(90 days)
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic herapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette designed as a connection between the arterial bloodline and the hemodialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CRIT-LINE Clip (CLiC) Blood Chamber, structured according to your request.
Overall Device Context:
The document relates to a 510(k) premarket notification for the CRIT-LINE Clip (CLiC) Blood Chamber, a sterile, single-use, disposable optical cuvette for non-invasively measuring hematocrit, percent change in blood volume, and oxygen saturation during hemodialysis. The goal is to demonstrate substantial equivalence to a predicate device (CRIT-LINE Blood Chamber (K935958)).
Important Note: This document is a 510(k) summary, which typically provides high-level results and conclusions rather than detailed study protocols and raw data. Therefore, some of the requested information (like specific effect sizes for MRMC studies, precise sample sizes for certain tests, or depth of ground truth establishment for training) may not be explicitly present. The information provided is based only on the text given.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list numerical "acceptance criteria" alongside "reported device performance" in a separate table for each test. Instead, it states the "Test Objective" and then reports "Pass - Results within acceptance criteria" or similar conclusive statements for all tests. This indicates that the tests met predefined criteria, but the specific numerical thresholds for these criteria are not provided in this summary.
| Test Method (as listed in document) | Test Objective (Acceptance Criteria Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Mechanical Characteristics / Structural Integrity | Ensure the blood chamber is capable of withstanding extreme positive and negative pressure conditions. | Pass - Results within acceptance criteria. |
| Dialyzer Connectors (Female Din connector) | Ensure the connectors meet the performance requirements of ISO 594-2. | Pass - Results within acceptance criteria. |
| Connector to Vascular Access Device (Male Luer Connector) | Ensure the connectors meet the performance requirements of ISO 594-2. | Pass – Results within acceptance criteria. |
| Endurance Performance Test: Extracorporeal Circuit Evaluation | Demonstrate the product performs at various flow rates and bloodline-dialyzer combinations without resulting in any tubing failure (i.e. loosening of connections). | Pass - Results within acceptance criteria. |
| Endurance Performance Test: Effects of Flow Rates on the CLiC Monitor Evaluation | Demonstrate varying flow rates do not affect the CLiC Blood Chamber's ability to allow the CLiC Monitor to record accurate and consistent measurements of Hematocrit (HCT) and Percent Oxygen Saturation (O2 Sat). | Pass - Results within acceptance criteria. |
| Endurance Performance Test: Extracorporeal Circuit Evaluation of Maximum Flow Rate | Demonstrate the product performs at maximum flow rates without resulting in any tubing failure (i.e. loosening of connections). | Pass - Results within acceptance criteria. |
| Bond Strength Testing | Confirm the solvent bonding between the CLiC Blood Chamber blue polycarbonate body and the clear PVC DIN Connector. | Pass - Results within acceptance criteria. |
| Torque Test | Test the material properties after Gamma sterilization. | Pass - Results within acceptance criteria. |
| Blood Pathway Volume (Priming Volume) | Establish the blood pathway volume of the blood chamber for the information for use (IFU). | Pass - Results within acceptance criteria. |
| Functional CLiC Chamber Test | Evaluate the repeatability of the CLiC Blood Chamber by examining differences in hematocrit and oxygen saturation readings between individual chambers and multiple blood chamber lots. | Pass - Results within acceptance criteria. |
| Mechanical Hemolysis Test | Evaluate the hemolytic properties of the CLiC Blood Chamber when exposed to circulating blood flow. | Pass - Results within acceptance criteria. |
| Ship Testing (ISTA 1A) | Ensure the package design is robust and prevents product damage. | Pass - Results within acceptance criteria. |
| Bubble emission test | Ensure packaging does not yield any gross leaks. | Pass - Results within acceptance criteria. |
| Dye Penetration test | Ensure the porous medical packaging does not yield seal leaks. | Pass - Results within acceptance criteria. |
| Peel Test | Determine that the packaging meets the specification for the force required to separate the label portion of the packaging from film at the separator tab. | Pass - Results within acceptance criteria. |
| Film Tensile Strength | Determine that the film used on the packaging meets specification. | Pass - Results within acceptance criteria. |
| Microbial Barrier Aerosol Spore Challenge | Determine the passage of airborne bacteria through CLiC Blood Chamber packaging occurs at an acceptable level. | Pass - Results within acceptance criteria. |
| Sterilization Validation | Validate the gamma radiation sterilization process of the CLiC Blood Chamber by achieving a required sterility assurance level. | Pass – Results within acceptance criteria. |
| Bioburden Validation | Demonstrate the established sterilization dose maintains acceptable levels of bioburden. | Pass – Results within acceptance criteria. |
| Bacterial Endotoxins Test (Nonpyrogenicity) | Validate the claim of “non-pyrogenic” on the device label. | Pass – Results within acceptance criteria. |
| Biological Safety | Demonstrate the biological safety of the CLiC Blood Chamber. | Pass - Results support the conclusion that the CLiC Blood Chamber is biologically safe. |
| Human Factors (Usability Testing) | Evaluate the use of the CLiC Blood Chamber in an environment representative of its intended use. Determine if the instructions for use (IFU) allowed the intended user population to connect the CLiC Blood Chamber to the extracorporeal circuit correctly, safely, and effectively for its intended use. | Pass - Results support a conclusion that the CLiC Blood Chamber has no unacceptable residual risk and is safe and effective for use by the intended user population. |
| CLiC Blood Chamber Storage Temperature Test | Validate the storage temperature requirement on the device label. | Pass - Results within acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact numerical sample sizes for each test listed (e.g., number of chambers tested for mechanical characteristics, number of blood samples for functional tests). It only states that tests were performed "to support the determination of substantial equivalence."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device accessory (a blood chamber), the tests are typically internal, in-house laboratory and engineering tests, rather than clinical trials with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable or not specified in the document. The tests performed are primarily engineering and laboratory performance tests, not diagnostic accuracy studies requiring expert interpretation of results for ground truth.
- Qualifications of Experts: Not applicable or not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. As mentioned, these are laboratory and engineering tests, not studies requiring expert adjudication of clinical outcomes or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable, as no MRMC study was conducted. The device is a physical component (blood chamber) of a hemodialysis system, not a diagnostic imaging algorithm that requires human-in-the-loop performance evaluation.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No, a standalone (algorithm only) performance study was not done. The device itself is a blood chamber, an accessory for a monitor, not an algorithm. The "Functional CLiC Chamber Test" evaluates the repeatability of the chamber's ability to allow the monitor to read HCT and O2 Sat, not the standalone performance of an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the various engineering and performance tests, the "ground truth" would be established by:
- Engineering Specifications/Standards: For mechanical, connector, bond strength, torque, and material property tests. (e.g., ISO 594-2 for connectors).
- Reference Methods/Instrumentation: For tests like blood pathway volume, functional repeatability (comparison to a known standard or highly precise reference method for HCT and O2 Sat measurement), and mechanical hemolysis (e.g., a standardized hemolysis assay).
- Regulatory Requirements: For sterilization, bioburden, and pyrogenicity (e.g., sterility assurance level (SAL), non-pyrogenic limits).
- Usability Best Practices: For human factors testing, evaluating successful vs. unsuccessful completion of tasks according to predefined criteria.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not describe any "training set" in the context of machine learning or AI models. This device is a physical medical accessory, and its evaluation relies on engineering and biological performance testing, not on data-driven algorithm development that typically involves training sets.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.