ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

K984582 · Bio-Detek, Inc. · MKJ · Mar 16, 1999 · Cardiovascular

Device Facts

• Record ID: K984582
• Device Name: ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
• Applicant: Bio-Detek, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Mar 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

ZOLL Superpadz Adult Multi-Function Electrodes will be used for the following clinical applications: - Defibrillation . - Cardioversion . - Noninvasive Pacing . - Electrocardiograph Monitoring . In conjunction with these devices: - ZOLL PD™ 1200 Pacemaker/Defibrillator . - ZOLL PD™ 1400 Pacemaker/Defibrillator . - ZOLL PD™ 2000 Pacemaker/Defibrillator . - ZOLL D 900 Defibrillator . - ZOLL D 1400 Defibrillator . - ZOLL D 2000 Defibrillator . - ZOLL 1600 Pacemaker/Defibrillator . - ZOLL 1700 Pacemaker/Defibrillator . - ZOLL NTP 1000 Noninvasive Temporary Pacemaker . - ZOLL M Series . By trained medical personnel, including physicians, nurses, paramedics, emergency medical technicians (EMT), and cardiovascular laboratory technicians in typical settings.

Device Story

Superpadz Adult Multi-Function Electrodes are conductive pads applied to patient skin for delivery of electrical therapy or signal acquisition. Device interfaces with ZOLL series pacemakers/defibrillators to facilitate defibrillation, cardioversion, noninvasive pacing, and ECG monitoring. Operated by trained medical personnel (physicians, nurses, paramedics, EMTs) in clinical or emergency settings. Electrodes transmit energy from the host device to the patient or capture cardiac electrical signals for display on the host monitor. Facilitates life-saving cardiac interventions and continuous patient monitoring.

Clinical Evidence

No clinical data provided; device cleared via 510(k) substantial equivalence pathway.

Technological Characteristics

Multi-function electrode pads designed for electrical coupling between host defibrillator/pacemaker and patient skin. Conductive interface for energy delivery and signal monitoring.

Indications for Use

Indicated for adult patients requiring defibrillation, cardioversion, noninvasive pacing, or ECG monitoring. Intended for use by trained medical personnel including physicians, nurses, paramedics, and EMTs in clinical settings.

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

• ZOLL PD™ 1200 Pacemaker/Defibrillator
• ZOLL PD™ 1400 Pacemaker/Defibrillator
• ZOLL PD™ 2000 Pacemaker/Defibrillator
• ZOLL D 900 Defibrillator
• ZOLL D 1400 Defibrillator
• ZOLL D 2000 Defibrillator
• ZOLL 1600 Pacemaker/Defibrillator
• ZOLL 1700 Pacemaker/Defibrillator
• ZOLL NTP 1000 Noninvasive Temporary Pacemaker
• ZOLL M Series

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1999

Mr. Michael R. Dupelle Bio-Detek Incorporated 525 Narragansett Park Drive Pawtucket, RI 02861-4323

Re: K984582 ZOLL Superpadz Adult Multi-Function Electrode Requlatory Class: III (three) Product Code: 74 MLN December 23, 1998 Dated: Received: December 24, 1998

Dear Mr. Dupelle:

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 A substantially equivalent determination assumes compliance to 895. 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. Michael R. Dupelle

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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510(k) Number (if known): K984582

Device Name: Superpadz Adult Multi-Function Electrodes

ZOLL Superpadz Adult Multi-Function Electrodes will be used for Indications For Use: the following clinical applications:

- Defibrillation .
- Cardioversion .
- Noninvasive Pacing .
- Electrocardiograph Monitoring .

In conjunction with these devices:

- ZOLL PD™ 1200 Pacemaker/Defibrillator .
- ZOLL PD™ 1400 Pacemaker/Defibrillator .
- ZOLL PD™ 2000 Pacemaker/Defibrillator .
- ZOLL D 900 Defibrillator .
- ZOLL D 1400 Defibrillator .
- ZOLL D 2000 Defibrillator .
- ZOLL 1600 Pacemaker/Defibrillator .
- ZOLL 1700 Pacemaker/Defibrillator .
- ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
- ZOLL M Series .

By trained medical personnel, including physicians, nurses, paramedics, emergency medical technicians (EMT), and cardiovascular laboratory technicians in typical settings.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. A. C.M.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)