STRADA CAROTID GUIDING SHEATH

K070166 · St Jude Medical · DYB · Apr 6, 2007 · Cardiovascular

Device Facts

• Record ID: K070166
• Device Name: STRADA CAROTID GUIDING SHEATH
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Apr 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.

Device Story

Strada™ Carotid Guiding Sheath is a single-use introducer system comprising a delivery sheath with hemostatic valve and a dilator. Used by clinicians to provide a pathway for diagnostic and interventional devices into the vasculature, including the carotid artery. Device features 80cm or 90cm lengths, 8F outer diameter, 6F inner diameter, hydrophilic coating on the distal 20cm, and a radiopaque marker. Operation is manual. Benefits include facilitating access for minimally invasive vascular procedures.

Clinical Evidence

No clinical data. Evidence consists of in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life/package testing, and sterilization validation. Results demonstrate the device meets specifications.

Technological Characteristics

Single-use catheter introducer. 8F outer diameter, 6F inner diameter. Lengths: 80cm, 90cm. Features: hemostatic valve, dilator, hydrophilic coating (20cm distal), radiopaque marker. Manual operation. Sterile, non-pyrogenic.

Indications for Use

Indicated for introduction of diagnostic and therapeutic devices into human vasculature, including carotid artery. No specific age or gender restrictions noted.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Destination® Carotid Guiding Sheath (K052185)

Submission Summary (Full Text)

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SJM ST. JUDE MEDICAL

# 510(K) SUMMARY

K070166

#### 1. ADMINISTRATIVE INFORMATION

| Name: | St. Jude Medical | APR - 6 2007 |
|-----------------|--------------------------------------------------------------|--------------|
| Address: | 6550 Wedgwood Road North, Suite 150<br>Maple Grove, MN 55311 | |
| Phone: | 763-463-5713 | |
| Fax: | 763-488-9780 | |
| Contact Person: | Jeff Sturm<br>Senior Regulatory Affairs Specialist | |
| Date: | January 17, 2007 | |

#### 2. DEVICE INFORMATION

| Name of Device: | Strada™ Carotid Guiding Sheath |
|----------------------|--------------------------------|
| Common Name: | Access Sheath, Introducer |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |

#### 3. PREDICATE DEVICE INFORMATION

The predicate device is the Destination® Carotid Guiding Sheath manufactured by Terumo and cleared by premarket notification in 2005 (K052185).

4. DEVICE DESCRIPTION

The Strada™ Carotid Guiding Sheath is designed to perform as an introducer and a guiding sheath. The device is a single-use system that consists of a delivery sheath with hemostatic valve and dilator. Upon removal of the dilator, the delivery sheath provides a pathway for diagnostic and interventional devices into the vasculature.

The Strada™ Carotid Guiding Sheath is available in 80 and 90cm lengths. The sheath has an 8F outer diameter and 6F inner diameter. The distal end is straight, has a hydrophilic coating (20cm) and has a radiopaque marker approximately 2.5 mm from the tip. The device is provided sterile and non-pyrogenic.

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Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of the letters "SJM" inside of an octagon on the left, followed by the words "ST. JUDE MEDICAL" in all caps. The text is in a bold, sans-serif font.

#### INTENDED USE 5.

The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to, the carotid artery.

The intended use is identical to the predicate device.

### 6. TECHNOLOGICAL CHARACTERISTICS

The device design and material types are key features that determine performance of the device. The components and material characteristics of the device are substantially equivalent to the predicate device. Both devices are used manually by the user.

### SUMMARY OF NON-CLINICAL TESTING 7.

Non-clinical testing of the Strada™ Carotid Guiding Sheath includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization validation. Results of the testing demonstrate that the Strada™ Sheath design meets product specifications and intended uses.

#### 8. SUBSTANTIAL EQUIVALENCE CONCLUSION

The Strada™ Carotid Guiding Sheath in this 510(k) is substantially equivalent to the Terumo Destination® Carotid Guiding Sheath (K052185). The intended use, design, material types, technology, and performance of the Strada™ Sheath is identical to the predicate device. There are no differences between devices which would raise issues of safety or effectiveness.

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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 stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

St. Jude Medical c/o Mr. Jeff Sturm Senior Regulatory Affairs Specialist 6550 Wedgwood Road North, Suite 150 Maple Grove, MN 55311

Re: K070166

Strada™ Carotid Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 30, 2007 Received: April 2, 2007

## Dear Mr. Sturm:

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.

APR - 6 2007

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## Page 2 - Mr. Jeff Sturm

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 begin 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/industry/support/index.html.

Sincerely yours.

Brent D. Zanke, M.D.

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):

Device Name: Strada™ Carotid Guiding Sheath

Indications for Use:

The Strada™ Carotid Guiding Sheath is indicated for the introduction of diagnostic and therapeutic devices into the human vasculature including, but not limited to the carotid artery.

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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K070/66

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