(259 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, with a trained individual available as needed who is considered competent in the use of the prescribing physician.
The Tablo® Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extra-corporeal access during hemodialysis. The Tablo Cartridge is compatible only with the Tablo Hemodialysis System.
The Tablo Hemodialysis System is a self-contained hemodialysis system intended for acute and chronic dialysis therapy, with or without ultrafiltration, in an acute or chronic care facility. The system's innovative design includes the:
- . Tablo Console, a single module consisting of multiple fluidic systems that perform the activities of a water purification system (WPS) and a conventional dialysis delivery system (DDS), and
- Tablo Cartridge, a single use blood tubing set attached to an organizer tray. The ethylene oxide (EO) sterilized and disposable cartridge is inserted onto the front panel of the console for each dialysis treatment (Figure 1).
- . Tablo Script, an accessory software to the Tablo Console, is designed for use by medical professionals to a) prepare, update and verify patient dialysis prescriptions b) view and export dialysis treatment information and billing activities and c) set and modify Tablo Console settings. Note: Tablo Script is optional, patient prescriptions can still be created or changed directly on the Tablo Console.
Here's a breakdown of the acceptance criteria and study findings for the Tablo Hemodialysis System and Tablo Cartridge, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Result |
|---|---|---|
| Biocompatibility testing (Tablo Cartridge) | Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Genotoxicity, as per FDA guidance "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions." Results must be passing under individual test conditions. | Pass |
| Biocompatibility testing (Tablo Console fluid contact materials) | Leachable testing conducted in accordance with FDA Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Toxicological assessment confirms materials are safe for intended use. | Pass |
| Electrical safety and electromagnetic compatibility (EMC) | System complies with ES 60601-1, main and its collateral standards. | Pass |
| Software Verification and Validation Testing | Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Major level of concern: failure could result in serious injury or death). | Pass |
| Device Performance (Shelf Life and Sterilization) | Device meets performance requirements following 1 year accelerated aging. | Pass |
| Packaging integrity (Shelf Life and Sterilization) | Packaging system meets performance requirements following 1 year accelerated aging. | Pass |
| Sterilization (Shelf Life and Sterilization) | Device is EO sterilized, meets SAL of 10^-6. | Pass |
| EO residuals (Shelf Life and Sterilization) | Meets ISO 10993-7 for prolonged contact device. | Pass |
| Bacterial endotoxin (LAL) testing (Shelf Life and Sterilization) | Meets ANSI/AAMI ST72. | Pass |
| 1. Environmental Operation (Bench Performance Testing) | The device shall meet the system requirements for environmental operation. | Pass |
| 2. Transit (Bench Performance Testing) | The system shall operate within specification after transit. | Pass |
| 3. Prime Discard (Bench Performance Testing) | The Tablo Cartridge shall meet the requirements for prime discard. | Pass |
| 4. Pinch Valve (Bench Performance Testing) | The system shall meet requirements for the blood and saline pinch valves. | Pass |
| 5. Maximum Power (Bench Performance Testing) | The system shall meet requirements for maximum power and current. | Pass |
| 6. Dialyzer Compatibility (Bench Performance Testing) | The system shall be compatible with hemodialyzers of sizes with the following ranges: Major Diameter: 2.14 - 2.75", Minor Diameter: 1.45 - 2.05", Total Length: 11.55 - 13.15", Dialysate Port Distance: 8.15 - 9.55". | Pass |
| 7. External Device Compatibility (Bench Performance Testing) | The system shall be compatible with external devices (i.e., external infusion pump, manual syringe injection of saline bolus and Transonic sensors (Transonic part number H4FX)). | Pass |
| 8. Cartridge Hemolysis Testing, 12 Hours (Bench Performance Testing) | The increase in hemolysis in a sample of blood circulating through the fluidic path during treatment as compared to a control sample of blood idle for the same amount of time shall not exceed 1%. The system shall meet its hemolysis requirements with a Crit-Line blood chamber (Fresenius part number 191058) connected within the extracorporeal circuit. | Pass |
| 9. Various hardware (Bench Performance Testing) | The system shall meet the following requirements for various hardware. | Pass |
| 10. Water Ingress (IP21) (Bench Performance Testing) | The console enclosure shall have an IP21 ingress protection rating per IEC 60529. | Pass |
| 11. Mechanical (Bench Performance Testing) | The system shall meet requirements for labeled priming volume, be designed with an ultrafilter that removes microbial materials and particles > 5nm, shall be designed with the required ports so that sampling for monitoring can be taken. | Pass |
