MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH

K034061 · Boston Scientific Corp · DYB · Jan 30, 2004 · Cardiovascular

Device Facts

• Record ID: K034061
• Device Name: MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
• Applicant: Boston Scientific Corp
• Product Code: DYB · Cardiovascular
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

Convoy Advanced Delivery Sheath Kit comprises disposable introducer sheath, vessel dilator, and guidewire with introducer. Device facilitates intracardiac placement of interventional cardiovascular catheters. Used by physicians in clinical settings. 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). Single or dual plane curves accommodate physician preference for anatomical navigation. Device is single-use and EO sterilized.

Clinical Evidence

Bench testing only. Non-clinical testing conducted in accordance with 21 CFR Part 58 (GLP) confirmed the device met design-input criteria and is safe and effective for its intended use.

Technological Characteristics

Cardiac introducer sheath system. Components: introducer sheath, vessel dilator, guidewire. Diameters: 8.5 F, 9.5 F. Lengths: 60 cm - 101.5 cm. Curves: 0° - 180°, 0.6" - 1.75" radius, single/dual plane. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for facilitating the intracardiac placement of interventional devices in patients requiring cardiovascular catheterization procedures.

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 (K022067)

Submission Summary (Full Text)

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# Attachment 5 510(k) Summary

#### General Information

| Category: | Comments: |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Boston Scientific Corporation<br>2710 Orchard Parkway<br>San Jose, Ca 95134 |
| Correspondent: | Christina L. Rowe<br>Senior 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 |
| 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

December 30, 2003

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#### Description of the Predicate Device

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.

#### Intended Use

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

#### Comparison to Predicate Device

| | Predicate Device | Modified Device |
|-----------------------|-----------------------------------------------------|--------------------|
| 510(k) Reference | K022067 | 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 |

#### Summary of the Non-clinical Data

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical testing conducted for the device showed the device met its design-input criteria, and was safe and effective for its intended

Boston Scientific Corporation Special 510(k) Submission

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

Boston Scientific Corporation c/o Ms. Christina L. Rowe Senior Regulatory Affairs Specialist 2710 Orchard Parkway San Jose, CA 95134

> K034061 Convoy Advanced Delivery Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: December 30, 2003 Received: January 2, 2004

#### Dear Ms. Rowe:

Re:

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.

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Page 2 - Ms. Christina L. Rowe

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least oc advisou that I Drive letting that your device complies with other requirements of the Act that I DX has intable a and regulations administered by other Federal agencies. You must or any I caelar statutes and registements, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) of bections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections (Section in your Section 510(k) I ms letter will anow you to ough mating of substantial equivalence of your device to a legally prematication on " 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 other Echorers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dunia R. Vu Chiner

A 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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## Attachment 3 Premarket Notification Intended Use Statement

1634061 510(k) Number (if known):_

Convoy Advanced Delivery Sheath Kit Device Name:

Indication for Use:

The intended use for the Convoy Advanced Delivery Sheath Kit is as follows:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diving R. Ve Anet
Division of Cardiovascular & Respiratory Devices
510(k) Number K034061

Prescription Use_

Over-the-Counter Use OR (Per 21 CFR §801.109)

(Optional Format 1-2-96)

Boston Scientific Corporation Special 510(k) Submission