K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

K012404 · Katecho, Inc. · DRO · Oct 12, 2001 · Cardiovascular

Device Facts

• Record ID: K012404
• Device Name: K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
• Applicant: Katecho, Inc.
• Product Code: DRO · Cardiovascular
• Decision Date: Oct 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

Device Story

Katecho KDP-85 is a non-sterile, disposable, single-patient-use multifunction electrode. Acts as a conductive interface between patient skin and external transcutaneous cardiac pacemakers or defibrillators. Used in clinical settings for defibrillation, cardioversion, pacing, and monitoring. Operated by healthcare professionals. Device connects to Agilent Technologies defibrillation equipment. Benefits patient by providing necessary electrical path for life-saving cardiac interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multifunction electrode; conductive interface; disposable; non-sterile; designed for compatibility with Agilent Technologies defibrillators (max 360 joules).

Indications for Use

Indicated for adult patients requiring external pacing, defibrillation, cardioversion, or monitoring. Designed for use with Agilent Technologies defibrillators (max 360 joules).

Regulatory Classification

Identification

An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.

Special Controls

*Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”

Submission Summary (Full Text)

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Public Health Service

Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a wavy line representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

OCT 1 2 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Warren R. Walters Katecho, Inc. 2500 Bell Avenue Des Moines, IA 50321

Re: K012404

Katecho KDP-85 Adult Defib/Pace Electrodes Regulation Number: 870.5550 Regulation Name: External Transcutaneous Cardiac Pacemaker (Noninvasive) Regulatory Class: II (two) Product Code: DRO Dated: July 25, 2001 Received: July 30, 2001

Dear Mr. Walters:

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

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## Page 2 - Mr. Warren R. Walters

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 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 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,

James F. Dillard III

ames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## KO12404 510k Number:

Katecho KDP-85 Adult Defib/Pace Multifunction Electrode Device Name:

## Indications For Use:

The Katecho external electrodes are indicated for use in external pacing, defibrillation, cardioversion and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-85 Electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

The Katecho KDP-85 Defib/Pace Electrodes are designed for, and to be used, with Agilent Technologies defibrillation devices.

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012404

Prescription Use

Over-The Counter Use