K Number
K984582
Device Name
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
Manufacturer
Date Cleared
1999-03-16

(83 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 .
Device Description
Superpadz Adult Multi-Function Electrodes
More Information

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Not Found

No
The document describes multi-function electrodes and their intended uses (defibrillation, pacing, monitoring) in conjunction with specific ZOLL devices. There is no mention of AI, ML, or any related technologies in the provided text.

Yes
The device is described as being used for clinical applications such as defibrillation, cardioversion, and noninvasive pacing, which are all therapeutic interventions.

No.
The device's intended uses are defibrillation, cardioversion, noninvasive pacing, and electrocardiograph monitoring, all of which are therapeutic or monitoring functions rather than diagnostic ones.

No

The device description explicitly states "Superpadz Adult Multi-Function Electrodes," which are physical hardware components used for medical procedures. The summary does not mention any software component as the primary or sole device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended uses listed (Defibrillation, Cardioversion, Noninvasive Pacing, Electrocardiograph Monitoring) are all direct therapeutic or monitoring procedures performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The device is described as "Superpadz Adult Multi-Function Electrodes," which are external components applied to the skin.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing specimens outside of the body.

Therefore, the ZOLL Superpadz Adult Multi-Function Electrodes are medical devices used for external electrical therapy and monitoring, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for 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 .

Product codes

74 MLN

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

Adult

Intended User / Care Setting

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

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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.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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.

1

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 (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, "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 (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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Page / of /

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)