(210 days)
The bm 25 Blood Monitor Pump with Ultrafiltration Controller is indicated for continuous solute and/or fluid removal in patients with acute renal failure, or fluid overload as prescribed by a physician.
The bm25 Blood Monitor Pump is designed for use in Continuous Renal Replacement Therapy
The provided text describes the bm25 Blood Monitor Pump with Ultrafiltration Controller. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, or the other requested information for AI/ML device evaluation.
The document is a 510(k) summary for a medical device (a blood monitor pump), which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance evaluation against specific, quantifiable acceptance criteria.
Therefore, I cannot provide answers to the requested points based on the provided text.
Here's a breakdown of what the document does state regarding validation, but without the requested detail:
Acceptance Criteria and Device Performance (Not explicitly detailed as requested):
- Acceptance Criteria: Not explicitly stated as quantifiable thresholds for specific performance metrics.
- Reported Device Performance:
"All functions of the bm25 Blood Monitor Pump with Ultrafiltration Controller were tested and validated according to design specifications. Based on the validation results, all functions meet their respective required specifications."- Comment: This is a general statement that "specifications were met," but it doesn't provide the actual specification values or the quantitative performance results against those values.
Other Requested Information (Not Available in the Provided Text):
- Sample size used for the test set and the data provenance: Not mentioned. The study appears to be an engineering validation rather than a clinical study with a "test set" in the context of AI/ML.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. "Ground truth" in the context of medical image analysis or similar AI applications isn't relevant here, as this is a hardware device validation.
- Adjudication method for the test set: Not applicable/not mentioned.
- 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 diagnostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: Not applicable. The validation likely involved engineering tests and measurements against design parameters.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
What was conducted according to the document:
- Design and material equivalence to the bm11a Blood Monitor Pump.
- Software module distinction between Master and Controller system errors.
- Design to UL2601 - "General electrical safety of medical equipment."
- A fault tree analysis.
- Hazard analysis.
- EMC testing.
- Software System integration validation.
Conclusion:
The provided document describes the safety and equivalence of a physical medical device (a blood monitor pump) through engineering validation and comparison to predicate devices, rather than a performance study for an AI/ML diagnostic tool. Therefore, most of the requested fields, which are specific to AI/ML device evaluation, cannot be answered.
§ 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.”