(28 days)
For use with System 100.
Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.
The device has identical materials of construction, packaging and sterilization. It is provided sterile and the fluid pathway is nonpyrogenic. The intended use is to connect the System 100 circuit outflow line to the access catheter for filtered blood return into the patient. Two changes are reflected in this submission for an alternate catheter extension and do not change the intended use.
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- One of the two proprietary connectors was replaced with a standard male luer connector.
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- Labeling was updated to allow use of the alternate extension catheter on the outflow side of the System 100, UF 500 extracorporeal filter circuit.
Acceptance Criteria and Study for Infusion Catheter Extension, Model 1513
This document summarizes the acceptance criteria and the study performed for the Infusion Catheter Extension, Model 1513, based on the provided 510(k) summary (K023224).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Aspect | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | The device must demonstrate acceptable flow rates when connected to a variety of access catheters. The device, an extension catheter, is intended to connect the System 100 circuit outflow line to the access catheter for filtered blood return into the patient. The acceptance criteria for "acceptable flow rates" are not explicitly quantified (e.g., minimum mL/min) but rather stated as "acceptable for use with the System 100," indicating that the flow rates achieve the intended therapeutic purpose of the System 100 (high permeability hemodialysis). The dimensional characteristics of the access catheters for which these flow rates are achieved also fall within the acceptance criteria. | Bench testing demonstrated that access catheters meeting or falling within specified dimensional characteristics for lumen diameter and length resulted in flow rates acceptable for use with the System 100. The specific "acceptable dimensional characteristics" were incorporated into the directions for use. |
| Material Equivalence | The device must utilize identical materials of construction to the predicate device (System 100, cleared under K013733). | The device has identical materials of construction as the predicate device. |
| Packaging Equivalence | The device must utilize identical packaging to the predicate device. | The device has identical packaging as the predicate device. |
| Sterilization Equivalence | The device must utilize identical sterilization methods to the predicate device. | The device has identical sterilization methods as the predicate device. |
| Sterility | The device must be provided sterile. | The device is provided sterile. |
| Non-pyrogenicity | The fluid pathway of the device must be nonpyrogenic. | The fluid pathway is nonpyrogenic. |
| Intended Use | The modifications to the device (one proprietary connector replaced with a standard male luer, and updated labeling to allow use on the outflow side of the System 100, UF 500 extracorporeal filter circuit) must not change its intended use, which is to connect the System 100 circuit outflow line to the access catheter for filtered blood return into the patient. | The two changes reflected in the submission for an alternate catheter extension do not change the intended use. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document states that "Bench testing was performed on a variety of access catheters." It does not specify the exact number of different access catheters or the total number of tests performed.
- Data Provenance: The study was a prospective bench test conducted by the submitter (CHF Solutions, Inc.). The country of origin of the data is not explicitly stated but can be inferred to be within the United States, given the submitter's address in Minnesota and the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
This submission does not involve human interpretation of data where expert consensus for ground truth would be required. The study is a bench test evaluating physical performance (flow rates) and material characteristics. Therefore, no experts were used to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication Method for Test Set
Not applicable. As this was a bench test evaluating physical and functional characteristics, there was no need for an adjudication method typically associated with human performance studies or clinical trials involving subjective assessments. The results would be objectively measured (e.g., flow rate values) against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a passive accessory (catheter extension) and its performance is evaluated through bench testing against functional and material specifications, not through human reading of medical images or diagnostic tasks.
6. Standalone (Algorithm Only without Human-in-the-loop Performance) Study
No, a standalone study in the context of an algorithm's performance was not done. This product is a physical medical device, not a software algorithm. Its performance is inherent to its physical design and materials, measured through bench testing.
7. Type of Ground Truth Used
The ground truth used was based on engineering specifications and functional requirements for flow rates that are "acceptable for use with the System 100." This includes objective measurements of flow through the device when connected to various access catheters of specified dimensions. Additionally, the ground truth for material composition, packaging, and sterilization was based on the established characteristics of the predicate device.
8. Sample Size for Training Set
Not applicable. This is a physical medical device submission, not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there was no training set for an algorithm.
§ 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.”