VENTURE WIRE CONTROL CATHETER, MODEL WCC

K042910 · Velocimed, Inc. · DQY · Nov 22, 2004 · Cardiovascular

Device Facts

• Record ID: K042910
• Device Name: VENTURE WIRE CONTROL CATHETER, MODEL WCC
• Applicant: Velocimed, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

Device Story

Venture Wire Control Catheter is a single-use, over-the-wire support catheter; features radiopaque deflectable tip. Physician operates rotating knob on handle to deflect tip up to 90° from catheter axis; provides instantaneous shaping and curvature control of 0.014" guidewires; supports guidewire navigation through coronary and peripheral vasculature. Luer attachment allows manual injection of saline or diagnostic contrast agents. Used in clinical settings by physicians to facilitate guidewire placement; improves access to discrete vascular regions.

Clinical Evidence

Bench testing only. Device performance validated against ISO 10555 (Part 1 and 4), ISO 10993-1 (biocompatibility), ASTM D-4169 (packaging), ISO 11607 (packaging), and ISO 11135 (sterilization).

Technological Characteristics

Single-use, over-the-wire support catheter; radiopaque deflectable tip; rotating handle mechanism for tip deflection; compatible with 0.014" guidewires; luer port for fluid delivery; ETO sterilized.

Indications for Use

Indicated for patients requiring coronary or peripheral vasculature access; used to direct, steer, control, and support a 0.014" guidewire and deliver saline or contrast agents.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Venture Wire Control Catheter (K040922)

Submission Summary (Full Text)

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# Ko42910

NOV 2 2 2004

# SECTION 3. 510(K) SUMMARY

#### 3.1 ADMINISTRATIVE INFORMATION

#### Name and address 3.1.1

| Submitted by: | Velocimed Inc<br>11400 73rd Avenue North, Suite 134<br>Minneapolis, MN 55369 |
|---------------|------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------|

| Contact Person: | John Carline |
|-----------------|--------------|
| Telephone No.: | 763-463-4742 |
| Facsimile No.: | 763-488-9780 |

Date Prepared: Oct 19, 2004

## 3.1.2 Device Name

| Trade Name | Venture Wire Control Catheter |
|---------------------|-------------------------------|
| Common Name | Catheter Steerable |
| Classification Name | Catheter, Intravascular |
| Classification | Class II |
| Model | DRA, DQY<br>WCC |

## 3.1.3 Applicant

| Applicant's Name: | Velocimed Inc |
|-------------------|------------------------------------|
| | 11400 73rd Avenue North, Suite 134 |
| | Minneapolis, MN 55369 |

#### 3.2 INDICATION FOR USE

The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

#### 3.3 DEVICE DESCRIPTION

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque deflectable tip. A rotating knob at the handle controls the tip deflection angle. The tip can be deflected continuously up to about 90° from the catheter axis.

The device is compatible with all 0.014" guidewires. It is torqueable and can be use to instantaneously shape, and control the curvature of the guidewire while in use as well as provide

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support to the guidewire when needed. A luer attachment is also provided to allow for the manual injection of dye through the guidewire lumen of the catheter

#### 3.4 SUBSTANTIAL EQUIVALENCE

The Venture™ Wire Control Catheter device covered by this submission is substantially equivalent to previous Venture Wire Control Catheter (K040922).

The Venture™ in this submission has the same indication for use, principles of operation, and technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy.

#### 3.5 PERFORMANCE DATA

The summary of the performance test data is provided in the 510(k) submission. The performance data demonstrates that the device complies with the applicable sections of: ISO 10555 (Part 1 and Part 4), ISO 10993-1, Product specification ASTM D-4169 (Packaging Integrity Testing) ISO 11607 (Packaging for terminally sterilized medical devices) ISO 11135: 1994(E) (Validation and routine control of ETO sterilization)

Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three horizontal lines that curve and converge, resembling a human figure in profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Velocimed, Inc. c/o Mr. John Carline RA Specialist 11400 7310 Avenue North, Suite 134 Minneapolis, MN 55369

Re: K042910

> Trade/Device Name: Venture Wire Control Catheter, Model WCC Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 19, 2004 Received: October 25, 2004

Dear Mr. Carline:

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 devive can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA enay 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

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Page 2 - Mr. John Carline

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decloils on a vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of worldwige to Aggil This letter will anow you to ought marketing your antial equivalence of your device to a legally premarket notification. The PDA miding of Sabsanalian of 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 If you desire specific davice for Jour avoiled. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misoranding by reference to premainteries in the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

inna R. Lochner

( / 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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# SECTION 2. INDICATION FOR USE

510(k) Number: K642910 _______________________________________________________________________________________________________________________________________________________

Venture Wire Control Catheter Device Name:

## Indication for Use

The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.

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)

Duma R. Vuchner

(Division Sign-Off) (Division Olgil-Six)
Division of Cardiovascular Devices

510(k) Number_K042910_________________________________________________________________________________________________________________________________________________________