(179 days)
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No
The document describes a standard defibrillator with a biphasic waveform and an AED function. There is no mention of AI or ML in the intended use, device description, or performance studies. The AED function is based on pre-defined clinical criteria, not adaptive learning.
Yes.
The device is used to convert life-threatening cardiac rhythms (ventricular fibrillation and tachycardias) to normal rhythms, which is a therapeutic intervention.
No
Explanation: The document clearly states that the device's primary purpose is defibrillation and cardioversion, which are therapeutic interventions. While it has an AED or advisory function to confirm the presence of ventricular fibrillation (based on clinical criteria of the patient), this is described as a confirmation step for a therapeutic action, not a standalone diagnostic process for a broad range of conditions. The "Indications for Use" section focuses on treating cardiac rhythms rather than diagnosing them.
No
The device description is not provided, but the intended use clearly describes a "Bi-Phasic Defibrillator" which is a hardware device that delivers electrical shocks. The summary also mentions clinical trials involving "transthoracic defibrillator" and "monophasic devices," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ZOLL M Series Bi-Phasic Defibrillator is used to deliver an electrical shock to the heart to correct abnormal rhythms. This is a direct intervention on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes the device's function in converting cardiac rhythms and terminating arrhythmias. This is a therapeutic or life-saving intervention, not a diagnostic test.
Therefore, the ZOLL M Series Bi-Phasic Defibrillator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
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, and 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 dinical trials.
There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatric applications. Or The M Secies Biohasionalisation for direct defibrillation of the heart during open chest surgical/ (procedures.
The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in palients 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 unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Warning Cardiopulmonary Resuscitation and AED, 3-5, 1998).
Prescription Use (Per 21 CFR 801.109)
Product codes
74 MKJ, DRO, LDD, and DPS
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
trans-thoracic, heart (during open chest surgical procedures)
Indicated Patient Age Range
Adult patients. Do not use the unit's AED function on patients under 8 years of age.
Intended User / Care Setting
Qualified medical personnel.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/10 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 SEP
Mr. Paul Dias QA Engineer ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420
Re: K990762 ZOLL M Series Bi-Phasic Option Regulatory Class: III (three) Product Code: 74 MKJ, DRO, LDD, and DPS July 2, 1999 Dated: Received: July 7, 1999
Dear Mr. Dias:
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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 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. Paul Dias
devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
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 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 not 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
Enclosures
2
510(k) NUMBER (IF KNOWN): K990762
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, and 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 dinical trials.
There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatric applications. Or
The M Secies Biohasionalisation for direct defibrillation of the heart during open chest surgical/ (procedures.
The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in palients 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 unit's AED function on patients under 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 IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Closer
2/2/32
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number