FAST-CATH (TM) INTRA-CARDIAC INTRODUCER

K973840 · Daig Corp. · DYB · May 21, 1998 · Cardiovascular

Device Facts

• Record ID: K973840
• Device Name: FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
• Applicant: Daig Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: May 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Fast-Cath™ Intra-Cardiac Introducer is intend for use when introducing various cardiovascular catheters or biopsy devices into the heart

Device Story

Device consists of radiopaque sheath and dilator with curved distal portions; includes hemostasis valve to minimize blood loss; side port with three-way stopcock for air aspiration, fluid infusion, and blood sampling. Used by clinicians to facilitate introduction of cardiovascular catheters or biopsy devices into heart. Device provides access path for interventional procedures; reduces complications associated with endomyocardial biopsy. Operates as mechanical conduit; no electronic or software components.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design similarity to predicate and clinical literature regarding endomyocardial biopsy procedures.

Technological Characteristics

Radiopaque sheath and dilator; hemostasis valve; side port with three-way stopcock. Mechanical device; no energy source. Sterilization method not specified.

Indications for Use

Indicated for use in introducing various cardiovascular catheters or biopsy devices into the heart.

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

• Fast-Cath™ Transseptal Introducer

Submission Summary (Full Text)

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K973840

MAI 2 1 1998

# 510(k) Summary

(As required by 21 CFR 807.92)

### Submitter Information A. .

Submitter's Name:

Address:

Daig Corporation, a Division of St. Jude Medical, Inc.

14901 Deveau Place Minnetonka, MN 55345-2126

Telephone Number:

Contact Person:

Dean Bruhn-Ding

[phone]

Submission Prepared:

October 6 , 1997

#### Device Information B.

Common or Usual Name:

Intra-Cardiac Introducer Catheter Introducer

Classification Name:

Predicate Device:

Device Description:

Catheter Introducer

Catheter Introducer

Catheter Fast-Cath™ Transseptal Introducer

The Daig Intra-Cardiac Introducer includes a radiopaque sheath and dilator with specially curved distal portions to accommodate specific requirements. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction / exchange. A side port with a three way stop cock is provided for air aspiration, fluid infusion, blood sampling, etc.

> Section 8 - 510(k) Summary Fast-Cath™ Intra-Cardiac Introducer - Page 1 of 2

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## Intended Use:

The Fast-Cath™ Intra-Cardiac Introducer is intend for use when introducing various cardiovascular catheters or biopsy devices into the heart

### Comparison of Required Technological Characteristics C.

All technological characteristics of the Fast-Cath™ Intra-Cardiac Introducer with new indication for use are identical to the predicate device including product design, packaging, sterilization, and labeling (with the exception of the new indications).

### D. Support of Substantial Equivalence

The Daig Corporation has received clearance to market the Fast-Cath™ Introducer for use in introducing cardiovascular catheters into the heart through the interatrial septum. The new indication for use included within the scope of this 510(k) also encompasses the use of Fast-Cath™ Introducers for Intra-Cardiac procedures that do not require penetration of the interatrial septum.

The clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy may reduce the complications associated with this procedure. Similar commercially available catheter introducers have been successfully used for introducing various cardiovascular catheters and biopsy devices into the heart. At least one of these devices bears labeling that is substantially equivalent to the indication for use included within the scope of this 510(k).

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 | 1998

Mr. Dean Bruhn-Ding, RAC Director of Regulatory Affairs DAIG Corporation 14901 Deveau Place Minnetonka, MN 55345-2126

Re: K973840 Fast-Cath™ Intra-Cardiac Introducer Trade Name: Requlatory Class: II Product Code: DYB Dated: February 19, 1998 Received: February 20, 1998

Dear Mr. Bruhn-Ding:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. . Existing major regulations affecting your device . can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical - General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Dean Bruhn-Dinq

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

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

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_______ of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Fast-Cath™ Intra-Cardiac Introducer Device Name:

Indications for Use:

The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when Introducing various cardiovascular catheters or biopsy devices into the heart.

DuAR

(Division Sign-Of Division of Car and Neurologica 19973891 510(k) Number_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Av -

OR

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