ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES by BIO-DETEK, INC.

The provided text is a 510(k) premarket notification letter from the FDA to Bio-Detek Incorporated for their ZOLL First Responder Padz Adult Defibrillation Electrodes. This document primarily focuses on the regulatory approval process and the determination of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information such as:

Table of acceptance criteria and reported device performance
Sample size and data provenance for a test set
Number and qualifications of experts for ground truth
Adjudication method
MRMC comparative effectiveness study results
Standalone performance
Type of ground truth used
Sample size for training set
Method for establishing ground truth for training set

This document is a regulatory approval letter, not a technical report or study summary.

Summary

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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.

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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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

(Optional Format 1-2-96)

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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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.