(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-170 Hemodialyzer
Model PSN-210 Hemodialyzer
This premarket notification (K980656) for the Polysynthane (PSN™) Hemodialyzer (Models 170 and 210) does not contain a study that directly compares the device's performance against specific acceptance criteria for clearance or other functional metrics in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device and compliance with established biological, sterilization, and manufacturing standards.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines several standards and tests met by the device, rather than explicit numerical performance targets compared to a predefined threshold for functional efficacy.
| Acceptance Criteria/Standard Met | Reported Device Performance |
|---|---|
| Biological Evaluation (ISO 10993-1) | Components of the subject PSN™ Hemodialyzers have met the biological requirements of ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Guidance on selection of tests. |
| Sterilization Assurance Level (SAL) (AAMI Guideline ST-27) | Validation of the sterilization cycle for the PSN™ Hemodialyzer is based upon the AAMI Guideline (ST-27) to ensure a sterility assurance level (SAL) of 1x10-6. |
| Sterilant Residues (Federal Register, June 23, 1978) | Prior to release, sterilant residues of EO, ECH, and EG are consistent with the proposed limits for the "blood ex vivo" device category as published in the June 23, 1978 Federal Register. |
| Pyrogen Testing (USP Chapter 161) | Pyrogen testing of the subject dialyzers meets the requirements of Chapter 161, Transfusion and Infusion Assemblies and Similar Medical Devices of Supplement 2 of the USP. |
| Particle Count (USP XXIII ) | Particles are counted per USP XXIII . (The specific count limit or result is not provided, only that it "meets the requirements," implying compliance with the specified standard.) |
| Blood Side Integrity & Conformance to Mfg. Specifications | Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections prior to product release ensuring a quality product. (No specific quantitative performance data is provided here.) |
| Clearance Values (Urea, Creatinine, Vitamin B12) & Ultrafiltration | The general function and materials are the same as the Baxter PSN™ Dialyzers with a slight change in clearance values for urea, creatinine, Vitamin B12, and ultrafiltration similar to that of the CAHP Hollow Fiber Dialyzers. (This implies comparison to predicate devices, but no specific targets or data are given for the subject device.) |
2. Sample Size for the Test Set and Data Provenance
The provided text does not mention a traditional "test set" or a clinical study with a defined sample size for performance evaluation in the way a contemporary AI/diagnostic device submission might. The testing described (biological, sterilization, pyrogen, particle, manufacturing inspections) are typically conducted on development or production samples, not a "test set" in the context of clinical performance evaluation.
- Sample Size: Not specified for any of the mentioned tests.
- Data Provenance: Not applicable in the context of a clinical test set. The tests described are laboratory and manufacturing quality control tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" for the tests mentioned (e.g., sterility, pyrogenicity, particle count) is defined by established regulatory standards and test methods (e.g., ISO, AAMI, USP), not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a human-adjudicated test set in the clinical sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted as described in this submission. This device is a hemodialyzer, not a diagnostic imaging or AI-assisted interpretation device that would typically involve human readers. The clinical data section explicitly states "N/A."
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This concept is not applicable to this device. The hemodialyzer is a physical medical device; it does not involve algorithms or AI for diagnostic or interpretive performance.
7. Type of Ground Truth Used
The "ground truth" for the various compliance tests is based on:
- Biological Compatibility Standards: ISO 10993-1.
- Sterilization Standards: AAMI Guideline ST-27.
- Chemical Residue Limits: Federal Register (June 23, 1978).
- Pharmacopoeial Standards: USP Chapter 161 (Pyrogen), USP XXIII (Particles).
- Manufacturing Specifications: Internal company standards for blood side integrity and other specifications.
These are regulatory and quality control standards and specifications, not pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML algorithm requiring a training set.
In summary:
This 1998 510(k) submission for a hemodialyzer demonstrates substantial equivalence through compliance with pre-existing biological, sterilization, and manufacturing standards, as well as a comparison of general function and materials to predicate devices. It is entirely focused on device safety and manufacturing quality, not on clinical performance metrics typically associated with studies involving "acceptance criteria" for diagnostic accuracy or efficacy in the context of AI or advanced diagnostic tools. The submission explicitly states "Clinical data: N/A," indicating no specific clinical trials were performed or submitted.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”