(260 days)
The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.
The H₂H™ Hemodiafiltration Module is a programmable electro-mechanical medical device designed to work in conjunction with and in close proximity to a hemodialysis machine during patient treatments. Upon installation, the H₂H Module is placed next to the hemodialysis machine (which can be on either side depending upon type and model of the hemodialysis machine) and is connected to the clinic's water supply, drain, and electricity.
The H₂H Hemodiafiltration Module serves two basic functions. The Module's primary function is to generate on-line substitution fluid for hemodiafiltration. The H₂H Module does this by ultrafiltering dialysate, provided by the hemodialysis machine, through a reusable substitution filter. The secondary function of the H₂H Hemodiafiltration Module is to serve as a substitution filter reprocessing machine. These steps are performed when the H₂H Hemodiafiltration Module is not connected to the hemodialysis machine. More detailed descriptions of the device, its accessories and how the system functions can be found in Section 11 (Device Description) of this submission.
The provided text is a 510(k) summary for the Nephros OLpūr® H₂H H₂H Hemodiafiltration (HDF) Module and OLpūr MD 220 Hemodiafilter. It focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.
However, this document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial report or performance study with detailed results against defined benchmarks. Instead, it refers to "Bench Analyses performed on the subject devices" in Section 18 and "clinical data supporting substantial equivalence" in Section 20 of the full application, which are not provided.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from the given 510(k) summary.
Here's what can be gathered and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics with numerical targets within this summary. Substantial equivalence is the overall goal, meaning the device performs as safely and effectively as predicate devices.
- Reported Device Performance: The summary states, "The proposed device has the same technological characteristics and is similar in design as compared to the predicate devices and already approved kidney dialysis therapy." This is a general statement of equivalency rather than specific performance numbers against acceptance criteria. The full submission's Section 18 and 20 would contain these details.
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 specified in this 510(k) summary.
- Data Provenance: Not specified in this 510(k) summary.
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 specified in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in this 510(k) summary.
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
- This device is a medical module and hemodiafilter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a physical medical device (hemodiafiltration module and filter), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable in this context. Its performance would be evaluated during its operation in conjunction with a hemodialysis machine.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not specified in this 510(k) summary. Given the nature of the device, ground truth would likely refer to performance metrics like filtration efficiency, ultrafiltration control accuracy, biocompatibility, and microbiological purity, established through bench testing and potentially in vivo studies (though clinical data reference focuses on substantial equivalence).
8. The sample size for the training set
- Not applicable/specified. This is a physical medical device, not an AI/machine learning model that typically has a "training set."
9. How the ground truth for the training set was established
- Not applicable/specified for the same reasons as 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.”