VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

K103260 · Vasonova, Inc. · OBJ · Feb 18, 2011 · Cardiovascular

Device Facts

• Record ID: K103260
• Device Name: VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
• Applicant: Vasonova, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Device Story

VPS System provides real-time guidance for peripherally inserted central catheter (PICC) placement. Input: physiological data via VPS Stylet (Doppler ultrasound sensor for blood flow; stainless steel wire for intravascular ECG). Console processes signals to determine catheter tip location relative to SVC/cavo-atrial junction. Output: visual guidance via PC-based GUI (colored icons, waveform data). Used in clinical settings by healthcare providers as an alternative to fluoroscopy or chest X-ray. Blue bull's-eye indicator confirms target location. Benefits: reduces reliance on ionizing radiation for tip placement confirmation.

Clinical Evidence

Prospective, single-armed, open design clinical study of 77 patients. Primary endpoint: accuracy of PICC tip placement. Results: VPS System correctly indicated proper tip placement in 98.4% of procedures.

Technological Characteristics

System includes PC-based console and polyimide stylet. Stylet features Doppler sensor and ivECG stainless steel wire. Connectivity: wired connection between stylet and console. Standards: IEC 60601-1, IEC 60601-1-4, IEC 60601-2-37, IEC 60601-2. Software-driven data acquisition and processing.

Indications for Use

Indicated for guidance and tip positioning of central venous catheters in adult patients. Contraindicated/limited use in patients with cardiac rhythm alterations (atrial fibrillation, flutter, tachycardia, pacemaker-driven rhythm) or femoral/saphenous vein access, where P-wave presentation is altered; requires additional confirmation method in these cases.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• FlowPICC Console (K081626)
• Sapiens™ Tip Location System (TLS) (K093775)

Submission Summary (Full Text)

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K103260 P1/3

FEB 1 8 2011

## Traditional 510(k) Summary 5.0

| Submitter Information | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | VasoNova, Incorporated |
| Address | 155 Jefferson Drive, Suite 100<br>Menlo Park, CA 94025 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration<br>Number | 3006795936 |
| Name of contact<br>person | Kim Tompkins, RN, MBA |
| Date prepared | October 29, 2010 |
| Name of device | |
| Trade or<br>proprietary name | Vascular Positioning System™ (VPS™ System) Console |
| Common or usual<br>name | Catheter, Ultrasound, Intravascular |
| Classification name | Diagnostic intravascular catheter, Class II |
| Classification panel | Cardiovascular |
| Regulation | 21 CFR §870.1200 |
| Product Code(s) | OBJ |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | FlowPICC Console (K081626)<br>Sapiens™ Tip Location System (TLS) (K093775) |
| Reason for 510(k)<br>submission | Expanded labeling |
| Device description | The VPS System consists of a VPS Console and VPS Stylet.<br>The VPS Console consists of two key integrated software-driven<br>components: a data acquisition module; and a PC with processing<br>and display capabilities. The data acquisition module of the console<br>transmits and receives ultrasound data while receiving electrical<br>signals from the heart through sensors mounted at the tip of the VPS<br>Stylet. Using signals gathered by the data acquisition module, the<br>graphical user interface of the PC provides the user with guidance for<br>tip positioning.<br>The VPS Stylet is a polyimide tube containing a Doppler sensor on a<br>coax cable and an intravascular electrocardiogram (ivECG) signal<br>sensing stainless steel wire. The Doppler sensor and the exposed<br>portion of the ivECG are located at the distal end of the stylet and are<br>used to detect and transmit physiological information to the VPS<br>Console for analysis. The proximal end contains a connector to the<br>VPS Console or to an extension cable that in turn connects to the<br>VPS Console. The stylet can be inserted and removed from any<br>catheter with a luminal diameter of at least 0.021 inches. |

