MODIFICATION TO MODIFIED HD GUIDE CATHETER

K092298 · Concentric Medical, Inc. · DQY · Nov 5, 2009 · Cardiovascular

Device Facts

• Record ID: K092298
• Device Name: MODIFICATION TO MODIFIED HD GUIDE CATHETER
• Applicant: Concentric Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Modified 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.

Device Story

Modified HD Guide Catheter is a percutaneous catheter used to facilitate insertion and guidance of microcatheters (occlusion/infusion) into peripheral, coronary, or neurovascular systems; also functions as diagnostic angiographic catheter. Device features single-lumen, braided, variable-stiffness shaft with distal radiopaque marker and proximal luer hub. Hydrophilic coating reduces friction. Includes rotating hemostatic valve with side-arm adapter. Used by physicians in clinical settings to navigate vasculature; output is physical access/guidance for secondary devices. Benefits include improved trackability and vessel access.

Clinical Evidence

Bench testing only. Verification and validation testing demonstrated the device performs as designed and is suitable for its intended use.

Technological Characteristics

Single-lumen, braided, variable-stiffness shaft; radiopaque distal marker; proximal luer hub; hydrophilic coating. Includes rotating hemostatic valve with side-arm adapter. Class II percutaneous catheter (21 CFR 870.1250).

Indications for Use

Indicated for facilitating insertion/guidance of occlusion, infusion, or microcatheters into peripheral, coronary, or neurovascular blood vessels; also for diagnostic angiography.

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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K0922987

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## General Information

NOV - 5 2009

| Trade Name | Modified HD Guide Catheter |
|----------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Submitter | Concentric® Medical, Inc.<br>301 E. Evelyn Avenue<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone] |
| Contact | Kirsten Valley<br>Senior Vice President, Technology & Regulatory Affairs |

## Intended Use

The Modified 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.

#### Predicate Device

HD Guide Catheter, K080583

#### Device Description

The Modified 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 coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

## Materials

1

All materials used in the manufacture of the Modified 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 Modified 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 Modified 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 Modified 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 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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV - 5 2009

Concentric Medical c/o Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View, CA 94041

Re: K092298

Trade/Device Name: Modified HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 22, 2009 Received: October 27, 2009

Dear Ms. Valley:

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. Kirsten Valley

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

uma R. bulmer

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 K092298 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified HD Guide Catheter |
| Indications for Use: | The Modified HD Guide Catheter is indicated for use in<br>facilitating the insertion and guidance of an occlusion catheter<br>infusion catheter or other appropriate microcatheter into a<br>selected blood vessel in the peripheral, coronary or neuro<br>vascular systems. It may also be used as a diagnostic<br>angiographic catheter. |

Prescription Use _X (Per 21 CFR 801.109) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

D.R.V
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Division of Cardiovascular Devices (L.S.

Division of
510(k) Number K092298