(255 days)
Not Found
No
The document mentions a "GE/Marquette 12SL™ Algorithm" for ECG analysis, which is a known algorithm for interpreting ECGs. However, the document does not explicitly state that this algorithm, or any other component of the device, utilizes AI or ML. The focus is on standard physiological monitoring and defibrillation functions.
Yes
The device performs defibrillation and noninvasive transcutaneous pacing, which are therapeutic interventions aimed at treating conditions like ventricular fibrillation, tachycardia, and asystole.
Yes.
The device is explicitly indicated for "identifying and diagnosing cardiac rhythms and dysrhythmias" and "diagnosis of patients with acute myocardial infarction (AMI) and... other transient cardiac arrhythmias," which are diagnostic actions. It also performs various monitoring functions to "facilitate the ability to monitor and assess the physiological characteristics."
No
The device description explicitly states it is an "External Defibrillator" and mentions hardware components like "paddles" and "MFE Pads" for defibrillation, indicating it is a physical device with hardware.
Based on the provided information, the ZOLL E Series External Defibrillator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ZOLL E Series Function: The ZOLL E Series directly interacts with the patient's body to perform functions like defibrillation, pacing, and monitoring vital signs (ECG, SpO2, EtCO2, NIBP). It does not analyze samples taken from the patient.
The device is a medical device used for direct patient care and monitoring.
N/A
Intended Use / Indications for Use
- Defibrillation: "The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport."
- Manual Operation: "Use of the E Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats."
- Semiautomatic Operation (AED): "The E Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse."
- External Pacemaker (Pacer Version Only): "This product may be used for temporary external, demand or non-demand pacing, as an alternative to endocardial stimulation. External cardiac pacing is indicated for use on conscious or unconscious patients in asystole, profound bradycardia or any other conditions determined by a clinician to require external pacing."
- ECG Monitoring: "The device is indicated for monitoring a patient's electrocardiogram (ECG), via the 3 or 5 lead patient cable, MFE Pads, or through the paddles, for the purposes of identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate."
- SpO2 Option (if equipped): "The SpO2 Option with Masimo Set Technology is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for adult, pediatric and neonatal patients, during both no motion and patient motion conditions, and for patients who are well or poorly perfusing in the hospital or pre-hospital environments."
- EtCO2 Option (if equipped): "The EtCO2 Option with Respironics Novametrix Technology and Capnostat® is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in adult, pediatric and neonatal patient's requiring ventilatory support, transport and anesthesia."
- 12SL Analysis Option (if equipped): "The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the 120E - Andrysis with acute myocardial infarction (AMI) and is useful in in the diagnosic of patiente with as other transient cardiac arrhythmias that the interprotution and Lead ECG Analysis is indicated for the recording and may oooal: - - That ECG signals acquired from adult and pediatric patients in the supine, resting position."
- NIBP Option (if equipped): "The NIBP Option with SunTech Medical Systems, Inc. Technology is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport."
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
"The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport. The ZOLL E Series intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
- SpO2: "adult, pediatric and neonatal patients"
- EtCO2: "adult, pediatric and neonatal patient's"
- 12SL Analysis: "adult and pediatric patients"
- NIBP: "adult, pediatric, and neonatal patients."
- Pediatric Pacing: "Pediatric patients weighing 33lbs / 15kg or less"
Intended User / Care Setting
"qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment."
Defibrillation: "This product should be used only by qualified medical personnel who are trained and authorized to respond to medical emergencies."
Semiautomatic Operation (AED): "emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient."
Care Setting: "critical care and transport", "hospital or pre-hospital environments"
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)
"Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards."
"Performance and safety testing of the ZOLL E Series Defibrillator demonstrates that its features, functions and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness."
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.
K990762, K982992, K993036, K991556, K032363, K033474
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.
0
APR 7 2005
Image /page/0/Picture/1 description: The image shows the word "ZOLL" in large, bold, black letters on the left side of the image. To the right of the word "ZOLL", there is a handwritten text "K042" in black ink. The text "K042" is smaller in size compared to the word "ZOLL". The background of the image is white.
ZOLL Medical Corporation
Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105 U.S.A.
(978) 421-9655 (978) 421-0025 Main Fax
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Sean Reynolds (978) 421-9655, Ext. 9386
Date Summary Prepared:
July 23, 2004
Device:
ZOLL E Series
Classification:
Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)
Automated External Defibrillator: Class III (21 CFR 870.5310)
Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300
Electrocardiograph: Class II (21 CFR 870.2340)
External Transcutaneous Cardiac Pacemakers (Non-invasive): Class II (21CFR 870.5550)
Analyzer, Gas, Carbon Dioxide; Class II (21 CFR 868.1400)
Oximeters: Class II (21 CFR 870.2700)
System, Measurement, Blood-Pressure, Non-Invasive: Class II (21 CFR 870.1130)
Description:
The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport. The ZOLL E Series intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment.
1
Substantial Equivalence:
K04J007
The features and functions of the ZOLL E SERIES are substantially equivalent to The Toutaroo and Rinces Biphasic: 510(k) No. K990762, cleared 9/03/1999, the M SERIES SpO2 Option 510(k) No. K982992, cleared 3/11/1999, the M the M OERIES End Tidal CO2 Option: 510(k) No. K993036 cleared 2/28/2000, the M SERIES 12SL Analysis Option 510(k) No. K991556 cleared 10/21/1999, the M SERIES Non-Invasive Blood Pressure measurement Option: 510(k) No. K032363, cleared 10/31/2003, and the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004.
Intended Use:
Defibrillation
Use of the E Series products in the manual mode for defibrillation is indicated for converting/terminating ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- Unconsciousness .
- Absence of breathing .
- . Absence of pulse.
