(67 days)
The Tablo® Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.
The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute, chronic care facility or in the home. The Tablo Hemodialysis System consist of:
- Tablo Console
- Tablo Cartridge
This appears to be a 510(k) summary for a medical device (Tablo Hemodialysis System) that has undergone a modification. The document states that the device has been found substantially equivalent to its predicate device (Tablo Hemodialysis System, K223248), specifically due to changes in the hydraulic material.
Crucially, this document is NOT a study report for a novel AI device or a device that required extensive clinical or human factors validation for its primary function. The modifications were related to material changes in the hydraulics, and the FDA determined that these changes did not impact the device's fundamental performance, safety, or effectiveness. Therefore, many of the typical acceptance criteria and study components you've listed for AI/human-in-the-loop devices are not applicable or were explicitly deemed unnecessary in this context.
I will address the questions based on the information provided, explicitly stating when a piece of information is not available or relevant to this specific submission.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct "acceptance criteria" table in the format typically seen for novel device performance or AI algorithms. Instead, the acceptance criteria for this submission revolve around demonstrating substantial equivalence to the predicate device despite the hydraulic material changes. Performance was demonstrated through various non-clinical tests to confirm the new materials didn't negatively impact the established performance of the device.
Since this submission is about material changes validated through bench testing, the "performance" is about maintaining the original specifications rather than achieving a new performance threshold.
| Acceptance Criteria (Implied for this 510(k) modification) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Meet ISO 10993-1:2018 and FDA guidance for new materials. | All evaluated endpoints (Cytotoxicity, Sensitization, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility, Chemical Characterization, Toxicological Risk Assessment) were met. |
| Electrical Safety & EMC: No negative impact due to hydraulic changes. | Changes to hydraulics do not impact electrical safety or EMC. No additional testing was conducted as it was deemed unnecessary. |
| Software Functionality: No software modifications were made. | No software modifications were made; no new software V&V testing required. |
| Sterilization & Shelf Life: No changes to these aspects for the Console. | Console remains reusable, non-sterile; disinfection methods unchanged. Cartridge unchanged within this submission. |
| Bench Performance: Maintain established performance of the predicate device for critical functions (e.g., dialysate temperature, fluid removal). | Bench tests confirmed the modified system meets system requirements and performs as intended, matching the predicate Tablo Hemodialysis System (K223248) for: |
- Dialysate Temperature Accuracy
- Fluid Removal Accuracy
- Chemical Disinfection
- Heat Disinfection
- Related Alarms |
| Human Factors/Usability: No negative impact on usability. | Modifications to hydraulics do not impact usability. No new Human Factors validation study deemed necessary. |
| Clinical Performance: No need for new clinical studies. | No clinical studies were conducted as the changes were deemed not to require them for substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes bench testing, biocompatibility testing, electrical safety/EMC analysis, and software/human factors assessments for a modification to an existing device. It's not a typical "test set" in the sense of a dataset for an AI algorithm or a patient cohort for a clinical trial.
- Sample Size for Bench Testing/Biocompatibility: The specific sample sizes for each type of bench test (e.g., number of units tested for dialysate temperature accuracy, number of samples for biocompatibility) are not provided in this 510(k) summary. These details would be in the full submission, but not in this public summary.
- Data Provenance: Not applicable in the context of patient data provenance for a test set. The tests described are laboratory-based and engineering assessments.
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 is not applicable. Ground truth, expert consensus, or clinical interpretation by medical experts are not detailed because this submission is about physical/material modificationsvalidated through non-clinical testing, not diagnostic performance or clinical outcomes directly assessed by experts interpreting data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in studies where human readers or interpreters are involved in generating or confirming ground truth, such as in imaging studies. This document concerns engineering and material changes validated through bench testing.
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, an MRMC study was not conducted. This submission is for modifications to a hemodialysis system, not an AI-powered diagnostic or assistive tool where human reader performance would be a relevant metric. The document explicitly states "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an AI algorithm. The device is a hemodialysis system, not an AI algorithm. Its performance is inherent to its mechanical, electrical, and material properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established performance specifications and safety profiles of the predicate device (K223248) and the relevant regulatory standards (e.g., ISO 10993-1, FDA guidance for hemodialysis delivery systems). The studies conducted (bench testing, biocompatibility) aim to demonstrate that the modified device continues to meet these established performance and safety requirements.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
§ 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.”