(383 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. This dialyzer is indicated for single use or reuse. If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed. No other reuse procedure or disinfectant has been evaluated for clinical acceptability.
Models CA-170, and CA-210 Hemodialyzers
The provided text describes a 510(k) premarket notification for a medical device, the CA® Cellulose Acetate Hollow Fiber Dialyzer. However, it does not describe the acceptance criteria and the study that proves the device meets those criteria in the typical format you've requested for AI/algorithm performance.
This document is from 1997, and the concept of AI/algorithm performance evaluation in the way you've outlined (sample size, data provenance, ground truth experts, MRMC studies, standalone performance, training set details) is not applicable to a physical hemodialyzer submitting for 510(k) clearance at that time. The "device" in this context is a physical medical device, not a software algorithm or AI.
Instead, the document details the performance of the physical dialyzer through various tests and comparisons to a predicate device. I will extract the information available, interpreting "acceptance criteria" and "device performance" in the context of this physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Requirements/Biocompatibility | Meet biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. | All patient contact components of the subject CA® Hemodialyzer have previously met the biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. |
| Sterility | Achieve a sterility assurance level (SAL) of 1 x 10^-6 following sterilization by Ethylene Oxide Gas (EtO). Validation based on AAMI Guideline (ST-27-Industrial Ethylene Oxide (EtO) Sterilization of Medical Devices). | Sterilized by Nissho corporation using EtO to a SAL of 1 x 10^-6. Validation of the sterilization cycle is based upon the AAMI Guideline (ST-27). |
| Sterilant Residues | Sterilant residues of EtO, ECH, and EG must be consistent with proposed limits for the "blood ex vivo" device category as published in the June 23, 1978 Federal Register. | Prior to release, sterilant residues of EtO, 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. |
| Pyrogenicity | Meet the requirements of JMHW Notification No. 494, "Approval Requirements for Dialyzers" and the Japanese Pharmacopeia "Pyrogen test." | Pyrogen testing meets the requirements of JMHW Notification No. 494, "Approval Requirements for Dialyzers" and the Japanese Pharmacopeia "Pyrogen test." |
| Particulate Matter | Compared to USP 23 limits for Large Volume Injections (LVI) solutions and ASTM F25-68. | Particles are compared to USP 23 limits for Large Volume Injections (LVI) solutions and ASTM F25-68. (Implies compliance, but doesn't state explicit pass/fail against specific limits for the device itself). |
| Functional Integrity | Blood side integrity and conformance to manufacturing 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. (This describes the process to ensure quality, implying the product consistently meets these internal specifications). |
| Performance Data | In Vivo and In Vitro performance data required, and directions for reuse to be included in labeling. (Implicitly, the performance data must demonstrate the device functions as intended and is safe for its intended use, likely through comparison to the predicate device and established performance standards for hemodialyzers). For reuse, the specified procedure and disinfectant must be followed. "No other reuse procedure or disinfectant has been evaluated for clinical acceptability." | In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling. Clinical data was collected according to the FDA Guidance for Hemodialyzer Reuse Labeling. (The submission implies this data met the necessary requirements for clearance, as the device was cleared. Specific metrics for this performance aren't detailed in the provided summary, but would be in the full submission). "If the dialyzer is reused on the same patient, the reuse procedure and disinfectant specified in the Direction Insert must be followed." |
| Substantial Equivalence | Functional and material similarity to the predicate CA® Cellulose Acetate Hollow Fiber Dialyzers. | The general function and materials of the subject CA® Hemodialyzers are identical to the Baxter predicate Dialyzers. The FDA deemed the device substantially equivalent. |
Information Not Applicable or Not Provided for an AI/Algorithm Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This is not an AI/algorithm study. "Clinical data" was collected for reuse labeling, but specific sample sizes, geographic origin, or retrospective/prospective nature are not detailed in this summary for the physical device.
3. 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 to this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to this type of device and submission.
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 is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable; this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical device, "ground truth" would be established by validated test methods (e.g., chemical analysis for residues, biological assays for pyrogens, mechanical tests for integrity, and in vivo performance data from clinical studies aligning with FDA guidance). Outcomes data and clinical data for reuse were part of the submission.
8. The sample size for the training set
- Not applicable, as this is not an AI/algorithm.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/algorithm.
§ 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.”