(113 days)
Hemodialysis with SyntraTM + dialyzers is indicated for patients with renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Model 200 Dialyzer
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a medical device (dialyzer) and not an AI/software-as-a-medical-device (SaMD) submission, so most of the AI-specific questions will be "N/A."
The provided document is a 510(k) Premarket Notification for the Syntra™ + Dialyzer, a conventional medical device (high permeability hemodialysis system), not a software or AI-driven device. As such, many of the requested categories related to AI/software performance, ground truth, expert review, and MRMC studies are not applicable. The acceptance criteria and "study" (validation) for this device focus on biological safety, sterilization, manufacturing quality, and functional equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Safety: Met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidance on selection of tests. | Components of the subject Syntra™ + dialyzer have met the biological requirements of ISO 10993-1. |
| Sterilization: Validation of gamma sterilization cycle per AAMI/ISO 11137:1994 "Sterilization of Healthcare Products -- Requirements for Validation and Routine Control - Radiation Sterilization." | The validation of the gamma sterilization cycle for the Syntra™ Plus dialyzer is based upon the AAMI/ISO 11137:1994. |
| Pyrogen Testing: Meets the requirements of USP 24 , Transfusion and Infusion Assemblies and Similar Medical Devices. | Pyrogen testing of the subject dialyzer meets the requirements of USP 24 . |
| Particle Count: Performed per USP XXIII Monograph . (Note: "For information only and is not a release criteria at this time.") | Particles are counted per USP XXIII Monograph . |
| Functional Testing (Blood Side Integrity & Conformance to Manufacturing Specifications): Performed as in-process and/or final inspections prior to product release to ensure a quality product. | Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections to ensure a quality product. |
| Technological Characteristics: Similar to predicate device (Syntra™ Dialyzer, K002210) and does not raise new safety and effectiveness issues. | The general design and material of the Syntra™ + Dialyzer is similar to the Syntra™ Dialyzers cleared under K002210, and do not raise any new types of safety and effectiveness issues. |
2. Sample size 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 explicitly stated as a single "test set" in the context of an AI device. The validation activities involve testing of device components and samples according to the referenced standards (ISO, AAMI/ISO, USP). The specific number of devices or components sampled for each test (e.g., biological testing, pyrogen testing, particle count) is not provided in this summary.
- Data Provenance: Not applicable in the context of patient data for a software/AI device. The data provenance would refer to the origin of the physical device samples used for testing (e.g., from the manufacturing line).
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 (N/A). This is a hardware medical device submission. Ground truth, in the AI context of expert consensus, is not relevant here. The ground truth for device performance is based on established engineering, material, and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used in expert consensus for AI model ground truth establishment. For this physical device, conformity to standards is typically assessed against predefined pass/fail criteria established by the standards themselves, not through expert adjudication of images or outputs.
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
- N/A. MRMC studies are specific to AI-assisted human performance evaluations. This submission is for a physical dialyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical hardware device; there is no algorithm to evaluate in standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by compliance with recognized international and national standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, AAMI/ISO 11137 for sterilization, USP 24 for pyrogenicity, USP XXIII Monograph for particle count). Additionally, functional testing and conformance to manufacturing specifications serve as the ground truth for acceptable product quality.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. As there is no training set, there is no ground truth for a training set to establish.
§ 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.”