(89 days)
The capillary dialyzer is intended for hemodialysis for the treatment of chronic and acute renal failure.
This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP), which is equivalent to the membrane utilized in the Gambro Polyflux H single use hemodialyzers cleared for marketing in the United States under 510K Notification (K030592). Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
The provided text describes a 510(k) premarket notification for a medical device, the Gambro Polyflux HD-C4 Capillary Dialyzer for Single Use. This filing primarily demonstrates substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device or Industry Standards) | Reported Device Performance (Gambro Polyflux HD-C4) |
|---|---|
| Performance characteristics similar to predicate device (Polyflux 210H Hemodialyzer / Filter K030592) in terms of: | Non-clinical in vitro testing indicated similar performance characteristics to the predicate configurations. |
| - Design | Similar design |
| - Function | Similar function |
| - Composition | Similar composition (membrane blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone(PVP)) |
| - Operation | Similar operation |
| Safety and Effectiveness | Testing indicated the device is safe and effective when used as instructed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "in vitro testing was conducted to compare the performance...". It does not specify the number of devices or iterations tested.
- Data Provenance: The testing was "non-clinical in vitro testing." The country of origin for the data is not specified, but the submitter is Gambro Renal Products, located in Lakewood, Colorado, USA. The testing would be considered prospective for the specific purpose of this 510(k) submission, even if the methods are established.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
- Not applicable. This submission relies on performance testing against a predicate device and does not involve human expert interpretation of data to establish a ground truth for a diagnostic or AI-driven device. The ground truth for performance is derived from established engineering and scientific principles for dialyzer function, and comparison to the well-characterized predicate device.
4. Adjudication Method for the Test Set
- Not applicable. As the "ground truth" is based on objective in vitro performance metrics compared to a predicate device, an adjudication method for human interpretation is not relevant.
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 comparative effectiveness study was not done. This device is a capillary dialyzer, not an AI-assisted diagnostic tool or an imaging device that would require human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (a dialyzer), not an algorithm or AI system. Its performance is evaluated through its physical and functional characteristics.
7. The Type of Ground Truth Used
- The ground truth used for this device is based on established performance characteristics of surgically implanted devices (specifically, hemodialyzers) and direct comparison to a legally marketed predicate device (Polyflux 210H, K030592). This includes measurements of design, function, composition, and operation in an in vitro setting.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.”