FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Fresenius 2008T Hemodialysis Machine (K111639) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, the blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient. The front of the machine, with three main sections, contains all of the controls the operator needs access to during a hemodialysis treatment. The top section of the 2008T Hemodialysis Machine contains the control panel and houses the computer, which runs the treatment program and the separate CDX PC board, which provides the platform for users to utilize medical information software of their choice. The CDX PC is physically located in the 2008T machine's cabinet, but operates independently of the 2008T machine with no capacity to either control the operation of the 2008T hemodialysis machine or influence its programming. The control panel includes the touchscreen display, fold-down keyboard, touchpad and keypad which allow the operator/user to control the operation of machine by aiding the setting of treatment parameters, monitoring treatment and patient status during dialysis. The center section contains the modules used for the safe transfer of blood to and from the dialyzer. Dialysate management occurs in the bottom section of the 2008T hemodialysis machine, where the acid and bicarbonate concentrates used to make up the dialysate are mixed and pumped to the dialyzer. Modifications to the previously cleared 2008T Hemodialysis Machine (K111639) include: CDX as an Optional Feature and Proposed maintenance changes (Fn Lock Keyboard).

AI/ML Overview

The provided text describes a Special 510(k) Notification for modifications to the Fresenius 2008T Hemodialysis Machine. This submission focuses on engineering changes rather than clinical performance comparisons. Therefore, much of the requested information regarding clinical study design (sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for test and training sets) is not applicable or cannot be extracted from this document, as the submission primarily addresses the safety and effectiveness of hardware and software modifications.

However, I can extract the acceptance criteria and a summary of the performance testing that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Functional Performance (Software)	- Software Verification (Functional Tests) completed.

Regression testing completed.
Safety Systems Verification completed.
Simulated Dialysis Treatment completed.
Production Test Procedure completed.
Unstructured and Static Code Verification completed. |
| Safety | - EMC Testing (ESD immunity, emissions) completed.
Risk Analysis completed, potential hazards identified and mitigated, and deemed acceptable after mitigation. |
| Durability/Reliability (Fn Lock Keyboard - Elastomer) | - Unit Testing (Fn Lock Keyboard) completed.
Physical Testing (Fn Lock Keyboard) completed, including High Tear Elastomer Use Life (Shelf Life) and Life Cycle. |
| Overall Device Functionality | - The modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria.
The modifications do not impact the essential performance, and the device functions as intended. |
| Substantial Equivalence | - The modified device is substantially equivalent to the named predicate device (K111639) and remains safe and effective for its intended use. |

2. Sample size used for the test set and the data provenance:

Not Applicable/Not Provided. The document describes engineering verification and validation testing for hardware and software modifications to an existing hemodialysis machine. It does not mention a clinical "test set" in the context of patient data or clinical outcomes. The performance testing involves various technical tests (e.g., software verification, safety, durability), not a study on a patient population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Provided. Ground truth (in a clinical sense) is not established or discussed for the types of engineering verification tests performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable/Not Provided. Adjudication methods are not relevant to the described engineering verification and validation testing.

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/Not Provided. This submission is for modifications to a hemodialysis machine, not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable/Not Provided. (See point 5).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable/Not Provided. For engineering verification, the "ground truth" would be objective engineering specifications, design requirements, and regulatory standards, rather than clinical ground truth types.

8. The sample size for the training set:

Not Applicable/Not Provided. The document describes modifications to an existing medical device, not a machine learning model requiring a "training set."

9. How the ground truth for the training set was established:

Not Applicable/Not Provided. (See point 8).

Study Proving Device Meets Acceptance Criteria:

The document section "G. Performance Testing" and "H. Conclusion" describe the study and its results:

Study Title: "Performance Testing" of the 2008T Hemodialysis Machine with CDX as an Optional Feature and other modifications.
Objective: To ensure that the modifications (CDX as an optional feature, Fn Lock Keyboard, new elastomer material) do not impact the essential performance of the device and that the device functions as intended, meeting pre-determined acceptance criteria.
Methodology: Design verification and validation testing, conducted according to existing FMCNA procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR 820).
- Tests Performed:
  - Software Verification and Validation Testing: Functional Tests, Regression, Safety Systems Verification, Simulated Dialysis Treatment, Production Test Procedure, Unstructured and Static Code Verification.
  - Safety Testing: EMC Testing (ESD immunity, emissions).
  - Unit Testing: Fn Lock Keyboard.
  - Physical Testing: Fn Lock Keyboard (High Tear Elastomer: Use Life, Life Cycle).
  - Risk Analysis: Completed to identify and mitigate potential hazards.
Results (as stated in Section H. Conclusion): "The test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results of functional and software validation, performance testing, risk analysis, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use."

The study described is an internal verification and validation process, typical for modifications to existing medical devices to ensure they continue to meet established performance and safety specifications. It explicitly states that "Design verification and validation testing were conducted to ensure that the modifications described in this submission will not impact the essential performance of the device and the device functions as intended."

Summary

Regulation Number and Section

§ 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.”