SONOTT FLOWLAB(R)

• K Number: K111730
• Device Name: SONOTT FLOWLAB(R)
• Manufacturer: EM-TEC GMBH
• Date Cleared: 2012-01-06 ( 200 days)
• Product Code: DPW , ITX
• Regulation Number: 870.2100
• Type: Abbreviated
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

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.

AI/ML Overview

The SonoTT FlowLab® is a blood flow meter that uses ultrasound transit-time and Doppler methods to measure liquid flow rate and blood velocity. It is intended for use in cardiovascular, vascular, and transplantation interventions, as well as for monitoring extracorporeal circulatory systems.

Acceptance Criteria and Device Performance:

The provided document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy thresholds for flow measurement). Instead, the substantial equivalence argument relies on demonstrating that the SonoTT FlowLab® performs as well as the predicate devices (MediStim VeriQ and SonoTT Ultrasonic Flowcomputer) based on intended use, patient population, measurement and sensor technology, and auxiliary channels.

However, the "Test Data" section indicates that various tests were performed to "assure reliable design and performance under the specified testing parameters." While the results are not detailed in the provided text, the successful completion of these tests suggests that the device met internal performance benchmarks.

Acceptance Criteria Category (Implied)	Reported Device Performance
Electrical Safety	Passed Electrical Safety Testing
Electromagnetic Compatibility (EMC)	Passed EMC Testing
Ultrasonic Acoustic Output	Passed Ultrasonic Acoustic Output Testing
Alarm Functionality	Passed Alarm Testing
Software Validation	Passed Software Validation
Mechanical Stability	Passed Mechanical Stability Testing
Packaging Integrity	Passed Packaging Testing
Biocompatibility (Vascular/Pulse Wave Doppler Probes)	Passed Biocompatibility Evaluation
Sterility (Vascular Probe)	Passed Sterility Evaluation
Usability	Passed Usability Validation

Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • The provided document does not specify sample sizes for any of the performance tests (e.g., number of measurements, number of devices tested).
   • There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not mention the use of experts to establish ground truth for the device performance tests. These tests (Electrical Safety, EMC, etc.) are typically evaluated against established engineering standards and specifications rather than expert consensus on clinical data.

3. Adjudication Method for the Test Set:

   • Not applicable as the nature of the described tests does not involve a need for adjudication in the context of clinical expert review.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or performed. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting medical images or data.

5. Standalone (Algorithm Only Without Human-In-The-Loop Performance) Study:

   • While the device functions as a standalone measurement instrument, the document does not describe a formal "standalone study" in the context of comparing its performance against a human operator or a gold standard algorithmically. The validation tests listed (electrical safety, EMC, etc.) focus on the device's adherence to regulatory and engineering standards.

6. Type of Ground Truth Used:

   • For the technical and performance tests listed (Electrical Safety, EMC, etc.), the "ground truth" would be established engineering standards, regulatory requirements, and internal design specifications.
   • For the core function of flow measurement, the accuracy would typically be validated against a known physical standard (e.g., a calibrated flow measurement system), though the details of such validation are not provided.

7. Sample Size for the Training Set:

   • Not applicable. The SonoTT FlowLab® is a hardware-based measurement device, not an AI or machine learning algorithm requiring a "training set" in the conventional sense. Its functionality is based on established physical principles (ultrasound transit-time and Doppler).

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

Summary

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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 [phone]. [phone], [e-mail]

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

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Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method. ،

Substantial Equivalence

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	Medi-Stim VeriQ	SonoTT UltrasonicFlowcomputer	SonoTT FlowLab®
	VQ1001- VQ4122
Indicationsfor use	The Medi-Stim VeriQSystem is anintraoperativediagnostic system thatutilizesultrasonography toguide surgeons tosuccessfully plan andaccomplish surgicalinterventions.	The Sono TT UltrasonicFlowcomputer isindicated for thevolumetric measurementof liquid flowing throughtubing systems ( withClamp-On Transducer).The measurementprinciple is theultrasound transit-timemethod. TheFlowcomputer isdesigned for continuousoperation in intensivecare unitsand operating rooms. Forthe patient's safety thedevice is to be operatedonly by qualifiedmedically-trainedpersonnel.	The SonoTT FlowLab®with the accessories is asystem to measure theflow rate of liquids (e.g.blood) with the ultrasonictransit-time and velocitypatterns of blood withDoppler method. Itsupports the planning,implementation, efficiencycontrol and documentationof interventions carried outin the area ofcardiovascular, vascularand, transplantation, or themonitoring ofextracorporeal circulatorysystems.
	The clinical indicationsfor the device are:	The medical use of thedevice is appropriate toprocedures such as thefollowing:	The following medicalapplications aresupported:
	1) Accurate transittime blood volume andDoppler velocity flowmeasurements duringcardiovascular-,vascular-,transplantation- andneuro-surgery	1) Extracorporeal flowmeasurement on tubingswith Clamp-OnTransducer duringinterventions like Cardio-pulmonary bypass,membrane-oxygenation,hemodialysis;hemofiltration,plasmapheresis,perfusion, infusion,transfusion	1) Intraoperative bloodflow measurement with theSonoTT Vascular Probe toassist surgeons at surgicalinterventions2) Measurement of flowdirection and velocities ofblood in vessels using theSonoTT Pulse WaveDoppler Probe to assist
	2) Simultaneousmeasurements ofblood pressure,vascular resistance,interfacedphysiological signalsand other derivedparameters duringthese procedures.3) Detection of normal		the surgeon in the non-invasive assessment ofvascular changes.3) Extracorporeal flowmeasurement incontinuous operation ontube systems incombination with theSonoTT Clamp-OnTransducer 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
Otherinputs	Blood pressure, ECG,Auxiliary inputs	Blood pressure, Auxiliaryinputs	Blood pressure, ECG,Auxiliary inputs

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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

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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:

• 1. Electrical Safety Testing
• EMC Testina 2.
• Ultrasonic acoustic output testing က
• 4. Alarm testing
• క్. Software Validation
• 6. Mechanical Stability Testing
• 7. Packaging Testing
• 8. Biocompatibility evaluation of Vascular Probe and Pulse Wave Doppler Probe
• တ် Sterility evaluation of Vascular Probe
• 10. 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.

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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

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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 [phone] or [phone] 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

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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: [phone], Fax: [phone], [e-mail] Contact Person: Mr. B. Brand, Phone: [phone], bernhardbrand(@)em-tec.de 1/2

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510(k) Submission Section D	SonoTT FlowLab
Indications for Use	FL-FDIU-1.1.doc	05/26/11	-- em-tecMEDICAL 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: [phone], Fax: [phone], [e-mail] Contact Person: Mr. B. Brand, Phone: [phone], bernhardbrand(@em-tec.de

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Regulation Number and Section

§ 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).