This product should be used only by qualified medical personnel who are trained and authorized to respond to medical emergencies.
External Pacemaker (Pacer Version Only)
This product may be used for temporary external, demand or non-demand pacing, as an alternative to endocardial stimulation. External cardiac pacing is indicated for use on conscious or unconscious patients in asystole, profound bradycardia or any other conditions determined by a clinician to require external pacing.
ECG Monitoring
The device is indicated for monitoring a patient's electrocardiogram (ECG), via the 3 or 5 lead patient cable, MFE Pads, or through the paddles, for the purposes of identifying and diagnosing cardiac rhythms and dysrhythmias and calculating heart rate.
SpO2 Option (if equipped)
The SpO2 Option with Masimo Set Technology is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for adult, pediatric and neonatal patients, during both no motion and patient motion conditions, and for patients who are well or poorly perfusing in the hospital or pre-hospital environments.
EtCO2 Option (if equipped)
The EtCO2 Option with Respironics Novametrix Technology and Capnostat® is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in adult, pediatric and neonatal patient's requiring ventilatory support, transport and anesthesia.
2
12SL Analysis Option (if equipped)
The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the 120E - Andrysis with acute myocardial infarction (AMI) and is useful in in the diagnosic of patiente with as other transient cardiac arrhythmias that the interprotution and Lead ECG Analysis is indicated for the recording and may oooal: - - That ECG signals acquired from adult and pediatric patients in the supine, resting position.
NIBP Option (if equipped)
The NIBP Option with SunTech Medical Systems, Inc. Technology is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.
Comparison of Technological Characteristics
The ZOLL E Series design characteristics are the same as those of the indicated predicate devices; the technology is very similar to that of the ZOLL M Series. The ZOLL E Series acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients. The ECG Analysis Algorithms are identical to those incorporated into the ZOLL AED Plus defibrillator. The ZOLL E Series provides multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non-Invasive Blood Pressure measurement, using technology very similar to those used by the ZOLL M Series.
Performance Testing:
Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Performance and safety testing of the ZOLL E Series Defibrillator demonstrates that its features, functions and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
3
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
APR 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zoll Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105
Re: K042007
Trade Name: Zoll E Series Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III Product Code: MKJ Dated: March 11, 2005 Received: March 16, 2005
Dear Mr. Reynolds:
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.
4
Page 2 -- Mr. Sean Reynolds
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill in I DA s issumes of a states complies with other requirements of the Act that FDA has made a decertimation administered by other Federal agencies. You must or ally redelal statutes and regaranents and admited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Part 807), idocing (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section your device as described in your Section 510(k) I ms letter will anow you to oegin maing of substantial equivalence of your device to a legally prematication. The PDF intalligstification 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 If you desire specific acreevier 7 at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
Blymmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use
510(k) Number (if known): __________________________________________________________________________________________________________________________________________________ K042007
ZOLL E Series Device Name:
Defibrillator Function
The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It The L Sches products oonline a DO achern synchronized cardioversion by using the R-wave of may be used in synchionized mode to perferm of hone increase or disposable, pre-gelled, MFE Pads for defibrillation.
Intended Use - Manual Operation
Use of the E Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- Unconsciousness •
- Absence of breathing .
- . Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
Intended Use - Semiautomatic Operation (AED)
The E Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- Unconsciousness ゃ
- Absence of breathing .
- . Absence of pulse.
(continued on next page)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hummumuma
scular Devices
Page 1 of 2
6
Indications for Use (continued from previous page)
External Pacemaker (Pacer Version Only)
Intended Use — Pacemaker
This product may be used for temporary external cardiac pacing in conscious or unconscious of This product may be aber to endocardial stimulation.
Note: This device must not be connected to internal pacemaker electrodes.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any etiology:
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagation standstill, drug induced standstill (due to procainamide, quiracy, angiography, and standstill, drug Induced (due (due verapamil, etc.) and unexpected circulatory artest (die to temporary and eneraliance of the more reliable, and other therapeutic or diagnosic procedures). It had also book and it is safer, more reliable, and bradycardia in Slokes-Adams discuse and olsk since bytal.
more rapidly applied in an emergency than endocardial or other temporary electrodes.
As a standby when standstill or bradycardia might be expected:
s a standby whon btandby when cardiac arrest or symptomatic bradycardia Noninvasive pacing may be useful as a stalius, and toxicity, anethesia or surgey. It is
might be expected due to acute myocardial infarction, and surgey. It is might be expected due to acule myocaration market implants or the introduction
also useful as a temporary treatment in patients awaiting pacing may provide an also useful as a temporary treathen in pating applications, noninvasive pacing may provide an
of transvenous therapy. In standby pacing applications, infortion, he of transvenous therapy. In Standby paong applications, nown as a morrhage, and morrhage, and alternative to transverlous therapy that avoids the netto or displayers, and members of ventricular embolization, "perforution," phistical with endocardial pacing.
Suppression of tachycardia:
uppression of table of catelling.
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL Pacing can be performed on pedialic patients weighing outlouting in need as not of the mates, could pediatic Thi E T ads. T folongour pasing (as necommended.
Monitor
Intended-Use Multi-parameter Monitoring .
This product may be used for monitoring various patient vital signs, including: electrocardiogram This product may be used for monitoring valious patient vital signo, moduling on and online of the sure (NIBP).
(NDT ).
ECG monitoring is indicated by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles.
will £ + as ; or this use the last in arterial oxygen saturation of blood and pulse rate for adult. SpO2 monitoring is indicated for ucteding archar oxygen sateralism of areas and patient motion conditions.
monon continuous .
EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO₂) and respiration rate for adult, pediatric and neonatal patients.
and respiration for adult postally posted for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction.
with actic myouthal marchiem.
NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.