(200 days)
MediStim VeriQ VQ1001- VQ4122, SonoTT Ultrasonic Flowcomputer
Not Found
No
The document describes standard ultrasound transit-time and Doppler methods for flow measurement and does not mention AI or ML.
No
The device is described as a system to measure flow rate and velocity patterns, and to support planning, implementation, control, and documentation. It does not perform any direct therapeutic action on the patient.
Yes
The device is described as measuring flow rate and velocity patterns of blood, supporting the assessment of vascular changes, and assisting surgeons in planning and controlling interventions related to cardiovascular and vascular systems. This information gathering is characteristic of a diagnostic device.
No
The device description explicitly mentions "accessories" and "probes" (SonoTT Vascular Probe, SonoTT Pulse Wave Doppler Probe, SonoTT Clamp-On Transducer) which are hardware components used for measurement. The testing section also includes hardware-related tests like Electrical Safety, EMC, Ultrasonic acoustic output, Mechanical Stability, Biocompatibility, and Sterility.
Based on the provided information, the SonoTT FlowLab® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed outside the living body.
- SonoTT FlowLab® Function: The SonoTT FlowLab® measures the flow rate and velocity of liquids (specifically blood) within the body (intraoperatively in vessels) or in extracorporeal circulatory systems. It uses ultrasound technology applied directly to the patient or the tubing system.
- Intended Use: The intended use clearly describes supporting surgical interventions, assessing vascular changes, and monitoring extracorporeal systems. These are all applications involving measurements taken directly from or in close proximity to the patient's circulatory system, not from a collected specimen.
The device is a medical device that performs measurements in vivo (within the body) or on extracorporeal systems, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems.
The following medical applications are supported:
- Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist e surgeons at surgical interventions
- Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse . Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes.
- Extracorporeal flow measurement in continuous operation on tube systems in . combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres
The following actions can be performed simultaneously when these measurements are in progress:
- Pressure measurement in combination with a standard blood pressure transducer t
- Secondary displays of additional physiological analogue signals and corresponding . derived parameters
The SonoTT Vascular Probe is intended for transient use only with continuous contact with patient of less than 60 minutes.
For the patient's safety they must be operated by qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
DPW, ITX
Device Description
The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiovascular, Vascular (arteries and veins)
Indicated Patient Age Range
Adult and pediatric (Not intended for examination of foetuses (prenatal) and neonates (foetal))
Intended User / Care Setting
Qualified medically-trained personnel (surgeon). Intensive care units and operating rooms/theatres.
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)
The SonoTT FlowLab® and the accessories were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Electrical Safety Testing
- EMC Testing
- Ultrasonic acoustic output testing
- Alarm testing
- Software Validation
- Mechanical Stability Testing
- Packaging Testing
- Biocompatibility evaluation of Vascular Probe and Pulse Wave Doppler Probe
- Sterility evaluation of Vascular Probe
- Usability Validation
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Meter.
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.
MediStim VeriQ VQ1001- VQ4122, SonoTT Ultrasonic Flowcomputer
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
KII1730
JAN - 6 2012
510(K) SUMMARY
Submitter Information
Contact Person :
Phone: Fax: E-Mail:
em-tec GmbH Lerchenberg 20 86923 Finning Germany www.em-tec.de
Mr. B. Brand Regulatory Affairs Manager +49(0)8806 9236 21. +49(0)8806 9236 50, bernhard.brand@em-tec.de
Date Prepared
Device Name
Trade/Proprietary Name:
Common/Usual Name:
Classification Name:
June 6, 2011
SonoTT FlowLab®
Blood Flow Meter
Flowmeter, Blood, Cardiovascular
CFR § 870.2100 Product Code
DPW
Classification:
Class II
Predicate Device Name
MediStim VeriQ VQ1001- VQ4122 Trade name:
SonoTT Ultrasonic Flowcomputer
These devices are the same in terms of Intended use/Indication, clinical applications, type of construction, measurement technology, sensor types, energy source and emitted energy, anatomical sites and material/biocompatibility issues.
Device Description
The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave
1
Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method. ،
Substantial Equivalence
.
.
