Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard ultrasound modalities and signal processing without mentioning AI or ML.

Therapeutic

No.
The device is used for diagnostic visualization of blood flow and guidance during surgical interventions, rather than for directly treating a condition.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the device is for "Detection of normal and abnormal blood volume and Doppler velocity flow patterns" and "Detection and quantification of the degree of stenosis in arteries." These activities are characteristic of diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system "incorporates several ultrasound modalities" and "utilizes the well established technology of transit-time flow measurements". It also mentions "The VeriQC transducer selection includes both transit-time probes... as well as an intraoperative imaging probe." These are hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Medi-Stim VeriQC System is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The Medi-Stim VeriQC System is an intraoperative system that uses ultrasonography to visualize blood flow and guide surgical interventions directly on the patient's body during surgery.

The intended use and device description clearly indicate that the system is used in vivo (within the living body) to provide real-time information to the surgeon during a procedure. It does not analyze samples taken from the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:

Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.
Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

Product codes (comma separated list FDA assigned to the subject device)

DPW, IYN, IYO, ITX

Device Description

The VeriQC system incorporates several ultrasound modalities that can be used during a variety of surgical interventions. The system utilizes the well established technology of transit-time flow measurements to accurately measure blood flow in veins and arteries intraoperatively. In addition, the system provides ultrasound echocardiography for intraoperative imaging of the cardiovascular circulatory system. The system supports both B-Mode (2D) grayscale imaging, color Doppler (CFM) and pulsed wave Doppler (PW-Doppler). The system also has the ability to connect other external physiological signals such as blood pressure, ECG and other auxiliary signals provided by other monitoring systems.

The VeriQC transducer selection includes both transit-time probes for blood flow measurements on various vessel sizes and types as well as an intraoperative imaging probe.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound (Transit-time, B-mode, Color Doppler, Power Doppler and PW Doppler ultrasound, Combined Mode)

Anatomical Site

Cardiovascular circulatory system, veins and arteries

Indicated Patient Age Range

Adult and pediatric

Intended User / Care Setting

Surgeons (intraoperative)

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)

Testing included EMC, Safety testing and Acoustic Safety Measurements. The MediStim VeriQC has also been verified and validated according to functional and software requirements.

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.

K040228, K041552

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

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).

Summary

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510(k) Summary

K102595 DEC 2 7 2010

Submitter: MediStim ASA Fernanda Nissensgt. 3 N-0484 Oslo Norway +47 2305 9660

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace NE Fridley, MN 55432 763-574-1976

Submission Date: September 3, 2010

Device Name and Classification: MediStim VeriQC System, Medical ultrasonic imaging and volume flow-meter with probes, Class II

Product Code:

		Product Code
Cardiovascular blood flowmeter	870.2100	DPW
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasound Transducer	892.1570	ITX

Equivalent Device Identification:

The MediStim VeriQ is substantially equivalent to the MediStim VeriQ model VQ4122 (K040228) manufactured by MediStim ASA, Fernanda Nissensgate 3, N-0484 OSLO, with added features equivalent to the GE Vivid 7 Diagnostic Ultrasound System with Diagnostic ultrasound transducers (K041552) manufactured by GE Medical systems, Ultrasound and Care Diagnostics, LLC PO Box 414, Milwaukee, WI 53201.

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Device Description:

The VeriQC system incorporates several ultrasound modalities that can be used during a variety of surgical interventions. The system utilizes the well established technology of transit-time flow measurements to accurately measure blood flow in veins and arteries intraoperatively. In addition, the system provides ultrasound echocardiography for intraoperative imaging of the cardiovascular circulatory system. The system supports both B-Mode (2D) grayscale imaging, color Doppler (CFM) and pulsed wave Doppler (PW-Doppler). The system also has the ability to connect other external physiological signals such as blood pressure, ECG and other auxiliary signals provided by other monitoring systems.

The VeriQC transducer selection includes both transit-time probes for blood flow measurements on various vessel sizes and types as well as an intraoperative imaging probe.

