(255 days)
The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.
The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines. The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand). During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution. The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.
Here's a breakdown of the acceptance criteria and the study details for the Wand Assemblies, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document does not explicitly list specific quantitative acceptance criteria or corresponding device performance values in a table format. Instead, it describes a general approach to demonstrating substantial equivalence through testing. The overarching "acceptance criteria" here is that the device should not raise new concerns regarding safety or effectiveness compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs its intended function (fluid pathway for concentrates/acetic acid) without issue. | "Performance Functional Verification" results demonstrate functional equivalence. |
| Biocompatibility: Device materials are safe for patient contact and do not cause adverse biological reactions. | "Biological Safety (per ISO 10993 and G95-1) Biocompatibility (GLP) and Chemical Evaluations" results demonstrate biocompatibility. |
| Material Safety: New materials (colorants, polypropylene resin) are safe and do not impact performance or safety. | Chemical evaluations and biocompatibility testing indicate no new safety concerns related to material differences. |
| Design/Configuration: New mold geometry for jug adapter does not compromise safety or effectiveness. | Functional verification and risk assessment concluded no new concerns due to design differences. |
Study Information
The provided text details a Traditional 510(k) submission, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with human subjects. Therefore, many of the requested items related to human reader studies or large-scale clinical trials are not applicable in this context.
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Sample Size used for the test set and the data provenance:
- The document does not specify explicit sample sizes for the "Performance Functional Verification" or "Biological Safety" testing. It mentions "testing was selected through the application of a risk management process, applicable guidance documents and relevant standards."
- Data Provenance: Not explicitly stated, but it would have been conducted internally by Fresenius Medical Care – Renal Therapies Group, LLC, or by contracted labs. The testing is retrospective, comparing the new device against established safety and performance benchmarks.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of study does not involve human expert interpretation for "ground truth" in the way a diagnostic imaging AI algorithm would. "Ground truth" here would be established by the engineering and quality control teams based on validated test methods and specifications.
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Adjudication method for the test set:
- Not Applicable. As there are no human experts interpreting data, an adjudication method for consensus is not relevant. The results of the functional and biological safety tests would be objectively assessed against pre-defined criteria.
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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 is a medical device for fluid transfer in hemodialysis, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Regulatory Standards: The "ground truth" for this device's performance and safety is derived from established engineering specifications (e.g., flow rates, leak integrity, connection strength) and adherence to regulatory standards (e.g., ISO 10993 for biocompatibility, FDA's G95-1 guidance). Functional tests confirm the device meets these specifications, and biological safety tests confirm compliance with biocompatibility requirements.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. There is no training set.
§ 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.”