MEDISTIM VERIQC SYSTEM

K102595 · Medi-Stim Asa · DPW · Dec 27, 2010 · Cardiovascular

Device Facts

• Record ID: K102595
• Device Name: MEDISTIM VERIQC SYSTEM
• Applicant: Medi-Stim Asa
• Product Code: DPW · Cardiovascular
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2
• Attributes: Pediatric

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: 1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery. 2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures. 3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures. 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. 5. Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.

Device Story

Intraoperative system using transit-time flow measurement (TTFM) and ultrasound imaging; inputs include ultrasound signals from probes, blood pressure, ECG, and auxiliary physiological signals; processes data to provide B-mode (2D) grayscale imaging, color Doppler (CFM), and pulsed wave (PW) Doppler; used by surgeons in OR to visualize blood flow, quantify stenosis, and guide surgical planning; output displayed to surgeon for real-time decision-making; benefits include improved surgical accuracy and vessel identification.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including EMC, safety testing, and acoustic safety measurements, alongside functional and software requirement verification and validation.

Technological Characteristics

System utilizes transit-time flow measurement and ultrasound imaging (B-mode, Color Doppler, PW-Doppler). Features a fully digitized ultrasound acquisition module. Supports external physiological signal inputs (ECG, blood pressure). Operates as an intraoperative system. Software requirements verified and validated.

Indications for Use

Indicated for adult and pediatric patients undergoing cardiovascular, vascular, or transplantation surgery. Used for intraoperative visualization of blood flow, transit-time blood volume/Doppler velocity measurements, detection of stenosis, and vessel localization.

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

• MediStim VeriQ model VQ4122 (K040228)
• GE Vivid 7 Diagnostic Ultrasound System (K041552)

Submission Summary (Full Text)

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## 510(k) Summary

K102595 DEC 2 7 2010

Submitter: MediStim ASA Fernanda Nissensgt. 3 N-0484 Oslo Norway [phone]

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:

| | | CFR Number | 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:

1. Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular- and transplantation-surgery.

2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.

3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.

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.

5. 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<br>System is intended for<br>use as an intraoperative<br>system utilizing<br>ultrasonography to<br>visualize blood flow and<br>to guide surgeons to<br>successfully plan and<br>accomplish surgical<br>interventions." | The Medi-Stim VeriQ<br>System is an<br>interaoperative diagnostic<br>system that utilizes<br>ultrasonography to guide<br>surgeons to successfully<br>plan and accomplish<br>surgical interventions. | The device is intended<br>for use by a qualified<br>physician for ultrasound<br>evaluation of Fetal;<br>Abdominal (including<br>renal and GYN);<br>Pediatric; Small Organ<br>(breast, testes, thyroid);<br>Neonatal Cephalic; Adult<br>Cephalic, Cardiac (adult<br>and pediatric); Peripheral<br>Vascular (PV); Musculo-<br>skeletal<br>Conventional;Urology<br>(including prostate),<br>Transesophageal;<br>Transrectal (TR);<br>Transvaginal (TV); and<br>Interaoperative<br>(abdominal, thoracic and<br>vascular) |
| | The clinical indications<br>for the device are:<br><br>1) Accurate transit time<br>blood volume and<br>Doppler velocity flow<br>measurements during<br>cardiovascular-, vascular-<br>and transplantation-<br>surgery.<br><br>2) Simultaneous<br>measurements of blood<br>pressure, vascular<br>resistance, interfaced<br>physiological signals and<br>other derived parameters<br>during these procedures.<br><br>3) Detection of normal<br>and abnormal blood<br>volume and Doppler<br>velocity flow patterns<br>during these procedures.<br>4) Provides guidance to<br>prepare surgical plans at<br>the initiation of surgery<br>and to support the<br>successful | The clinical indications<br>for the device are:<br><br>1) Accurate transit time<br>blood volume and<br>Doppler velocity flow<br>measurements during<br>cardiovascular-, vascular-<br>, transplantation- and<br>neuro-surgery.<br><br>2) Simultaneous<br>measurements of blood<br>pressure, vascular<br>resistance, interfaced<br>physiological signals and<br>other derived parameters<br>during these procedures.<br><br>3) Detection of normal<br>and abnormal blood<br>volume and Doppler<br>velocity flow during<br>these procedures. | |
| | | | |
| | accomplishment of<br>surgery including<br>detection and location of<br>vessels during surgical<br>procedures.<br><br>5) Detection and<br>quantification of the<br>degree of stenosis in<br>arteries by using the<br>Doppler velocity profile." | 4) Provides guidance to<br>prepare surgical plans at<br>the initiation of surgery<br>and to support the<br>successful<br>accomplishment of<br>surgery including<br>detection and location of<br>vessels during surgical<br>procedures<br><br>5) Detection and<br>quantification of the<br>degree of stenosis in<br>arteries by using the<br>Doppler velocity profile. | |
| Patient group | Adult and pediatric | Adult and pediatric | Neonatal, adult and<br>pediatric |
| Ultrasound modalities | Transit-time, B-mode,<br>Color Doppler, Power<br>Doppler and PW Doppler<br>ultrasound, Combined<br>Mode. | Transit-time, PW<br>Doppler | B-Mode, M-Mode, PW<br>Doppler, Color Doppler,<br>Color M Doppler, Power<br>Doppler, Combined<br>modes, Coded Pulse |
| Other inputs | Blood pressure, ECG,<br>Auxiliary inputs | Blood pressure, ECG,<br>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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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 [phone] or [phone] 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.
- 2. Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures.
- 3. Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures.
- 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.
- 5. 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