(264 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. These dialyzers are 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.
Model CAHP-90 Hemodialyzer
The provided text describes specific acceptance criteria and the study that proves the device meets those criteria.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Safety (USP XXI Class VI materials) | All patient contact components of the subject CAHP™ Hemodialyzer have previously met the biological requirements of the guidelines for safety screening of materials for USP XXI Class VI materials. |
| Sterility Assurance Level (SAL) of 1 x 10-6 | Sterilized by the Nissho corporation using Ethylene Oxide Gas (EtO) to a sterility assurance level (SAL) of 1 x 10-6. Validation based upon AAMI Guideline (ST-27-Industrial Ethylene Oxide (EO) Sterilization of Medical Devices). |
| Sterilant Residues (EtO, ECH, EG) | 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. |
| Pyrogen Testing (JMHW Notification No. 494 and Japanese Pharmacopeia "Pyrogen test") | Pyrogen testing meets the requirements of JMHW Notification No. 494, "Approval Requirements for Dialyzers" and the Japanese Pharmacopeia "Pyrogen test." |
| Particles (USP 23 for LVI solutions and ASTM F25-68) | Particles are compared to USP 23 limits for Large Volume Injections (LVI) solutions and ASTM F25-68. |
| Functional Testing (Blood side integrity and manufacturing specifications conformance) | 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. |
| In Vivo and In Vitro performance data, and directions for reuse included in the labeling | In Vivo and In Vitro performance data, and directions for reuse have been included in the labeling. This indicates that the necessary data and instructions are available, implying the device performs as expected for both single-use and reuse scenarios. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size for a "test set" in the context of device performance. The clinical data was collected "according to the FDA Guidance for Hemodialyzer Reuse Labeling," which suggests a prospective clinical study, though the exact nature (e.g., number of patients) is not provided. The origin of the clinical data is not specified. Other tests, like pyrogen testing, refer to JMHW Notification (Japanese) and Japanese Pharmacopeia, implying that some testing relates to Japanese regulatory standards, but doesn't specify if the samples themselves were from Japan.
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):
This information is not provided in the document. The document describes compliance with established standards and guidelines (e.g., USP, AAMI, FDA guidance, Japanese Pharmacopeia) for device testing, rather than a system where human experts establish ground truth for a discrete test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The document outlines a typical regulatory submission for a medical device involving adherence to performance standards and safety guidelines, not a comparative study relying on expert adjudication of a test set.
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device, a hemodialyzer, is a piece of medical equipment, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable to the device described. The hemodialyzer is a physical device used in treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by adherence to documented performance standards and regulatory guidelines rather than a clinical ground truth like pathology or outcomes data in the typical sense of diagnostic devices. For example:
- Biological safety: Compliance with USP XXI Class VI materials.
- Sterility: Achieved SAL of 1 x 10-6 validated by AAMI guidelines.
- Pyrogenicity: Meeting standards of JMHW Notification and Japanese Pharmacopeia.
- Particle limits: Comparison to USP 23 and ASTM F25-68.
- Functional integrity: Conformance to manufacturing specifications.
- Clinical performance: Demonstrated by "In Vivo and In Vitro performance data" and compliance with "FDA Guidance for Hemodialyzer Reuse Labeling."
8. The sample size for the training set:
Not applicable. The CAHP™ Hemodialyzer is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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.