(237 days)
Not Found
Unknown
The document mentions an "ECG Rhythm Advisory Algorithm" and a "CPRReadyCharge algorithm" that performs ECG rhythm analysis. While algorithms can be AI/ML, the document does not explicitly state that these algorithms utilize AI or ML techniques. The lack of mention of training/test sets or performance metrics typically associated with AI/ML models makes it difficult to definitively confirm its presence.
Yes
The device is indicated for defibrillation, pacing, and cardioversion, which are all therapeutic interventions used to treat patients.
Yes
The device is described as performing "multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance" and facilitating the ability to "monitor and assess the physiological characteristics of the indicated patients," which are all diagnostic functions. It also performs "ECG Rhythm Advisory Algorithm" and "ECG rhythm analysis" to "detect shockable rhythms," which are diagnostic in nature.
No
The device description clearly states it is an "External Defibrillator" and includes hardware components such as a DC defibrillator, paddles, MFE Pads, and a transcutaneous demand pacemaker. While it includes software components like the CPRReadyCharge algorithm, it is not solely software.
Based on the provided text, 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.
- Device Function: The ZOLL E Series® External Defibrillator is used for external defibrillation, transcutaneous pacing, and monitoring of vital signs directly from the patient's body (ECG, pulse oximetry, end tidal CO2, blood pressure, CPR performance).
- Intended Use: The intended use clearly describes direct patient interaction and intervention (defibrillation, pacing, monitoring) rather than analysis of bodily specimens.
Therefore, the device falls under the category of a therapeutic and monitoring medical device, not an IVD.
N/A
Intended Use / Indications for Use
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, CPR performance and data printing and recording for resting patients in critical care and transport. The device is 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. The device is light weight and easy to carry for transport.
The proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.
Intended Use - Manual Operation
Use of the E Series units in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- Unconsciousness
- Absence of breathing, and
- Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular fibrilation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heats. In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
Intended Use -- CPRReadyCharge Mode
Use of the E Series unit in CPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReadyCharge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG. The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of any therapy. See Table A-4 in Appendix A for a summary ofthe performance. E Series products with CPRReadyCharge Mode 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. Use of the E Series units in CPRReadyCharge Mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation. E Series units in CPRReadyCharge Mode, when used in conjunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during CPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReadyCharge Mode prepares the defibrillator to deliver a shock at the end of the CPR interval.
Intended Use - Semiautomatic Operation (AED)
The E Series AED unit is 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. Use of the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. Specifications for the ECG rhythm analysis function are provided at the end of this section.
Intended Use - CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage resouers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
Intended Use - Pacemaker
This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include:
• Resuscitation from standstill or bradycardia ofany etiology
• As a standby when standstill or bradycardia might be expected
• Suppression of tachycardia
Product codes (comma separated list FDA assigned to the subject device)
MKJ, DPS, LIX
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, CPR performance and data printing and recording for resting patients in critical care and transport. The device is 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. The device is light weight and easy to carry for transport.
The proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.
The E Series products contain a DC defibrillator capableof delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ECG
Anatomical Site
Not Found
Indicated Patient Age Range
The CPR monitoring function is not intended for use on patients under 8 years of age.
Do not use the unit's AED function on patients under 8 years of age.
Pacing can be performed on pediatic patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads.
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. The device is light weight and easy to carry for transport.
Manual Operation
qualified medical personnel
CPRReadyCharge Mode
qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support)
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.
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)
Performance and safety testing of the device demonstrates that its features, functions and incorporated ECG advisory processing 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.
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
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A
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:
Eileen M. Boyle (978) 421-9655, Ext. 9171
Date Summary Prepared:
April 20, 2009
Device:
ZOLL E Series® with CPRReadyCharge
Classification:
Defibrillators, Automatic, External, Class III (21 CFR Part 870.5310) Electrocardiograph: Class II (21 CFR Part 870.2340) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
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, CPR performance and data printing and recording for resting patients in critical care and transport. The device is 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. The device is light weight and easy to carry for transport.
The proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.
DEC 2 3 2009
1
Substantial Equivalence:
The E Series with CPRReadyCharge is equivalent to the predicate product. The features and functions of the E Series with CPRReadyCharge are based on the same technology as that found in the E Series product, reviewed and cleared by the FDA under K042007.
Defibrillator Function
The E Series products contain a DC defibrillator capableof delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG
as a timing reference. The unit uses paddles or disposable, pre-qelled, MFE Pads for defibrillation, The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Intended Use - Manual Operation
Use of the E Series units in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- · Unconsciousness
- Absence of breathing, and
- · Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular fibrilation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heats. In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the Rwave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
Intended Use -- CPRReadyCharge Mode
Use of the E Series unit in CPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReadyCharge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG. The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of anv therapy. See Table A-4 in Appendix A for a summary ofthe performance. E Series products with CPRReadyCharge Mode 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. Use of the E Series units in CPRReadyCharge Mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. E Series units in CPRReadyCharge Mode, when used in conjunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during CPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReadyCharge Mode prepares the defibrillator to deliver a shock at the end of the CPR interval.
Intended Use - Semiautomatic Operation (AED)
The E Series AED unit is 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. Use of the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. Specifications for the ECG rhythm analysis function are provided at the end of this section.
2
Intended Use - CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage resouers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
Contraindications for Semiautomatic Operation
Do not use the unit's AED function on patients under 8 years of age. The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during patient movement on a stretcher or in an ambulance or other conveyance. A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all movement of the stretcher or vehicle prior to analyzing the ECG. If you are using the device in an emergency vehicle, bring the vehicle to a half before activating the analysis function.
Defibrillator Complications
Inappropriate defibrillation or cardioversion of a patient (e.g., with no malignant arrhythmia) may orecipitate ventricular fibrillation, asystole, or other dangerous arrhythmias. Defibrillation without proper application of electrode pads or paddle electrolyte gel may be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles or MFE Pads often occurs; this effect is usually enhanced along the perimeter of the paddle or electrode. This reddening should diminish substantially within 72 hours.
Defibrillator Output Energy
The E Series products may deliver up to 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patients transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10-12 kilograms (22-26.4 lbs) must be applied to each paddle in order to minimize this impedance. If MFE pads are used, make sure that they are properly applied. (Instructions for proper application are located in "MFE Pad Application")" on page 1-9).
External Pacemaker Function (Pacer
version only)
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry. Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated. Proper operation of the device, together with correct electrode placement, is critical to obtaining optimal results. Every operator must be thoroughly familiar with these operating instructions. The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm). The pacing output pulse is delivered to the heart by specially designed ZOLL MFE Pads placed on the back and the precordium. The characteristics of the output pulse, together with the design and placement of the electrodes, minimize cutaneous nerve stimulation threshold currents, and reduce discomfort due to skeletal muscle contraction. The unique design of the E Series products allow clear viewing and interpretation of the electrocardiogram (ECG) on the display without offset or distortion during external pacing.
Intended Use - Pacemaker
This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include:
· Resuscitation from standstill or bradycardia ofany etiology
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.
Page 3 of 5
3
· As a standby when standstill or bradycardia might be expected
Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
· Suppression of tachycardia
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
Pacemaker Complications
Ventricular fibrillation does not respond to pacing and requires immediate defibrillation. Therefore, the patient's dyschythmia must be determined immediately, so that you can employ appropriate therapy. If the patient is in ventricular fibrillation is successful but cardiac standstill (asystole) ensues, you should use the pacemaker. Ventricular or supraventricular tachycardias may be interrupted with pacing but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain. (See "Synchronized Cardioversion" on page 5-1). Electromechanical dissociation may occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing may then produce ECG responses without effective mechanical contractions, and other treatment is required. Pacing may evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or other cardiac diseases. Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing, particularly at rapid rates, can cause ventricular standstill and should be avoided. Noninvasive Temporary Pacing may cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients, Similarly, unavoidable skeletal muscle contraction may be troublesome in very sick patients and may limit continuous use to a few hours. Enthema or hyperemia of the skin under the MFE Pads often occurs: this effect is usually enhanced along the perimeter of the electrode. This reddening should substantially lessen within 72 hours. There have been reports of burns under the anterior electrode when pacing adult palients with severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised. There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen.
