(419 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-120 PSN Hemodialyzer
Model PSN-140 PSN Hemodialyzer
Here's an analysis of the provided documents regarding the Polysynthane (PSN) Hemodialyzer, focusing on the acceptance criteria and the study that proves the device meets these criteria.
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 1996/1997. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial with detailed acceptance criteria and performance metrics for an entirely novel device. Therefore, much of the requested information, particularly regarding specifics of clinical studies, AI performance, and expert ground truth, is not present or applicable.
Acceptance Criteria and Device Performance
The acceptance criteria for the Polysynthane (PSN) Hemodialyzer are derived from demonstrating equivalence to predicate devices and meeting established safety and performance standards for hemodialyzers. The "reported device performance" columns below reflect how the device was shown to meet these criteria, primarily through bench testing and adherence to existing standards rather than clinical study outcomes.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Biocompatibility | USP XXI Class VI materials guidelines | Components (excluding fiber bundle) previously met USP XXI Class VI. |
| ISO 10993-1: Biological Evaluation of Medical Devices - Part 1 | Fiber bundle tested as suggested by ISO 10993-1 guidelines. | |
| Sterilization | AAMI Guideline (ST-27) for industrial EO | Validation of sterilization cycle to ensure SAL of 1x10^-6. |
| Sterilant Residues (EO, ECH, EG) | Residues consistent with proposed limits for "blood ex vivo" device category. | |
| Pyrogenicity | USP Chapter 161 (Transfusion and Infusion Assemblies and Similar Medical Devices) | Subject bloodlines meet requirements of USP Chapter 161. |
| Particulate Matter | USP 23 limits for Large Volume Injections (LVI) solutions | Particles compared to and implied to meet USP 23 limits. |
| Integrity & Manufacturing Specifications | In-process and/or final inspections | Functional testing for blood side integrity and conformance to manufacturing specifications performed. |
| Functional Performance (Clearances) | Equivalence to predicate dialyzers | Slight changes in clearance values for urea, creatinine, and Vitamin B12 compared to predicate, but still considered substantially equivalent. The specific values demonstrating equivalence are not provided in the summary. |
Note: The 510(k) summary explicitly states "Clinical data: N/A". This indicates that the regulatory clearance was not based on a clinical study demonstrating patient outcomes or comparative effectiveness in a clinical setting. Instead, it relied on bench testing, material compatibility, and adherence to established performance standards for similar devices.
Study Details
Given that the "Clinical data" section is marked as "N/A" and the submission is a 510(k) summary for a hemodialyzer, many of the requested details about human-in-the-loop studies, ground truth establishment by experts, and sample sizes for clinical trials are not applicable. The "study" here refers to the non-clinical testing and validation summarized in the document.
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of clinical subjects. For non-clinical tests (material, sterilization, pyrogenicity, etc.), the sample sizes would refer to the number of device units or material samples tested, which are not detailed in this summary.
- Data Provenance: Not specified. Testing for biocompatibility, sterility, etc., would typically be conducted in laboratories adhering to relevant standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The ground truth for this medical device submission is established through adherence to recognized international and national standards (e.g., USP, ISO, AAMI) for material safety, sterilization efficacy, and physical performance. It does not involve expert consensus on clinical diagnoses or interpretations in the way AI/radiology devices might.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is needed. For this device, "ground truth" is determined by empirical measurements against pre-defined physical, chemical, and biological standards.
4. 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
- No. This is a hemodialyzer, not an AI-assisted diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.
5. 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.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's submission is derived from:
- Validated Standards: Meeting specifications outlined in USP, ISO, AAMI guidelines for material biocompatibility, sterility, and pyrogenicity.
- Bench Test Results: Direct measurements of physical integrity and clearance characteristics.
- Equivalence to Predicate: Comparison of performance characteristics (like clearance values) to legally marketed predicate devices to establish substantial equivalence.
7. The sample size for the training set
- Not Applicable. This is a physical medical device, not an algorithm that requires a training set.
8. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.