(266 days)
VIE-U is intended for use in hemodialysis for the treatment of patients who have acute or chronic renal failure. ViE-U is intended for single use only.
The ViE-U is a high flux hollow fiber hemodialyzer. The device is sold sterile and is intended for single use only. All the materials including the hollow fiber membrane, housing, headers, potting material and stoppers are identical to those previously cleared in the predicate device (APS). The additional coating of vitamin E on the hollow fiber membrane uses an equivalent material and technology to the predicate device (CLIRANS).
This document is a 510(k) summary for a medical device (dialyzer), not an AI/ML-driven device, therefore, many of the requested criteria are not applicable. I will extract the relevant information regarding performance testing and acceptance criteria as described in the document.
Acceptance Criteria and Device Performance (Based on available information regarding device testing):
The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting specific numerical acceptance thresholds for independent performance metrics for this
Submission documents for medical devices (especially 510(k)s) don't always contain explicit tables of acceptance criteria and performance data in the way one might expect for an AI/ML model where specific sensitivity, specificity, or AUC targets are set. Instead, for devices like dialyzers, performance is demonstrated through a series of tests to show it meets required standards and is equivalent to previously approved devices.
Here's a breakdown of the performance data reported based on the provided text, and how acceptance criteria are implied or stated:
Table of Acceptance Criteria and Reported Device Performance (Implied from the text):
| Test/Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Equivalence | Materials must be identical or equivalent to predicate device (APS) and Vitamin E coating (CLIRANS). | All materials (hollow fiber membrane, housing, headers, potting material, stoppers) are identical to predicate device (APS). Additional Vitamin E coating on hollow fiber membrane uses equivalent material and technology to predicate device (CLIRANS). |
| Biocompatibility Testing (ISO 10993-1) | Conformance to ISO 10993-1 for external communicating devices, circulating blood, prolonged contact. | Biocompatibility testing performed per ISO 10993-1. Clinical study data (WBC, platelets, complement activation) also collected, showing equivalence to control dialyzers. |
| In vitro Performance (ISO 8637) | Conformance to ISO 8637 for specified parameters. | Testing performed per ISO 8637 for: |
- Clearance (urea, creatinine, phosphate, vitamin B12 at blood flow rates 200-500 mL/min.)
- Pressure drop
- Kuf
- Priming volume (Blood compartment volume)
- Maximum TMP |
| Sterilization Validation (ISO 11137-2) | Conformance to ISO 11137-2. | Performed per ISO 11137-2. |
| Pyrogenicity Testing | Passing pyrogenicity test. | Testing performed. (Result implied as successful, given overall conclusion of substantial equivalence). |
| Expiration Date Testing | Device maintains performance until expiration. | Testing performed. (Result implied as successful). |
| Packaging & Transportation Testing (ASTM D4169-14) | Conformance to ASTM D4169-14. | Performed per ASTM D4169-14. |
| Clinical Performance (In vivo) | Equivalence to control dialyzer for ultrafiltration coefficient (KuF) and removal rates for urea, albumin, and beta 2-microglobulin. | Evaluation showed equivalence of the ViE-21U and control dialyzers. Specifically, in vivo KuF and removal rates for urea, albumin, and beta 2-microglobulin were evaluated. The clinical performance and biocompatibility evaluation showed equivalence of the ViE-21U and control dialyzers. |
| Clinical Safety | Acceptable safety profile, comparable to control dialyzer, with no serious related adverse events. | Two possible related adverse events (pruritus and full body rash) occurred in one patient, resolved without sequelae. No serious adverse events determined to be related to the ViE-21U. The device was shown to be safe as compared to the control dialyzer. |
(2) Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Clinical Study: 17 patients enrolled.
- Clinical Performance & Biocompatibility Evaluation: 12 patients (those who completed all 36 sessions with the ViE-21U dialyzer).
- Safety Evaluation: All 17 enrolled patients.
- Data Provenance:
- Country of Origin: Canada (single site).
- Retrospective or Prospective: Prospective.
(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes a clinical study for a medical device (dialyzer), not an AI/ML system that requires expert annotation for ground truth. The 'ground truth' for performance assessment would be the objective measurements from the in vitro and in vivo testing, compared against established standards or a control device.
(4) Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is a medical device performance study and not an AI/ML model requiring human consensus for ground truth, there is no mention of an adjudication method. Data would be collected, and its validity based on standard statistical and clinical methodology.
(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 is not an AI/ML device, and no human reader comparative effectiveness study was performed. The study compared the device (ViE-U) to a control dialyzer.
(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Applicable (but not for an algorithm). The device itself operates "stand-alone" in terms of its function (dialysis), in that it does not involve human-in-the-loop assistance in the way an AI diagnostic tool would. However, its overall effectiveness is measured in the context of patient treatment, involving healthcare professionals. The in vitro and in vivo clinical studies assessed the device's function directly.
(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Primary Ground Truth:
- In vitro performance: Objective measurements against ISO 8637 standards (e.g., clearance rates, pressure drops, Kuf, priming volume, maximum TMP).
- Clinical Performance: Direct physiological measurements (e.g., ultrafiltration coefficient (KuF), removal rates for urea, albumin, beta 2-microglobulin), compared against a control dialyzer.
- Biocompatibility: Measurements of biological markers (e.g., white blood cells, platelets, complement activation).
- Safety: Incidence and type of adverse events.
- Material Equivalence: Chemical and physical analysis of materials.
(8) The sample size for the training set:
- Not Applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.
(9) How the ground truth for the training set was established:
- Not Applicable. As this is not an AI/ML device, there is no "training set" requiring ground truth establishment in that context.
§ 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.”