WARNING!: This device must not be connected to internal pacemaker electrodes.
Pediatric Pacing
Pacing can be performed on pediatic patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.
Paddle and Electrode Options
The E Series products will defibrillate, cardiovert and monitor ECG using either defibrillation paddles or ZOLL Multi-Function Electrode (MFE) Pads. The pacer version of the E Series paces using ZOLL MFE Pads.
ENERGY SELECT, CHARGE, and SHOCK controls are located on the paddles and front panel. When using MFE Pads, you must use the controls on the front panel of the unit. To switch from paddles to MFE Pads, remove the Multi-Function cable from the apex paddle and connect the MFE pads to the Multi-Function cable. You cannot activate the Advisory function unless MFE Pads are attached to the Multi-Function Cable and used as the ECG monitoring lead. Adult and pediatric MFE Pads, statypadz, and ECG electrodes (not the ECG cable) are disposable, single use items.
4
Comparison of Technological Characteristics
- The design characteristics have not been changed from those, which were reviewed and cleared by FDA under premarket notification 510(k) K042007. With the
- CPRReadyCharge Mode will reduce the amount of time delay between the end of manual CPR compressions and the delivery of defibrillation shock.
Performance Testing:
- Extensive performance testing ensures that the device 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 device demonstrates that its features, functions and incorporated ECG advisory processing algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
Zoll Medical Corporation Worldwide Headquarters c/o Ms. Eileen M. Boyle Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105
Re: K091265
Zoll E Series with CPRReadyCharge Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, DPS, LIX Dated: December 11, 2009 Received: December 14, 2009
Dear Ms. Boyle:
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 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.
6
Page 2 - Ms. Eileen M. Boyle
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
SECTION 4 - INDICATIONS FOR USE
| (k) Number (if known): | |
|---|---|
| ------------------------ | -- |
KOG1265
Device Name: ZOLL E Series
Defibrillator Function
The E Series products contain a DC defibrillator capableof delivering up to 200 ioules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.
Intended Use - Manual Operation
Use of the E Series units in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
-
· Unconsciousness
510 -
· Absence of breathing, and
-
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. In Manual mode, the E Series unit may also be used for
synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the Rwave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
Intended Use -- CPRReadyCharge Mode
Use of the E Series unit in CPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReadyCharge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) alcorithm used with artifact-free ECG. The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of any therapy. See Table A-4 in Appendix A for a summary ofthe performance. E Series products with CPRReadyCharge Mode 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. Use of the E Series units in CPRReadyCharge Mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation. E Series units in CPRReadyCharge Mode, when used in coniunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during CPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReadyCharge Mode prepares the defibrillator to deliver a shock at the end of the CPR interval.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of 3
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K091265 |
8
Intended Use - Semiautomatic Operation (AED)
The E Series AED unit is 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. Use of the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. Specifications for the ECG rhythm analysis function are provided at the end of this section.
Intended Use - CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage resouers to perform chest compressions at the AHAJERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
Contraindications for Semiautomatic Operation
Do not use the unit's AED function on patients under 8 years of age. The rhythm analysis function may not reliably identify ventricular fibrillation in the presence of an implanted pacemaker. Inspection of the electrocardiogram and clinical evidence of cardiopulmonary arrest should be the basis for any treatment of patients with implanted pacemakers. Do not use the rhythm analysis function during patient movement on a stretcher or in an ambulance or other conveyance. A patient must be motionless during ECG analysis. Do not touch the patient during analysis. Cease all movement of the stretcher or vehicle prior to analyzing the ECG. If you are using the device in an emergency vehicle to a halt before activating the analysis function.
