(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.
{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 PackardHP 21362B | DatascopeACCUCOR | DeltexEDM | SometecDYNEMO 3000 | |
|---|---|---|---|---|
| Transesophageal probeAdult probe length (cm)Adult probe diameter (mm)Distal tip diameter (mm)Pediatric probe length (cm)Pediatric probe diam. (mm)Distal tip diameter (mm) | 1009.811.01009.8 size permitting11.0 | 767.97.9No pediatric probe-- | 8066No pediatric probe-- | 61773555 |
| Pulsed Doppler TransducerCenter frequency (MHz)Pulse duration (μs)Entry beam diameter (mm)Pulse rep. frequency (kHz)Intensity Ispta (mW/cm²) | 50.741012.9184 | 2.5346.05.9100 | 417Continuous100 | 511412.4165 |
| M-mode EchographCenter frequency (MHz)Pulse duration (μs)Entry beam diameter (mm)Pulse rep. frequency (Hz)Intensity Ispta (mW/cm²) | 50.28103.935 | None | None | 100.225346.9<1 |
| Measurement RangesAdult ProbeBlood Flow Velocity (cm/sec)Aortic Diameter (mm)Cardiac Output (l/min)Aortic Blood Flow (l/min) | Not available | 10-300None0-20- | 10-220None0-20 estimated- | 10-1967.9-48Not measured0.3-20 |
| Pediatric ProbeBlood Flow Velocity (cm/sec)Aortic Diameter (mm)Cardiac Output (l/min)Aortic Blood Flow (l/min) | Not available | None--- | None--- | 10-1963-36Not measured0-20 |
| Hewlett PackardHP 21362B | DatascopeACCUCOM | DeltexEDM | SometecDYNEMO 3000 | |
| Transesophageal probeFlexible shaftAdult probe sheathPediatric probe sheathSheath materialPositioning balloonRotatable transducer(s) | YesRecommendedLatexNoYes | YesNoNoNo: entire probe | YesSingle use probeNoNo: entire probe | YesSingle use sheathSingle use sheathSiliconeYes Adult $\phi$ 18 mmPediatric $\phi$ 8/12mmYes |
| Operating Mode | ||||
| Continuous flow monitorSingle beat measurementCardiac Output calibration | YesYesNone | YesYesBy suprastemal notch/By entering known CO | Yes | No |
| Aortic diameter | M-mode measurement | Nomogram (height,weight, age, sex) | Nomogram (height,weight, age, sex) | M-modemeasurement |
| Blood pressure inputECG signal inputEnd-tidal CO2 input | Automatic or manualNoneNone | NoneNoneNone | AutomaticAutomaticAutomatic | |
| Display Ranges | Not available | |||
| Heart Rate Sensing (b/mn)Flow Velocity (cm/sec)Cardiac Output (l/min)Aortic Blood Flow (l/mn)Stroke Volume (ml) aortaMean blood pressure(mm/Hg)Systemic vascular resistanceSystolic time intervals | 30-20010-3000-200-300External monitor range0-9990 | 30-20010-2200-20 estimated0-300 estimatedExternal monitor rangeFlow time/ Peak velocity | 34-23010-1170-203-15035-240300-15000PEPI: 75-240LVETI: 250-600 | |
| Screen display | ||||
| Doppler signal traceAortic walls separation traceComposite numericalhemodynamic profile | YesYes | YesNoHR, CO, CI, LVETTSVR | YesNoHR, CO, SV, MAPFlow time Peak velocityAccelrtn | YesYesHR, ABF, Sva, ABP,TSVR, PEPI, LVETIPetCO2, Diam |
| Parameter trends | No | Yes | Yes | |
| Doppler audio confirmationColor screenPatient analysis software | Yes | NoMonochromeNo | YesColorNo | YesMonochromeDYNESOFT |
| Hewlett PackardHP 21362B | DatascopeACCUCOM | DeltexEDM | SometecDYNEMO 3000 | |
| Transesophageal probe | ||||
| Target | Heart & vessels | Aorta | Aorta | Aorta |
| Measured parameter(s) | Blood flow velocitiesin heart & vesselsAnatomic physiologicparametersof heart & vessels | Cardiac Output | Cardiac Output | Aortic Blood Flow |
| Patient populationAdults/ Pediatrics | Adults and Pediatrics(size permitting) | Adults | Adults | Adults & Pediatrics |
| Patient status | Anesthetized patientsAwake patients | Anesthetized patientsICU patients | Anesthetized patientsHigh risk patientsCritically ill patients | Anesthetized patientsICU patients |
| Intended Use | Non-invasivecardiac studies | Non-invasive,continuous cardiacoutput monitoring | Non-invasive,cardiac functionmonitoring | Non-invasive,continuous aortic bloodflow monitoring |
| Contraindications | Existing gastro-esophagealabnormalities | Esophagealabnormalities | Esophagealabnormalities | Oro-pharyngealmalformationsEsophageal distortionsAortic coarctationEsophageal carcinoma |
{4}------------------------------------------------
TABLE B: Equivalence Table: Technical Features
Non-Invasive Transesophageal Pulsed Doppler and Echographic Devices
{5}------------------------------------------------
TABLE C: Equivalence Table: Clinical Characteristics
Non-Invasive Transesophageal Pulsed Doppler and Echographic Devices
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1998
Jean-Luc Boulnois, Ph.D. President & CEO Sometec, Inc. 92 Montvale Avenue-Suite 3150 Stoneham, MA 02180
Re : K972798 DYNEMO 3000 (Cardiac Output Monitor) Dated: November 24, 1997 Received: November 25, 1997 II Regulatory class: 21 CFR 870.2100/Procode: 74 DPW 21 CFR 870.2300/Procode: 74 DPT
Dear Dr. Boulnois:
We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the DYNEMO 3000 Cardiac Output Monitor, as described in your premarket notification:
Transducer Model Number
Adult Model 200-018 Pediatric Model 200-019
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major regulations affecting your device can be additional controls. found in the Code of Federal Regulations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g.,
{7}------------------------------------------------
Page 2 - Jean-Luc Boulnois, Ph.D.
acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
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
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | |||||||||
| Trans-esophageal | X | |||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | ||||||||||
| 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:
| ClinicalApplication | Mode of Operation | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |||||
|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | ||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative(Specify) | |||||||||
| Intra-operativeNeurological | |||||||||
| Pediatric | |||||||||
| Small Organ(Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | X | ||||||||
| Trans-esophageal | X | ||||||||
| Trans-Rectal | |||||||||
| Trans-Vaginal | |||||||||
| Trans-Urethral | |||||||||
| Intra-Luminal | |||||||||
| PeripheralVascular | |||||||||
| 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
§ 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).