TORFLEX TRANSSEPTAL GUIDING SHEATH

K013919 · Baylis Medical Co., Inc. · DBY · Feb 22, 2002 · Immunology

Device Facts

• Record ID: K013919
• Device Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Applicant: Baylis Medical Co., Inc.
• Product Code: DBY · Immunology
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5520
• Device Class: Class 1

Intended Use

The TorFlex Transseptal Guiding Sheath is indicated for the percutaneous introduction of various cardiovascular catheters into the heart chambers, including the left atrium via transseptal puncture/perforation.

Device Story

TorFlex Transseptal Guiding Sheath facilitates percutaneous access to heart chambers. Device functions as a conduit for cardiovascular catheters to reach the left atrium via transseptal puncture. Used in clinical settings by physicians; provides stable pathway for diagnostic or therapeutic catheter placement. Benefits include minimally invasive access to left-sided heart structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Catheter introducer; Class II; Product Code DBY; Regulation 870.1340. Designed for percutaneous introduction of cardiovascular catheters.

Indications for Use

Indicated for percutaneous introduction of cardiovascular catheters into heart chambers, including left atrium via transseptal puncture/perforation.

Regulatory Classification

Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Mr. Kris Shah Vice President, Product Development Baylis Medical Company Inc. 33-5160 Explorer Drive Mississauga, Ontario L4W 4T7

Re: K013919

> TorFlex Transseptal Guiding Sheath Regulation Number: 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II Product Code: DBY Dated: November 19, 2001 Received: November 27, 2001

Dear Mr. Shah:

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 - Mr. Kris Shah

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O insi goneral million 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,

Dailer Miller

ram Zuckerman, N Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of 1

unknown 510(k) Number (if known):

K013919

3 1 (1)
Device Name: TorFlex Transseptal Guiding Sheath

Indications For Use:

modicile For Society Transseptal Guiding Sheath is indicated for the percutaneous introduction of various I he For rex Transseptar Galang Bircheart chambers, including the left atrium via transseptal puncture/perforation.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Cardior Division of (Optional Format 3-10-98) 510(k) Number

Prescription Use
(Per 21 CFR 801.109)