(235 days)
The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultration, 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 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 consists of: Tablo Console and Software, Tablo Cartridge. The TabloCart™ is an optional accessory to the Tablo Hemodialysis System that raises the height of the Tablo console and includes larger wheels that rotate and lock in more functional directions than the Tablo console without a cart, aiding in overall system mobility. When configured with a Prefiltration Drawer, the cart has replaceable, large-capacity cartridge filters (sediment and/or carbon) that serve as "prefilters" to help remove major sediment and chlorine/chloramines from supply water before it enters the Tablo console's water purification system. The cart with prefiltration also includes backflow prevention and a booster pump to transport water from the incoming water supply to the Tablo console. The TabloCart with Prefiltration Drawer consists of: Tablo Cart Wheeled Platform, Fluidics Drawer and Software.
The provided document is an FDA 510(k) Premarket Notification review letter for the Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776). This document primarily focuses on demonstrating substantial equivalence to a predicate device (Tablo Hemodialysis System, K223248) rather than detailing specific acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" as requested in the prompt typically refer to a device's performance against predefined metrics (e.g., clinical accuracy, diagnostic performance, or a specific functional output) which are common for AI/algorithm-based devices. However, the Tablo Hemodialysis System and its accessory cart are not an AI/algorithm-based device in the common sense (e.g., for image analysis or disease diagnosis). Instead, it's a medical device for renal replacement therapy, and the 510(k) submission focuses on demonstrating that the new accessory (the cart with prefiltration) does not alter the fundamental safety and effectiveness of the existing, cleared hemodialysis system.
Therefore, many of the specific questions in the prompt (e.g., sample size for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of device and submission. The "study" proving acceptance criteria here is primarily a series of bench performance tests, biocompatibility testing, electromagnetic compatibility (EMC) and electrical safety testing, and software verification and validation testing to confirm that the addition of the cart does not negatively impact the established safety and performance of the base hemodialysis system.
Here's an attempt to address the prompt based on the available information, highlighting what is applicable and what is not:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the Tablo® Hemodialysis System with TabloCart™ with Prefiltration Drawer (K232776)
Given that this 510(k) submission is for an accessory cart to an already cleared hemodialysis system, the "acceptance criteria" revolve around demonstrating that the modified device (system with cart) maintains the same safety and effectiveness as the predicate device (system without cart). The "study" is a compilation of various engineering and performance tests rather than a single clinical trial or AI validation study.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device and submission, the acceptance criteria are largely implied by demonstrating substantial equivalence to the predicate device. They are not typically laid out as quantitative performance metrics (like accuracy or sensitivity) as would be for an AI diagnostic device. Instead, they relate to maintaining fundamental safety, performance, and functionality.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Maintenance of Predicate Indications for Use | The Tablo® Hemodialysis System and TabloCart retains the same Indications for Use as the predicate Tablo Hemodialysis System (K223248), with the addition of "and TabloCart" to the statement. This indicates that the addition of the cart does not change the medical conditions for which the device is intended. |
| Maintenance of Predicate Intended Use | The primary intended use of the Tablo Hemodialysis System (treatment of ESRD patients needing hemodialysis) remains unchanged. The TabloCart has its own specific intended use as an accessory (increased height, improved mobility, additional prefiltration), which complements, rather than alters, the console's existing intended use. |
| Biocompatibility | Materials used for the Tablo Hemodialysis System and the TabloCart with Prefiltration Drawer are considered equivalent to the predicate. Biocompatibility evidence was provided in the submission. |
| Electromagnetic Compatibility (EMC) and Electrical Safety | No difference in EMC and electrical safety from the predicate device was found. Existing evidence from K223248, which included the Tablo Hemodialysis System and TabloCart with Prefiltration (implying this configuration was already considered in the predicate's testing), was deemed sufficient. No additional testing was needed. |
| Software Functionality and Safety | The cart's software functions independently of the console's software. If the cart's software fails, it enters bypass mode without interrupting the console's operation. Software verification and validation (V&V) testing was conducted and passed at the system level (console with cart). The cart's software was assessed as a Minor Level of Concern according to FDA guidance. Cybersecurity risks were evaluated. This demonstrates that the addition of the cart does not introduce new software-related safety- or effectiveness issues. |
| Sterilization & Shelf Life (Cleaning, Disinfection) | The TabloCart is a reusable, non-sterile accessory. Cleaning and disinfection methods for the cart are the same as for the predicate Tablo Hemodialysis System and are described in the device labeling. The addition of the cart does not modify the console's existing cleaning/disinfection protocols. |
| Bench Performance (Physical/Mechanical Functionality, Water Filtration) | Additional bench testing was conducted to support the accessory TabloCart with Prefiltration, focused on its new functionalities (e.g., mobility, physical dimensions, prefiltration capabilities). While specific metrics are not detailed in the summary, the "performance characterization of the subject device is the predicate Tablo Hemodialysis System" indicating that the core hemodialysis function is maintained, and the cart's new features perform as intended without compromising the primary device. This includes the cart's ability to "help remove major sediment and chlorine/chloramines from supply water" before it enters the console's purification system, implying successful filtration performance. Specific configurations of filters (2S, 2C, SC) are noted, suggesting testing for these variants. |
| No New Human Factors Issues | No new Human Factors validation study was deemed necessary. This implies that the usability and user interaction with the system, even with the added cart, are not negatively impacted or present new risks, maintaining consistency with the predicate device's established usability. |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of typical AI/algorithm test sets. The "test set" here refers to the physical device and its components undergoing engineering and functional verification.
- Data Provenance: The testing was conducted by the manufacturer, Outset Medical, Inc., presumably in their facilities (San Jose, CA, USA). The studies are prospective in the sense that they were designed and executed specifically to support this 510(k) submission for the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/diagnostic device where expert consensus defines a "ground truth" for disease states in a dataset. "Ground truth" for this device is based on engineering specifications, physical measurements, chemical analysis (for water purity), and functional performance verification against design requirements. The "experts" involved would be engineers, quality control personnel, and regulatory specialists within Outset Medical, Inc.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data (e.g., medical images). For engineering tests, results are typically objective measurements or pass/fail criteria based on predefined specifications.
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:
- Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical hemodialysis system with an accessory, not a standalone algorithm.
7. The type of ground truth used:
- Engineering Specifications and Physical/Chemical Standards: For example, the ground truth for water quality would be established by relevant water quality standards for hemodialysis (e.g., AAMI standards). For mechanical aspects, it would be the design specifications (dimensions, mobility, filter capacity). For software, it would be the functional requirements and safety standards.
8. The sample size for the training set:
- Not applicable. This refers to machine learning models, which is not what this device is.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.”