (e.g., blood urea nitrogen sampling and calculation, or comparison to an established device known to be accurate). This is not detailed in the document.
8. The sample size for the training set
- Not applicable / Not provided. While the Adimea option includes "controlling software," it is not described as a machine learning or AI algorithm that requires a "training set" in the typical sense. It appears to be based on spectral analysis and calculation. If there was any calibration or model development data, it's not referred to as a "training set" here and its size is not provided.
9. How the ground truth for the training set was established
- Not applicable / Not provided. (See point 8).
§ 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.”