(90 days)
Not Found
Not Found
No
The document describes a standard defibrillator with an AED function, focusing on waveform technology and clinical trial results. There is no mention of AI or ML.
Yes
The device is intended for converting life-threatening cardiac arrhythmias (ventricular fibrillation and tachycardia, atrial fibrillation) back to a normal rhythm, which is a direct treatment for a disease state.
Yes
Explanation: The device has an AED or advisory function that "should only be used to confirm the presence of ventricular fibrillation". This indicates a diagnostic capability.
No
The device is described as a "Bi-Phasic Defibrillator," which is a hardware device used for delivering electrical shocks. The description of its intended use and function clearly indicates a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for treating cardiac arrhythmias (defibrillation and cardioversion) and assessing the presence of ventricular fibrillation based on clinical signs (unconsciousness, unresponsiveness, apnea, pulselessness).
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The other sections (image processing, AI/ML, input imaging modality, anatomical site, training/test sets, performance studies, key metrics, predicate/reference devices) do not contain information that would suggest an IVD function. The performance studies focus on the effectiveness of the waveform in treating cardiac conditions, not on diagnostic testing of samples.
In summary, the ZOLL M Series Bi-Phasic Defibrillator is a therapeutic and assessment device used directly on the patient, not a device used for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
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 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).
Product codes
MKJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Adult patients. Do not use the units AED function on patients under the 8 years of age.
Intended User / Care Setting
qualified medical personnel
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)
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.
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.
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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 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.
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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.
1
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
2
510(k) Number (if known):
M Series Bi-Phasic Option Device Name:
Indications for Use:
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 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