(8 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 Tablo Hemodialysis System is also indicated for use in the home.
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. This premarket notification is an indication expansion to include home use of the device. The product described in this submission includes:
- . 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
- . The following accessories/components
- Tablo Script (optional accessory software) o
- Tablo Straws O
- O Outset Acid Concentrate 1K, 2K and 3K
- Outset Bicarbonate Concentrate O
- Patient USB Stick O
- Hand Crank O
- O Locking Power Cord
- Drain Line O
- O Water Line
- Disinfectant Straw O
Here's an analysis of the acceptance criteria and supporting studies for the Tablo Hemodialysis System, based on the provided FDA 510(k) summary:
The document describes the acceptance criteria and performance for several bench performance tests and mentions a clinical study to support the device's substantial equivalence and expanded indication for home use.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Performance Testing | ||
| AAMI Water and AAMI Dialysate Quality Verification | The system shall meet ANSI/AAMI 13959:2014 and ANSI/AAMI 11663:2014 requirements for water and dialysate under worst-case input test conditions. | Pass |
| 1K Concentrate Compatibility Verification | The system shall be compatible with the Outset branded 1K acid concentrate. | Pass |
| Drip Chamber Level Sensor Verification | The modified sensors shall meet pre-specified functional and performance requirements. | Pass |
| Suitability Test - USP Microbial Enumeration Test | The system shall not inhibit detection and/or the recovery of potential organisms. | Pass |
| Reprocessing Disinfection Validation | The system shall be labeled with cleaning instructions in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," issued March 17, 2015. | Pass |
| Clinical Study (for home use indication) | ||
| Safety (Adverse Events) | (Implicitly: low adverse event rate) The Tablo Hemodialysis System is associated with a low adverse event rate and can safely be used at home. | Low adverse event rate |
| Adequacy (Weekly standardized Kt/V) | (Implicitly: consistently and effectively deliver a weekly standardized Kt/V of 2.1) The recommended adequacy target of home hemodialysis (a weekly standardized Kt/V of 2.1) can consistently and effectively be delivered. | Achieved |
| Ultrafiltration Goals | (Implicitly: reliably achieve ultrafiltration goals) Patients reliably achieve ultrafiltration goals using the System at home. | Reliably achieved |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Performance Tests: No specific sample sizes (e.g., number of units tested) are provided for these tests within the summary.
- Clinical Study: No specific sample size (number of patients) is explicitly stated in the summary.
- Data Provenance: The clinical study is described as a "prospective, multicenter, open label, non-randomized, cross-over study." This indicates the data was collected prospectively from multiple clinical sites. The country of origin is not specified but is implicitly the US, given the FDA submission context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Performance Tests: Not applicable. Ground truth for these tests is based on established engineering and regulatory standards (e.g., AAMI, USP, FDA guidance).
- Clinical Study: Not applicable in the traditional sense of expert consensus on image interpretation. The "ground truth" for the clinical study involved direct measurement of patient outcomes (adverse events, Kt/V, ultrafiltration) which are objective physiological parameters.
4. Adjudication Method for the Test Set
- Bench Performance Tests: Not applicable. These are objective tests against defined physical or chemical standards.
- Clinical Study: Not explicitly stated. For clinical trial outcome measures like adverse events and adequacy, typically events are recorded as they occur and then reviewed by study investigators and/or an independent data safety monitoring board.
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 is typically used for diagnostic imaging devices where human readers interpret medical images. The Tablo Hemodialysis System is a medical device for therapy, not diagnosis.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
A "standalone" performance evaluation in the context of an AI algorithm is not applicable here. The Tablo Hemodialysis System is a physical medical device that interacts directly with patients, albeit with software control. Its performance is evaluated through its direct physical and physiological effects, not through an algorithm's interpretive ability. The software reliability improvements mentioned refer to the device's operational software, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Bench Performance Tests: Regulatory and engineering standards (e.g., ANSI/AAMI, USP, FDA guidance for reprocessing).
- Clinical Study: Objective physiological measurements of patient outcomes:
- Safety: Adverse event rates.
- Adequacy: Weekly standardized Kt/V (a measure of dialysis efficacy).
- Ultrafiltration: Achievement of ultrafiltration goals.
8. Sample Size for the Training Set
- Software Verification and Validation: No specific sample size (e.g., lines of code, test cases) is provided for the "training set" of the software. Instead, the summary states that "Software verification and validation testing were conducted and passed for the incremental software changes," following FDA guidance for "major" level of concern software. This implies a comprehensive testing process, but not a "training set" in the machine learning sense.
- Clinical Study: Not applicable; the clinical study evaluated the device's performance, it did not "train" a model.
9. How the Ground Truth for the Training Set Was Established
- Software Verification and Validation: Not applicable in the context of a machine learning "training set." The "ground truth" for software validation would be the defined functional and non-functional requirements and specifications against which the software's behavior is tested.
- Clinical Study: Not applicable.
§ 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.”