がない。
『
| | Medi-Stim VeriQ | SonoTT Ultrasonic
Flowcomputer | SonoTT FlowLab® |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VQ1001- VQ4122 | | |
| Indications
for use | The Medi-Stim VeriQ
System is an
intraoperative
diagnostic system that
utilizes
ultrasonography to
guide surgeons to
successfully plan and
accomplish surgical
interventions. | The Sono TT Ultrasonic
Flowcomputer is
indicated for the
volumetric measurement
of liquid flowing through
tubing systems ( with
Clamp-On Transducer).
The measurement
principle is the
ultrasound transit-time
method. The
Flowcomputer is
designed for continuous
operation in intensive
care units
and operating rooms. For
the patient's safety the
device is to be operated
only by qualified
medically-trained
personnel. | The SonoTT FlowLab®
with the accessories is a
system to measure the
flow rate of liquids (e.g.
blood) with the ultrasonic
transit-time and velocity
patterns of blood with
Doppler method. It
supports the planning,
implementation, efficiency
control and documentation
of interventions carried out
in the area of
cardiovascular, vascular
and, transplantation, or the
monitoring of
extracorporeal circulatory
systems. |
| | The clinical indications
for the device are: | The medical use of the
device is appropriate to
procedures such as the
following: | The following medical
applications are
supported: |
| | 1) Accurate transit
time blood volume and
Doppler velocity flow
measurements during
cardiovascular-,
vascular-,
transplantation- and
neuro-surgery | 1) Extracorporeal flow
measurement on tubings
with Clamp-On
Transducer during
interventions like Cardio-
pulmonary bypass,
membrane-oxygenation,
hemodialysis;
hemofiltration,
plasmapheresis,
perfusion, infusion,
transfusion | 1) Intraoperative blood
flow measurement with the
SonoTT Vascular Probe to
assist surgeons at surgical
interventions
2) Measurement of flow
direction and velocities of
blood in vessels using the
SonoTT Pulse Wave
Doppler Probe to assist |
| | 2) Simultaneous
measurements of
blood pressure,
vascular resistance,
interfaced
physiological signals
and other derived
parameters during
these procedures.
3) Detection of normal | | the surgeon in the non-
invasive assessment of
vascular changes.
3) Extracorporeal flow
measurement in
continuous operation on
tube systems in
combination with the
SonoTT Clamp-On
Transducer in intensive |
| | and abnormal blood | | |
| | volume and Doppler | | care units and operating |
| | velocity flow patterns | | theatres |
| | | | |
| | during these | | The following actions can |
| | procedures. | | be performed |
| | | | simultaneously when |
| | | | these measurements are |
| | | | |
| | 4) Provides guidance | | in progress: |
| | to prepare surgical | | |
| | plans at the initiation of | | 4) Pressure measurement |
| | surgery and to support | | in combination with a |
| | the successful | | standard blood pressure |
| | accomplishment of | | transducer |
| | surgery including | | |
| | detection and location | | |
| | of vessels during | | 5) Secondary displays of |
| | | | additional physiological |
| | surgical procedures. | | analogue signals and |
| | | | corresponding derived |
| | | | parameters |
| | | | |
| | 5) Detection and | | The SonoTT Vascular |
| | quantification of the | | Probe is intended for |
| | degree of stenosis in | | transient use only with |
| | arteries by using the | | continuous contact with |
| | Doppler velocity | | |
| | profile. | | patient of less than 60 |
| | | | minutes. |
| | | | |
| | | | For the patient's safety |
| | | | they must be operated by |
| | | | qualified medical |
| | | | personnel. |
| Patient | Adult and pediatric | No restrictions acc. | Aduit and pediatric |
| group | | operator manual | |
| | Not intended for any | | Not intended for |
| | kind of fetal | | examination of foetuses |
| | applications. acc. | | (prenatal) and neonates |
| | operator manual | | (foetal) . |
| | | | |
| | | | |
| Ultrasound | Transit-time, | Transit time, | Transit time, |
| modalities | | | |
| | PW Doppler | PW Doppler | PW Doppler |
| | | | |
| Measureme | Vessel transducer, | | |
| nt Probes | Doppier Probe | Clamp-on Sensor | Vessel transducer, |
| | | | Doppler Probe, |
| | | | |
| | | | Clamp-on Sensor |
| Other
inputs | Blood pressure, ECG,
Auxiliary inputs | Blood pressure, Auxiliary
inputs | Blood pressure, ECG,
Auxiliary inputs |
2
The proposed device is substantial equivalent to the predicate devices with respect to intended use, patient population, measurement and sensor technology and auxiliary channels. Therefore it meets the requirements for section 510(k) substantial equivalence and is as safe, as effective, and performs as well as the predicate devices
3
Test Data
The SonoTT FlowLab® and the accessories were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
-
- Electrical Safety Testing
- EMC Testina 2.
