CHAPERON GUIDING CATHETER

K082385 · MicroVention, Inc. · DQY · Dec 11, 2008 · Cardiovascular

Device Facts

• Record ID: K082385
• Device Name: CHAPERON GUIDING CATHETER
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.

Device Story

Chaperon Guiding Catheter System is a two-catheter system (outer and inner catheter) designed to advance interventional and diagnostic devices through vasculature. Used in neuro and peripheral vasculature; operated by physicians. Can be used individually with 0.035 in or 0.038 in guidewire or together with inner catheter to access anatomy. Facilitates introduction of diagnostic or therapeutic devices. Benefits include improved access to desired anatomy for interventional procedures.

Clinical Evidence

Bench testing only. Testing included surface contamination, dimensional inspection, tensile strength, hub/tip attachment strength, leakage, flow rate, radio-detectability, stiffness, kink resistance, and durability/lubricity/fatigue. All tests met established criteria.

Technological Characteristics

Two-catheter system (outer and inner). Compatible with 0.035 in or 0.038 in guidewires. Features include radio-detectability, lubricity, and kink resistance. Sterilized using standard processes.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate introduction of diagnostic or therapeutic devices. Not for use in coronary arteries.

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

• Penumbra Neuron Intracranial Access System (K070970)

Submission Summary (Full Text)

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MicroVention Inc.

Trade Name:

Generic Name:

Classification:

Submitted By:

| 510(k) Summary | K082385 |
|----------------------------------|-------------|
| Chaperon Guiding Catheter System | |
| Percutaneous Catheter | |
| Class II, 21 CFR 870.1250 | DEC 11 2008 |

75 Columbia Aliso Viejo, California U.S.A. Florin Truuvert Contact:

MicroVention, Inc

## Predicate Device:

| Number | Description | Predicate For | Clearance Date |
|---------|--------------------------------------------------------|-------------------------------------|--------------------|
| K070970 | Penumbra Inc.,<br>Neuron Intracranial<br>Access System | Chaperon Guiding<br>Catheter System | August 17,<br>2007 |

#### Device Description

The Chaperon Guiding Catheter system is designed to advance interventional and diagnostic devices through the vasculature. The device is intended for general intravascular use, including the neuro and peripheral vasculature. The Chaperon Guiding Catheter is a two-catheter system comprised of the outer catheter and the inner catheter. The Chaperon Guiding Catheter system can be used individually with 0.035 in or a 0.038 in guidewire or together with the Inner Catheter to access the desired anatomy.

## Indication For Use

Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.

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Verification and Test Summary Table

| Bench Testing | Result |
|----------------------------------------------|--------------------------|
| Surface Contamination & Tip Configuration | Met established criteria |
| Dimensional Inspection & Physical Attributes | Met established criteria |
| Tensile Strength | Met established criteria |
| Hub Attachment Strength | Met established criteria |
| Tip Attachment Strength | Met established criteria |
| Freedom from Leakage - Fluid & Air | Met established criteria |
| Leak Test (High Static Pressure) | Met established criteria |
| Hub Gauging | Met established criteria |
| Separation Force | Met established criteria |
| Stress Cracking | Met established criteria |
| Screwing Torque | Met established criteria |
| Ease of Assembly | Met established criteria |
| Resistance to Overriding | Met established criteria |
| Flow Rate | Met established criteria |
| Radio-Detectability | Met established criteria |
| Catheter Burst & Leakage | Met established criteria |
| Stiffness & Kink Resistance | Met established criteria |
| Durability & Lubricity & Fatigue | Met established criteria |

# Summary of Substantial Equivalence

The data presented in this submission demonstrates the technological similarity and equivalency of the Chaperon Guiding Catheter System compared with the predicate device Penumbra Neuron Intracranial Access System (K070970).

The devices,

- Have the same intended use, .
- Use the same operating principle, .
- Incorporate the same basic design, .
- Use similar construction and material, .
- Are packaged and sterilized using same processes. .

In summary, the Chaperon Guiding Catheter System described in this submission is, in our opinion, substantially equivalent to the predicate device.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 2008

Microvention, Inc. c/o Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K082385

Trade/Device Name: Chaperon Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: November 11, 2008 Received: November 12, 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of December 11, 2008.

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 (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.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 continue 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Radiological Health

D. Vahner

Image /page/3/Picture/6 description: The image contains a handwritten symbol or signature. It appears to be a stylized letter or a unique mark, possibly representing initials or a personal identifier. The symbol is composed of curved and straight lines, with a flowing, calligraphic quality. The overall impression is that of a deliberate and artistic design.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name: Chaperon Guiding Catheter System

Indications for Use:

Chaperon Guiding Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. Chaperon Guiding Catheter can be used to facilitate introduction of diagnostic or therapeutic devices. Chaperon Guiding Catheter is not intended for use in coronary arteries.

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 OF NEBDED)

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K062385 |

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