TEMPORARY CARDIAC PACING WIRE

K980503 · ETHICON, Inc. · LDF · Apr 10, 1998 · Cardiovascular

Device Facts

• Record ID: K980503
• Device Name: TEMPORARY CARDIAC PACING WIRE
• Applicant: ETHICON, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Apr 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Temporary Cardiac Pacing Wire with wave is intended for use in temporary cardiac pacing or monitoring.

Device Story

Temporary Cardiac Pacing Wire with wave is a lead for temporary cardiac pacing or monitoring. Device consists of uninsulated multifilament stainless steel wire electrode and insulated multifilament conductor coated with blue polyethylene; attached to straight Keith needle. Distal end features preformed 'wave' shape attached to curved needle. Device connects to external temporary cardiac pacing or monitoring equipment. Used by clinicians in clinical settings to provide temporary electrical stimulation or signal monitoring to heart. 'Wave' design provides increased resistance to pullout force after myocardial insertion compared to predicate.

Clinical Evidence

Bench testing only. Nonclinical laboratory testing performed to measure pullout force after implantation; results showed increased resistance to pullout force for the 'wave' design compared to the predicate device.

Technological Characteristics

Materials: multifilament stainless steel wire electrode, blue polyethylene insulated multifilament conductor. Form factor: lead with preformed 'wave' distal end and Keith needle. Connectivity: connects to external pacing/monitoring device. No changes in materials or electrical resistance from predicate.

Indications for Use

Indicated for temporary cardiac pacing or monitoring in patients requiring such intervention.

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

• Temporary Cardiac Pacing Wire (K980503)

Submission Summary (Full Text)

{0}------------------------------------------------

K980503

APR 1 0 1998

### SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

MODIFIED DEVICE NAME: Temporary Cardiac Pacing Wire

PREDICATE DEVICE NAME: Temporary Cardiac Pacing Wire

#### 510(k) SUMMARY

Device Description

The Temporary Cardiac Pacing Wire with wave is a lead that consists of an uninsulated multifilament stainless steel wire electrode and an insulated multifilament conductor coated with blue polyethylene attached to a straight Keith needle. There is no exposed wire at the point of the swage to the straight Keith needle. The Keith needle is scored eliminating the need to cut the needle. The Keith needle is connected to an external temporary cardiac pacing or monitoring device. A 'wave' is preformed into the uninsulated distal end, then attached to a curved needle.

Continued on next page

Temporary Cardiac Pacing Wire with wave ETHICON, Inc.

{1}------------------------------------------------

## SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

:

な

?

510(k) SUMMARY, Continued

| Intended Use | The Temporary Cardiac Pacing Wire with wave is intended for<br>use in temporary cardiac pacing or monitoring.<br><br>The Temporary Cardiac Pacing Wire with wave has the same<br>intended use as predicate device Temporary Cardiac Pacing<br>Wire (TPW). |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Statement | The Temporary Cardiac Pacing Wire with wave is intended for<br>use in temporary cardiac pacing or monitoring. |
| Technological<br>Characteristics | The modified device has the same technological<br>characteristics as the predicate device. There is no change in<br>material, insulated coating or electrical resistance. |
| Performance Data | Nonclinical laboratory testing was performed to determine<br>pullout force after implantation. It was determined that the<br>Temporary Cardiac Pacing Wire with wave has an increased<br>resistance to pullout force after it is inserted into the<br>myocardium when compared to the predicate device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>new device is substantially equivalent to the Predicate Device<br>under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Gregory R. Jones<br>Director, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | February 6, 1998 |

Temporary Cardiac Pacing Wire with wave
ETHICON, Inc.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 1998

Mr. Gregory R. Jones Director, Requlatory Affairs Ethicon, Incorporated P.O. Box 151 Somerville, NJ 08876-0151

Re: K980503 Temporary Cardiac Pacing Wire Trade Name: Regulatory Class: II Product Code: LDF Dated: February 6, 1998 February 9, 1998 Received:

Dear Mr. Jones:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

{3}------------------------------------------------

#### Page 2 - Mr. Gregory R. Jones

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATION FOR USE

4980503 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

Temporary Cardiac Pacing Wire

Indications for Use:

The Temporary Cardiac Pacing Wire 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) | | | | | | |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|-------------------------------------------------------------------|--|---------------|----------|
| | <table><tr><td>(Division Sign-Off)</td><td></td></tr><tr><td>Division of Cardiovascular, Respiratory, and Neurological Devices</td><td></td></tr><tr><td>510(k) Number</td><td>K980 503</td></tr></table> | (Division Sign-Off) | | Division of Cardiovascular, Respiratory, and Neurological Devices | | 510(k) Number | K980 503 |
| (Division Sign-Off) | | | | | | | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | | | | | | | |
| 510(k) Number | K980 503 | | | | | | |
| Prescription Use (Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"><div> <svg height="10" width="10"> <path d="M0 0 L10 10 M0 10 L10 0" stroke="black"></path> </svg> </div></div> | | | | | | |
| OR | Over-The Counter Use | | | | | | |
| | (Optional Format 1-2-9G) | | | | | | |

Temporary Cardiac Pacing Wire with wave ETHICON, Inc.

(