- Ultrasonic acoustic output testing က
-
- Alarm testing
- క్. Software Validation
-
- Mechanical Stability Testing
-
- Packaging Testing
-
- Biocompatibility evaluation of Vascular Probe and Pulse Wave Doppler Probe
- တ် Sterility evaluation of Vascular Probe
-
- Usability Validation
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Meter.
4
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 6 2012
em-tec GmbH c/o Mr. Olaf Teichert TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Ste 104 New Brighton, MN 55112-1891
K11730 Re:
Trade/Device Name: SonoTT FlowLab® Flowmeter Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Codes: DPW, ITX Dated: December 28, 2011 Received: December 30, 2011
Dear Mr. Teichert:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for tegary manated to of the Medical Device Ameral Food Drug commerce prior to May 28, 1776, the enacintent with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with and proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval or of the Act and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, becjost to the group registration, listing of
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the trectine, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SC above) into extine major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation affect if may be subject to additional controls. Entroling major and on 898. In addition, FDA may lound in the Code of I cacial Regulations, Four device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated on a banded with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmanon alla Jour access of by other Federal agencies. You must
5
Page 2 – em-tec GmbH c/o Mr. Olaf Teichert
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
6
| 510(k) Submission Section D | SonoTT FlowLab | ||
|---|---|---|---|
| Indications for Use | FL-FDIU-1.1.doc | 05/26/11 | -em-tec |
MEDICAL TECHNOLOGY |
Indications for Use
510(k) Number (if known): _ K | | 7 30
Device Name: SonoTT FlowLab
Indications for Use
The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems.
The following medical applications are supported:
- Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist e surgeons at surgical interventions
- Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse . Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes.
- Extracorporeal flow measurement in continuous operation on tube systems in . combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres
The following actions can be performed simultaneously when these measurements are in progress:
- Pressure measurement in combination with a standard blood pressure transducer t
- Secondary displays of additional physiological analogue signals and corresponding . derived parameters
The SonoTT Vascular Probe is intended for transient use only with continuous contact with patient of less than 60 minutes.
.............................................................................................................................................
For the patient's safety they must be operated by qualified medical personnel.
Contraindication
The SonoTT FlowLab® and the accessories Vascular Probe, Clamp-On Transducer and Pulse Wave Doppler Probe were exclusively designed for the described intended use.
The device is expressly not intended for the following:
- The Vascular Probe for measurements on stented areas of blood vessels. .
- Examination of foetuses (prenatal) and neonates (foetal) with the Doppler Probe .
- Doppler measurements of eyes (ophthalmology), in gynaecology or in obstetrics .
- Monitoring of vital physiological parameters .
- Measurements at human arteries or veins using the Clamp-On Transducer .
Applicant: em-tec GmbH, Lerchenberg 20, 86923 Finning, Germany, www.em-tec.de Phone: +49(0)8806 9236 0, Fax: +49(0)8806 9236 50, info@em-tec.de Contact Person: Mr. B. Brand, Phone: +49(0)8806 9236 21, bernhardbrand(@)em-tec.de 1/2
7
| 510(k) Submission Section D | SonoTT FlowLab | ||
|---|---|---|---|
| Indications for Use | FL-FDIU-1.1.doc | 05/26/11 | -- em-tec |
| MEDICAL TECHNOLOGY |
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ 11/730
Applicant: em-tec GmbH, Lerchenberg 20, 86923 Finning, Germany, www.em-tec.de Phone: +49(0)8806 9236 0, Fax: +49(0)8806 9236 50, info@em-tec.de Contact Person: Mr. B. Brand, Phone: +49(0)8806 9236 21, bernhardbrand(@em-tec.de
2/2