ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

K981802 · Bio-Detek, Inc. · MKJ · Nov 25, 1998 · Cardiovascular

Device Facts

• Record ID: K981802
• Device Name: ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003
• Applicant: Bio-Detek, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Nov 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Modified stat padz Adult Multi-Function Electrodes will be used for the following clinical applications: - Defibrillation . - Cardioversion . - Noninvasive Pacing . - Electrocardingraph 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 NTP 1000 Noninvasive Temporary Pacemaker - ZOLL M Series .

Device Story

Modified stat-padz Adult Multi-Function Electrodes are disposable, adhesive electrodes designed for use with ZOLL series pacemakers and defibrillators. The device functions as an interface between the patient and the host device to deliver electrical therapy (defibrillation, cardioversion, pacing) or acquire ECG signals. Operated by trained medical personnel (physicians, nurses, paramedics, EMTs) in clinical or emergency settings. The electrodes attach to the patient's skin; the host device monitors the signal or delivers the required energy based on clinician input. The device facilitates life-saving cardiac interventions and continuous monitoring.

Technological Characteristics

Disposable, adhesive multi-function electrodes. Designed for electrical interface with ZOLL defibrillator/pacemaker systems. Used for ECG signal acquisition and delivery of therapeutic electrical energy.

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, EMTs, and cardiovascular laboratory technicians in typical 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. Above the profiles are three diagonal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

NOV 2.5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K981802 Modified stat•padz Adult Multi-Function Electrodes Regulatory Class: III (three) Product Code: 74 MKJ Dated: May 15, 1998 Received: May 21, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. 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 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. 9 allahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

Page 1 of 2

510(k) Number (if known): __ K981802

Device Name: Modified stat padz Adult Multi-Function Electrodes

Indications For Use:

Modified star padz Adult Multi-Function Electrodes will be used for the following clinical applications:

- Defibrillation .
- Cardioversion .
- Noninvasive Pacing .
- Electrocardingraph 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 NTP 1000 Noninvasive Temporary Pacemaker .
- ZOLL M Series .

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Concurrence of CDRH Office of Device Evaluation (ODE)

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

| Perscription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|

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Page 2 of 2

By trained medical personnel, including:

- Physicians .
- Nurses ●
- Paramedics .
- Emergency Medical Technicians (EMT) ●
- 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) James 'ign-Off) Divisia: Cardiovascular, Respiratory, Division and Need ogical Devices 510(k) Monber _ OR Over-The-Counter Use Perscription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)