SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT by CHF SOLUTIONS, INC.

The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.

This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."

Reported Device Performance:

Assessment Area	Reported Performance
Materials	Identical to predicate devices
Packaging	Identical to predicate devices
Sterilization	Identical to predicate devices
Sterility	Provided sterile
Pyrogenicity	Nonpyrogenic
Compatibility	Bench tests demonstrate the modified UF500 remains compatible with the System 100.
Intended Use	Safe and effective for its intended use (aspiration, injection, or gravity flow of fluids using a male luer fitting with System 100).
Substantial Equivalence	Substantially equivalent to predicate devices (CHF Solutions, System 100 (K013733) and B. Braun Medical Inc.'s ULTRASITE® valve (K955585)).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an AI or software device, and no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This is a physical medical device (circuit with a port), not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned or relevant for this type of device modification.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set is mentioned or relevant for this type of device modification.

Summary of the Study (as described in the document):

The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:

Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.

The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.

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.”