ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984

K070417 · St Jude Medical · DYB · Jun 5, 2007 · Cardiovascular

Device Facts

• Record ID: K070417
• Device Name: ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
• Applicant: St Jude Medical
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The St. Jude Medical ACross™ Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

Device Story

ACross™ Transseptal Access System is a procedural tool for transseptal catheterization. Components include a radiopaque sheath, radiopaque dilator, and a stainless steel Brockenbrough-style transseptal needle. Proximal ends interlock to form a handle. Sheath features a hemostasis seal, side-port, and three-way stopcock for aspiration, fluid infusion, blood sampling, and pressure monitoring. Used by physicians in clinical settings to puncture the interatrial septum and facilitate the introduction of cardiovascular catheters into the left heart. System includes a compatible guidewire.

Clinical Evidence

Bench testing only. Testing included in vitro bench testing, biocompatibility, shelf-life, packaging, and sterilization validation. Results demonstrate the device meets product specifications and intended use.

Technological Characteristics

System consists of a radiopaque sheath, radiopaque dilator, and stainless steel Brockenbrough-style needle. Features include a hemostasis seal, side-port, and three-way stopcock. Components are designed for manual operation during cardiac catheterization. No electronic or software components.

Indications for Use

Indicated for patients undergoing transseptal catheterization procedures requiring puncture of the interatrial septum and introduction of cardiovascular catheters into the left 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

• St. Jude Medical Swartz™ Braided Transseptal Guiding Introducer (K052644)
• Thomas Medical Products, Inc. Transseptal Needle (K011727)

Submission Summary (Full Text)

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# 510(k) Summary

As required by 21 CFR 807.92(c)

## 510(k) Number: K070417

## JUN - > 2007

## Date Prepared:

May 4, 2007

## Submitter Information:

| Submitter's Name/<br>Address: | St. Jude Medical<br>14901 DeVeau Place<br>Minnetonka, MN 55345-2126 |
|-------------------------------|---------------------------------------------------------------------|
|-------------------------------|---------------------------------------------------------------------|

Contact Person:

Laura Moen-Ftacek Regulatory Affairs Specialist Tel: [phone] Fax: [phone] lmoen-ftacek a sjimeom

#### Device Information:

| Trade Name: | ACross™ Transseptal Access System |
|----------------------|---------------------------------------------------------------------------------------------------|
| Common Name: | Trocar and Catheter Introducer |
| Classification Name: | Trocar and Catheter Introducer |
| Class: | Class II, 21 CFR 870.1390, Product Code DRC<br>and<br>Class II, 21 CFR 870.1340, Product Code DYE |

#### Predicate Device:

1. St. Jude Medical Swartz™ Braided Transseptal Guiding Introducer (K052644)

2. Thomas Medical Products, Inc. Transseptal Needle (K011727)

## Device Description:

The St. Jude Medical ACross™ Transseptal Access System consists of three main components; ( ) ) a radiopaque sheath, (2) a radiopaque dilator, (3) a transseptal luminal stainless steel needle (1) a factopaque sheam; (2) a factopaque on has a specially curved distal portion to with a sond stanness stool as the atrial septum. The proximal ends of each component interlock to form a handle. The product is also packaged with a compatible guidewire.

The sheath is fitted with a seal to provide hemostasis during catheter introduction and/or I the sitean is thited with a soar to provith a side-port and three-way stopcock to provide for aspiration, fluid infusion, blood sampling, and pressure monitoring. The transseptal needle aspiration, that mitasion, oroca sampling, as accommodate positioning in the cardiac contisis of a Drockenbrough style carreng for air aspiration, fluid infusion, blood sampling, and pressure monitoring.

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#### Indications for Use:

The St. Jude Medical ACross™ Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of the heart.

#### Comparison to Predicate Devices:

The ACross™ Transseptal Access System has the same general intended use and similar The ACTOSS - Francoopial as the predicate devices. The addition of the proximal handle features does not affect the intended use or the scientific technology of the device.

## Summary of Non-Clinical Testing:

Non-clinical testing of the ACross™ Transseptal Access System includes in vitro bench testing, ron onnountion, biocompatibility testing, shelf-life and packaging testing, and sterilization allinal oranancil, of the testing demonstrates that the ACross™ Transseptal Access System design meets product specifications and intended uses.

#### Statement of Equivalence:

The St. Jude Medical ACross™ Transseptal Access System has the same general indications for The bt. Jade Hearistics of other legally marketed devices. Based on this and the design and engineering data provided in the pre-market notification, SJM's ACross™ Transseptal doorgen and been shown to be substantially equivalent to other legally marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of a series of overlapping human profiles, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2007

St. Jude Medical c/o Ms. Laura Moen-Ftacek Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345-2126

Re: K070417

ACross™ Transseptal Access System Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: II (two) Product Code: DYB Dated: May 4, 2007 Received: May 7, 2007

Dear Ms. Moen-Ftacek:

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. Laura Moen-Ftacek

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, 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. This letter will allow you to begin marketing your device as described in your Section 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), 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 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,

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 (if known):

Device Name: ACoss™ Trasseptal Access System

Indications for Use:

The St. Jude Medical ACross™ Transseptal Access System is used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left side of 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 OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------|---------|
| Division of Cardiovascular | |
| 510(k) Number | K070417 |

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