ISOFLOW INFUSION CATHETER

K081147 · Vascular Designs, Inc. · KRA · May 29, 2009 · Cardiovascular

Device Facts

• Record ID: K081147
• Device Name: ISOFLOW INFUSION CATHETER
• Applicant: Vascular Designs, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

Device Story

IsoFlow is a 2.4F multi-lumen dual-balloon infusion catheter; used with 4F guide catheters and 0.010" guidewires. Operates by inflating two compliant balloons simultaneously via radiopaque fluid to isolate a vascular segment; allows localized infusion between balloons or distal tip delivery. Features hydrophilic coating; radiopaque markers for fluoroscopic positioning. Used by physicians in clinical settings to isolate treatment regions while maintaining blood perfusion via a bypass lumen. Output is the targeted delivery of physician-specified fluids; enables localized therapy while minimizing systemic exposure or maintaining distal flow. Single-use; sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

Multi-lumen dual-balloon catheter; 2.4F diameter; 120cm length. Features hydrophilic coating. Radiopaque markers for fluoroscopic visualization. Compliant balloons inflated via radiopaque fluid. Sterile, single-use device.

Indications for Use

Indicated for isolation of a specific vascular treatment region from blood flow to allow localized fluid infusion while maintaining distal blood perfusion. Used for delivery of physician-specified fluids to target regions or distal tip. Prescription use only.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• DISPATCH™ Coronary Infusion Catheter (K932616)
• ISOLATE™ Infusion Catheter System (K913517)

Submission Summary (Full Text)

{0}------------------------------------------------

## 5. 510(k) Summary

## VascularDesigns™

MAY 2 9 2009

Kosjitt

Submitter's name: Address:

Vascular Designs Inc 5655 Silver Creek Valley Road #512 San Jose, CA 95138

Phone: Fax number: 408-230-5560 408-416-4116

Name of contact person:

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone] Email: [e-mail]

Date the summary was prepared: April 16, 2008

| Name of the device: | IsoFlow |
|------------------------------|-----------------------------------------------------|
| Trade or proprietary name: | IsoFlow |
| Common or usual name: | Infusion catheter |
| Classification name: | Catheter, percutaneous<br>Continuous flush catheter |
| CFR Classification Reference | 870.1250<br>870.1210 |
| Class | Class II (two) |
| Product Code | DQY<br>KRA |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

| Predicate Device Name | Submitted By | 510k<br>Reference # |
|-----------------------------------------|------------------------------|---------------------|
| DISPATCH™ Coronary Infusion<br>Catheter | SCIMED | K932616 |
| ISOLATE™ Infusion Catheter System | Lake Region Mfg. Co.<br>Inc. | K913517 |

{1}------------------------------------------------

Description of the device:

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region. The exterior surface of the distal 120cm catheter length is treated with a hydrophilic coating.

The 2.4F IsoFlow™ Infusion Catheter System is intended to be used with guide catheters 4F (0.050") and larger, along with a 0.010" guide wire for positioning the catheter in the desired region. A standard Y-adaptor RHV provides for guide wire entry and saline flush into the main guide wire / bypass lumen of the catheter. Radiopaque markers at the distal tip and between the two balloons allow for final position adjustment under fluoroscopy guidance.

The two compliant balloons are inflated simultaneously using radiopaque fluid delivered via a single inflation lumen.

Physician specified infusion fluid through either the labeled infusion lumen or the labeled guidewire lumen is delivered via the 1-way stopcock connection. The mixture of infusion and radiopaque agents is delivered directly to the target region between the balloons, or out the distal tip respectively.

For infusion out of the sideport holes, retracting the guide wire to the radiopaque marker band proximal to both balloons allows blood to bypass the isolated tarqet region via holes connecting the guide wire / bypass lumen with the catheter exterior. Complete removal of the guidewire allows delivery from the distal tip.

All components of the catheter system are provided sterile. Each device is intended for single use. Do not reuse or attempt to resterilize any component of the system.

Indications:

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

{2}------------------------------------------------

Summary of characteristics of our device compared to the predicate device:

| ISO Flow Catheter versus predicate devices | | |
|--------------------------------------------|-----------------------------------------|--------------------------------------|
| | DISPATCH™ Coronary<br>Infusion Catheter | ISOLATE™ Infusion<br>Catheter System |
| Parameter | K932616 | K913517 |
| Intended Use | Substantially Equivalent | Substantially Equivalent |
| Physical Description | Substantially Equivalent | Substantially Equivalent |
| Anatomical Sites | Substantially Equivalent | Substantially Equivalent |
| Design | Substantially Equivalent | Substantially Equivalent |
| Materials | Substantially Equivalent | Substantially Equivalent |

| IsoFlow Catheter versus predicate devices | | | |
|-------------------------------------------|--|--|--|
|-------------------------------------------|--|--|--|

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Designs C/O Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Consultant 3722 Ave: Sausalito Irvine, CA 92606

MAY 2 9 2009

Re: K081147

> Trade/Device Name: IsoFlow Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY Dated: May 4, 2009 Received: May 6, 2009

Dear Ms. Holland:

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 intestate 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, IDA 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 nf 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{4}------------------------------------------------

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 predicate 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 Biometric's (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. Directory Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## 4. Indications for Use Statement Indications for Use

510(k) Number (if known): Koogli47

Device Name: IsoFlow

Indications for Use:

The IsoFlow™ Infusion Catheter is a multi-lumen dual balloon catheter designed to isolate a specific treatment region from blood flow while allowing infusion of fluids into the region and perfusion of blood past the region.

The device also has the ability to deliver physician specified fluids out the distal tip with or without inflation of the balloons.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

h

(Division/Sign-C Dill rdiovascular Devices

Page 1 of 1