VENTURE WIRE CONTROL CATHETER

K040922 · Velocimed, Inc. · DQY · Aug 18, 2004 · Cardiovascular

Device Facts

• Record ID: K040922
• Device Name: VENTURE WIRE CONTROL CATHETER
• Applicant: Velocimed, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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; designed for use in coronary and peripheral vasculature. Device features a deflectable tip, controllable up to 90° from the catheter axis, allowing for instantaneous shaping and steering of the guidewire. Compatible with 0.014" guidewires; includes a luer attachment for infusion of saline or contrast agents. Operated by physicians in clinical settings to facilitate guidewire navigation through complex vascular anatomy. Provides support and torqueability to assist in accessing discreet regions. Benefits include improved guidewire control and navigation during interventional procedures.

Clinical Evidence

Bench testing included dimensional verification, tip integrity, tensile strength, torque strength, flexibility, and trackability. Animal study conducted on four subjects (nine coronary vessels) to validate performance and safety.

Technological Characteristics

Single-use, over-the-wire support catheter. Features deflectable tip (up to 90°). Compatible with 0.014" guidewires. Materials/testing comply with ISO 10555 (Parts 1 and 4), ISO 10993-1, and ISO 11607. Sterilization via ETO (ISO 11135).

Indications for Use

Indicated for directing, steering, controlling, and supporting a guidewire to access coronary and peripheral vasculature; may be used for manual delivery of saline or diagnostic 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

• IntraLuminal Therapeutics Deflectable Catheter (K004785)
• Xtrak TOPS catheter

Submission Summary (Full Text)

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K040922

AUG 1 8 2004

# SECTION 2. 510(K) SUMMARY

#### Administrative Information 2.1

#### Name and address 2.1.1

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

| Contact Person: | Sew-Wah Tay, Ph.D. |
|-----------------|--------------------|
| Telephone No .: | 763-463-4707 |
| Cell Phone: | 612-801-6782 |
| Facsimile No .: | 763-488-9780 |

April 5, 2004 Date Prepared:

## 2.1.2 Device Name

| Trade Name | Venture Guidewire Control |
|----------------|---------------------------|
| | Catheter |
| Common Name | Catheter Steerable |
| Classification | Catheter, Intravascular |
| Name | |
| Classification | Class II |
| | DRA, DQY |
| Model | WCC |

### 2.1.3 Applicant

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

#### Indication for use 2.2

The Venture™ Guidewire Control Catheter is indicated for directing, steering, controlling, and I he Venture™ Guidewire Control Cather Cather is of the coronary and peripher a seats. supporting a guide wire to access assess assessed in or diagnostic contrast agents.

#### DEVICE DESCRIPTION 2.3

The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a The Venute While Control Cancer is a single ass, over acceptrols the tip deflection angle. The factiopaque deflected continuously up to about 90° from the catheter axis.

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The device is compatible with all 0.014" guidewires. It is torqueable and can be use to The device is companible with an 0.01 - gaidence the guidewire while in use as well as well as instantaneously shape, and control the curration of the gatachment is also provided to allow for
provide support to the guidewire when needed. A luer attachment is also prov provide support to the gailewire the guidewire lumen of the catheter

#### SUBSTANTIAL EQUIVALENCE 2.4

4 - SUBSTARTIAL EQUIPALE: 2017/22/2017 - 11:51 PM IS submission is substantially The Venure™ Guidewire Conner Cannot Cannely, IntraLuminal Therapeutics Deflectable
equivalent to other legally marketed devices namely, Antal (K. 004785) and Xtrak TOPS equivalent to other legally marketed devices nationy, matheter (K 904785) and Xtrak TOPS catheter

The Venture™ has the same general indication for use, similar principles of operation, and i he Venture … nas the same general matedical concerners predicate devices. The similar rechnological characteristics as the previously co.
differences between this device and its predicate devices do not raise new questions of safety or efficacy.

#### Performance Data 2.5

The performance test data is provided in the 510(k) submission. The performance data The performance tost data is promoties 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)

Performance testing included dimensional verification; tip integrity, catheter tensile strength, Performance testing metaded unneresbility. Four chronic animals (total of nine coronary torque sitengni, nextbirty, and tractise control Catheter to test and validate the vessels) were treated with the 7 enter. Test results demonstrate that the device meets or performance and surery of the as resndards and performs substantially equivalent to the predicate devices.

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Image /page/2/Picture/11 description: The image shows a circular seal with the words "HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has three lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 2004

Velocimed Inc. c/o Sew-Wah Tay, Ph.D. V.P. Regulatory and Clinical Affairs 11400 73to Avenue North, Suite 134 Minneapolis, MN 55369

Re: K040922

> Trade Name: Venture™ Wire Control Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 9, 2004 Received: August 10, 2004

Dear Dr. Tay:

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.

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Page 2 - Sew-Wah Tay, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DA 3 issuance or our device complies with other requirements of the Act that I DA has made a decembations administered by other Federal agencies. You must of ally it catal statutes and regarations, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN i art 607), adoning (21 OFF Part 820); and if applicable, the electronic form in the quality systems (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) This icher will anow you'll cognification of substantial equivalence of your device to a legally premarked 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 and If you desire specific advice to: Jour avoitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0671. Additionally, for questions on the promotion and advertising of Compliance at [phone]. Thanks Compliance at [phone]. Also, please note the your device, picase connered by reference to premarket notification" (21CFR Part 807.97). regulation entitiou, "Thisocanants or esponsibilities under the Act may be obtained from the Other general miormation on your respational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil R.F. Ogden

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

K040922 510(k) Number:

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)

Neil R.P. Oyler

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number