(88 days)
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer. The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module. The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.
This is a 510(k) premarket notification for a medical device, specifically a hemodialysis blood tubing set. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets specific performance acceptance criteria through clinical or AI-based evaluation.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria (such as sample size for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of submission.
The "Performance Data" section (G.) in the document describes validation and verification testing performed to support substantial equivalence to the predicate device, not to establish novel performance metrics or human-AI improvement.
Here's a breakdown of what can be extracted from the provided text based on the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of precise numerical acceptance criteria alongside corresponding quantitative device performance results (e.g., a specific pressure tolerance in psi for structural integrity testing). Instead, it lists general categories of testing performed to demonstrate equivalence.
| Acceptance Criteria (General Category) | Reported Device Performance (Summary) |
|---|---|
| Biological Safety (Biocompatibility) | Testing performed. (Details of specific levels or pass/fail not provided in this summary.) |
| Sterility and Nonpyrogenicity | Testing performed. (Details of specific levels or pass/fail not provided in this summary.) |
| Structural Integrity (Pressure and Pull Testing) | Testing performed. (Details of specific pressure/pull forces or pass/fail not provided in this summary.) |
| Performance of Connectors | Testing performed for hemodialyzer, vascular access device, and ancillary components (pressure/dimensional). |
| Needle Access Ports | Pressure testing after repeated use performed. |
| Transducer Protectors | Pressure testing performed. |
| Endurance Testing (Complete Bloodline) | Testing performed using specified hemodialysis machines. |
| Clamp Testing | Ability to occlude and effects of repeated use tested. |
| Usability Evaluation | Evaluation performed. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The document mentions "testing was selected through the application of a risk management process," implying a chosen sample size for various tests, but the actual numbers are not reported.
- Data Provenance: Not specified. As a device manufacturer, Fresenius Medical Care would conduct these tests in their own facilities or through contracted labs. The data would be internally generated for regulatory submission. It is not clinical data from patients or countries.
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 engineering and laboratory testing for device safety and performance, not a diagnostic or AI-driven system requiring expert-established ground truth for a test set. The "ground truth" for these tests would be established by validated test methods and measurement equipment.
4. Adjudication method for the test set
- Not Applicable. As above, this pertains to laboratory and engineering testing, not interpretation of clinical data by multiple experts.
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 device is a physical hemodialysis blood tubing set. It is not an AI-based diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the performance testing mentioned (e.g., structural integrity, pressure testing, sterility), the "ground truth" is derived from established engineering principles, scientific measurements, and validated laboratory test methods. For example, a pressure test would have a defined acceptable pressure range, and the device either passes or fails based on direct measurement, not expert consensus or pathology.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.