(206 days)
System 100 is indicated for temorary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
System 100 consists of the:
• S-100 console
• UF 500 set
• Venous access catheters
• Catheter extension set
• Needless flushing port
• Catheter insertion kit
The provided text describes the "System 100" device, a high-permeability hemodialysis system, and its FDA 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a complete description of the device's performance against predefined metrics.
The text primarily focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states that "CHF Solutions, Inc. performed non-clinical testing on System 100 to demonstrate that the device met its functional and performance specification." and "Clinical data confirm that the device is safe and effective for its intended use." However, it does not explicitly define these "functional and performance specifications" as acceptance criteria, nor does it provide quantitative results or metrics against which performance was measured.
2. Sample Size Used for the Test Set and Data Provenance
| Sample Size (Test Set) | Data Provenance |
|---|---|
| Not specified | Not specified |
Explanation: The document mentions "Clinical data confirm that the device is safe and effective." However, it does not provide any details about the sample size of the clinical study, whether it was prospective or retrospective, or the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
| Number of Experts | Qualifications of Experts |
|---|---|
| Not applicable | Not applicable |
Explanation: This type of information is typically relevant for interpretative diagnostic devices where human experts establish ground truth for testing AI algorithms. The System 100 is a medical device for ultrafiltration, not an AI-powered diagnostic tool, so this concept does not directly apply.
4. Adjudication Method for the Test Set
| Adjudication Method |
|---|
| Not applicable |
Explanation: As with the previous point, adjudication methods are typically used for establishing ground truth from multiple expert interpretations, which is not relevant for this type of medical device's performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
| MRMC Study Conducted | Effect Size (Human readers improved with AI vs. without AI) |
|---|---|
| No | Not applicable |
Explanation: An MRMC comparative effectiveness study is specific to evaluating the impact of AI assistance on human reader performance, usually in image-based diagnostics. The System 100 is a physical medical device, not an AI system, so this type of study would not be applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
| Standalone Study Conducted |
|---|
| Not applicable |
Explanation: "Standalone" performance refers to an algorithm's performance without human intervention, again, relevant for AI diagnostic systems. This device is not an AI algorithm.
7. The Type of Ground Truth Used
| Type of Ground Truth |
|---|
| Not specified |
Explanation: While "Clinical data confirm that the device is safe and effective," the specific type of ground truth (e.g., patient outcomes, physiological measurements, laboratory results) used in these clinical studies to evaluate safety and effectiveness is not detailed. For a device like this, ground truth would likely involve measurements of fluid removal, patient vital signs, and adverse event reporting.
8. The Sample Size for the Training Set
| Sample Size (Training Set) |
|---|
| Not applicable |
Explanation: The concept of a "training set" is typically associated with machine learning or AI models. The System 100 is a physical medical device, not an AI algorithm, so it does not have a training set in this context.
9. How the Ground Truth for the Training Set Was Established
| How Ground Truth was Established (Training Set) |
|---|
| Not applicable |
Explanation: As stated above, there is no training set for this type of device.
In summary: The provided 510(k) summary focuses on the regulatory aspects of substantial equivalence. It confirms that non-clinical and clinical data were generated to demonstrate safety and effectiveness but does not provide the granular details requested regarding specific acceptance criteria, study methodologies, or quantitative performance metrics. Such details would typically be found in more comprehensive study reports or validation documentation, which are not part of this 510(k) summary.
§ 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.”