ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

K990106 · Bio-Detek, Inc. · MKJ · Feb 26, 1999 · Cardiovascular

Device Facts

• Record ID: K990106
• Device Name: ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
• Applicant: Bio-Detek, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications: - Defibrillation - Electrocardiograph Monitoring In conjuction 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 1700 Facemanen sive Temporary Pacemaker - ZOLL M Series By trained personnel, including: - Physicians - Nurses - Paramedics - Emergency Medical Technicians (EMT) - Policemen/women - Firemen/women In typical settings.

Device Story

First Responder Padz are adult defibrillation electrodes designed for use with specific ZOLL pacemaker/defibrillator models. Electrodes function as the interface between the patient and the defibrillator, enabling delivery of therapeutic electrical shocks for defibrillation and acquisition of ECG signals for monitoring. Operated by trained personnel (physicians, nurses, paramedics, EMTs, first responders) in typical emergency or clinical settings. Output is delivered directly to the patient via the electrode pads; ECG data is processed by the connected ZOLL device to assist clinicians in rhythm assessment and decision-making regarding defibrillation therapy. Benefits include rapid deployment and reliable signal/energy transfer during cardiac emergencies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable adult defibrillation electrodes. Designed for use with ZOLL pacemaker/defibrillator series. Provides conductive interface for energy delivery and ECG signal acquisition. Connectivity via proprietary cable interface to ZOLL host devices.

Indications for Use

Indicated for adult patients requiring defibrillation or electrocardiograph monitoring. Intended for use by trained personnel including physicians, nurses, paramedics, EMTs, police, and fire personnel.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1999

Ms. Carolyn Schmiedeknecht Bio-Detek Incorporated 525 Narragansett Park Drive Pawtucket, RI 02861

K990106 Re : ZOLL First Responder Padz Adult Defibrillation Electrodes Requlatory Class: III (three) Product Code: 74 MLN Dated: February 12, 1999 Received: February 16, 1999

Dear Ms. Schmiedeknecht:

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 qeneral 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 requlations 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 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 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.

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

Page 2 - Ms. Carolyn Schmiedeknecht

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 regurers: 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, (21 CFR 807.97) 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, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

2/06/99

510(k) Number (if known):

Device Name: First Responder Padz Adult Defibrillation Electrodes

X495706

Indications For Use:

ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications:

- Defibrillation ●
- Electrocardiograph Monitoring ●

In conjuction 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 1700 Facemanen sive Temporary Pacemaker .
- ZOLL M Series .

Perscription Use_L (Per 21 CFR 801.109)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

es K990106

K990106

Over-The-Counter Use

OR

(Optional Format 1-2-96)

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

By trained personnel, including:

- Physicians ●
- Nurses .
- Paramedics ●
- Emergency Medical Technicians (EMT) ●
- Policemen/women .
- Firemen/women .

In typical settings.

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

## Concurrence of CDRH Office of Device Evaluation (ODE)

| Perscription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |
| | |

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

2