VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

K103255 · Vasonova, Inc. · OBJ · Feb 18, 2011 · Cardiovascular

Device Facts

• Record ID: K103255
• Device Name: VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
• 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 Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, 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 bullseye, 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 guides PICC placement to cavo-atrial junction. Input: intravascular ECG (ivECG) signals via stainless steel wire and blood flow data via Doppler sensor at stylet tip. Console processes signals to provide real-time tip location guidance. Output: visual indicator (blue bullseye) on PC display. Used in clinical settings by healthcare providers. Replaces fluoroscopy/chest X-ray for tip confirmation. Benefits: reduces radiation exposure; provides real-time positioning feedback.

Clinical Evidence

Prospective, single-armed, open design 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

Polyimide stylet tube (6 ft) with distal Doppler sensor and stainless steel ivECG wire. Compatible with catheters ≥0.021 inch lumen. Console includes data acquisition module and PC. Sterilization: EtO (ANSI-AAMI-ISO 11135-1:1994). Biocompatibility: ISO 10993-1:2003 compliant.

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, severe tachycardia, pacemaker-driven rhythm) or femoral/saphenous vein access, where P-wave presentation is altered; requires alternative 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 Stylet (K081625)
• Sapiens™ Tip Location System (TLS) (K093775)

Submission Summary (Full Text)

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KIP3522 6/14

#### 5.0 Traditional 510(k) Summary

FEB 18 2011

# 510(k) SUMMARY

# A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Submitter Information | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | VasoNova, Inc. |
| Address | 155 Jefferson Drive, Suite 100<br>Menlo Park, CA 94025 |
| Phone number | 650.388.5605 |
| Fax number | 650.388.5611 |
| Establishment<br>Registration<br>Number | 3006795936 |
| Name of contact<br>person | Kim Tompkins, RN, MBA |
| Date prepared | October 27, 2010 |
| Name of device | |
| Trade or proprietary<br>name | Vascular Positioning System™ (VPS™ System) Stylet |
| Common or usual<br>name | Catheter, Ultrasound, Intravascular |
| Classification name | 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 Stylet (K081625)<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. |
| | The VPS Console consists of two key integrated<br>software-driven components: a data acquisition module;<br>and a PC with processing and display capabilities. |
| | The VPS Stylet is a polyimide tube containing a Doppler<br>sensor on a coax cable and an intravascular<br>electrocardiogram (ivECG) signal sensing stainless steel<br>wire. The Doppler sensor and the exposed portion of the<br>ivECG are located at the distal end of the stylet and are<br>used to detect and transmit physiological information to<br>the VPS Console for analysis. The proximal end<br>contains a connector to the VPS Console or to an<br>extension cable that in turn connects to the VPS<br>Console. The stylet can be inserted and removed from<br>any catheter with a luminal diameter of at least 0.021<br>inches. |
| | The data acquisition module of the console transmits<br>and receives ultrasound data while receiving electrical<br>signals from the heart through sensors mounted at the<br>tip of the VSP Stylet. Using signals gathered by the data<br>acquisition module, the graphical user interface of the<br>PC provides the user with guidance for tip positioning. |
| Intended use of the<br>device | The intended use of the VPS Stylet and Console (VPS<br>System) is to quickly and accurately guide market<br>available peripherally inserted central catheters (PICCs)<br>to the goal location which is the cavo-atrial junction near<br>the sino-atrial node. |
| Indications for use | The VPS Stylet and Console are indicated for guidance and<br>tip positioning for central venous catheters. The Stylet<br>provides stiffness for use in placement of the catheter,<br>intravascular capability for ECG detection and recording<br>and intravascular ultrasound for catheter guiding and<br>positioning. The VPS Stylet, when used with the VPS<br>Console, provides real-time catheter tip location information<br>by using the patient's physiological (cardiac electrical<br>activity and blood flow) information. When the VPS System<br>guidance indicator shows a blue bullseye, the catheter tip is<br>in the desired location. The VPS System is indicated for<br>use as an alternative method to fluoroscopy or chest x-ray<br>for central venous catheter tip placement confirmation in<br>adult patients. |
| | Limiting but not contraindicated situations for this technique<br>are in patients where alterations of cardiac rhythm change<br>the presentation of the P-wave as in atrial fibrillation, atrial<br>flutter, severe tachycardia and pacemaker-driven rhythm,<br>and in central venous catheterization procedures performed<br>through femoral or saphenous vein access which change<br>the presentation of the P-wave. In such patients, who are<br>easily identifiable prior to central venous catheter insertion,<br>the use of an additional method is required to confirm<br>catheter tip location. |
| | |

