FLOWPICC STYLET

K081625 · Vasonova, Inc. · OBJ · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K081625
• Device Name: FLOWPICC STYLET
• Applicant: Vasonova, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.

Device Story

FlowPICC System comprises a console and a 6-foot polymeric stylet (0.019" OD) inserted into a PICC catheter (min 0.021" lumen). Stylet integrates a Doppler sensor for blood flow detection and a wire for intravascular ECG (ivECG) sensing. System provides real-time catheter tip location by processing cardiac electrical activity and blood flow signals. Used during PICC placement procedures to guide and position the catheter tip. Clinicians use the console output to navigate the catheter, potentially improving placement accuracy and reducing complications. Stylet also provides mechanical stiffness to facilitate catheter insertion.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Polymeric stylet (6 ft length, 0.019" OD); Doppler sensor for blood flow; wire for ivECG sensing; console-based signal processing; compatible with PICC catheters (min 0.021" lumen).

Indications for Use

Indicated for patients requiring PICC catheter placement to assist in real-time catheter tip location and positioning within the vasculature.

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

• ComboMap (Volcano K041134)
• Sherlock (Bard K063240)

Submission Summary (Full Text)

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## SEP 2 6 2008

#### 510(k) Summarv K081625

| Date Prepared | September 26, 2008 |
|------------------------------------|----------------------------------------------------------------------------------|
| Submitted by | VasoNova, Inc.<br>1368 Bordeaux Drive, Ste 100<br>Sunnyvale, CA 94089 |
| Contact | Sorin Grunwald, Ph.D., MBA, Chief Technology Officer |
| Proprietary Name<br>Classification | FlowPICCT™ Stylet, name subject to change<br>870.1200 Class II/880.5970 Class II |
| Predicates | ComboMap (Volcano K041134 SE 6/2/04)<br>Sherlock (Bard K063240 SE 11/21/06) |

#### Device Description

The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.

#### Intended Use

The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICCTM Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.

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### Performance Data

Performance test results support the performance characteristics of the device and support substantial equivalence to the currently marketed predicate devices.

### Conclusion

The FlowPICC Stylet has the same intended use and utilizes the same fundamental scientific technology as that of the referenced predicate devices.

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SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VasoNova, Inc. c/o Sorin Grunwald, PhD, MBA Chief Technology Officer 1368 Bordeaux Drive, Ste. 100 Sunnyvale, CA 94089

Re: K081625

Trade/Device Name: FlowPICCTM Stylet Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: August 29, 2008 Received: September 2, 2008

Dear Dr. Grunwald:

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 such 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 or

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#### Page 2 - Sorin Grunwald, PhD, MBA

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

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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# 510(k) Indications for Use

Page 1 of 1

510(k) Number (if known): K081625

Device Name:

FlowPICC Stylet

Indications for use:

The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. 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.

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

Over-The-Counter Use (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)

K081625

(Division 56)
Division of Cardiovascular Devices

510(k) Number K081675