(165 days)
The Diacap Pro Dialyzer is designed for single use in acute and chronic hemodialysis.
The Diacap Pro dialyzer is a polysulfone high flux dialyzer with the surface areas 1.3 sqm, 1.6 sqm, 1.9 sqm. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
This document is a 510(k) summary for the Diacap Pro Dialyzer. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with a defined ground truth, a common practice for AI/ML devices. Therefore, a direct response to your request, specifically sections 1-9 as they apply to AI/ML device studies, cannot be fully provided from the given text.
However, I can extract the relevant performance testing that was done and the comparison to the predicate device to illustrate how equivalence was demonstrated for this medical device, which is a key part of its acceptance for market.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device through functional and performance testing, rather than a specific numeric threshold for an AI model's output. The "reported device performance" is a comparison of the proposed device's characteristics and performance to the predicate device.
| Performance Metric/Characteristic | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Diacap Pro Dialyzer Performance (Proposed Device) | Predicate Diacap HI PS Dialyzer Performance (Predicate Device) |
|---|---|---|---|
| Indications for Use | Same as predicate device | Designed for single use in acute and chronic hemodialysis | Designed for single use in acute and chronic hemodialysis |
| Membrane Type | Same as predicate device | Asymmetric microporous hollow fiber | Asymmetric microporous hollow fiber |
| Chemical Composition of Membrane | Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight (same range as predicate) | Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight | Polysulfone 90-99% by weight, Polyvinylpyrrolidone 1-10% by weight |
| Effective Membrane Surface Area (m^2) | Within acceptable range/comparable to predicate models | 1.3, 1.6, 1.9 | 1.2, 1.5, 1.8, 2.0 |
| Number of Fibers (mean) | Within acceptable range/comparable to predicate models | 8800 (13H), 10840 (16H), 12870 (19H) | 8180 (12), 10150 (15), 12250 (18), 13310 (20) |
| Mean effective (free) length of fibers (mm) | Same as predicate device | 235 | 235 |
| Fiber inner diameter (nominal) in µm | Same as predicate device | 200 | 200 |
| Wall thickness (nominal) | Comparable to predicate, with justification for difference | 37 µm (separation layer: 1 µm, support layer: 36 µm) | 40 µm (separation layer: 1 µm, support layer: 39 µm) - Note: A difference acknowledged and justified. |
| Sterilization | Same as predicate device | Gamma | Gamma |
| Volume, blood compartment (mL) | Within acceptable range/comparable to predicate models | 82 (13H), 100 (16H), 120 (19H) | 68 (12), 90 (15), 110 (18), 121 (20) |
| Outer diameter cylindrical part (mm) | Within acceptable range/comparable to predicate models | 39.6 (13H), 42.6 (16H), 47.6 (19H) | 39.6 (12), 42.6 (15), 47.6 (18, 20) |
| Outer diameter (mm) blood cap | Within acceptable range/comparable to predicate models | 54.0 (13H), 57.4 (16H), 62.4 (19H) | 54.0 (12), 57.4 (15), 62.4 (18, 20) |
| Length without protection cap (mm) | Similar to predicate device | 294.0 (13H), 294.6 (16H, 19H) | 293 (all models) - Note: A slight difference acknowledged. |
| Connector blood side | Designed According to ISO 8637 | Designed According to ISO 8637 | Designed According to ISO 8637 |
| Connector dialysate fluid side | Designed According to ISO 8637 | Designed According to ISO 8637 | Designed According to ISO 8637 |
| Functional/Performance Testing Results | Performed similarly to predicate device; within acceptable safety and effectiveness parameters. | Testing demonstrated similar performance to the predicate device and safe/effective use (details not quantified in this summary, but studies were conducted). | Established performance in accordance with FDA guidance and ISO 8637. |
2. Sample size used for the test set and the data provenance
The document mentions "functional and performance testing" and "comparative testing" on "the proposed Diacap Pro dialyzers" and "the proposed and predicate device." It also states "The following in-vitro testing was performed on the proposed device..." and "The following comparative testing was performed on the proposed and predicate device..." and "The following clinical testing was performed on the proposed device..."
However, specific sample sizes for these tests (e.g., number of dialyzers tested for each model) are not explicitly provided in this 510(k) summary. The summary refers to the methods in FDA Guidance and ISO 8637, implying that standard testing protocols were followed, which would include appropriate sample sizes.
Data provenance: Not specified, but likely laboratory testing conducted by the manufacturer or a contracted lab. This is not retrospective or prospective patient data in the context of an AI/ML study, but rather in vitro and in vivo (clinical) testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here as this is not an AI/ML device study. Performance is assessed through physical and chemical measurements (e.g., ultrafiltration rate, clearances, pressure drops, hemolysis) and clinical testing, not human expert interpretation of an AI output.
4. Adjudication method for the test set
Not applicable as this is not an AI/ML device study requiring expert adjudication of results.
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. No AI component is described in this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. No AI component is described in this device.
7. The type of ground truth used
For the functional and performance testing, the "ground truth" would be the:
- Physical measurements and chemical analyses: e.g., precisely measured ultrafiltration rates, clearance values, pressure drops, and assessment of hemolysis, according to established scientific and engineering standards (e.g., ISO 8637).
- Clinical data: for in-vivo ultrafiltration coefficient.
This is fundamentally different from a human-labeled ground truth for an AI/ML algorithm.
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set." The device is physically manufactured, not trained.
9. How the ground truth for the training set was established
Not applicable. No AI/ML training set.
§ 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.”