(164 days)
The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.
The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.
The provided document is a 510(k) premarket notification for a medical device, the Dideco DHF Hemoconcentrator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.
Therefore, many of the requested points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or
not explicitly detailed in this type of submission. The 'acceptance criteria' here refer to the performance specifications the device must meet to be considered equivalent to existing devices and safe for its intended use.
Here's an analysis based on the provided text, addressing the applicable points:
Acceptance Criteria and Device Performance for Dideco DHF Hemoconcentrator
The Dideco DHF Hemoconcentrator underwent non-clinical and in vitro testing to demonstrate compliance with safety and effectiveness requirements and substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical values or ranges. Instead, it states that the results of the tests "met established specifications" and showed "comparable or even better performances" with respect to the predicate devices. The types of performance criteria evaluated are listed.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Nonclinical Tests | Meet requirements of ISO 10993-1:1997 and FDA May 1, 1995 Memorandum (Biocompatibility) | "The results of this testing met established specifications." |
| Sterility | Meet established specifications | "Sterility... testing were also conducted. The results of this testing met established specifications." |
| Pyrogenicity | Meet established specifications | "Pyrogenicity... testing were also conducted. The results of this testing met established specifications." |
| ETO Residuals | Meet established specifications | "ETO residuals... testing were also conducted. The results of this testing met established specifications." |
| Package Integrity | Meet established specifications | "Package integrity testing were also conducted. The results of this testing met established specifications." |
| Accelerated Aging | Maintain performance after accelerated aging equivalent to five years real-time aging | "Tests were performed on devices accelerated aged to an equivalent of five years real time aging." The results of all tests after aging "met established specifications." |
| In Vitro Tests | Meet requirements of "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" (CDRH 1998) and EN 1283:1996 | "The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications." "Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Cobe HC 700 Midi and HPH 400 apply to the DHF 0.6 and DHF 0.2 hemoconcentrators." |
| Priming Volume | Meet established specifications and be comparable to predicate devices | Met established specifications and provided comparable or better performance. |
| Pressure Drop | Meet established specifications and be comparable to predicate devices | Met established specifications and provided comparable or better performance. |
| Ultrafiltration Rate | Meet established specifications and be comparable to predicate devices | Met established specifications and provided comparable or better performance. |
| Sieving Coefficient | Meet established specifications and be comparable to predicate devices | Met established specifications and provided comparable or better performance. |
| Mechanical Integrity | Meet established specifications and be comparable to predicate devices | Met established specifications and provided comparable or better performance. |
| Blood Trauma | Meet established specifications and be comparable to predicate devices (including plasma free hemoglobin and index of hemolysis) | Met established specifications and provided comparable or better performance. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices or repeat tests performed for each in vitro and non-clinical test. It states "The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications." This implies multiple units of each model were tested.
- Data Provenance: Not explicitly stated, but based on the submitter's location (Italy) and adherence to international (ISO, EN) and US (FDA) standards, the testing was likely conducted in a laboratory setting, potentially in Italy or a contracted facility. The data is retrospective in the sense that the tests were performed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (hardware) submission focused on physical and biological performance characteristics, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" here is determined by objective measurements and standardized test methods.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like '2+1' or '3+1' are typically used for establishing ground truth in image interpretation or diagnostic studies, which is not applicable to the in vitro and non-clinical testing of a hemoconcentrator.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. The Dideco DHF Hemoconcentrator is a physical device used during cardiopulmonary bypass; it is not an AI/software tool, and human interpretation of outputs in the clinical context is not evaluated in this way in this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. The device is a physical hemoconcentrator. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties and performance without human interaction as part of the test itself (though a human operates the test equipment).
7. Type of Ground Truth Used
The "ground truth" for the performance characteristics was established through:
- Established Specifications/Standards: Reference to ISO 10993-1:1997, FDA May 1, 1995 Memorandum, FDA "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" (1998), and EN 1283:1996 when applicable. These documents define the accepted test methods and, implicitly or explicitly, the performance thresholds for safety and effectiveness.
- Predicate Device Performance: The primary comparative "ground truth" was the established performance of the legally marketed predicate devices (Cobe HC 700 Midi Hemoconcentrator (K003023) and Hemocor HPH 400 Hemoconcentrator (K923139)). The new device was deemed acceptable if its performance was "comparable or even better" than these predicates.
- Objective Measurements: Laboratory measurements of physical properties (priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity) and biological indicators (plasma free hemoglobin, index of hemolysis) against predefined limits.
8. Sample Size for the Training Set
N/A. This submission does not involve a "training set" as it is not an AI/machine learning device. The tests are for device validation, not model training.
9. How the Ground Truth for the Training Set Was Established
N/A. See 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.”