K Number
K990106
Device Name
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
Manufacturer
Date Cleared
1999-02-26

(45 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
Device Description
Not Found
More Information

Not Found

Not Found

No
The document describes defibrillation electrodes and their compatible devices, with no mention of AI or ML technology in the intended use, device description, or other sections.

No
The device, ZOLL First Responder Padz Adult Defibrillation Electrodes, is indicated for use in defibrillation and ECG monitoring in conjunction with pacemaker/defibrillator devices, which are therapeutic. However, the electrodes themselves are accessories that transmit the therapeutic energy/signal, rather than being the therapeutic device itself.

No

The device is described as "Adult Defibrillation Electrodes" used for "Defibrillation" and "Electrocardiograph Monitoring". While electrocardiograph monitoring provides diagnostic information by measuring the electrical activity of the heart, the primary listed function for these electrodes is "Defibrillation" which is a therapeutic intervention. The electrodes themselves are accessories used with a defibrillator/pacemaker rather than presenting a standalone diagnostic capability that renders a diagnosis. Diagnostic devices are primarily used to identify or clarify a disease or condition, whereas the primary use case here is therapeutic (defibrillation) with monitoring as a secondary function of the electrodes.

No

The device description is not found, but the intended use clearly states the device is "ZOLL First Responder Padz Adult Defibrillation Electrodes," which are physical electrodes used in conjunction with defibrillators. This indicates a hardware component.

Based on the provided information, the ZOLL First Responder Padz Adult Defibrillation Electrodes are not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended uses listed are Defibrillation and Electrocardiograph Monitoring. These are direct physiological interventions and measurements performed on the patient's body, not tests performed on samples taken from the body.
  • Device Description: While the description is "Not Found," the intended use clearly points to a device that interacts directly with the patient's electrical activity.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ZOLL First Responder Padz are electrodes that deliver electrical current to the body and monitor electrical signals from the body.

N/A

Intended Use / 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

Product codes

74 MLN

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult

Intended User / Care Setting

By trained personnel, including:

  • Physicians
  • Nurses
  • Paramedics
  • Emergency Medical Technicians (EMT)
  • Policemen/women
  • Firemen/women

In typical settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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 (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

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