(121 days)
The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.
The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.
The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.
The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.
The provided text is a 510(k) Summary for the NIPRO Transducer Protector TP-SURE. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or an analytical study that rigorously proves the device meets such criteria as would typically be described in a research paper or a detailed performance validation report.
The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use" and that "The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO Transducer Protector TP-SURE performs equivalent to the predicate device and is safe and effective when used as intended." This general statement indicates that tests were performed, but it lacks the specifics requested in your prompt.
Therefore, for almost all of your requested information, the answer is "Not provided in the document."
Here's a breakdown of what can be extracted or inferred, and what is not provided:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in a tabular format. The general criteria are implied to be "safe and effective for its intended use" and "performs equivalent to the predicate device."
- Reported Device Performance: No specific quantitative performance metrics (e.g., filtration efficiency, pressure drop, burst strength) with their respective values are provided.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as this device does not involve expert interpretation or diagnosis for "ground truth." The performance testing would be against engineering specifications for physical characteristics and filtration efficacy.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable, as this device does not involve expert interpretation or diagnosis.
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
- MRMC Study: No. This is a medical device (a transducer protector) that does not involve AI assistance or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an "algorithm." The device's performance is inherently "standalone" in its mechanical and filtration function.
7. The type of ground truth used
- Type of Ground Truth: For a physical device like this, "ground truth" would typically be established through engineering specifications, validated test methods (e.g., for filtration efficiency, material compatibility, pressure resistance), and compliance with relevant standards. The document mentions "Biocompatibility testing" and "performance testing" which would fall under this category, but specific details of the ground truth (e.g., exact pore size verification, bacterial challenge results) are not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a manufactured physical good, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.
In summary, the provided document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device and general statements about performance and biocompatibility testing, rather than detailed analytical study results proving specific acceptance criteria.
§ 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.