(186 days)
The Baxter Accura System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Baxter Accura System may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Accura System hardware consists of blood pumps, scales and various monitoring detectors and alarms designed for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange Therapy. This device was developed to provide pump assisted Slow Continuous Ultrafiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD) and Continuous Veno-Venous Hemodiafiltration (CVVHDF); four modalities used for treating acute renal failure and/or fluid overload. Additionally, the Accura System was developed to provide the pump assisted Therapeutic Plasma Exchange (TPE) therapy.
The Baxter Accura System is a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE) therapies. The provided summary states "All functions of the Baxter Accura System were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications." However, specific numerical acceptance criteria and reported device performance metrics are not detailed in the provided document.
Therefore, the table below will reflect the general statement of compliance rather than explicit numbers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device functions meet design specifications | All functions meet their respective required specifications |
| Components of disposable tubing set meet biological requirements | Met ISO 10993-1: Biological Evaluation of Medical devices – Part: Guidance on selection of tests |
| Sterilization cycle validated | Based upon ANSI/AAMI/ISO 11135:1994 "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization" |
| Compliance with applicable IEC 60601 standards | Meets IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-16 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size used for the test set" in terms of patient data or the number of units tested.
The validation was conducted on the "functions of the Baxter Accura System" and "components of the disposable tubing set," implying laboratory or engineering testing rather than human subject data.
Data Provenance: Not applicable as no clinical (human subject) data was used for performance validation. The validation appears to be entirely technical/engineering in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The validation was based on engineering design specifications, biological requirements (ISO 10993-1), and sterilization standards (ANSI/AAMI/ISO 11135), and safety standards (IEC 60601), not on expert consensus regarding clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as the validation was against predefined technical specifications and standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states "Clinical Data: N/A". This device validation did not involve human readers or a comparative effectiveness study with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a medical system for physical therapies (CRRT, TPE) and does not involve an algorithm with standalone performance metrics in the way an AI-driven diagnostic tool would. Its performance is related to its mechanical and electrical functions and compliance with safety standards.
7. Type of Ground Truth Used
The "ground truth" for this device's validation were:
- Design Specifications: All functions were tested and validated against their specific design requirements.
- International Standards:
- Biological requirements per ISO 10993-1.
- Sterilization cycle validation per ANSI/AAMI/ISO 11135:1994.
- Electrical safety and general standards per IEC 60601 series.
8. Sample Size for the Training Set
Not applicable. This product is a physical medical device (hardware and disposable tubing set) and its validation did not involve a "training set" in the context of machine learning or AI algorithms. The testing was for compliance with engineering specifications and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the context of machine learning or AI. The "ground truth" for the device's development and validation was established through engineering design, international standards, and regulatory requirements.
§ 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.”