STEELEX ELECTRODE SET

K030556 · Aesculap, Inc. · LDF · Apr 22, 2003 · Cardiovascular

Device Facts

• Record ID: K030556
• Device Name: STEELEX ELECTRODE SET
• Applicant: Aesculap, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Apr 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.

Device Story

Steelex Electrode Set consists of stainless steel 316L braided wire with polyethylene insulation; armed with stainless steel 420 needles (round-bodied 1/2 or 3/8 circle) at one end and a straight break-off needle at the other. The straight needle functions as the connection point to an external cardiac pacing generator. Used in clinical settings for temporary cardiac pacing or monitoring; operated by healthcare professionals. Device provides electrical pathway between heart tissue and external pacing/monitoring equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel 316L (ASTM-F138) wire, polyethylene insulation, stainless steel 420 (ASTM-F899) needles. Dimensions: USP sizes 3-0 to 2. Sensing/Actuation: Passive electrical conduction for pacing/monitoring. Energy: External generator source. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring temporary cardiac pacing or monitoring.

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.

Predicate Devices

• Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503)
• Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459)

Submission Summary (Full Text)

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APR 22 2003

K030556

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [in Accordance with SMDA of 1990]

#### Steelex Electrode Set

February 20, 2003

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|----------------------------------------------------------------------|
| | Establishment Registration Number: 2916714 |
| CONTACT: | Georg Keller<br>800-258-1946 x 5073 (phone)<br>610-791-6882 (fax) |
| TRADE NAME: | Steelex Electrode Set |
| COMMON NAME: | Temporary Pacing Electrode |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 74LDF |
| CLASSIFICATION: | 870.3680 - Electrode, Pacemaker, Temporary |
| REVIEW PANEL: | Cardiovascular |

## INDICATIONS FOR USE

The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.

## DEVICE DESCRIPTION

The Steelex Electrode Set comprises a stainless steel 316L braided wire (ASTM-F138), with a plastic isolating cover (Polyethylene). One end of the wire is armed with a stainless steel 420 (ASTM-F899) ½ circle or 3% circle round-bodied needle and the other end is armed with a stainless steel (ASTM-F899) straight needle (break-off). The straight break-off needle also serves as the connection to the generator. The needle sizes for Steelex Electrode Set are available in the USP sizes 302, 420 or 420F, 0, 1-0, 2-0 and 3-0.

## PURPOSE FOR SUBMISSION

This submission seeks marketing clearance for Aesculap's Steelex Electrode Set.

## PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices.

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Steelex Electrode Set is substantially equivalent to:

- Ethicon, Inc .; Temporary Cardiac Pacing Wire (K980503) ●
- Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459) ●

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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human profile with three faces overlapping each other. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo, curving to follow the shape of the profile. The logo is black and white.

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2003

Aesculap®, Inc. c/o Mr. Georg Keller Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, PA 18034

Re: K030556

Trade Name: Steelex Electrode Set Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: Class II (two) Product Code: LDF Dated: February 20, 2003 Received: February 21, 2003

Dear Mr. Keller:

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

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Page 2 - Mr. Georg Keller

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,

QedrTh

am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# B. INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number: K030556

Steelex Electrode Set Device Name:

#### Indication for Use:

The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or Over-the-Counter Use
(per 21 CFR 801.109)

V. Deaton

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K030556