Intended Use:

The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are:

Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.
Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

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Comparison Table:

	MediStim VeriQC	MediStim VeriQ	GE Vivid 7
Indications for use	"The Medi-Stim VeriQC
System is intended for
use as an intraoperative
system utilizing
ultrasonography to
visualize blood flow and
to guide surgeons to
successfully plan and
accomplish surgical
interventions."	The Medi-Stim VeriQ
System is an
interaoperative diagnostic
system that utilizes
ultrasonography to guide
surgeons to successfully
plan and accomplish
surgical interventions.	The device is intended
for use by a qualified
physician for ultrasound
evaluation of Fetal;
Abdominal (including
renal and GYN);
Pediatric; Small Organ
(breast, testes, thyroid);
Neonatal Cephalic; Adult
Cephalic, Cardiac (adult
and pediatric); Peripheral
Vascular (PV); Musculo-
skeletal
Conventional;Urology
(including prostate),
Transesophageal;
Transrectal (TR);
Transvaginal (TV); and
Interaoperative
(abdominal, thoracic and
vascular)
	The clinical indications
for the device are:

Accurate transit time
blood volume and
Doppler velocity flow
measurements during
cardiovascular-, vascular-
and transplantation-
surgery.
Simultaneous
measurements of blood
pressure, vascular
resistance, interfaced
physiological signals and
other derived parameters
during these procedures.
Detection of normal
and abnormal blood
volume and Doppler
velocity flow patterns
during these procedures.
Provides guidance to
prepare surgical plans at
the initiation of surgery
and to support the
successful | The clinical indications
for the device are:
Accurate transit time
blood volume and
Doppler velocity flow
measurements during
cardiovascular-, vascular-
, transplantation- and
neuro-surgery.
Simultaneous
measurements of blood
pressure, vascular
resistance, interfaced
physiological signals and
other derived parameters
during these procedures.
Detection of normal
and abnormal blood
volume and Doppler
velocity flow during
these procedures. | |
| | | | |
| | accomplishment of
surgery including
detection and location of
vessels during surgical
procedures.
Detection and
quantification of the
degree of stenosis in
arteries by using the
Doppler velocity profile." | 4) Provides guidance to
prepare surgical plans at
the initiation of surgery
and to support the
successful
accomplishment of
surgery including
detection and location of
vessels during surgical
procedures
Detection and
quantification of the
degree of stenosis in
arteries by using the
Doppler velocity profile. | |
| Patient group | Adult and pediatric | Adult and pediatric | Neonatal, adult and
pediatric |
| Ultrasound modalities | Transit-time, B-mode,
Color Doppler, Power
Doppler and PW Doppler
ultrasound, Combined
Mode. | Transit-time, PW
Doppler | B-Mode, M-Mode, PW
Doppler, Color Doppler,
Color M Doppler, Power
Doppler, Combined
modes, Coded Pulse |
| Other inputs | Blood pressure, ECG,
Auxiliary inputs | Blood pressure, ECG,
Auxiliary inputs | Not available in summary |

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Summary of Testing: Testing included EMC, Safety testing and Acoustic Safety Measurements. The MediStim VeriQC has also been verified and validated according to functional and software requirements.

Conclusion: The indication for use statements of the two predicate devices with regard to patient groups and surgical procedures are equivalent to the indications for use statement of the Medi-Stim VeriQC System.

The main clinical applications for all devices are the same namely cardiovascular-, and transplantation-surgery.

The technology platform for the VeriQ and the VeriQ predicate device are identical with respect to computing platform, operating system and TTFM acquisition hardware. The ultrasound frontend of the VeriQ is based on the same principles as the predicate GE device, providing a modern fully digitized ultrasound acquisition module. The devices share the same imaging modalities and base the acoustic safety system on the same principles.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 7 2010

MediStim ASA C/O Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace NE Fridley, MN 55432

Re: K102595

Trade/Device Name: MediStim VeriQC System Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II (Two) Product Code: DPW, IYO, IYN, and ITX Dated: December 12, 2010 Received: December 15, 2010

Dear Ms. Bundy:

ー

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must 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/CDRH/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/ReportalProblem/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,

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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Indications for Use

K102595

510(k) Number (if known): K102595

DEC 2 7 2010

Device Name: MediStim VeriOC system

Indications For Use:

The Medi-Stim VeriQC System is intended for use as an intraoperative system utilizing ultrasonography to visualize blood flow and to guide surgeons to successfully plan and accomplish surgical interventions." The clinical indications for the device are:

1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.
1. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
1. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
1. Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures.
1. Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (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 Cardiovascular Devices

510(k) Number K102595