FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

K061015 · St Jude Medical · DYB · Aug 3, 2006 · Cardiovascular

Device Facts

• Record ID: K061015
• Device Name: FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart. The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Story

Fast-Cath introducers facilitate percutaneous access for cardiovascular catheters or biopsy devices. Devices feature 10F inner diameter, hemostasis valve to minimize blood loss, and sideport with three-way stopcock for aspiration, infusion, sampling, and pressure monitoring. Distal tips available in various curve configurations for anatomical access. Sheaths contain radiopaque materials for fluoroscopic visualization. Packaged with plastic dilator and stainless steel guidewire to assist vascular passage. Used by physicians in clinical settings to provide a conduit for diagnostic or therapeutic cardiac procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

10F inner diameter sheath; radiopaque materials for fluoroscopy; hemostasis valve; sideport with three-way stopcock; includes plastic dilator and stainless steel guidewire. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring cardiovascular catheter or biopsy device introduction into the heart (hemostasis model) or into the left side of the heart via the interatrial septum (transseptal model).

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 Intracardiac Introducer (K982187, K973840)
• Fast-Cath Transseptal Introducer (K052644)
• Fast-Cath Transseptal Catheter Introducer (K964518)

Submission Summary (Full Text)

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K061015

# 510(k) SUMMARY

| | AUG 0 3 2006 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | St. Jude Medical |
| Address: | 14901 DeVeau Place<br>Minnetonka, MN 55345 |
| Tel: | 952-933-4700 |
| Fax: | 952-930-9481 |
| Contact Person: | Glenn Jacques |
| Date of Summary Preparation: | April 12, 2006 |
| Device Common Name: | Introducer, Catheter |
| Device Trade Name: | Fast-Cath Hemostasis Introducer<br>Fast-Cath Transseptal Introducer |
| Device Classification Name: | 21 CFR 870.1340<br>Classification: Class II<br>Product Code: DYB |
| Predicate Devices: | Fast-Cath Intracardiac Introducer<br>K982187, K973840<br>Fast-Cath Transseptal Introducer<br>K052644<br>Fast-Cath Transseptal Catheter Introducer<br>K964518 |

#### Device Description

Both the Fast-Cath hemostasis and transseptal introducers are used for introducing various catheters into the heart. The inner diameter measures 10F. The distal tips of the introducers are available in a variety of curve configurations to meet physician preferences for accessing different parts of the cardiac anatomy. Each introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and exchange over a guidewire. A sideport with a three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheaths contain radiopaque materials for visualization under fluoroscopy. A plastic dilator and stainless steel guidewire are packaged with the introducers and are designed to facilitate the introduction and passage of the introducer through the vasculature.

#### Indications for Use

The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.

The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

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## [510(k) Summary continued]

## Comparison to Predicate Device

The catheters have similar design, materials, and technical requirements as the predicate devices.

### Summary of Testing

Testing has demonstrated that the new devices are substantially equivalent to the predicate devices.

### Conclusion

The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance specifications.

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Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

AUG 0 3 2006

St. Jude Medical c/o Mr. Glenn Jacques Regulatory Affairs Manager 14901 DeVeau Place Minnetonka, MN 55345

Re: K061015

> Fast-Cath Hemostasis Introducer & Transseptal Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. Jacques:

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. TDA max publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Glenn Jacques

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of acrised that I that your device complies with other requirements of the Act that I Drines Intacted and regulations administered by other Federal agencies. You must or any I outdi states and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. product rainill allow you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated 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 in you atten 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 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,

simon R. V. Levin

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:

K061015

Device Name:

Fast-Cath Transseptal Introducer

Indications for Use: The Fast-Cath Transseptal Introducer is indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Prescription Use X (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nivin R. W. Lund

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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### INDICATIONS FOR USE

510(k) Number:

K041015

Device Name:

Fast-Cath Hemostasis Introducer

Indications for Use: The Fast-Cath hemostasis introducer is indicated for the introduction of various cardiovascular catheters or biopsy devices into the heart.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deane P. Manig

Division Sign-Off) Division Olgh Sin

510(k) Number k061015