(161 days)
The Crit-Line Clip Monitor (CLiC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
The intended use of the Crit-Line III (CLM III) Monitor is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement. The CLM III is used primarily as a monitor for dialysis treatments.
The CLM III uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT). The HCT values are then used to calculate the related Blood Volume (BV) percentage change relative to the starting BV based on the beginning HCT.
The CLM III consists of a microprocessor-controlled main circuit board located within the display housing. The display housing contains the sensor clip driver measurementcalculation circuitry and display screen circuitry. The sensor clip with optical system (LED array and a photodetector array) is tethered to the main housing and circuit board by a multi-conductor cable. The cable connects to a single-use, sterile cuvette (K935958) installed in-line with the arterial line of the dialysis tubing set.
Calculations performed on the main circuit board within the display housing yield the hematocrit, oxygen saturation and the related value of blood volume measurement results and are displayed on the LCD display screen.
Modifications to the previously cleared Crit-Line III Monitor include:
- Miniaturization/Re-packaging
The CLiC Monitor incorporates all hardware/electronic components - miniaturized and contained within the sensor clip housing, for measuring indicated parameters (HCT O2 SAT). The primary modification of the device involves integrating a miniaturized microprocessor with the required electronic circuitry and software to drive the existing optical system (LED and photo-detector array) within the plastic sensor clip housing. The CLiC utilizes the same, previously cleared Crit-Line technology (K972470), sensor clip and optical system. The operating principles and fundamental measurement methods of the CLiC are the same as the predicate device.
- Distributed Process Technology
A standard USB cable replaces the tethering multi-conductor cable used in the CLM III Monitor. USB-compatible hardware and software are incorporated in the CLiC housing. The CLiC can be hosted on a medical grade computer system (Windows OS) that can interface with, power a USB peripheral and operate supporting drivers. CLiC interlocks with a singleuse, sterile cuvette (K935958) which is located in-line with the arterial line of the dialysis tubing set for indicated measurements. The lightwave measurements are performed autonomously by the CLiC. Blood parameters are then calculated and transmitted to the host computer display microprocessor in text format by means of the USB interface. The accompanying display software installed on the host computer system facilitates the display of measured parameters: hematocrit, oxygen saturation and blood volume changes on the display screen.
Here's a summary of the acceptance criteria and the study details for the CLiC Monitor (K121599) based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the CLiC Monitor focuses on demonstrating substantial equivalence to its predicate device, the Crit-Line III Monitor (K972470), rather than establishing new, specific numerical acceptance criteria for its performance metrics (hematocrit, oxygen saturation, and percent change in blood volume).
The key "acceptance criteria" presented are:
- The CLiC Monitor's accuracy is equivalent to the predicate device specifications for both hematocrit and oxygen saturation measurements.
- The percentage blood volume comparisons are also equivalent due to the equivalence in hematocrit.
- The device functions as intended and met pre-determined acceptance criteria (though these specific criteria are not quantitatively laid out in the summary).
- The modifications did not affect the essential performance of the device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Hematocrit Measurement Accuracy | Equivalent to predicate device specifications. | Shown to be equivalent to predicate device specifications. |
| Oxygen Saturation Measurement Accuracy | Equivalent to predicate device specifications. | Shown to be equivalent to predicate device specifications. |
| Percent Change in Blood Volume | Equivalent to predicate device specifications (derived from HCT). | Equivalent to predicate device specifications. |
| Essential Performance | Modifications do not affect essential performance. | Design verification and validation tests confirmed that modifications did not affect essential performance. |
| Intended Function | Device functions as intended. | Test results demonstrated the modified CLiC Monitor functions as intended and met pre-determined acceptance criteria. |
| Safety and Effectiveness | Device is safe and effective for its intended use. | Test results from performance testing (in vitro bench testing), safety testing, and usability testing indicate the modified CLiC device is substantially equivalent to the predicate and remains safe and effective for its intended use. |
| Compliance | Adherence to relevant standards (UL 60601-1/IEC 60601-1, IEC 60601-1-2) | Certified to comply with UL 60601-1/IEC 60601-1, and EMC standard 60601-1-2. |
| Risk Mitigation | Potential hazards are identified and mitigated; risks acceptable. | A risk analysis per ISO 14971 was completed, and all potential risks were deemed acceptable after mitigation. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "performance testing (in vitro bench testing), safety testing and usability testing," and "System verification and validation testing." However, no specific sample sizes for test sets (e.g., number of patients, number of blood samples, specific data points) are provided. The data provenance (country of origin, retrospective/prospective) is also not specified. The focus is on demonstrating equivalence to the predicate device through technical evaluation rather than large-scale clinical trials.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention using experts to establish ground truth for a test set in the context commonly associated with AI/algorithm performance studies. The evaluation is against the performance of a known predicate device and compliance with engineering standards.
4. Adjudication Method:
Given that there's no mention of experts establishing a ground truth for a test set, an adjudication method (like 2+1 or 3+1) is not applicable and therefore not mentioned in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or mentioned. This submission is for a device based on an existing technology (Crit-Line III) with modifications related to miniaturization, distributed process technology, and software, rather than a novel AI diagnostic algorithm requiring human-in-the-loop performance evaluation.
6. Standalone Performance:
The 510(k) summary describes the standalone performance of the CLiC Monitor relative to its predicate. The CLiC performs the lightwave measurements autonomously and transmits blood parameters for calculation and display. The core measurement functions (hematocrit, oxygen saturation, blood volume changes) are evaluated based on their equivalence to the predicate device's established performance specifications. The "algorithm" in this context refers to the inherent calculations performed by the device, and its stand-alone accuracy is assessed against the predicate's known accuracy.
7. Type of Ground Truth Used:
The ground truth used for performance validation is implicitly the established performance specifications and measurements of the legally marketed predicate device, the Crit-Line III Monitor. The CLiC Monitor is evaluated to ensure its measurements of hematocrit, oxygen saturation, and calculated blood volume changes are equivalent to those obtained from the predicate device under similar conditions. This involves direct comparison to a validated, previously cleared device, likely through in vitro bench testing (as mentioned).
8. Sample Size for the Training Set:
This device is not presented as an AI/machine learning device that requires a "training set" in the conventional sense. It uses existing, cleared technology and optical principles. Therefore, no specific sample size for a training set is applicable or mentioned.
9. How the Ground Truth for the Training Set was Established:
As this is not an AI/ML device with a training set, the question of how ground truth was established for a training set is not applicable. The device functions based on established light absorption and scattering principles and signal processing, akin to an updated version of an existing physical measurement device. Its performance is validated against the known performance characteristics of its predecessor.
§ 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.