(203 days)
The bm11a Blood Monitor Pump is designed for continuous renal replacement therapy in patients with acute renal failure, as prescribed by a physician.
The bm11a Blood Monitor Pump is designed for use in the following extracorporeal therapies:
- Continuous Venovenous Hemofiltration (CVVH)
- Continuous Venovenous Hemodiafiltration (CVVHD)
- Slow Continuous Ultrafiltration (SCUF)
The provided text describes a 510(k) summary for the bm11a Blood Monitor Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness, rather than reporting on a study with acceptance criteria and device performance in the way a clinical trial might for a diagnostic AI device.
Therefore, the requested information cannot be fully extracted in the format requested as the submission pertains to a different type of device (a pump) and evaluation process. However, based on the available information, here's what can be gathered, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions "design specifications" and "required specifications" but does not explicitly list them or their corresponding performance metrics in a table. The summary states: "All functions of the bm11a Blood Monitor Pump were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The testing described is functional validation of a pump, not a diagnostic device using a "test set" of patient data. The validation was conducted on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of device performance for this pump, refers to engineering and functional specifications, not a medical "ground truth" established by experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as would be used for expert review of images or data in a diagnostic study.
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
No. This device is a blood monitor pump, not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical pump. The "standalone" performance would be its functional operation in a clinical setting, which is implicitly covered by the "all functions...meet their respective required specifications."
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be its design specifications and engineering requirements for flow rates, safety mechanisms, electrical performance, etc. The document mentions "UL2601 - General electrical safety of medical equipment," "fault tree, hazard analysis, EMC testing, and software System integration validation" as methods used to assess compliance with these requirements.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned or relevant for this device.
§ 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.”