HD GUIDE CATHETER

K090335 · Concentric Medical, Inc. · DQY · May 6, 2009 · Cardiovascular

Device Facts

• Record ID: K090335
• Device Name: HD GUIDE CATHETER
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic anqiographic catheter.

Device Story

HD Guide Catheter is a single-lumen, braided, variable-stiffness catheter; features radiopaque distal marker, proximal luer hub, and hydrophilic coating to reduce friction. Supplied with rotating hemostatic valve and side-arm adapter. Used by clinicians to facilitate insertion/guidance of microcatheters into peripheral, coronary, or neurovascular systems; also functions as diagnostic angiographic catheter. Device provides mechanical pathway for interventional tools; aids in navigating vasculature. Benefits include improved trackability and access to target vessels.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-lumen, braided, variable-stiffness shaft; radiopaque distal marker; proximal luer hub; hydrophilic coating. Includes rotating hemostatic valve with side-arm adapter.

Indications for Use

Indicated for facilitating insertion and guidance of microcatheters (occlusion, infusion, etc.) into peripheral, coronary, or neurovascular blood vessels; also for diagnostic angiography. No specific patient population or contraindications provided.

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

• HD Guide Catheter (K080583)

Submission Summary (Full Text)

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- 6 2009

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## General Information

| Trade Name | HD Guide Catheter |
|----------------|--------------------------------------------------|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Submitter | Concentric® Medical, Inc. |
| | 301 E. Evelyn Avenue |
| | Mountain View, CA 94041 |
| | Tel [phone] |
| | Fax [phone] |
| Contact | Laraine Pangelina |
| | Director, Regulatory Affairs |

#### Intended Use

The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic anqiographic catheter.

#### Predicate Device

HD Guide Catheter, K080583

## Device Description

The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coaling to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

## Materials

All materials used in the manufacture of the HD Guide Catheter are suitable for the intended use of the device and have been used in numerous previously cleared products,

## Testing Summary

The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

## Summary of Substantial Equivalence

The HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are written around the eagle in a circular fashion.

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical c/o Ms. Laraine Pangalina Director, Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041

Re: K090335

Trade/Device Name: Concentric HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 16, 2009 Received: April 20, 2009

Dear Ms. Pangalina:

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 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); medical device reporting (reporting of medical

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Page 2 - Ms. Laraine Pangalina

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

.

| 510(k) Number (if known): | This application |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | HD Guide Catheter |
| Indications for Use: | The HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | 5/5/09 |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K090335 |