(84 days)
Medisystems Transducer Protectors are indicated for use as protective devices for pressure monitors on hemodialysis machines as well as to help protect the sterility of the blood tubing fluid pathway. The filter helps prevent cross-contamination by viruses, bacteria, and other particulate matter while preventing the flow of fluids to the hemodialysis machine's pressure transducer.
Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 um hydrophobic filter helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor. The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, viruses, bacteria, and particulate matter into the pressure monitor at pressures lower than the rated pressure of the device.
The provided text describes a 510(k) submission for "Medisystems Transducer Protectors" and focuses on establishing substantial equivalence to previously marketed devices. It details the device's intended use and technological characteristics. However, it does not contain the specific information required to complete the requested table and answer the study-related questions.
The document primarily states that the product is "tested and must meet all required release specifications before distribution," including "sterility, pyrogenicity, physical testing, and visual examination." It refers to "written and approved procedures that conform to the product design specifications" in "Device Master Records," but these specifics are not provided.
Therefore, for most of the requested points, the information is not available in the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility | Passed (Implied by "meet all required release specifications") |
| Pyrogenicity | Passed (Implied by "meet all required release specifications") |
| Physical testing | Passed (Implied by "meet all required release specifications") |
| Visual examination | Passed (Implied by "meet all required release specifications") |
| Prevents flow of fluids, viruses, bacteria, and particulate matter into pressure monitor | Achieved (Stated in sections VII and IX, the 0.2 um hydrophobic filter "helps prevent cross-contamination by viruses, bacteria and particulate matter while preventing the flow of fluids") |
Study Information (Based on availability in the text):
- 2. Sample size used for the test set and the data provenance: Not available. The document states "To assure that the device is safe and effective, all finished products are tested," implying ongoing manufacturing testing rather than a single clinical study for market approval.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This sounds like an AI/machine learning evaluation, which is not the context of this 510(k) submission. For mechanical devices like transducers, "ground truth" typically refers to established engineering standards and test methods.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not available.
- 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 k-submission is for a physical medical device (transducer protector), not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For manufacturing release, the "ground truth" would be the pre-defined engineering and sterility specifications (e.g., lack of bacterial growth for sterility, specific pressure tolerance for physical testing).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a regulatory submission for a physical medical device. It outlines the device's function and the general commitment to quality control testing, but it does not describe a clinical study or performance evaluation in the way that would typically be associated with software or AI-driven diagnostics, which is what the detailed questions seem to be geared towards. The "study" here is the ongoing manufacturing testing to meet "release specifications."
§ 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.