FAST-CATH INTRA-CARDIAC INTRODUCER

K982187 · Daig Corp. · DYB · Sep 16, 1998 · Cardiovascular

Device Facts

• Record ID: K982187
• Device Name: FAST-CATH INTRA-CARDIAC INTRODUCER
• Applicant: Daig Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

The Fast-Cath™ Intra-Cardiac Introducer is a medical device consisting of a radiopaque sheath and a dilator with curved distal portions. It is designed to facilitate the introduction of cardiovascular catheters or biopsy devices into the heart. The sheath includes a hemostasis valve to minimize blood loss during catheter introduction or exchange, and a sideport with a three-way stopcock for air aspiration, fluid infusion, or blood sampling. The device is used by clinicians in a cardiac setting to provide access to the heart via arterial or venous sites.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by clinical literature regarding the use of catheter introducers for endomyocardial biopsy and cardiac catheterization.

Technological Characteristics

Radiopaque sheath and dilator with curved distal portions; includes hemostasis valve and sideport with three-way stopcock. Materials and sterilization methods are identical to the predicate device.

Indications for Use

Indicated for use when 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™ Intra-Cardiac Catheter Introducer

Reference Devices

• Daig's Fast-Cath™ Transseptal Catheter Introducers

Submission Summary (Full Text)

{0}------------------------------------------------

B

510(k) Summary

K982187

## 510(k) Summary

(as required by 21 CFR 807.92)

## Submitter Information A.

| B. | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name | Daig Corporation, a St. Jude Medical Company |
| Address | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number | [phone] |
| Contact Person | Dean Bruhn-Ding |
| Submission Prepared | June 19, 1998 |
| Device Information | |
| Common or Usual Name | Intra-Cardiac Introducer, Catheter Introducer |
| Classification Name | Catheter Introducer |
| Predicate Device | Fast-Cath™ Intra-Cardiac Catheter Introducer |
| Device Description | The Daig Intra-Cardiac Introducer includes a radiopaque<br>sheath and dilator with specially curved distal portions to<br>accommodate specific requirements. The introducer sheath<br>is fitted with a hemostasis valve to minimize blood loss<br>during catheter introduction/exchange. A sideport with a<br>Three-way stopcock is provided for air aspiration, fluid<br>infusion, blood sampling, etc. |
| Intended Use | The Fast-Cath™ Intra-Cardiac Introducer is intended for use<br>when introducing various cardiovascular catheters or biopsy<br>devices into the heart. |
| | |

## C. Comparison of Required Technological Characteristics

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 contraindications and instructions for use).

## D. Support of the Substantial Equivalence

The clinical literature has demonstrated that the use of an introducer to perform endomyocardial biopsy and cardiac catheterization may reduce the complications associated with this procedure. Literature supports the use of these products from both venous and arterial access Similar commercially available catheter introducers have been successfully used for sites. introducing various cardiovascular catheters and biopsy devices into the heart from both the arterial and venous access sites. In addition, Daig's Fast-Cath™ Transseptal Catheter Introducers (Reference Device) are routinely used on the septal side of the heart via transseptal access.

{1}------------------------------------------------

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the central emblem.

SEP 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dean Bruhn-Ding, RAC Director of Requlatory Affairs DAIG Corporation 14901 Deveau Pl. Minnetonka, MN 55345

Re : K982187 Fast-Cath™ Intra-Cardiac Introducer Trade Name: Regulatory Class: II Product Code: DYB Dated: June 19, 1998 Received: June 22, 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 Devices: 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 regulation 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

{2}------------------------------------------------

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 requlations.

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. Callahon

Thomas J. Callan Director Division of Cardiovascular, Respiratory ----and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page _ 1 of

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Fast-Cath™ Intra-Cardiac Introducer

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ta A. R

ision Sign-OM
on of Cardiovascular, Respiratory,
eurological Devices
Number. K982187