(291 days)
The HPH™ Junior Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. It is indicated for all patients (including all pediatric patients) according to physician assessment of the patient and the Instructions for Use. In pediatric patients this device must be used only as a part of a cardiopulmonary bypass or circulatory support circuit, with the circuit being connected to the patient.
The HPH Junior Hemoconcentrator consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemoconcentration removes large quantities of plasma water, and small and medium sized solutes (such as IL-6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.
The provided text describes the HPH™ Junior High Performance Hemoconcentrator and its substantial equivalence to a predicate device, the HPH Mini. The study focuses on demonstrating this equivalence through functional and safety testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it states that the performance characteristics of the HPH Junior are "substantially equivalent" to the predicate device, HPH Mini. The reported device performance is presented as a comparison to the HPH Mini.
| Acceptance Criteria (Implied) | Reported Device Performance (HPH Junior) | Predicate Device (HPH Mini) Performance | Notes |
|---|---|---|---|
| Material Equivalence | Uses same materials and manufacturing processes | Uses same materials and manufacturing processes | Explicitly stated as equivalent. |
| Static Prime Volume | 9 ml | 14 ml | HPH Junior has a lower prime volume, which is a key distinguishing feature and advantage. |
| Ultrafiltration Performance | Substantially equivalent | - | Tested and found equivalent to predicate. |
| Blood Path Pressure Drop | Substantially equivalent | - | Tested and found equivalent to predicate. |
| Protein Sieving (albumin, myoglobin, inulin) | Substantially equivalent | - | Tested and found equivalent to predicate. |
| Structural Integrity | Substantially equivalent | - | Tested and found equivalent to predicate. |
| Membrane Integrity | Substantially equivalent | - | Tested and found equivalent to predicate. |
| Hemolysis | Substantially equivalent | - | Tested and found equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the testing. It mentions "functional and safety testing" performed on "both the HPH Junior and the HPH Mini for comparison purposes." This implies a retrospective comparison as the HPH Mini is an existing device.
The data provenance is not specified beyond being internal testing conducted by Minntech Corporation to support their 510(k) submission to the U.S. FDA. There is no information regarding the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing appears to be functional and safety testing conducted in a laboratory setting, not involving expert interpretation of patient data or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the study did not involve human interpretation or subjective assessment that would require an adjudication method. The testing was objective, measuring physical and performance characteristics.
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
An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the nature of this hemoconcentrator device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a mechanical medical device like a hemoconcentrator. The device itself performs its function (ultrafiltration) in a standalone manner, but there is no "algorithm" in the sense of AI or software processing data that would have a standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on objective measurements and engineering specifications as defined by relevant FDA guidances and ISO standards (specifically ISO 8637:2004E). The predicate device (HPH Mini) served as the benchmark for "substantially equivalent" performance.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this device. The study is a comparison of two physical devices based on their functional and safety characteristics, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as in 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.”