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The ZOLL Autoclavable Internal Handles are to be used with interchangeable electrodes and a manually operated ZOLL Defibrillator to defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature. the ZOLL Autoclavable Internal Handles allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles are intended for use by or under the direction of a physician.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to provide defibrillation therapy directly to the heart during surgical procedures.

When used with a ZOLL Defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allows the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

The ZOLL Autoclavable External Paddles are to be used with manually operated ZOLL M Series Defibrillator products to perform closed chest defibrillation of a patient when sterlization of the paddles is required either before or after the defibrillation event.

The ZOLL Autoclavable External Paddles are intended for use by trained personnel and are for use on Adult patients only.

The ZOLL Autoclavable External Paddles are intended for use by or under the direction of a physician.

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This document describes a 510(k) premarket notification for the "Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes and Zoll Autoclavable External Paddles." This is a regulatory clearance for a medical device and not a study proving device performance against acceptance criteria.

The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not typically part of a 510(k) submission document in the way it would be for a clinical trial reporting.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the device was found to be as safe and effective as a device already on the market, not that a new study with explicit acceptance criteria was performed.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not a detailed performance study with acceptance criteria.

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The ZOLL Autoclavable Internal Handles with Integrated Electrodes are to be used with a manually operated ZOLL Defibrillator to defibrillate the heart during surgical procedures.

When used with a ZOLL defibrillator equipped with an advisory or ECG analysis feature, the ZOLL Autoclavable Internal Handles with Integrated Electrodes allow the defibrillator to operate only as a manual device.

The ZOLL Autoclavable Internal Handles with Integrated Electrodes are intended for use by or under the direction of a physician.

ZOLL Autoclavable Internal Handles with Integrated Electrodes

This document is a 510(k) premarket notification decision letter from the FDA for the ZOLL Autoclavable Internal Handles with Integrated Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory approval letter, not a technical study report.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device

Ask a specific question about this device