(89 days)
Hemodialysis with these dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It may also be indicated in the treatment of patients intoxicated with poisons or drugs.
Model PSN-130 Hemodialyzer
Model PSN-150 Hemodialyzer
The provided text describes a 510(k) summary for the Polysynthane (PSN™) Hemodialyzer, which is a medical device for use in patients with acute or chronic renal failure, or those intoxicated with poisons or drugs. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against pre-defined acceptance criteria in the way one would for a novel device or a clinical trial.
Therefore, the requested information elements related to clinical study design, sample sizes, expert ground truth, MRMC studies, or standalone performance studies are addressed as "Not Applicable" or "Not Provided" based on the content. The acceptance criteria in this context are primarily related to safety and manufacturing quality rather than specific performance metrics demonstrated through a clinical study.
Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implied by compliance with established standards and comparison to predicate devices, particularly regarding safety and manufacturing quality. The reported device performance relates to these compliance activities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Components met biological requirements of ISO 10993-1. |
| Sterilization Assurance | Validation of sterilization cycle based on AAMI Guideline (ST-27) to ensure a sterility assurance level (SAL) of 1x10⁻⁶. Sterilant residues (EO, ECH, EG) consistent with proposed limits published in Federal Register (June 23, 1978). |
| Pyrogenicity | Pyrogen testing meets USP Chapter 161 requirements for Transfusion and Infusion Assemblies and Similar Medical Devices. |
| Particulate Matter | Particles counted per USP XXIII . |
| Manufacturing Integrity | Functional testing for blood side integrity and conformance to manufacturing specifications performed as in-process and/or final inspections. |
| Functional Equivalence | General function and materials are the same as Baxter predicate Dialyzers. Slight change in clearance values for urea, creatinine, Vitamin B12, and ultrafiltration, similar to CA® Hollow Fiber Dialyzers. (This is a comparison point, not a strict "acceptance criterion" in itself without specific thresholds provided, but it's central to the 510(k) argument). |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. The submission does not describe a "test set" in the context of clinical performance evaluation. The data presented is related to materials testing, sterilization validation, and manufacturing controls.
- Data Provenance: Not applicable/Not provided in terms of geographic origin or prospective/retrospective for a specific test set. The data arises from internal testing and compliance activities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment by experts for a test set is not relevant to this type of submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/None. No adjudication method is described as there is no clinical test set requiring such expert consensus.
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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 hemodialyzer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a hemodialyzer; it does not involve algorithms or human-in-the-loop performance in the context of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided in the clinical sense. The "ground truth" here is compliance with established biological, sterility, pyrogenicity, and particulate standards, as well as manufacturing specifications, rather than clinical outcomes or diagnostic accuracy.
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The sample size for the training set: Not applicable/Not provided. This submission does not involve a "training set" as it is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable/Not provided. Not relevant to this device type.
Summary of Device and 510(k) Approach:
The provided document is a 510(k) premarket notification for a hemodialyzer. The primary method for demonstrating its acceptability is by proving "substantial equivalence" to legally marketed predicate devices (CA® Hollow Fiber Dialyzers, PSN™ Polysynthane Dialyzers). This means the device functions similarly and uses similar materials to previously cleared devices, and it meets established safety and manufacturing standards.
The "studies" mentioned are not clinical trials evaluating efficacy or diagnostic performance, but rather:
- Biological safety testing: Compliance with ISO 10993-1.
- Sterilization validation: Compliance with AAMI Guideline (ST-27) and residue limits.
- Quality control testing: Pyrogen testing (USP), particulate counting (USP), and functional testing (in-process/final inspections).
- Performance comparison: Clearance values for urea, creatinine, Vitamin B12, and ultrafiltration are compared to predicate devices, showing "slight change" but overall similarity.
There were "no clinical data" provided as explicitly stated in the document, which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical means.
§ 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.