PERIPHERAL GUIDING SHEATH

K070816 · Micrus Design Technology, Inc. · DYB · Sep 19, 2007 · Cardiovascular

Device Facts

• Record ID: K070816
• Device Name: PERIPHERAL GUIDING SHEATH
• Applicant: Micrus Design Technology, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Micrus Design Technology Peripheral Guiding Sheaths are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Device Story

Peripheral Guiding Sheath is a single-lumen catheter used to facilitate percutaneous introduction of intravascular devices into arterial and venous systems. Device consists of Pebax body reinforced with stainless steel wire coil; intermediate segment also features stainless steel coil to reduce kinking and improve torque response. Available in 5Fr, 6Fr, 7Fr, and 8Fr diameters and 45cm, 55cm, and 90cm lengths. Operated by clinicians in clinical settings to provide access for other intravascular devices. Device provides a conduit for interventional procedures; benefits include improved trackability and torque control during navigation of vasculature.

Clinical Evidence

Bench testing only. Mechanical laboratory testing performed to verify compliance with device specifications. Biocompatibility testing performed on materials.

Technological Characteristics

Single-lumen catheter; Pebax body; stainless steel wire coil reinforcement; 5Fr-8Fr diameters; 45cm-90cm lengths; various shapes. Biocompatible materials. Non-powered, manual device.

Indications for Use

Indicated for patients undergoing arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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

• Terumo Pinnacle Destination
• Cook Shuttle/Flexor

Submission Summary (Full Text)

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Kono816 P. Loff

## Section 5: 510(k) Summary

SEP 1 9 2007

| Submitter's<br>Information | Micrus Design Technology<br>9344 NW 13 Street<br>Miami, Florida 33172 USA<br>Telephone: [phone]<br>Contact: Marianne Grunwaldt, MS, CQE |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 19 March 2007 |
| Name of Device | Common/Classification Name: Catheter Introducer<br>Trade Name: Micrus Design Technology Peripheral Guiding Sheath |
| Predicate Devices | Terumo Pinnacle Destination<br>Cook Shuttle/Flexor |
| Intended Use | Micrus Design Technology Peripheral Guiding Sheaths are intended for<br>use in arterial and venous procedures requiring percutaneous introduction<br>of intravascular devices. |
| Device Description<br>and Summary of<br>Technological<br>Characteristics | The Micrus Design Technology Peripheral Guiding Sheaths are single<br>lumen catheters, incorporating a Pebax® body reinforced with a stainless<br>steel wire coil. The intermediate segment is also Pebax® with a stainless<br>steel coil to reduce kinking and to promote improved torque response.<br>They are available in 5 Fr, 6Fr, 7Fr, and 8 Fr and 45 cm, 55 cm and 90<br>cm in length, and in a variety of shapes. The technological characteristics<br>are equivalent to the predicate device. |
| Testing Summary | Mechanical laboratory testing has been performed on the Micrus Design<br>Technology Peripheral Guiding Sheaths to assure compliance to the<br>specifications. In addition, testing has been performed on the materials to<br>assure biocompatibility. |
| Conclusions | The non-clinical tests as discussed above demonstrate that, like the<br>predicate devices, the Micrus Design Technology Peripheral Guiding<br>Sheath is safe and effective for its intended use. |

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2007

Micrus Design Technology, Inc. c/o Ms. Marianne Grunwaldt, MS, CQE Product Assurance Engineer 9344 NW 13 Street Miami, FL 33172

Re: K070816

> Trade/Device Name: Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: July 25, 2007 Received: July 27, 2007

Dear Ms. Grunwaldt:

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 devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA max publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Marianne Grunwaldt

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Dana R. Rohner

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): Ko 40816

Device Name: Micrus Design Technology Peripheral Guiding Sheath

Indications for Use:

Micrus Design Technology Peripheral Guiding Sheaths are indicated for arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Varliner

(Division Si Off) Division In Cardiovascular Devices

510(k) Number Ko 70816

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