(165 days)
Not Found
No
The document describes standard defibrillation, pacing, and monitoring functions. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies sections. The CPR monitoring function provides feedback based on pre-defined parameters (rate and depth), not adaptive learning.
Yes.
The device is used to perform defibrillation, temporary external cardiac pacing, and CPR monitoring, all of which are direct interventions for treating medical conditions.
Yes
The device is indicated for "multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance" and is intended to "facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment." It also has an "advisory function" to confirm ventricular fibrillation or wide complex ventricular tachycardia. These functions are diagnostic as they involve monitoring and assessing physiological characteristics to identify or confirm medical conditions.
No
The device description explicitly states it is an "External Defibrillator" and mentions hardware components like a pulse generator and ECG-sensing circuitry, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The R Series product described is a defibrillator, pacemaker, and multi-parameter monitor. Its functions involve:
- Defibrillation and Pacing: Delivering electrical shocks to the chest wall to restore normal heart rhythm. This is a direct intervention on the patient's body.
- ECG Monitoring: Measuring electrical activity of the heart through electrodes placed on the skin. This is a non-invasive measurement of a physiological signal.
- Pulse Oximetry: Measuring oxygen saturation and pulse rate through a sensor placed on the skin. This is a non-invasive measurement of physiological parameters.
- CPR Monitoring: Providing feedback on chest compressions. This is monitoring a physical action performed on the patient.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient's body (like blood, urine, etc.). All measurements and interventions are performed externally or through non-invasive contact with the patient.
Therefore, the R Series product falls under the category of a medical device used for diagnosis, monitoring, and treatment, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use - Manual Operation
Use of the R 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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arthythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
R 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.
Use of the R Series 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.
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
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.
Intended Use - Pacemaker
This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any etiology.
As a standby when standstill or bradycardia might be expected.
Suppression of tachycardia.
Intended Use - SpO2 Monitoring
The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no-motion and patient motion conditions for adult patients, and no motion conditions for pediaatric and neonatal patients in a hospital or prehospital environment.
Product codes
MKJ
Device Description
The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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 design facilitates table top use while still providing a light weight and easy to carry device for transport.
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
When the patient is less than 8 years of age or weighs less that 55 Ibs. (25 Kg), you must use ZOLL pediatic defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
The CPR monitoring function is not intended for use on patients under 8 years of age.
Pacing can be performed on pediatric patients weighing 33 1b. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes.
Adult patients, and pediatric and neonatal patients.
Intended User / Care Setting
Qualified medical personnel who are trained and authorized to respond to medical emergencies.
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.
Personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Hospital or prehospital environment.
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 R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications.
Testing of the R Series Defibrillator with BLS Option demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the word "ZOLL" in large, bold letters. Below the word "ZOLL" is the phrase "Advancing Resuscitation. Today." in a smaller font. There is a curved line below the phrase, which may be part of the company's logo. The text and line are all in black and white.
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 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
DEC 0 9 2008
Contact Person:
Eileen M. Boyle (978) 421-9655, Ext. 9171
Date Summary Prepared:
June 20, 2008
Device:
ZOLL R Series with BLS Option Defibrillator
Classification:
Defibrilltors, Automatic, External, Class III (21 CFR Part 870.5310)
Description:
The ZOLL R Series® External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R Series 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 design facilitates table top use while still providing a light weight and easy to carry device for transport.
1
Intended Use:
Intended Use - Manual Operation
Use of the R 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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arthythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
R 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.
Use of the R Series 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.
Specifications for the ECG rhythm analysis function are provided in this section, "ECG Rhythm Analysis Algorithm Accuracy" on page 29.
When the patient is less than 8 years of age or weighs less that 55 Ibs. (25 Kg), you must use ZOLL pediatic defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
2
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
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.
Semiautomatic Operation Contraindications for Use
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 ECC. If you are using the R Series in an emergency vehicle, bring the vehicle to a halt before activating the analysis function.
Defibrillator Complications
Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias.
Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually enhanced along the perimeter of the paddles or electrodes. This reddening should diminish substantially within 72 hours.
Defibrillator Output Energy
R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patient's transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this impedance. If hands-free therapy electrodes are used, make sure that they are properly applied. (Refer to the instructions on the electrode package).
3
External Pacemaker (Optional)
Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated.
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), by increments of 2.
The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing electrodes placed on the patient's 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 R Series BLS products allow clear viewing and interpretation of the electrocardiogram on the display without offset or distortion during external pacing.
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.
Intended Use - Pacemaker
This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any 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 can 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 might 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 might prevent tachycardia.
This device can only be used for external pacing of patients and cannot be used for internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
4
Pacemaker Complications
Ventricular fibrillation does not respond to pacing and 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 is successful but cardiac standstill (asystole) ensues, you should use the pacemaker.
Ventricular or supraventricular tachycardias can be interrupted with pacing, but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain.
Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing might then produce ECG responses without effective mechanical contractions, making other effective treatment necessary.
Pacing can 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 can cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients.
Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should lessen substantially 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.
This device can only be used for external pacing of patients and cannot be used for internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33 1b. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended.
Intended Use - SpO2 Monitoring
The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no-motion and patient motion conditions for adult patients, and no motion conditions for pediaatric and neonatal patients in a hospital environment.
5
Substantial Equivalence:
The R Series with BLS Option is equivalent to the predicate products. The features and functions of the R Series BLS Option are based on the same technology as that found in the ZOLL R Series product, reviewed and cleared by FDA under K060559.
