TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

K033858 · European Custom Manufacturing BV · LDF · Jul 12, 2004 · Cardiovascular

Device Facts

• Record ID: K033858
• Device Name: TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
• Applicant: European Custom Manufacturing BV
• Product Code: LDF · Cardiovascular
• Decision Date: Jul 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.

Device Story

Temporary Bipolar Myocardial Pacing Wire; used post-cardiac surgery for temporary electrical pacing. Device placed in direct contact with native myocardium of atrium or ventricle during open-heart procedures. Facilitates transmission of pacing signals from external pulse generator to heart. Used in clinical/surgical settings by physicians. Benefits patient by providing temporary cardiac rhythm management during immediate post-operative period.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bipolar pacing wire; temporary implantable electrode; designed for direct myocardial contact; compatible with external pacing pulse generators.

Indications for Use

Indicated for temporary electrical heart pacing in patients undergoing cardiac surgery. The device is placed in direct contact with the native myocardium of the atrium or ventricle while the heart is surgically exposed.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2004

European Custom Manufacturing B.V. c/o Mr. Maarten Kanters QA Manager Oost-Om 54 P.O. Box 53 NL-5420 AB Gemert Netherlands

Re: K033858

Trade Name: Temporary Bipolar Myocardial Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: II (two) Product Code: LDF Dated: May 25, 2004 Received: June 28, 2004

Dear Mr. Kanters:

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. Ilsting 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 - Mr. Maarten Kanters

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/dsma/dsmamain.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 Statement

K033858 510(K) Number:

Temporary Bipolar Myocardial Pacing Wire Device Name:

Indications for use: The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed.

The wire may be used on either the atrium or ventricle.

Sincerely,

Maarten Kanters

QA Manger European Custom Manufacturing BV

Division Sion-C n of Cardiovascular Devices

510(k) Number /<033858

Prescription Use X Counter Use (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-

(21 CFR 807