(210 days)
The HD01-CO monitor is intended for use by trained medical personnel, for assessment of a patient's hemodynamic condition through estimation of cardiac output while undergoing hemodialysis treatment in a non-critical care setting.
For use only by or on the order of a physician licensed by law to use or order the use of this device.
The HD01 family of devices use transit-time ultrasound principles to measure blood flow and to register sound velocity indicator dilution curves. Standard Stewart-Hamilton equations are employed for the various calculations. All Transonic HD01-series hemodialysis monitor devices consist of the following components: HD01 Flow/Dilution meter, Dual flow/dilution sensor, and Monitor software. The various HD01 devices differ in their indications for use through the supplied software routines.
Here's a breakdown of the acceptance criteria and the study information for the Transonic HD01-CO Cardiac Output Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Predicate Device COC-1) | Reported Device Performance (Transonic HD01-CO) |
|---|---|---|
| Bench Accuracy (in vitro) | ± 3% (0-4 ℃), or ± 4% (19-25 ℃) + thermistor-related sensing errors | ± 5% (From all sources) |
| Bench Computational Variations | ± 3% | Negligible |
| Repeatability (all sources) | Not Specified | ± 4% |
| In Vivo Accuracy | ± 20% (inferred from literature) | ± 20% |
| Cardiac Output Measurement Range | 0.1 to 20 L/min | 1 to 20 L/min |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a specific sample size for a dedicated test set nor details about data provenance (country of origin, retrospective/prospective) for this particular 510(k) submission's effectiveness study.
Instead, the submission refers to a list of published studies (Table 2-2) that "document the effectiveness of the HD01-CO cardiac output measurements." These are:
- Krivitski, N.M., "Novel Method to Measure Access Flow During Hemodialysis by Ultrasound Dilution Technique," ASAIO Journal, Vol. 41, p. M741-M745, 1995.
- Krivitski, N.M., "Cardiac Output Measurement in Extracorporeal Systems by Ultrasound Dilution," ASAIO Journal Abstracts, p. 82, 1994.
- Nikiforov, U.V., Kisloukhine, V.V., Chaus, N.I., "Validation of a New Method to Measure Cardiac Output During Extracorporeal Detoxification," ASAIO Journal Vol. 42, No. 5, p. M903-M905, 1996.
- Kisloukhine, V.V, Dean, D.A., "Validation of a Novel Ultrasound Dilution Method to Measure Cardiac Output During Hemodialysis," ASAIO Journal, Vol. 42, No. 5, p. M906-M907, 1996.
- Glidden, D., Miranda, C.. "Access Flow Measured during Hemodialysis," ASAIO Journal, Vol. 42, No. 5, p. M530-M532, 1996.
- Depner, T.A., Eder, L.A., "Changes in Access Blood Flow and Appearance of Recirculation during Hemodialysis," XIIIth International Congress of Nephrology Abstracts, p. 570, 1995.
- Chaus, N.I, Kislukhin, V.V., Dzemeshkevich, S.L., Zhidkov, I.L., "Comparison of Sound Velocity, Impedance, and Optical with Thermal Methods for Cardiac Output," FASEB Journal, Vol. 11, No. 3, Abstract #2872, 1997.
- Depner, T.A. & Krivitski, N.M., "Influence of Access Blood Flow (AF) on Systemic Blood Flow in Hemodialysis Patients," JASN. Vol.8, p. 155A, 1997.
To determine sample sizes and specific data provenance, one would need to review each of these referenced publications. The submission itself does not provide these details directly.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that the effectiveness is supported by "bench and clinical tests cited above" and external publications, the document does not specify the number of experts or their qualifications for establishing ground truth across all studies. Ground truth for in vivo accuracy is inferred from literature. For the predicate device, the "medical community raises serious concerns on a possible higher co-morbidity when Swan-Ganz catheters are used", suggesting clinical expertise is involved in assessing its performance. However, this is not about establishing ground truth for the HD01-CO's test set directly.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for a specific test set. The validation relies on comparisons to existing methods (thermodilution) and published studies, which would typically have their own internal validation and statistical analysis methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. The device is a measurement tool, not an interpretation tool that human readers would use to make a diagnosis or assessment, thus such a study would not be applicable. The comparison is between the performance of the device and a predicate device/established methods.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The accuracy and performance metrics provided (Bench Accuracy, Computational Variations, Repeatability, In Vivo Accuracy) directly reflect the standalone (algorithm only) performance of the device, as it is designed to measure cardiac output based on ultrasonic dilution principles and calculations. There is no human-in-the-loop performance described for the device's functional output.
7. Type of Ground Truth Used
The ground truth for effectiveness is primarily established through:
- In vitro measurements: For bench accuracy and computational variations.
- Comparison to predicate device/established methods: The "In Vivo Accuracy" of ±20% for both the predicate and the HD01-CO is likely derived from comparisons to established, more invasive methods of cardiac output measurement (e.g., invasive thermodilution with Swan-Ganz catheter, as mentioned for the predicate). The listed publications delve into validating the ultrasound dilution technique against other methods.
- Performance standards: The device's performance is measured against quantifiable metrics like accuracy and repeatability, which are intrinsically tied to an objective "true" value in a controlled setting or validated clinical comparison.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This device primarily uses established physical principles (transit-time ultrasound, Stewart-Hamilton equations) and a fixed algorithm for calculations. It is not an AI/machine learning device that typically undergoes a distinct "training" phase with a large dataset in the conventional sense. The "training" would be more akin to calibration and testing during development to ensure the algorithm correctly implements the physiological model.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of an AI/ML algorithm is not applicable here. The device relies on fundamental physics and mathematical equations. The ground truth for validating its performance (which could be considered a form of "training" or "calibration" in a broader sense) would be established through:
- Known physical standards: For bench testing (e.g., precise volumes, flow rates).
- Clinical comparison to gold standard methods: In a clinical setting, cardiac output measurements from established, validated, and often more invasive methods would serve as the ground truth against which the HD01-CO's measurements are compared. The referenced publications would contain details on these comparison methodologies.
§ 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.