| 12. Front Panel Interface with Cartridge Installed (Bench Performance Testing) | The system shall meet the following requirements for front panel interface with the cartridge installed. | Pass |
| 13. Essential Performance per IEC 60601-2-16 (Bench Performance Testing) | The system shall meet Essential Performance per IEC 60601-2-16. | Pass |
| 14. Battery Failure (Bench Performance Testing) | The system shall prevent treatment initiation if it detects a low battery voltage. | Pass |
| 15. AAMI Water and Dialysate Quality (Bench Performance Testing) | The system shall meet ANSI/AAMI 13959:2014 and ANSI/AAMI 11663:2014 requirements for water and dialysate. | Pass |
| 16. Total Dissolved Solids (Bench Performance Testing) | - Water sample results meet ANSI/AAMI 13959 toxic contaminant standards and ISO 23500 trace element standards. |
- Water from the Post RO sample port meets ISO 23500 electrolyte concentration limits when prepared from water with hardness of 150 mg/L. | Pass |
| 17. Water Treatment System (Bench Performance Testing) | The system shall meet requirements for a water treatment system. | Pass |
| 18. Dialysate flow and Conductivity Monitoring (Bench Performance Testing) | The system shall meet requirements for dialysate flow, temperature, volume, and conductivity monitoring. | Pass |
| 19. Air-In-Line (Bench Performance Testing) | The system shall meet requirements related to the system's purging and detection of air bubbles in the extracorporeal circuit. | Pass |
| 20. Pre-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for pre-treatment mode. | Pass |
| 21. Post-Treatment Mode (Bench Performance Testing) | The system shall meet requirements for post-treatment mode. | Pass |
| 22. Blood Pump and Pinch Valve Control, and Saline Delivery Performance (Bench Performance Testing) | The system shall meet requirements for operation, performance, and control of the peristaltic blood pump. | Pass |
| 23. Heat Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for heat disinfection mode. | Pass |
| 24. Chemical Disinfection Mode (Bench Performance Testing) | The system shall meet requirements for chemical disinfection mode. | Pass |
| 25. Ultrafiltration Accuracy (Bench Performance Testing) | The system shall provide a treatment fluid removal accuracy of +/- 100 mL per hour of the treatment time. | Pass |
| 26. Maintenance and Service User (Bench Performance Testing) | The system shall meet requirements for maintenance and service user. | Pass |
| 27. Maintenance and Service User (Mock Treatments) (Bench Performance Testing) | The system shall allow the user to run mock treatments in Service Interface without the need of a Patient USB. | Pass |
| 28. Heat and Chemical Disinfection Effectiveness (Bench Performance Testing) | Disinfection validation was performed on n=3 consoles per organism, totaling n=6 consoles to demonstrate that chemical and heat disinfection cycles reduce vegetative bacterial species (e.g., Pseudomonas aeruginosa) by six logs and non-tuberculous Mycobacterium species (e.g., Mycobacterium terrae) by three logs. | Pass |
| 29. External Disinfectant Chemical Compatibility Testing (IEC 60601-2-16 Test) (Bench Performance Testing) | The system and its accessories shall be capable of withstanding daily cleaning, using specified chemicals (70% Isopropyl Alcohol, 10% bleach, PDI Super Sani Cloth Germicidal Wipes, CaviWipes, CaviWipes1 Disinfecting Wipe, Oxivir 5, Oxivir TB Wipes) over the service life of the device per the chemical manufacturer instructions. | Pass |
| 30. Bring Your Own Concentrate Conductivity Test (Bench Performance Testing) | The system shall be compatible with dialysis fluid concentrates intended for a 45X-proportioning ratio. When mixed at a 45X ratio, the acid concentrate should comply with the following labeled formulation range: Sodium 100 mEq/L, Potassium 0 - 4 mEq/L, Calcium 0 - 3.5 mEq/L, Acetate 4 mEq/L. | Pass |
| 31. Human Factors Validation (Bench Performance Testing) | The system shall be assessed for usability with representative users (i.e., nurses and patient care technicians in clinical settings and acute-care facilities) in accordance with its intended use/indications for use. | Pass |
The document states that "Non-clinical testing supports the safety and effectiveness of the Tablo Hemodialysis System and Tablo Cartridge. The bench testing demonstrates that the device systems comparably to the predicate device and is substantially equivalent to the legally marketed device." This implies that all listed acceptance criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a general "test set" sample size for all performance tests. Specific sample sizes are mentioned for certain tests:
- Shelf Life and Sterilization Testing: The specifics of how many cartridges were subjected to accelerated aging are not detailed, but it's implied that the testing was sufficient to justify a 12-month shelf life.