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| Intended use of the device | The intended use of the VPS Stylet and Console (VPS System) is to<br>quickly and accurately.guide market available peripherally inserted<br>central catheters (PICCs) to the goal location which is the lower third<br>of the SVC or at the cavo-atrial junction. | | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The VPS Stylet and Console are indicated for guidance and tip<br>positioning for central venous catheters. The Console is intended<br>for use with the stylet supplied by VasoNova. The VPS System<br>consists of a Console and associated power supply and cabling and<br>a stylet. The VPS Console, when used with the VPS Stylet, provides<br>real-time catheter tip location information by using the patient's<br>physiological (cardiac electrical activity and blood flow) information.<br>When the VPS System guidance indicator shows a blue bull's-eye,<br>the catheter tip is in the desired location. The VPS System is<br>indicated for use as an alternative method to fluoroscopy or chest x-<br>ray for central venous catheter tip placement confirmation in adult<br>patients.<br>Limiting but not contraindicated situations for this technique are in<br>patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location. | | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE<br>DEVICE | | | |
| Characteristic | VPS Console | FlowPICC Console<br>(K081626) | Sapiens TLS<br>(K093775) |
| Guidance indicator | Colored icons, waveform<br>data | Colored icons, waveform<br>data | Waveform data |
| Guidance signal type(s) | ivECG, Doppler<br>ultrasound | ivECG, Doppler<br>ultrasound | ivECG |
| Signal Conductor | Two conductor stylet<br>wires | Two conductor stylet<br>wires | Saline column via saline<br>adapter or<br>commercially-available<br>(unspecified)<br>conducting stylet or<br>guidewire via electrical<br>adapter |
| Acoustic Output | One setting; not<br>controlled by the user | One setting; not<br>controlled by the user | N/A |
| Method of Use | Percutaneous<br>Intravascular | Percutaneous<br>Intravascular | Percutaneous<br>Intravascular |
| User Interface | PC-based system with<br>keyboard and touch<br>screen and mouse | PC-based system with<br>keyboard and touch<br>screen and mouse | PC-based system with<br>keyboard and mouse |

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| PERFORMANCE DATA | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | |
| Performance Test Summary-New Device: | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Electromagnetic<br>Compatibility | IEC 60601-2:2007 | Compliant |
| Electrical Safety and<br>Acoustic Safety | IEC 60601-1:1988 + A1:1991; A2:1995<br>IEC 60601-1-4:1996 + A1:1999 (Cons. Ed 1.1)<br>IEC 60601-2-37:2001 +A1:2004; A2:2005<br>VasoNova SOP | Compliant |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR<br>OF CLINICAL INFORMATION | | |
| Clinical Performance Data/Information. | | |
| The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement<br>procedures in a prospective, single-armed, open design clinical study of 77 patients. | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | |

The vast similarities of the VPS Console to the VasoNova FlowPICC Console predicate device support the substantial equivalence in intended use, function, and basic composition. The nonclinical testing to voluntary standards and applicable FDA guidance documents provide additional evidence the VPS Console is substantially equivalent to the VasoNova FlowPICC Console predicate device in terms of safety, efficacy, and performance.

The clinical testing of the VPS Console supports the substantial equivalence in indications for use to the Romedex Sapiens™ TLS predicate device.

The minor differences between the VPS Console and the predicate devices do not raise new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized graphic of three wavy lines above the text. The text is arranged in a circular pattern around the graphic.

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

VasoNova. Incorporated c/o Ms. Kim Tompkins VP, Regulatory/Clinical Corporate Compliance Officer 155 Jefferson Drive. Suite 100 Menlo Park, CA 94025

FEB 1 8 201

Re: K103260

Trade/Device Name: Vascular Positioning System™ (VPSTM) Console Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: February 1, 2011 Received: February 3, 2011

Dear Ms. Tompkins:

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.

and the country of the country of the county of the county of the county of the county of the county of the count

:

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Page 2 - Ms. Kim Tompkins

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 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 lisuing (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/ucm1118001 http://www.faor. 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/ResourcesforYou/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 Statement 4.0

510(k) Number: To be determined

Device Name: VasoNova™ Vascular Positioning System™ (VPS™ System) Console

- The VPS Stylet and Console are indicated for guidance and tip Intended Use: positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: NO (Part 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)

W.W.

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103260