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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE<br>COMPARED TO THE PREDICATE DEVICE | | |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | New Device | Predicate |
| Materials, design | 6 foot long polymeric tube<br>which contains a Doppler<br>sensor at the distal tip and an<br>intravascular<br>electrocardiogram (ivECG)<br>signal sensing wire. | Identical (FlowPICC,<br>K081625) |
| Intended Use | When the VPS System<br>guidance indicator shows a<br>blue bull's-eye, the catheter tip<br>is in the desired location. The<br>VPS System is indicated for<br>use as an alternative method<br>to fluoroscopy or chest x-ray<br>for central venous catheter tip<br>placement confirmation in adult<br>patients. | Sapiens™ TLS is<br>indicated for use as an<br>alternative method to<br>chest X-ray or fluoroscopy<br>for central venous<br>catheter tip placement<br>confirmation in adult<br>patients. (Sapiens TLS,<br>K093775) |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION<br>OF SUBSTANTIAL EQUIVALENCE | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Performance Testing: | Tensile strength, torque strength,<br>tip flexibility, catheter<br>compatibility and electrical safety<br>testing were performed on the<br>VPS Stylet | Met all<br>specifications |
| Biocompatibility Testing | Cytotoxicity: ISO Elution Test<br>(MEM extract), Cytotoxicity: ISO<br>Direct Contact, Cytotoxicity: ISO<br>Agar Diffusion Test, Murine Local<br>Lymph Node Assay, Hemolysis,<br>Partial Thromboplastin Test,<br>Intracutaneous (intradermal)<br>Reactivity Test (ISO), Acute<br>systemic toxicity test, Ames<br>Mutagenicity Test, Prothrombin<br>Time Test, Thrombogenicity<br>study in Dogs (ISO), ISO implant<br>test (7 days), ISO implant test<br>(90 days) | Compliant with ISO<br>10993-1:2003 |
| Sterilization and Shelf-life<br>Testing: | Sterilization validation and EtO<br>Residuals testing per ANSI-<br>AAMI-ISO 11135-1:1994 -<br>Sterilization Validation. Shelf-life<br>testing to 24 months has been<br>performed. | Passed |

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| Comparative Performance Information Summary | | | |
|---------------------------------------------|-------------|------------|--------------------------|
| Characteristic | Requirement | New Device | Predicate<br>Device(s) |
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | | | Same |
| ECG | | | Same |
| Ultrasound | | | Same (FlowPICC,<br>only) |

# SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information

The VPS System correctly indicated proper PICC tip placement in 98.4% of the placement procedures in a prospective, single-armed, open design study clinical study of 77 patients.

# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The VPS Stylet is identical in design and materials to the FlowPICC Stylet (K081625) and has been clinically demonstrated to be substantially equivalent to the Sapiens™ TLS Tip Location System (K093775) with regard to intended use.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 18 201

Re: K103255

Trade/Device Name: Vascular Positioning System™ (VPSTM) Stylet 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 2, 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 country of the county of the county of the county of

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Page 2 – Ms. Kim Tompkins

Enclosure

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 lisung (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.hypn1 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.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely vours.

W. Mcd

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### 4.0 Indications for Use Statement

| 510(k) Number: | To be determined |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VasoNova™ Vascular Positioning System™ (VPS™ System)<br>Stylet |
| Intended Use: | The VPS Stylet and Console are indicated for guidance and tip<br>positioning for central venous catheters. The Stylet provides stiffness for<br>use in placement of the catheter, intravascular capability for ECG<br>detection and recording and intravascular ultrasound for catheter guiding<br>and positioning. The VPS Stylet, when used with the VPS Console,<br>provides real-time catheter tip location information by using the patient's<br>physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, 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.<br>Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-<br>wave as in atrial fibrillation, atrial flutter, severe tachycardia and<br>pacemaker-driven rhythm, and in central venous catheterization<br>procedures performed through femoral or saphenous vein access which<br>change the presentation of the P-wave. In such patients, who are easily<br>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)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.D.

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103253