SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

K052644 · St Jude Medical · DYB · Dec 5, 2005 · Cardiovascular

Device Facts

• Record ID: K052644
• Device Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The St. Jude Medical Transseptal Catheter Introducer Set is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Story

The Swartz™ Braided Transseptal Guiding Introducer is a single-use, sterile catheter introducer set comprising a fixed compound curve introducer, dilator, and guidewire. It is used by physicians in a clinical setting to facilitate the introduction of cardiovascular catheters into the left heart through the interatrial septum. The device features a hemostasis valve to reduce blood loss, a sideport with a three-way stopcock for fluid infusion, blood sampling, pressure monitoring, and aspiration, and distal vent holes to minimize cavitation. A radiopaque tip marker is included to assist with fluoroscopic visualization during placement. The device provides a stable conduit for catheter exchange and navigation, aiding the physician in performing cardiac procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fixed compound curve introducer set including dilator and guidewire. Features hemostasis valve, sideport with three-way stopcock, distal vent holes, and radiopaque tip marker. Sterile, single-use. Materials and design are substantially equivalent to predicate devices.

Indications for Use

Indicated for the introduction of various cardiovascular catheters into the left side of the heart via the interatrial septum.

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™ (Two-Piece AMAS) Transseptal Catheter Introducers (K964518)
• Agilis™ Steerable Catheter Introducer (K042623)

Submission Summary (Full Text)

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

K052644

# 510(k) Summary (As required by 21 CFR 807.92)

## Submitter Information A.

| Submitter's Name: | St. Jude Medical |
|---------------------------|-----------------------------------------|
| Address: | 14901 DeVeau Place |
| | Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | 1-800-328-3873 |
| Fax Number: | (952) 930 - 9481 |
| Contact Person: | Glenn Jacques |
| Date Submission Prepared: | September 23, 2005 |

#### B. Device Information

| Trade Name: | Swartz™ Braided Transseptal Guiding Introducer |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Transseptal Catheter Introducer |
| Classification Name: | Catheter Introducer (per 21CFR 870.1340) |
| Predicate Devices: | Fast-Cath™ (Two-Piece AMAS) Transseptal Catheter<br>Introducers (K964518) |
| | Agilis™ Steerable Catheter Introducer (K042623) |
| Device Description: | The Swartz™ Braided Transseptal Guiding Introducer<br>set consists of a fixed compound curve, dilator, and<br>guidewire. The fixed curve Swartz introducer is fitted<br>with a hemostasis valve to minimize blood loss during<br>catheter introduction and/or exchange. A sideport with<br>three-way stopcock is provided for air or blood<br>aspiration, fluid infusion, blood sampling and pressure<br>monitoring. The introducer features distal vent holes to<br>facilitate aspiration and minimize cavitation, and a<br>radiopaque tip marker to improve fluoroscopic<br>visualization. The device is provided sterile and is<br>intended for single-use only. |
| Intended Use: | The St. Jude Medical Transseptal Catheter Introducer<br>Set is used for introducing various cardiovascular<br>catheters into the left side of the heart through the<br>interatrial septum. |

### Comparison of Required Technological Characteristics ं

All technological characteristics of the Swartz™ Braided Transseptal Guiding Introducer are substantially equivalent to the predicate devices including product design, packaging, biocompatibility, sterilization, and labeling. Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical testing demonstrated that these differences do not adversely affect safety and effectiveness.

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

## Support of the Substantial Equivalence D.

St. Jude Medical considers the Swartz™ Braided Transseptal Guiding Introducer to be St. Jude Medical considers the predicate devices, Fast-Cath™ (Two-Piece AMAS) Transseptal Substancially oquivalorit to the pilis™ Steerable Catheter Introducer.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC & 2005

St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 Deveau Pl. Minntonka, MN 55345

> K052644 Swartz™ Braided Transseptal Guiding Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: September 23, 2005 Received: September 26, 2005

## Dear Mr. Jacques:

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.

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

Page 2 - Mr. Glenn Jacques

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised film i Dri b looka.co or our device complies with other requirements of the Act that IDA has made a determination and Joinistered by other Federal agencies. You must of ally reactal statutes and regulanents ancluding, but not limited to: registration and listing (21 comply will an the rice orequirements)01); good manufacturing practice requirements as set CFK Fat 807), adoling (21 OF R Part 820); and if applicable, the electronic forth in the quality by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) 100 marketing your device as described in your Section 510(k) I his icher will anow you to begin mailing of substantial equivalence of your device to a legally prematice notification: "The 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 If you desire specific arrivater J at [phone]. Also, please note the regulation entitled, Conidor the Office of Comment 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 general 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,

Dina R. Vachner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE

510(K) Number (if known):

Device Name:

Swartz™ Braided Transseptal Guiding Introducer

Indications for Use:

The St. Jude Medical Transseptal Catheter Introducer Set is used Fire Bt. Jude House cardiovascular catheters into the left side of the heart through the interatrial septum.

X Prescription Use _ (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)

10 Market States Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments o

Page 1 of 1

Duma R. Vines

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K052644