DUOFLO CATHETER

K080700 · Thermopeutix, Inc. · MJN · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K080700
• Device Name: DUOFLO CATHETER
• Applicant: Thermopeutix, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DuoFlo™ Catheter is intended for general intravascular use in the perioheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries. The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

Device Story

DuoFlo™ Catheter is a sterile, single-use, multi-lumen intravascular device; features concentric shafts with four lumens accessed via Luer connectors: one for balloon inflation, one for pressure monitoring, two for infusate injection or extracorporeal circuit connection; central lumen accommodates up to 0.038" guidewire. Used by clinicians in peripheral vasculature to control blood flow and deliver agents. Device enables regional flow control when connected to extracorporeal circuits; assists in targeted therapy delivery. Benefits include localized infusion and flow management in peripheral arteries.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility studies per ISO 10993-1 and physical integrity testing (catheter body and balloon burst pressure).

Technological Characteristics

Sterile, single-use, multi-lumen catheter. Four-lumen design with Luer connectors for balloon inflation, pressure monitoring, and infusion/extracorporeal circuit connection. Central lumen for 0.038" guidewire. Materials have established history of use in similar devices. Sterilization to SAL 10^-6.

Indications for Use

Indicated for general intravascular use in peripheral arteries ≥3.5 mm diameter for infusion of diagnostic/therapeutic agents and blood flow control via extracorporeal circuit. Contraindicated for coronary and intracranial arteries. Not for embolic protection or aspiration.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• OriGen Dual Lumen Catheter (K003288)
• Coaxia FloControl™ Catheter (K023914)
• Couxia Remote Access Perfusion Catheter (K990573)

Submission Summary (Full Text)

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2080700

SEP 2 6 2008

ThermopeutiX, Inc. September 25, 2008

### 510 (k) SUMMARY

### Applicant

ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: [phone] Fax: [phone]

Manufacturer

ThermopeutiX, Inc. 9925B Business Park Avenue San Diego, California 92131 Phone: [phone] Fax: [phone]

Contact Person

Thomas Schroeder, Director, RA/QA

- Temporary Intravascular Occluding Catheter Common Names: Diagnostic Intravascular Catheter Classification Names: Devices of this type are classified as Class II under 21 CFR Part 870.1200, Diagnostic Intravascular Catheter (Product Code DQO) and 21 CFR Part 870.4450, Vascular Clamp (Product Codes MJN and DXC). DuoFlo™ Catheter Proprietary name:
#### Predicate Devices

The ThermopeutiX DuoFlo™ is substantially equivalent in general indications and design and features to temporary occluding catheters, perfusion catheters and diagnostic intravascular catheters; these devices are:

- 1) OriGen Dual Lumen Catheter (K003288) DQO
- 2) Coaxia FloControl™ Catheter (K023914) MJN
- 2) Couxia Remote Access Perfusion Catheter (K990573) DXC

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## 510 (k) SUMMARY

### Indications for Use

Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in the perioheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.

The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

## Device Description

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

### Tecnnological Characteristics Comparison

Th a catheter is equivalent in design and construction to currently marketed temporary occluding catheters and intravascular continuous flush catheters. The construction materials used have an established history of safe use in similar medical devices.

## Primance and Safety

The biological safety of the device has been demonstrated through biocompatibility studies of n : ' bloghour banderials in accordance with the standards outlined in ISO 10993-1. Physical te : ing was performed to assure catheter integrity including verification of catheter body and balioon burst pressure.

The device is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10° The supplied instructions for use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device.

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Public Health Service

SEP 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ThermopeutiX, Inc. c/o Ms. Dawn Tibodeau Project Coordinator TUV SUD America Inc. 1775 Old Hwy 8 NW, Stc 104 New Brighton, MN 55112-1891

Re: K080700

> Trade/Device Name: DuoFlo™ Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 9, 2008 Received: September 10, 2008

Dear Ms. Tibodeau:

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 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

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Page 2 - Ms. Dawn Tibodeau

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) promarket 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 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.

Sincercly yours,

R. Vochines

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

510(k) Number (if known):

KO80700

Device Name: DuoFlo™ Catheter

Indications for use: The DuoFlo™ Catheter is intended for general intravascular use in Indications for assulature in arteries 3.5 mm and larger. Once placed in the selected the porferer rater face intelled of diagnostic and/or therapeutic agents, and region, the bathleter connected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.

The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

Prescription Use: _ X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Sochares

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko80700