(222 days)
The Quick-Prime Hemoconcentrator is designed for use in cardiopulmonary bypass surgery to remove excess fluid and low molecular weight blood constituents from the extracorporeal circuit. It is also indicated for use for patients with acute or chronic fluid overload when conservative therapy is inadequate.
The HQ-7000™ GOLD, HQ-7005™ GOLD, and HQ-7005L™ GOLD devices are coated with the Duraflo® Treatment. The Duraflo® Treatment may improve the blood compatibility of non-biological surfaces. Devices with this treatment are used when a heparin-treated blood path is desired. The Duraflo® Treatment provides a heparin-treated blood path containing up to 900 USP units of heparin on the hemoconcentrator.
The Quick-Prime Hemoconcentrator devices have a 1.25 m² total planar membrane area and a priming volume of approximately 81 mL. Hansen port caps are provided with the Quick-Prime Hemoconcentrator. A yellow adapter connector covers the upper port to allow for filtration. A white cap seals the port at the base of the device. The HQ-7005™ GOLD, and HQ-7005L™ GOLD devices contain pre-connected blood inlet and outlet tubing is graduated in size with 1/4 inch (6.35 mm) I.D. ends that are ready for connection to the extracorporeal circuit. The HQ-7005L™ GOLD has male Luer fittings at each end for connection in the extracorporeal circuit.
This document is a 510(k) summary for a medical device and does not contain the specific type of acceptance criteria, study design, and results typically found in a clinical study report or a robust performance study for AI/machine learning devices. The information provided focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and bench testing, rather than a clinical effectiveness study with human readers or standalone AI performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format you requested, nor can I answer many of the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.
However, I can extract the information that is present concerning the testing performed:
1. A table of acceptance criteria and the reported device performance
The document lists "studies were conducted to qualify" the device, implying that each test had an associated acceptance criterion that was met. However, the specific quantitative acceptance criteria and the numerical results (device performance) are not reported in this summary. It only states that the testing "demonstrated that units with the proposed addition of the Duraflo® Treatment are substantially equivalent to the predicate (uncoated) device, and that there were no adverse effects on overall hemoconcentrator performance."
Here's a table based on the available information, noting the missing details:
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Presumed to meet existing standards for: | |
| Prime Volume | Met substantial equivalence, no adverse effects on performance. |
| Leak Test | Met substantial equivalence, no adverse effects on performance. |
| Ultrafiltration Rate vs. Transmembrane Pressure | Met substantial equivalence, no adverse effects on performance. |
| Blood Chemistry | Met substantial equivalence, no adverse effects on performance. |
| Generated Plasma Hemoglobin | Met substantial equivalence, no adverse effects on performance. |
| Blood Damage | Met substantial equivalence, no adverse effects on performance. |
| Heparin Leaching | Demonstrated. |
| Heparin Quantitation | Demonstrated. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These appear to be bench tests, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. The "ground truth" for these tests would be the established engineering and laboratory standards for device performance, not expert clinical interpretation.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. These are engineering/laboratory tests, not clinical interpretations requiring 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
- MRMC study: No. This document describes a medical device (hemoconcentrator) and its coating, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional characteristics. The listed tests would represent its standalone performance in a laboratory setting.
7. The type of ground truth used
- Type of ground truth: Established engineering specifications, laboratory standards, and the performance of the predicate device for comparison.
8. The sample size for the training set
- Sample size: Not applicable. There is no concept of a "training set" in the context of this traditional medical device.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable.
§ 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.”