Comparison of Technological Characteristics
The ZOLL R Series Defibrillator with BLS Option utilizes the same interpretive features and functions to those of the currently marketed ZOLL R Series (K060559) which was reviewed and cleared by FDA.
The proposed enhancement to the R Series will provide the user with a simplified user interface. The ZOLL R Series BLS Defibrillator combines an AED operating mode with manual override capability.
Performance Testing:
Extensive performance testing ensures that the R Series Defibrillator with BLS Option meets all of its functional requirements and performance specifications. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software and hardware did not degrade or impact other product features, functions or performance specifications.
Conclusion
Testing of the R Series Defibrillator with BLS Option demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
6
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2008
Zoll Medical Corporation Worldwide Headquarters c/o Ms. Eileen M. Boyle 269 Mill Road Chelmsford, MA 01824-4105
Re: K081828
Trade/Device Name: Zoll R Series AED with BLS Option Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: November 26, 2008 Received: December 1, 2008
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 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.
7
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); 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
K//
Drury D. Zuckerman, M
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
SECTION 4 - INDICATIONS FOR USE (0)
Intended Use - Manual Operation
Use of the R 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.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (listed above).
Intended Use - Semiautomatic Operation (AED)
R 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.
Use of the R Series 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) -
(21 C
(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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K081828 |
Page 1Page 1 of 6
9
Specifications for the ECG rhythm analysis function are provided in this section. "ECG Rhythm Analysis Algorithm Accuracy" on page 29.
When the patient is less than 8 years of age or weighs less that 55 Ibs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient's exact age or weight.
Intended Use - ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Intended Use - CPR Monitoring
The CPR monitoring function provides visual and audio feedback designed to encourage rescuers 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.
Semiautomatic Operation Contraindications for Use
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 R Series in an emergency vehicle, bring the vehicle to a halt before activating the analysis function.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X Over-The-Counter Use
AND/OR
(Part 21 CFR 801 Subpart D)
(24. SEP. 23. 4.)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
10
Defibrillator Complications
Inappropriate defibrillation or cardioversion of a patient (for example, with no malignant arrhythmia) may precipitate ventricular fibrillation, asystole, or other dangerous arrhythmias.
Defibrillation without proper application of electrodes or paddle electrolyte gel might be ineffective and cause burns, particularly when repeated shocks are necessary. Erythema or hyperemia of the skin under the paddles, or electrodes often occurs; this effect is usually enhanced along the perimeter of the paddles or electrodes. This reddening should diminish substantially within 72 hours.
Defibrillator Output Energy
R Series defibrillators can deliver as much as 200 joules into a 50 ohm impedance. The energy delivered through the chest wall, however, is determined by the patient's transthoracic impedance. An adequate amount of electrolyte gel must be applied to the paddles and a force of 10 to 12 kilograms (22 to 26.4 pounds) must be applied to each paddle in order to minimize this impedance. If hands-free therapy electrodes are used, make sure that they are properly applied. (Refer to the instructions on the electrode package).
External Pacemaker (Optional)
Some R Series products include an optional transcutaneous pacemaker consisting of a pulse generator and ECG-sensing circuitry. Noninvasive transcutaneous pacing (NTP) is an established and proven technique. This therapy is easily and rapidly applied in both emergency and nonemergency situations when temporary cardiac stimulation is indicated.
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), by increments of 2.
The pacing output pulse is delivered to the heart via ZOLL hands-free defibrillation/pacing electrodes placed on the patient's back and 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 R Series BLS products allow clear viewing and interpretation of the electrocardiogram on the display without offset or distortion during external pacing.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
11
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.
Intended Use — Pacemaker
This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any 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 can 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 might 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 offen suppress ventricular ectopic activity and might prevent tachycardia.
This device can only be used for external pacing of patients and cannot be used for internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
Prescription Use _________________ X ____________________________________________________________________________________________________________________________________________________________________________
==============================================================================================================================================================================
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
12
Pacemaker Complications
Ventricular fibrillation does not respond to pacing and 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 can be interrupted with pacing, but in an emergency or during circulatory collapse, synchronized cardioversion is faster and more certain.
Pulseless electrical activity (PEA) can occur following prolonged cardiac arrest or in other disease states with myocardial depression. Pacing might then produce ECG responses without effective mechanical contractions, making other effective treatment necessary.
Pacing can 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 can cause discomfort of varying intensity, which occasionally can be severe and preclude its continued use in conscious patients.
Similarly, unavoidable skeletal muscle contraction might be troublesome in very sick patients and might limit continuous use to a few hours. Erythema or hyperemia of the skin under the hands-free therapy electrodes often occurs; this effect is usually enhanced along the perimeter of the electrode. This reddening should lessen substantially 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.
This device can only be used for external pacing of patients and cannot be used for
internal pacing. Do not connect internal pacing lead wires to the ZOLL defibrillator.
Prescription Use X
AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
13
Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33 lb. (15 kg) or less using ZOLL pediatric hands-free therapy electrodes. Prolonged pacing (in excess of 30 minutes), particularly in neonates, can cause burns. Periodic inspection of the underlying skin is recommended.
Intended Use - SpO2 Monitoring
The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate during both no-motion and patient motion conditions for adult patients, and no motion conditions for pediaatric and neonatal patients in a hospital or prehospital environment.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR