(211 days)
- Adults (Transesophageal Probe Model 200-018)
- Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult patients under anesthesia and/or in intensive care.
- Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO2 pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.
- Pediatrics (Transesophageal Probe Model 200-019)
- Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for pediatric patients under anesthesia and/or in intensive care.
- Derivation of real-time composite hemodynamic profile (aortic blood flow, arterial pressures, heart rate, stroke volume in the aorta, end-tidal CO2 pressure, systemic vascular resistances for aortic circuit, systolic time intervals), providing indications of cardiovascular status.
The DYNEMO 3000 is a non-invasive hemodynamic diagnostic device designed to provide the anesthesiologist, cardiologist, and intensive care physician with a noninvasive continuous hemodynamic profile derived from measurement and monitoring of the aortic blood flow (ABF) in real time. The DYNEMO 3000 is designed to operate in a clinical setting in which an adult or pediatric patient is under anesthesia and/or in intensive care. This type of monitoring device also offers the anesthesiologist and intensive care physician the capability of tracking critical parameters providing indications on the patient's cardiovascular status.
The DYNEMO 3000's principle of operation is based on the simultaneous. realtime ultrasound measurement of aortic diameter and blood velocity, independently. This is achieved by inserting an endo-esophageal (or transesophageal) probe equipped with two (2) ultrasonic transducers is inserted into the patient's esophagus either trans-orally or trans-nasally.
The measurement of the descending aortic diameter is made through M-Mode echo ultrasonography at a 10 MHz frequency. A thin beam resulting from the 10 MHz ultrasonic wave, produces high resolution images of the aortic walls. Through the manual rotation of the probe's distal end by the user, the M-Mode signal can be optimized, thereby providing an accurate measurement of the instantaneous aortic diameter.
A second transducer measures the Doppler signal. The 5 MHz Doppler velocimeter allows for the precise velocity measurement over the section of the aorta.
These two (2) ultrasound measurements are combined in real-time to provide an accurate measurement of the aortic blood flow (ABF) in the descending aorta. The microprocessor based DYNEMO 3000 unit communicates with external peripheral monitors including ECG, non-invasive blood pressure, and capnograph. A specialized software then synchronously combines data with that from these peripheral monitors to continuously display the composite hemodynamic profile of the patient in real time:
- · Aortic blood flow.
- · Arterial pressures,
- · Heart rate.
- · Stroke volume in aorta,
- · Total systemic vascular resistance for aortic circuit
- · Systolic time intervals, and,
- · End-tidal CO2 pressure.
The DYNEMO 3000 consists of five primary components:
- · the main console.
- · the transesophageal probe,
- · the disposable silicone sheath including an inflatable balloon,
- · the probe support, and,
- · the probe cable.
The main console provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the DYNEMO 3000 device. It contains a 7" screen used to display the parameters and the charts associated with the patient's ABF measurement. The console also houses the electrical components, and a data recording unit. The device operates from a 100-240V supply.
The adult and pediatric transesophageal probe is comprised of a flexible "insertion tube", a sensor tip, and a mechanical head.
The flexible "insertion tube" is used for mechanical and electrical connection between the mechanical head and the sensors. It is fitted with a sliding O ring indicator to mark the depth of insertion. A cable located inside of the insertion tube can rotate along its axis without movement of the outer casing.
The sensor tip, comprises of two (2) piezo-electric transducers.
The mechanical head rotates axially with an index that moves in front of another reference index located on the fixed section. This constitutes the onentation mechanism of the ultrasound transducers. A fixed section supports a lock and tap for filling and emptying a silicone balloon sheath. This section also permits to lock the transesophageal probe to the flexible probe support.
A single-use, disposable adult or pediatric balloon sheath is chosen according to the selected probe, and the transesophageal probe is inserted inside the balloon sheath which then covers the entire probe, including the sensor tip. When filled with de-mineralized water, the balloon sheath inflates up to the esophageal wall, immobilizes the probe into the esophagus, directs the ultrasound sensors to the aortic target, and guarantees a parallel positioning between the sensor sub-assembly and the axis of the aorta.
The mechanical head of the transesophageal probe remains fixed adjacent to the patient's head and is locked to the patient's operating table or bed with a probe support.
The provided K972798 510(k) summary for the SOMETEC DYNEMO 3000 device does not contain a study that demonstrates the device meets specific acceptance criteria based on performance quantitative metrics, particularly as would be expected for an AI/ML device.
