ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) by ZOLL MEDICAL CORP.

The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in patients meeting the following clinical criteria:

the patient should be unconscious and unresponsive
the patient should be apneic (not breathing)
the patient should be pulseless .

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the ZOLL M Series Bi-Phasic Option, a low energy DC defibrillator.

This document does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

However, the third page (Image /page/2/Picture/1) of the document mentions:

"The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices."

This sentence indicates that clinical trials were performed to demonstrate the effectiveness of the device's waveform. However, the letter does not provide specific details regarding:

Acceptance Criteria Table: No table of acceptance criteria or reported device performance is present.
Sample Size or Data Provenance for Test Set: The document states "multi-center, prospective, randomized... clinical trials" but does not provide specific sample sizes or countries of origin.
Number/Qualifications of Experts for Ground Truth: Not mentioned.
Adjudication Method: Not mentioned.
MRMC Comparative Effectiveness Study: The letter states the device was "proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices." This implies a comparison, but it doesn't specify if it was an MRMC study with human readers or solely focused on device performance. No effect size for human reader improvement is provided.
Standalone Performance: The "proven to defibrillate and cardiovert" statement implies standalone performance was assessed.
Type of Ground Truth: Implied to be clinical outcomes (defibrillation/cardioversion success), but not explicitly detailed.
Training Set Sample Size: Not mentioned, as this is a clinical trial, not an AI model training.
Ground Truth for Training Set: Not applicable in the context of device performance trials as typically described in this letter.

In summary, while the document states that clinical trials were performed and were successful in demonstrating the device's capability, it does not provide the level of detail requested regarding acceptance criteria, study design parameters, or ground truth establishment that would be found in a comprehensive study report for an AI/CADe device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle's head in profile, with three horizontal lines extending from the back of the head, representing the agency's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

ZOLL Medical Corporation c/o Mr. Scott August Quality Assurance Engineer 269 Mill Road Chelmsford, MA 01824

Re: K032439

Trade Name: M Series Bi-Phasic Option Regulation Number: 21 CFR 870.5300 Regulation Name: Low Energy DC -- Defibrillator (including paddles) Regulatory Class: Class III (three) Product Code: MKJ Dated: August 7, 2003 Received: August 7, 2003

Dear Mr. August:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Scott August

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.

Mia Heenlu for
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

M Series Bi-Phasic Option Device Name:

Indications for Use:

The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices. The M Series Biphasic option incorporates some user selectable energy settings, which are lower than those used during those clinical trials.

There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatic applications.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in patients meeting the following clinical criteria:

the patient should be unconscious and unresponsive ●
the patient should be apneic (not breathing) ●
the patient should be pulseless .

Do not use the units AED function on patients under the 8 years of age. (Per AHA Guidelines for Adult Warning Cardiopulmonary Resuscitation and AED, 3-5, 1998).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dha Aeuh
(Division Sign-Off)

Division of Cardiovascular Devices
Number KU32439

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.