- Heat and Chemical Disinfection Effectiveness: n=3 consoles per organism, totaling n=6 consoles for disinfection validation.
- Data Provenance: The data is from non-clinical bench performance testing and biocompatibility testing. It is not patient-derived data. The country of origin is not specified but implicitly refers to testing performed by or for Outset Medical, Inc., a U.S. company. The studies are prospective in the sense that they were designed and executed to evaluate the device.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth for Biocompatibility: Not applicable in the sense of expert consensus on qualitative data. The ground truth here is derived from standardized laboratory tests and their established pass/fail criteria (e.g., cytotoxicity, sensitization, hemocompatibility). Interpretation of these results would be done by qualified laboratory personnel and toxicologists. The specific number and qualifications are not detailed.
- Ground Truth for Performance Testing: Not applicable. Performance tests (e.g., flow rates, pressures, temperatures, disinfection efficacy, ultrafiltration accuracy) are measured against predefined engineering and regulatory specifications and standards (e.g., IEC standards, AAMI standards). The ground truth is the objective measurement comparing the device's output to these quantitative standards.
- Ground Truth for Human Factors Validation: The "ground truth" here is the assessment of usability in accordance with intended use. While representative users (nurses and patient care technicians) are involved, the document does not specify the number of experts (e.g., human factors engineers) who established the protocol or interpreted the findings, nor their specific qualifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1, 3+1) typically applies to studies where human readers are interpreting ambiguous data (e.g., medical images, clinical diagnoses) and discrepancies need to be resolved. This is not applicable to the non-clinical, objective functional and safety performance tests described for the Tablo Hemodialysis System. The results are based on direct measurements and adherence to engineering and biological standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the diagnostic performance or interpretative accuracy of humans (with or without AI assistance) on a set of cases. The studies presented are non-clinical engineering and safety performance tests of a medical device.
6. Standalone Performance Study (Algorithm Only)
The term "standalone" performance usually refers to the algorithm's performance without human intervention, particularly in the context of AI/software. While "Software Verification and Validation Testing" was performed for the Tablo system, the documentation doesn't describe it as an isolated algorithm performance study in the way an AI diagnostic tool would be evaluated. The software is an integrated component controlling the physical device, and its validation is part of the overall system's functional assessment. Therefore, a standalone algorithm performance study, as typically understood for AI, was not explicitly detailed as such.
7. Type of Ground Truth Used
The ground truth used for these studies is primarily:
- Established industry standards and regulatory guidelines: Examples include ISO 10993-7, ANSI/AAMI ST72, ES 60601-1, IEC 60601-2-16, ANSI/AAMI 13959:2014, ANSI/AAMI 11663:2014, and ISO 23500.
- Engineering specifications and design requirements: These define the expected performance of various components and the system as a whole (e.g., maximum power, dialyzer compatibility dimensions, ultrafiltration accuracy of +/- 100 mL/hr, specified concentrate parameters).
- Biological and chemical pass/fail criteria: For biocompatibility, sterilization, and disinfection effectiveness tests, which are based on scientific principles and regulatory limits.
There are no mentions of expert consensus, pathology, or outcomes data being directly used to establish the ground truth for these specific non-clinical tests.
8. Sample Size for the Training Set
Not applicable. This document describes the performance testing of a physical medical device (hemodialysis system and cartridge), not an AI algorithm that requires a "training set" of data. The software within the device underwent verification and validation, but this is distinct from machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, this is not an AI algorithm document where a training set and its ground truth would be relevant.
§ 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.”