Who is the manufacturer of DYNEMO 3000?

Sometec, Inc. filed the 510(k) submission for DYNEMO 3000 (K972798).

What is the FDA product code for DYNEMO 3000?

DPW. It is classified under 21 CFR 870.2100 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for DYNEMO 3000?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DYNEMO 3000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DYNEMO 3000

Q: What are the predicate devices for DYNEMO 3000?

Hewlett Packard HP 21362B (K884395); Datascope ACCUCOM (K851426); Deltex EDM (K951369).

K972798 · Sometec, Inc. · DPW · Feb 24, 1998 · Cardiovascular

Device Facts

Record ID	K972798
Device Name	DYNEMO 3000
Applicant	Sometec, Inc.
Product Code	DPW · Cardiovascular
Decision Date	Feb 24, 1998
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2100
Device Class	Class 2
Attributes	Pediatric

Indications for Use

Non-invasive, continuous, real-time measurement and monitoring of the aortic blood flow for adult and 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.

Device Story

DYNEMO 3000 is a non-invasive hemodynamic monitor for anesthesiologists and intensive care physicians. It uses a transesophageal probe with two ultrasonic transducers: a 10 MHz M-Mode transducer for aortic diameter and a 5 MHz Doppler velocimeter for blood velocity. The probe is inserted trans-orally or trans-nasally and stabilized via an inflatable silicone balloon sheath. The device integrates these ultrasound inputs with external peripheral monitor data (ECG, non-invasive blood pressure, capnograph) to calculate and display real-time hemodynamic parameters including aortic blood flow, stroke volume, systemic vascular resistance, and systolic time intervals. The system provides continuous monitoring to assist clinicians in assessing cardiovascular status and guiding clinical decision-making for anesthetized or critically ill patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical comparison and performance specifications of the ultrasound transducers and hemodynamic monitoring capabilities.

Technological Characteristics

System includes main console, transesophageal probe, and disposable silicone balloon sheath. Sensing: 10 MHz M-Mode transducer (aortic diameter) and 5 MHz pulsed Doppler transducer (velocity). Connectivity: Interfaces with external ECG, blood pressure, and capnograph monitors. Power: 100-240V. Software: Microprocessor-based system for real-time data integration and display. Sterilization: Disposable single-use sheaths.

Indications for Use

Indicated for adult and pediatric patients under anesthesia or in intensive care requiring non-invasive, continuous hemodynamic monitoring of aortic blood flow and cardiovascular status. Contraindicated in patients with oro-pharyngeal malformations, esophageal distortions, aortic coarctation, or esophageal carcinoma.

Regulatory Classification

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.

Predicate Devices

Hewlett Packard HP 21362B (K884395)
Datascope ACCUCOM (K851426)
Deltex EDM (K951369)

Submission Summary (Full Text)

{0}------------------------------------------------ K972798 #### 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 <1 | | Measurement Ranges Adult Probe Blood Flow Velocity (cm/sec) Aortic Diameter (mm) Cardiac Output (l/min) Aortic Blood Flow (l/min) | Not available | 10-300 None 0-20 - | 10-220 None 0-20 estimated - | 10-196 7.9-48 Not measured 0.3-20 | | Pediatric Probe Blood Flow Velocity (cm/sec) Aortic Diameter (mm) Cardiac Output (l/min) Aortic Blood Flow (l/min) | Not available | None - - - | None - - - | 10-196 3-36 Not measured 0-20 | | | Hewlett Packard HP 21362B | Datascope ACCUCOM | Deltex EDM | Sometec DYNEMO 3000 | | Transesophageal probe Flexible shaft Adult probe sheath Pediatric probe sheath Sheath material Positioning balloon Rotatable transducer(s) | Yes Recommended Latex No Yes | Yes No No No: entire probe | Yes Single use probe No No: entire probe | Yes Single use sheath Single use sheath Silicone Yes Adult $\phi$ 18 mm Pediatric $\phi$ 8/12 mm Yes | | Operating Mode | | | | | | Continuous flow monitor Single beat measurement Cardiac Output calibration | Yes Yes None | Yes Yes By suprastemal notch/ By entering known CO | Yes | No | | Aortic diameter | M-mode measurement | Nomogram (height, weight, age, sex) | Nomogram (height, weight, age, sex) | M-mode measurement | | Blood pressure input ECG signal input End-tidal CO2 input | | Automatic or manual None None | None None None | Automatic Automatic Automatic | | 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) aorta Mean blood pressure(mm/Hg) Systemic vascular resistance Systolic time intervals | | 30-200 10-300 0-20 0-300 External monitor range 0-9990 | 30-200 10-220 0-20 estimated 0-300 estimated External monitor range Flow time/ Peak velocity | 34-230 10-117 0-20 3-150 35-240 300-15000 PEPI: 75-240 LVETI: 250-600 | | Screen display | | | | | | Doppler signal trace Aortic walls separation trace Composite numerical hemodynamic profile | Yes Yes | Yes No HR, CO, CI, LVET TSVR | Yes No HR, CO, SV, MAP Flow time Peak velocity Accelrtn | Yes Yes HR, ABF, Sva, ABP, TSVR, PEPI, LVETI PetCO2, Diam | | Parameter trends | | No | Yes | Yes | | Doppler audio confirmation Color screen Patient analysis software | Yes | No Monochrome No | Yes Color No | Yes Monochrome DYNESOFT | | | Hewlett Packard HP 21362B | Datascope ACCUCOM | Deltex EDM | Sometec DYNEMO 3000 | | Transesophageal probe | | | | | | Target | Heart & vessels | Aorta | Aorta | Aorta | | Measured parameter(s) | Blood flow velocities in heart & vessels Anatomic physiologic parameters of heart & vessels | Cardiac Output | Cardiac Output | Aortic Blood Flow | | Patient population Adults/ Pediatrics | Adults and Pediatrics (size permitting) | Adults | Adults | Adults & Pediatrics | | Patient status | Anesthetized patients Awake patients | Anesthetized patients ICU patients | Anesthetized patients High risk patients Critically ill patients | Anesthetized patients ICU patients | | Intended Use | Non-invasive cardiac studies | Non-invasive, continuous cardiac output monitoring | Non-invasive, cardiac function monitoring | Non-invasive, continuous aortic blood flow monitoring | | Contraindications | Existing gastro- esophageal abnormalities | Esophageal abnormalities | Esophageal abnormalities | Oro-pharyngeal malformations Esophageal distortions Aortic coarctation Esophageal 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: - 1. 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. - 2. 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

DYNEMO 3000

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Device Story

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DYNEMO 3000

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