This document is a 510(k) submission from 1998, which predates the widespread use of AI/ML in medical devices and the typical methodologies for evaluating such devices. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices based on technical characteristics, intended use, and general performance ranges, rather than a clinical trial with specific performance acceptance criteria for a new algorithmic output.
Therefore, many of the requested sections below cannot be fully addressed from the provided text.
Here's an attempt to extract the relevant information based on the prompt's requirements, acknowledging the limitations of the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that an AI/ML device would typically have, nor does it present a study to prove such criteria are met for the DYNEMO 3000's primary output (Aortic Blood Flow).
Instead, the submission for the DYNEMO 3000 focuses on demonstrating substantial equivalence to predicate devices (Hewlett Packard HP 21362B, Datascope ACCUCOM, Deltex EDM) by comparing technical specifications and functional capabilities. The "performance data" presented in Table A are primarily ranges of measurements for various parameters and features, not statistical performance metrics against a gold standard.
| Parameter | Acceptance Criteria (Not Explicitly Stated as such in the document for DYNEMO 3000 performance, but derived from predicate device ranges for comparison) | Reported DYNEMO 3000 Performance (Range) |
|---|---|---|
| Adult Probe Measurements | ||
| Blood Flow Velocity (cm/sec) | (Predicate range: 10-300 cm/sec) | 10-196 cm/sec |
| Aortic Diameter (mm) | (Predicate range: Not available for HP, None for others) | 7.9-48 mm |
| Cardiac Output (l/min) | (Predicate range: 0-20 l/min estimated) | Not measured (This highlights a difference from some predicates) |
| Aortic Blood Flow (l/min) | (Predicate range: 0-20 l/min estimated) | 0.3-20 l/min |
| Pediatric Probe Measurements | ||
| Blood Flow Velocity (cm/sec) | (Predicate range: No pediatric probe for Datascope/Deltex) | 10-196 cm/sec |
| Aortic Diameter (mm) | (Predicate range: No pediatric probe for Datascope/Deltex) | 3-36 mm |
| Cardiac Output (l/min) | (Predicate range: No pediatric probe for Datascope/Deltex) | Not measured |
| Aortic Blood Flow (l/min) | (Predicate range: No pediatric probe for Datascope/Deltex) | 0-20 l/min |
| Heart Rate Sensing (b/mn) | (Predicate range: 30-200 b/mn) | 34-230 b/mn |
| Stroke Volume (ml) aorta | (Predicate range: 0-300 ml) | 3-150 ml (Note: The predicate Datascope ACCUCOM lists 0-300 for cardiac output, not specifically stroke volume in ml) |
| Systemic vascular resistance | (Predicate range: 0-9990) | 300-15000 |
| Systolic time intervals (PEPI) | (Predicate range: Flow time/Peak velocity for Deltex) | 75-240 |
| Systolic time intervals (LVETI) | (Predicate range: Flow time/Peak velocity for Deltex) | 250-600 |
The key "acceptance criteria" appear to be that its ranges of measurement are comparable to or within the expected physiological ranges covered by the predicate devices, and that its technical features and intended use align sufficiently for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a specific "test set" in terms of patient data used for evaluating the DYNEMO 3000's primary performance metrics against a ground truth. The submission mainly relies on comparisons with predicate device specifications. There is no information on sample size, country of origin, or whether any data used was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a test set validated by experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a test set or an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device that assists human readers/users in interpretation, but rather a direct measurement device itself. There is no mention of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The DYNEMO 3000 is a standalone monitoring device that measures and displays parameters. Its performance is inherent in its measurements. The "performance" described is the device's ability to measure and derive hemodynamic parameters, which is a standalone function. There isn't a separate "algorithm only" performance study presented in the context of an AI/ML algorithm that might have human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the core measurements of aortic diameter and blood velocity, the "ground truth" implicitly relies on established physical principles of ultrasound measurement. However, no specific ground truth validation (e.g., comparing DYNEMO 3000's output to an invasive gold standard like thermodilution) is detailed or referenced in this summary. The submission focuses on the method of measurement (M-Mode echo and Doppler signal) and its combination to derive ABF, rather than clinical validation of the derived ABF against an external gold standard.
8. The sample size for the training set
Not applicable. The device is not described as utilizing AI/ML that requires a training set. It's a bio-physical measurement device.
9. How the ground truth for the training set was established
Not applicable. The device is not described as utilizing AI/ML that requires a training set.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).