K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

K981737 · Katecho, Inc. · MKJ · Dec 9, 1998 · Cardiovascular

Device Facts

• Record ID: K981737
• Device Name: K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
• Applicant: Katecho, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation 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 Joulc maximum).

Device Story

KDP-60 K-Defib/Pace Adult Electrode serves as a conductive interface between patient skin and external defibrillation/pacing/monitoring equipment. Device is a non-sterile, disposable, single-patient-use electrode. Applied by clinicians to adult patients requiring cardiac resuscitation or pacing. Connects to low-power defibrillators (max 360 Joules). Facilitates electrical energy delivery from the instrument to the patient for defibrillation or pacing, and signal acquisition for monitoring. Benefits include providing a standardized, compatible interface for various commercial defibrillator/pacemaker systems, ensuring effective energy transfer and monitoring capability during emergency or clinical cardiac care.

Clinical Evidence

Bench testing only. The device was tested to the ANSI/AAMI DF39-1993 standard to verify performance and compatibility with equipment from multiple manufacturers (Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard).

Technological Characteristics

Non-sterile, disposable, single-patient-use electrode. Conductive interface for defibrillation, pacing, and monitoring. Designed for compatibility with low-power defibrillators (up to 360 Joules). Tested to ANSI/AAMI DF39-1993 standard.

Indications for Use

Indicated for adult patients requiring external pacing, defibrillation, and monitoring. Used as a conductive interface between the patient's skin and defibrillator/transcutaneous cardiac pacemaker equipment. Contraindicated for use on non-adult patients or with high-power defibrillators exceeding 360 Joules.

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Reference Devices

• Laerdal (equipment)
• Heartstream (equipment)
• Marquette (equipment)
• Physio Control (equipment)
• Survivalink (equipment)
• First Medic (equipment)
• Hewlett-Packard (equipment)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 1998 DEC

Mr. Lorne Scharnberg Katecho, Inc. P.O. Box 21247 2500 Bell Avenue 50321 Des Moines, IA

K981737 Re: "K-Defib/Pace Adult Electrode" Regulatory Class: III (three) Product Code: MLN Dated: September 24, 1998 September 28, 1998 Received:

Dear Mr. Scharnberg:

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 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). 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 Regulations, 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 Regulation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 regulations.

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Page 2 - Mr. Lorne Scharnberg

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 requlation (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. Callahan

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

Enclosure

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## Indications for use Statement

510(k) Number (if known): K981737

Device Name:

"KDP-60 K-Defib/Pace Adult Electrode"

Indications For Use:

The Katecho "K-Defib/Pace Adult Electrode it is indicated for use in external Pacing. Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KDP-60 K-Defib/Pace Adult Electode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation 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 Joulc maximum).

This device has been tested to the ANSI/AAMI DIF39-1993 standard for use with equipment by the following manufacturers; Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

mark Krame

| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | |
|---------------------------------------------------------------------------------------|-------------------------|
| 510(k) Number | |
| Prescription Use <span style="text-decoration: underline;">✓</span> | OR Over-The-Counter Use |

(Per 21 CFR 801.109)

P.O. Box 21247 • 2500 Bell Avenue • Des Moines, Iowa 50321 • Phone [phone] • FAX [phone]