CONVOY ADVANCED DELIVERY SHEATH

K072719 · Boston Scientific Corp · DYB · Mar 7, 2008 · Cardiovascular

Device Facts

• Record ID: K072719
• Device Name: CONVOY ADVANCED DELIVERY SHEATH
• Applicant: Boston Scientific Corp
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

Device Story

Convoy Advanced Delivery Sheath Kit facilitates intracardiac placement of interventional cardiovascular catheters. Kit includes disposable introducer sheath, vessel dilator, and guidewire with introducer. Sheaths available in 8.5 F and 9.5 F diameters; various curve configurations (0°-180°), radii (0.6"-1.75"), and lengths (60 cm-101.5 cm). Used by physicians in clinical settings to navigate interventional devices to the heart. Device is single-use and EO sterilized. Modification adds contraindication for femoral approach in patients with vena cava embolic filters or femoral thrombus.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Introducer sheath, vessel dilator, and guidewire. Diameters 8.5 F and 9.5 F. Lengths 60-101.5 cm. Curve configurations 0-180 degrees. Single-use. EO sterilized.

Indications for Use

Indicated for facilitating intracardiac placement of interventional devices. Contraindicated for femoral approach in patients with vena cava embolic filter devices or known femoral thrombus.

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

• Convoy Advanced Delivery Sheath Kit (K013866)
• Convoy Advanced Delivery Sheath Kit (K022067)
• Convoy Advanced Delivery Sheath Kit (K034061)

Submission Summary (Full Text)

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K072719 page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for Boston Scientific. The text is in a serif font and is black. The word "Boston" is on top of the word "Scientific".

MAR – 7 2008

# 510(k) Summary

# General Information

| Category: | Comments: |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, Ca 95134 |
| Correspondent: | Cindy Morrow<br>Principal Regulatory Affairs Specialist<br>Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Contact Information: | E-mail: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Proprietary Name | Convoy Advanced Delivery Sheath Kit |
| Device Classification | 21 CFR §870.1340<br>Product Code: DYB |
| Predicate Device | Convoy Advanced Delivery Sheath Kit |
| Predicate Device Manufacture(s) | Boston Scientific Corporation |
| Predicate Device Proprietary Name(s) | Convoy Advanced Delivery Sheath Kit |
| Predicate Device Classification | 21 CFR §870.1340 |
| Predicate Device Classification # | Class II |

# Date Summary Prepared

November 20, 2007

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### Description of the Predicate Device

The Boston Scientific (BSC) Convoy Advanced Delivery Sheath Kit is identical to the BSC Convoy Advanced Delivery Sheath Kit described in K013866, K022067, and K034061 approved on December 14, 2001, September 11, 2002, and January 30, 2004 respectively.

The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.

The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

| | Predicate Device | Modified Device |
|-----------------------|-----------------------------------------------------|--------------------|
| 510(k) Reference | K034061, K022067, and<br>K013866 | Current Submission |
| Intended Use | Intracardiac Placement of<br>Interventional Devices | Same |
| Device Description | Intracardiac Introducer Sheath | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Device Manufacturer | Boston Scientific Corporation | Same |
| Regulatory Class | II | Same |
| Device Classification | 21 CFR §870.1340 | Same |

#### Comparison to Predicate Device

#### Change to Labeling Being Effected

A new contraindication has been added to the labeling:

Insertion of the Convoy Advanced Delivery Sheath is contraindicated from the femoral approach in patients who have vena cava embolic filter devices, or from a leg with a known femoral thrombus.

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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 or bird-like figure with three curved lines representing its body and wings. The bird is positioned above a wavy line, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 7 2008

Ms. Cindy Morrow Principal Regulatory Affairs Specialist Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re: K072719

Trade/Device Name: Convoy Advanced Delivery Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: December 7, 2007 Received: December 10, 2007

Dear Ms. Morrow:

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.

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

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Page 2 – Ms. Cindy Morrow

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,

Duna R. bochner

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): k 072 719

Device Name: Convoy Advanced Delivery Sheath Kit

Indications for Use:

The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. vchues

on Sign-Off Division of Cardiovascular Devices

510(k) Number k072719

Page _1 of _1

(Posted November 13, 2003)