(90 days)
The BioZ.com Hemodynamic Monitor is intended to monitor a patient's hemodynamic parameters. These parameters include: ECG, Heart Rate, Pre-ejection Period, Left Ventricular Ejection Time, Systolic Time Ratio, Stroke Volume, Cardiac Output, Cardiac Index, Systemic Vascular Resistance, End Diastolic Volume, End Diastolic Index, Index of Contractility, Acceleration Index, Left Cardiac Work, Thoracic Fluid Content, Respiration Rate.
The BioZ.com System is a self-contained computer-based product utilizing the same CardioDynamics proprietary DSP circuitry and software as its predicate device. It consists of an Instrument (containing DSP and Patient Interface Circuitry, Intel 80X86 Processor Board, DSP firmware and user software, power supply, built-in flat-panel screen, keyboard/keypad, power cord), Patient Cable, and Electrodes/Transducers. It is portable and can operate from AC power or an internal rechargeable battery. It uses thoracic electrical bioimpedance (TEB) by attaching 8 electrodes to the patient and injecting a minimal current to measure hemodynamic parameters.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BioZ.com System:
1. Table of Acceptance Criteria and Reported Device Performance
The submission acts as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device rather than setting new, explicit performance-based acceptance criteria in the traditional sense for a novel device. The "acceptance criteria" here are implied by the claim of functional equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintenance of functional equivalence to predicate device. | An "Accuracy and Equivalency Test" was performed. |
| Measurement and calculation of hemodynamic parameters. | "Digitized waveforms from a number of patients with various clinical conditions were input into the BioZ Portable System and then the BioZ.com System. After one minute, three parameters were recorded for each device. The measurement and calculations performed by the device achieved the expected results." The specific parameters recorded are not detailed in the summary, but the general claim is that the BioZ.com produced results comparable to the BioZ Portable. |
| Substantial equivalence in design, intended use, and operation. | The document extensively details the similarities in proprietary DSP circuitry, software, formulas, algorithms, and required input parameters. Differences (e.g., hardware platform, screen display, battery operation) are described, and the study aims to show these differences do not impact functional output. |
| Ability to noninvasively measure hemodynamic parameters using TEB. | Implied by the successful equivalency test, given the predicate device already performs this function. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "a number of patients" (specific number not provided).
- Data Provenance: "Digitized waveforms from a number of patients with various clinical conditions." This suggests retrospective data, likely from existing patient recordings that were processed by both devices. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The study description focuses on comparing the output of the two devices against each other, rather than against a separate "ground truth" established by experts.
4. Adjudication Method for the Test Set
- None specified. The study describes a direct comparison between the two devices' outputs rather than an adjudication process involving human review against a benchmark.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. The study was a "device-to-device" comparison using digitized waveforms, not an assessment of human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in effect. The study described is a standalone performance assessment comparing the BioZ.com's output to the BioZ Portable's output when processing the same "digitized waveforms." There is no mention of human intervention or interpretation influencing the output being compared.
7. Type of Ground Truth Used
- The "ground truth" in this context is the output of the predicate device (CardioDynamics BioZ Portable System). The study's purpose was to demonstrate that the BioZ.com System is "substantially equivalent" to this established predicate.
- It is not expert consensus, pathology, or outcomes data external to the device capabilities themselves.
8. Sample Size for the Training Set
- Not applicable / Not provided. This device is a medical monitoring system that calculates hemodynamic parameters using bioimpedance, not a machine learning or AI device that typically involves a distinct "training set." The algorithms and software are described as essentially the same as the predicate, derived from "CardioDynamics proprietary DSP circuitry and software."
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As noted above, there is no mention of a training set for machine learning. The "ground truth" (or established performance) for the underlying algorithms would have been developed during the initial creation and validation of CardioDynamics' proprietary DSP circuitry and software for the predicate device, but that information is not detailed here.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.