TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75

K031949 · Baylis Medical Co., Inc. · DXF · Dec 10, 2003 · Cardiovascular

Device Facts

• Record ID: K031949
• Device Name: TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
• Applicant: Baylis Medical Co., Inc.
• Product Code: DXF · Cardiovascular
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5175
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Creation of an atrial septal defect in the heart. Secondary Indications For Use: applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Device Story

Toronto RF Septostomy Catheter is a medical device used for creating atrial septal defects; also facilitates transseptal access, pressure monitoring, blood sampling, and fluid infusion. Operated by physicians in clinical settings. Device functions as a catheter-based tool for cardiac intervention. Benefits include minimally invasive access to cardiac chambers for diagnostic and therapeutic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Catheter-based device for cardiac septostomy and access. Class II, Product Code DXF. Operates under 21 CFR 870.5175.

Indications for Use

Indicated for patients requiring creation of an atrial septal defect, transseptal heart access, intracardiac pressure monitoring, blood sampling, or solution infusion.

Regulatory Classification

Identification

A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

Baylis Medical Co., Inc. c/o Ms. Amanda Hartley R&D Engineer 5160 Explorer Drive, Unit 33 Mississauga, ON L4W 4T7 Canada

K031949 Re:

> Trade/Device Name: Toronto RF Septostomy Catheter Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy Catheter Regulatory Class: Class II Product Code: DXF Dated: November 18, 2003 Received: November 20, 2003

Dear Ms. Hartley:

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.

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

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Page 2 - Ms. Amanda Hartley

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/dsma/dsmamain.html

Sincerely yours,

Oma Fleischer Jr.

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:_

Creation of an atrial septal defect in the heart. Secondary Indications For Use: applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Prescription Use X (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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