Defibrillator Complications
Inappropriate defibrillation or cardioversion of a patient (e.g., with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias. Defibrillation without proper application of electrode pads or paddle electrolyte gel may be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles or MFE Pads often occurs; this effect is usually enhanced along the perimeter of the paddle or electrode. This reddening should diminish substantially within 72 hours.
Defibrillator Output Energy
The E Series products may deliver up to 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patients transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10-12 kilograms (22-26.4 lbs) must be applied to each paddle in order to minimize this impedance. If MFE pads are used, make sure that they are properly applied. (Instructions for proper application are located in "MFE Pad Application" on page 1-9).
External Pacemaker Function (Pacer
version only)
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry. Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated. Proper operation of the device, together with correct electrode placement, is critical to obtaining optimal results. Every operator must be thoroughly familiar with these operating instructions. The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm). The pacing output pulse is delivered to the heart by specially designed ZOLL MFE Pads placed on the precordium. The characteristics of the output pulse, together with the design and placement of the electrodes, minimize cutaneous nerve stimulation, cardiac stimulation threshold currents, and reduce discomfort due to skeletal muscle contraction. The unique design of the E Series products allow clear viewing and interpretation of the electrocardiogram (ECG) on the display without offset or distortion during external pacing.
9
Intended Use - Pacemaker
This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include:
· Resuscitation from standstill or bradycardia ofany etiology
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine,digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.
· As a standby when standstill or bradycardia might be expected
Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
· Suppression of tachycardia
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
Pacemaker Complications
Ventricular fibrillation does not requires immediate defibrillation. Therefore, the patient's dysrhythmia must be determined immediately, so that you can employ appropriate therapy. If the patient is in ventricular fibrillation and defibrillation is successful but cardiac standstill (asystole) ensues, you should use the pacemaker. Ventricular or supraventricular tachycardias may be interrupted with pacing but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain. (See "Synchronized Cardioversion" on page 5-1). Electromechanical dissociation may occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing may then produce ECG responses without effective mechanical contractions, and other treatment is required. Pacing may evoke undesirable repetitive responses, tachycardia, or fibrillation in the presence of generalized hypoxia, myocardial ischemia, cardiac drug toxicity, electrolyte imbalance, or other cardiac diseases. Pacing by any method tends to inhibit intrinsic rhythmicity. Abrupt cessation of pacing, particularly at rapid rates, can cause ventricular standstill and should be avoided. Noninvasive Temporary Pacing may cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients. Similarly, unavoidable skeletal muscle contraction may be troublesome in very sick patients and may limit continuous use to a few hours. Erythema or hyperemia of the skin under the MFE Pads often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should substantially lessen within 72 hours. There have been reports of burns under the anterior electrode when pacing adult patients with severely restricted blood flow to the skin. Prolonged pacing should be avoided in these cases and periodic inspection of the underlying skin is advised. There are reports of transient inhibition of spontaneous respiration in unconscious patients with previously available units when the anterior electrode was placed too low on the abdomen.
WARNINGI: This device must not be connected to internal pacemaker electrodes.
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.
Paddle and Electrode Options
The E Series products will defibrillate, cardiovert and monitor ECG using either defibrillation paddles or ZOLL Multi-Function Electrode (MFE) Pads. The pacer version of the E Series paces using ZOLL MFE Pads.
ENERGY SELECT, CHARGE, and SHOCK controls are located on the paddles and front panel. When using MFE Pads, you must use the controls on the front panel of the unit. To switch from paddles to MFE Pads, remove the Multi-Function cable from the apex paddle and connect the MFE pads to the Multi-Function cable. You cannot activate the Advisory function unless MFE Pads are attached to the Multi-Function Cable and used as the ECG monitoring lead. Adult and pediatric MFE Pads, statspadz, and ECG electrodes (not the ECG cable) are disposable, single use items.