(208 days)
The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG, Cardiac Output, Thoracic Fluid Content, Left Vent. Ejection Time, End Diastolic Volume, Systemic Vascular Resistance, PressureLeft Cardiac Work, Diastolic Blood Pressure, Pre-Ejection Period, Heart Rate, Acceleration Index, Index of Contractility, Mean Blood Pressure, Systolic Time Ratio, End diastolic Index, Cardiac Index, Stroke Volume, Systolic Blood Pressure.
The BioZDx Hemodynamic Monitor is a portable device for use in the hospital, outpatient and clinical settings. It noninvasively measures a patient's hemodynamic parameters using Impedance Cardiography (ICG) by attaching 8 electrodes to the patient, injecting a minimal current, and reading the returning voltage waveform. It utilizes proprietary DSP electronic circuitry and software incorporating formulas and algorithms to calculate various hemodynamic parameters based on patient inputs (gender, body frame size, height, weight, age, blood pressure) and measured ICG signals. The device includes a built-in printer for reports and an improved patient cable.
This 510(k) submission (K041294) describes the BioZDx Hemodynamic Monitor, which is stated to be substantially equivalent to its predicate devices, the BioZ.pc System (K001081) and the BioZ.com System (K974725). The submission primarily focuses on the device's design, operational principles, software characteristics, and the similarities to the predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics for a novel medical device. The device is largely a repackaging and porting of existing functionality to a new platform.
Therefore, for the BioZDx Hemodynamic Monitor, a direct "acceptance criteria" table with specific quantitative performance metrics and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study demonstrating a new level of accuracy or effectiveness are not provided or required in this 510(k) submission.
Instead, the submission relies on demonstrating substantial equivalence to already cleared predicate devices. The "acceptance criteria" are implicitly met by showing that the new device performs equivalently to the predicate devices for its intended use, with any changes verified and validated.
Here's an analysis based on the provided document, addressing your points where possible, and noting where information is not present due to the nature of a substantial equivalence submission for a re-packaged device:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit acceptance criteria with specific quantitative performance metrics for the BioZDx Hemodynamic Monitor are not presented in this 510(k) summary. The submission focuses on hardware, software, and functional equivalency to the predicate devices. The "performance" is implicitly considered equivalent to the predicate devices.
The justification for substantial equivalence is primarily presented in "Table 1 Device Equivalency" which compares attributes of the new device to the predicates. This table highlights design and functional aspects rather than quantitative performance.
| Attribute | BioZDx (New) | BioZ.pc (Predicate) | BioZ.com (Predicate) |
|---|---|---|---|
| Packaging | Separate computer and Patient Interface Module (PIM) | Separate computer and Patient Interface Module (PIM) | Self-contained instrument (computer and Patient Interface Electronics) |
| Pt. Interface Circuitry and sensors | Same as BioZ.com and BioZ.pc with addition of continuous lead fail. All accessories except patient cable same as BioZ.com | Same as new device with exception of continuous lead fail. All accessories except patient cable same as new device | Same as new device with exception of continuous lead fail. All accessories except patient cable same as new device |
| Defib Protection | Moved to yoke of patient cable | Internal to BioZ.pc Instrument | Internal to BioZ.com Instrument |
| CPU | Intel 586 equivalent PC | Intel 586 or Equivalent PC | Intel 386EX PC |
| CPU Packaging | Separate from patient interface circuitry, connected with serial link | Separate from patient interface circuitry, connected with serial link | Internal to BioZ.com Instrument |
| CPU Communications | USB Serial | RS323 Serial (External) | RS232 Serial (Internal) |
| PC Operating System | Windows CE® | Windows 98 or NT® | DOS 6.22 |
| PC Software Installation Kit | Manufactured and supplied per CDIC Manufacturing Procedure 02-121 | Manufactured and supplied per CDIC Manufacturing Procedure 02-121 | Manufactured and supplied per CDIC Manufacturing Procedure 02-121 |
| Printer | Internal to Cardiograph HPGL Protocol | Externally connected HPGL Protocol | Externally connected HPGL Protocol |
| User Interface software | BioZDx ver V1.0x9 | BioZ.pc V1.52 | BioZ.com V2.26 |
| User Display | Internal VGA Screen | External PC VGA Screen | BioZ.com internal ¼ VGA screen |
| Blood Pressure Electronics | Internal to BioZ.dx PIM Suntech Module | Internal to BioZ.pc PIM Suntech Module | Internal to instrument CAS or Suntech Module |
| Pulse Oximeter Electronics | Discontinued as a product feature | Internal to PIM | Externally connected to instrument via serial data cable |
| DSP Packaging | Internal to PIM | Internal to PIM | Internal to BioZ.com Instrument |
| DSP Firmware | CDIC ZMARC+ Ver V00.04.16.10.09 | CDIC ZMARC Ver1.09 | CDIC ZMARC Ver 2.15 |
| Patient Simulator | Built-In for user convenience | Separate Device (BZ-4525) | Separate Device (BZ-4525) |
The document states, "There were no unexpected test results due to these changes and the validation of these changes is included in Section J." This implies that the validation confirmed the device continued to perform as expected, consistent with the predicate devices, despite the modifications.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the summary. The submission primarily discusses design controls, verification, and validation processes, but does not detail a specific test set (e.g., patient data) for evaluating the device's hemodynamic measurement accuracy. As it's a re-packaging, the core algorithms and signal processing are stated to be "nearly identical" or improved versions of the predicate. The validation would likely involve engineering tests and comparison to the predicate's known performance, rather than a new clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided as there is no mention of a clinical test set that required ground truth establishment by experts. The focus is on the device's engineering and software changes and their verification.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a clinical test set or expert adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typical for medical imaging AI systems to evaluate human reader performance with and without AI assistance. The BioZDx is a hemodynamic monitoring device, and this type of study is not applicable to its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a standalone hemodynamic monitor. Its performance would inherently be "algorithm only" in terms of its ability to measure and calculate hemodynamic parameters. However, the document does not present separate standalone performance metrics (e.g., accuracy, precision) against a defined ground truth for the algorithms themselves. Instead, it states that "the validation of these changes is included in Section J" for the enhanced fiducial point detection techniques and the statistical based modulation factor for dZ/dTmax. This implies internal testing was done to ensure algorithm performance was maintained or improved, but specific results are not detailed in this summary.
7. The Type of Ground Truth Used
The type of ground truth is not explicitly stated for any performance evaluation. Given the context of a 510(k) for a re-packaged device, it is highly likely that the "ground truth" for validation of algorithmic changes would involve known physiological signals generated by test equipment or validated against established measurement standards rather than pathology or outcomes data. For example, a patient simulator (which the BioZDx now has built-in, where predicates used an external one) would be used to simulate expected hemodynamic signals, and the device's measurements would be compared against the known simulator outputs.
8. The Sample Size for the Training Set
This information is not provided. The device uses "proprietary DSP electronic circuitry and software incorporating formulas and algorithms," including "enhanced fiducial point detection techniques" and "a statistical based modulation factor for dZ/dTmax." While these might imply some form of algorithm development, the document does not refer to a "training set" in the context of contemporary machine learning. The algorithms are likely based on established impedance cardiography principles and refined through engineering.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as there is no mention of a training set or its ground truth.
§ 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.