(211 days)
Not Found
No
The description focuses on the physical components, ultrasound principles, and data integration from external monitors. There is no mention of AI or ML algorithms being used for data processing, analysis, or derivation of the hemodynamic profile.
No
The device is described as a "non-invasive hemodynamic diagnostic device" used for "measurement and monitoring" of various cardiovascular parameters, providing "indications of cardiovascular status." Its function is solely to provide information for diagnosis and monitoring, not to treat or alter a physiological state.
Yes
This device is explicitly described as a "non-invasive hemodynamic diagnostic device" in the "Device Description" section, and its function involves measuring and monitoring physiological parameters to provide indications of cardiovascular status, which is a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a main console, transesophageal probe, disposable silicone sheath, probe support, and probe cable. It also describes the physical operation of the probe and console.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The DYNEMO 3000 directly measures and monitors physiological parameters within the patient's body (aortic blood flow, arterial pressures, heart rate, etc.) using ultrasound. It does not analyze samples taken from the patient.
- Intended Use: The intended use is for real-time measurement and monitoring of cardiovascular status in patients under anesthesia or in intensive care. This is a direct physiological measurement, not an analysis of a biological specimen.
Therefore, the DYNEMO 3000 falls under the category of a medical device that performs physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DPW, 74 DPT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Aorta
Indicated Patient Age Range
Adults, Pediatrics
Intended User / Care Setting
Anesthesiologist, cardiologist, intensive care physician, clinical setting. Patients under anesthesia and/or in intensive care.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SMDA Summary of Safety and Effectiveness - "510(k) Summary" 10.
FEB 2 4 1998
-
A. Submittor Information Sponsor:
SOMETEC, Inc. c/o Interactive Consulting Inc. 70 Walnut Street Wellesley, MA 02181 (617) 239-8108 (617) 674-2002 Fax -
SOMETEC Manufacturer: 60 rue de Wattignies 75012 Paris, FRANCE
011-331-40-28-57-90 Telephone:
Contact Person: Jean-Luc Boulnois, Ph.D. President
Date Prepared: July 17, 1997
B. Device Identification
Common/Usual Name Proprietary Name:
Aortic Blood Flow Monitor DYNEMO 3000
- C. Identification of Predicate Device(s)
The DYNEMO 3000 is substantially equivalent to the following previously cleared and currently marketing devices:
Hewlett Packard HP 21362B (K884395) Datascope ACCUCOM (K851426) Deltex EDM (K951369)
D. Device Description
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
1
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.
2
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.
E. Substantial Equivalence
The technical characteristics are almost identical to those of the Hewlett Packard HP21362B (K884395), the Datascope ACCUCOM (K851426), and the Deltex EDM (K951369) previously cleared predicate devices. Refer to Tables A, B, and C for a comparison of these predicate devices. Differences that exist between these devices in terms of technical specifications, ultrasonic technology, functions, performances, intended use, and methods of application, do not affect the relative safety or effectiveness of the DYNEMO 3000 device.
The intended use for the DYNEMO 3000 device, as with the previously cleared devices, is to provide the anesthesiologist, cardiologist and intensive care physician with
- . a non-invasive, continuous real-time measurement and monitoring of the aortic blood flow for adult or pediatric patients under anesthesia and/or in intensive care;
- . The derivation of real-time composite hemodynamic profile providing indications on the patient's cardiovascular status.
The composite hemodynamic profile consists of the following:
- · Aortic blood flow.
- · Arterial pressures,
- · Heart rate,
- · Stroke volume in the aorta.
- · Total Systemic vascular resistances for aorta circuit,
- · Systolic time intervals, and,
- · End-tidal CO2 pressure.
3
TABLE A: Equivalence Table: Performance Data
Non-Invasive Transesophageal Pulsed Doppler and Echographic Devices
| | Hewlett Packard
HP 21362B | Datascope
ACCUCOR | Deltex
EDM | Sometec
DYNEMO 3000 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Transesophageal probe
Adult probe length (cm)
Adult probe diameter (mm)
Distal tip diameter (mm)
Pediatric probe length (cm)
Pediatric probe diam. (mm)
Distal tip diameter (mm) | 100
9.8
11.0
100
9.8 size permitting
11.0 | 76
7.9
7.9
No pediatric probe
-
| 80
6
6
No pediatric probe
-
| 61
7
7
35
5
5 |
| Pulsed Doppler Transducer
Center frequency (MHz)
Pulse duration (μs)
Entry beam diameter (mm)
Pulse rep. frequency (kHz)
Intensity Ispta (mW/cm²) | 5
0.74
10
12.9
184 | 2.5
34
6.0
5.9
100 | 4
17
Continuous
100 | 5
11
4
12.4
165 |
| M-mode Echograph
Center frequency (MHz)
Pulse duration (μs)
Entry beam diameter (mm)
Pulse rep. frequency (Hz)
Intensity Ispta (mW/cm²) | 5
0.28
10
3.9
35 | None | None | 10
0.225
3
46.9
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
for
Yamil G. Kogan
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, nd Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known): K972798
Device Name: DYNEMO 3000
Indications for Use:
-
- 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K972798
Prescription Use (Per 21 CFR 801.109)
OR
Over-the Counter Use
(Optional Format 1-2-96)
9
4 Ultrasound Device Indications Statement Page of
| 510(k) Number (if known): | K972798 |
|---|---|
| Device Name: | DYNEMO 3000 (Adult Model 200-018) |
Fill out one form for each ultrasound system and each transducer.
Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human body as follows:
Mode of Operation
| Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | X | | | | | | | | |
| Trans-esophageal | | X | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
| Additional Comments: | | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF MEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number
Prescription Use (Per 21 CFR 801.109)
10
510(k) Number (if known):__ K972798 DYNEMO_3000 Device Name: _______________
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical
Application | Mode of Operation | | | | | | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|---------------------------------|-------------------|---|---|-----|-----|------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color
Doppler | | | |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | X | | | | | | |
| Trans-esophageal | | | | | X | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Luminal | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | |
| Other (Specify) | | | | | | | | | |
| Additional Comments: | | | | | | | | | |
Mode of Operation
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological De
Prescription Use (Per 21 CFR 801.109)
510(k) Number
COUNTS