(230 days)
The Tablo™ 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, with a trained individual available as needed who is considered competent in the use of the prescribing physician.
The Tablo™ Console is a self-contained hemodialysis system (Console) intended for acute and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. The console consists of fluidic systems that perform the activities of a Water Purification System (WPS) and a conventional Dialysis Delivery System (DDS). Since the original 510(k) clearance, the Tablo Console has incorporated design and corresponding labeling updates whose purpose was to improve ease of manufacturing, increase reliability, simplify the design, and optimize performance.
This document is a 510(k) summary for the Tablo Console, a hemodialysis system. The primary purpose of this submission is to describe expanded wireless communication capabilities and other design updates.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for a specific diagnostic performance metric. Instead, it details various types of performance testing against established standards and internal requirements. The "reported device performance" is a general statement of compliance rather than specific numerical results.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility Standards | No specific criteria or numerical results provided. Statement: "Design updates to the fluidic system have been made to the modified device and biocompatibility has been evaluated. There were no changes to the material type, formulation, chemical composition, material processing or contact duration. No additional testing was required." |
| Electrical Safety Standards | Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-2-16. |
| Performance: "The Tablo Console with Wireless Capability has been evaluated against the requirements for Electromagnetic Compatibility and Electrical Safety." (Implied compliance) | |
| Electromagnetic Compatibility (EMC) Standards | Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-2-16. |
| Performance: "The Tablo Console with Wireless Capability has been evaluated against the requirements for Electromagnetic Compatibility and Electrical Safety." (Implied compliance) | |
| Software Verification and Validation | Criteria: Functional and performance software requirements. |
| Performance: "For all software modifications, system level software verification testing demonstrated that the Tablo meets functional and performance software requirements." | |
| System Performance Testing | Criteria: Verification of design updates specific to: Fluidic System Optimization, Front Panel Interface, Console External and Internal Design, System Accessories, Dialyzer Prime, Heat Disinfection. |
| Performance: Testing demonstrated compliance with performance specifications. (Implied compliance) | |
| Overall Conclusion | "The performance testing demonstrates that the Tablo Console with expanded wireless capability meets all performance specifications and complies with applicable standards and FDA Guidance Documents." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic performance involving patient data. The various tests performed (biocompatibility, electrical safety, EMC, software, system performance) would have used devices or components of the device as the test "samples." No information is provided regarding the specific number of devices tested for each type of engineering or software verification test.
Since no clinical studies were performed, there is no patient data, and therefore no information on country of origin or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This submission concerns device modifications and engineering verification, not a diagnostic algorithm requiring ground truth established by medical experts from patient data.
4. Adjudication Method
Not applicable, as there is no diagnostic algorithm performance evaluation against ground truth from patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed in support of the modifications." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. Standalone Performance Study
Yes, in a sense. The entire submission focuses on the standalone performance of the device and its modified components (hardware, software, wireless capabilities) against engineering and safety standards. There is no AI component that would have distinct "standalone algorithm performance" versus "human-in-the-loop performance." The device itself is the "algorithm" in terms of its operational functionality.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests was based on:
- Established international and national standards (e.g., IEC 60601 series).
- Internal functional and performance requirements for software and system operation.
- Design specifications for hardware and fluidic systems.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of patient data. The "training" for the device would be its initial design, development, and iterative testing/refinement phases.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML training set in the context of this device. The "ground truth" for the device's design and functionality would stem from engineering principles, medical device regulatory requirements, and user needs for hemodialysis.
§ 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.”