(28 days)
Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.
The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.
The provided text describes a 510(k) submission for a device modification, specifically the Fresenius F Series Low Volume Hemoconcentrator. This document is a regulatory submission for a medical device whose performance is characterized by physical specifications and in-vitro performance rather than clinical outcomes or diagnostic accuracy. Therefore, many standard AI/ML evaluation metrics like sensitivity, specificity, or AUC, and ground truth establishment methods typically associated with clinical studies, are not applicable here.
The "acceptance criteria" and "device performance" are presented as a comparison table between the modified device and its predicate device, demonstrating that the new device meets the necessary physical and performance characteristics to be considered substantially equivalent.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are implicitly defined by its substantial equivalence to the predicate device (F400 Hemoconcentrator, K974584), meaning its specifications and performance characteristics must be comparable or within acceptable ranges relative to the predicate. The reported device performance for the new "Low Volume Hemoconcentrator" is shown in the table below, alongside the predicate device's data for comparison.
| Product Specifications | Acceptance Criteria (Predicate F400 Hemoconcentrator) | Reported Device Performance (Low Volume Hemoconcentrator) | Met? |
|---|---|---|---|
| Indication for Use | Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood. | Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood. | Yes |
| Active Membrane Surface (M²) | 0.7 | 0.35 | N/A |
| Priming Volume (ml) | 42 | 27 | N/A |
| Unit Length (with endcaps) (cm) | 33 | 33 | Yes |
| Unit Inner Diameter (cm) | 2.8 | 2.8 | Yes |
| Number of Fibers | 4,600 | 2530 | N/A |
| Fiber Lumen Diameter (µm) | 200 | 200 | Yes |
| Fiber Wall Diameter (µm) | 40 | 40 | Yes |
| Fiber Length (cm) | 22.5 | 22.5 | Yes |
| Fiber Membrane Material | Fresenius Polysulfone | Fresenius Polysulfone | Yes |
| Housing Material | Polycarbonate | Polycarbonate | Yes |
| Potting (resin) Material | Polyurethane | Polyurethane | Yes |
| End Cap | Screw-type, silicone O-ring | Screw-type, silicone O-ring | Yes |
| Blood Connector | Luer connector | Luer connector | Yes |
| Ultrafiltrate Connector (cm, inch) | 6.35, ¼ | 6.35, ¼ | Yes |
| Sterilization | EtO | EtO | Yes |
| Pyrogenicity | Non-pyrogenic (LAL assay) | Non-pyrogenic (LAL assay) | Yes |
| Glycerol rinse required | No | No | Yes |
| Molecular Weight Cutoff (daltons) | Approx. 65,000 | Approx. 65,000 | Yes |
| Max. Transmembrane Pressure (mmHg) | 600 | 600 | Yes |
| Max. Blood Flow (ml/min) | 500 | 300 | N/A |
| Pressure Drop (mmHg) at QB = 100 ml/min | 32.50 | 80.00 | N/A |
| Pressure Drop (mmHg) at QB = 200 ml/min | 85.00 | 172.50 | N/A |
| Pressure Drop (mmHg) at QB = 300 ml/min | 116.25 | 270.00 | N/A |
| Ultrafiltration Rate (ml/min) at TMP=525, QB = 100 ml/min | 54.0 | 46.0 | N/A |
| Ultrafiltration Rate (ml/min) at TMP=525, QB = 200 ml/min | 84.0 | 68.0 | N/A |
| Ultrafiltration Rate (ml/min) at TMP=525, QB = 300 ml/min | 106.5 | 84.7 | N/A |
Note: For parameters like Active Membrane Surface, Priming Volume, Number of Fibers, Max. Blood Flow, Pressure Drop, and Ultrafiltration Rate, changes are expected due to the "Low Volume" nature of the device modification. The "Met?" column indicates whether the new device's characteristic is identical to the predicate (Yes) or if it's a designed difference due to the modification (N/A – meaning it's not expected to be identical but aligns with the intended modification and is presumed acceptable by the FDA for substantial equivalence).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific "test set" sample sizes in the context of clinical or performance data collection on multiple units. The data presented is for the design specifications and nominal performance characteristics of the device itself.
- Sample Size: Not explicitly stated as this is a device modification submission based on technical specifications and in-vitro performance, not a clinical trial. The performance characteristics (e.g., pressure drop, ultrafiltration rate) are likely derived from bench testing or engineering calculations based on the design, rather than a "test set" of many devices.
- Data Provenance: Not specified, but generally, such technical specifications and in-vitro test data would be generated within the manufacturing and R&D facilities of Fresenius Hemotechnology Inc. (location: Concord, CA). The data is not derived from human subjects, thus "retrospective or prospective" is not applicable in the typical clinical sense.
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)
This is not applicable to this type of device submission. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations for this mechanical device. The "truth" lies in the engineering specifications and in-vitro performance data, which are verified through standard engineering and laboratory testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or clinical 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 hemoconcentrator, not an AI/ML-enabled diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device modification is the verified engineering specifications, material properties, and in-vitro performance measurements (e.g., pressure drop, ultrafiltration rates) obtained through standardized laboratory testing and quality control processes. This is analogous to "bench testing" or "design verification" rather than clinical "ground truth."
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.”