ZOLL R SERIES DEFIBRILLATOR
Device Facts
| Record ID | K060559 |
|---|---|
| Device Name | ZOLL R SERIES DEFIBRILLATOR |
| Applicant | ZOLL Medical Corporation |
| Product Code | MKJ · Cardiovascular |
| Decision Date | Aug 17, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5310 |
| Device Class | Class 3 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
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.
Device Story
ZOLL R Series is a multi-parameter external defibrillator/monitor for critical care and transport. Inputs include ECG signals (via leads/paddles), SpO2 (via Masimo SET sensors), and CPR compression data (via specialized electrodes). Device processes ECG to detect shockable rhythms using an advisory algorithm; provides visual/audio feedback for CPR rate/depth; performs non-invasive pacing. Operated by qualified medical personnel (physicians, nurses, emergency responders). Output includes defibrillation shocks, pacing pulses, and real-time physiological data/prompts on display. Benefits include rapid resuscitation, standardized CPR performance, and continuous patient monitoring. Device facilitates clinical decision-making by providing automated rhythm analysis and actionable feedback during cardiac emergencies.
Clinical Evidence
Bench testing only. Extensive performance and software testing conducted to verify functional requirements, safety standards, and algorithm accuracy. No clinical trial data presented.
Technological Characteristics
Multi-parameter monitor/defibrillator. Features ECG monitoring, Masimo SET pulse oximetry, and CPR feedback. Uses proprietary ECG analysis algorithms identical to ZOLL AED Pro. Form factor designed for tabletop and transport. Connectivity includes data printing/recording. Software-based advisory algorithm for rhythm classification.
Indications for Use
Indicated for defibrillation, noninvasive pacing, and monitoring (ECG, SpO2, CPR) in adult, pediatric, and neonatal patients experiencing cardiac arrest, bradycardia, or requiring vital sign assessment in critical care/transport. CPR monitoring contraindicated for patients under 8 years. Pediatric pacing indicated for patients 15kg or less.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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# ZOLL Medical Corpora
Worldwide Headquarters 269 Mill Boad Chelmsford, Massachusetts 01824-4105 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:
February 24, 2006
Device:
ZOLL R Series
Classification:
Defibrillator, Low-energy -- DC: Class II (21 CFR 870.5300)
Automated External Defibrillator: Class III (21 CFR 870.5310)
Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300
External Transcutaneous Cardiac Pacemakers (Non-invasive): Class II (21CFR 870.5550)
Oximeters: Class II (21 CFR 870.2700)
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.
The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing an adult or pediatric patient's ECG signal via the Advisory feature on the device. The Advisory Alqorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in
# AUG 1 7 2006
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the event of a shock advised determination. The user will be prompted to rethe overte of a choolhe event a no shock advised determination is returned.
Therapy is provided by using defibrillation electrode products specifically Therapy 1s "provided" by "acing" usens" with a series. When used in conjunction with ZOLL Ready padz One-step™ CPR or Ready padz One-step™ Complete 2OEL Tready paul - One SERIES provides CPR compression performance Manufation Elootrodoo the 17 & Lisplayed symbols, text messages and voice prompts.
#### Substantial Equivalence:
The features and functions of the ZOLL R SERIES are substantially equivalent to The Touth of the ZOLL E SERIES Defibrillator: 510(k) No. k042007, cleared 1/07/2005, and the ZOLL AED Pro Defibrillator, 510(k) No. k041892, cleared 2/04/2005.
#### Intended Use:
#### Defibrillation
Use of the R Series products in the manual and semiautomatic modes for OSC of the 11 'Golfoo productims 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 rms product entricular and rapid ventricular tachycardia to sinus rhythm or other venthoular Inbhilation all of producing hemodynamically significant heartbeats.
In manual mode, the unit can also be used for synchronized cardioversion to in manufal fibrillation (AF) or ventricular tachycardia (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 The advisory function cardia in patients meeting the three conditions indicating lack of circulation (previously listed).
# External Pacemaker (Pacer Version Only)
This product may be used for temporary external, demand or non-demand This product may be about to endocardial stimulation. External cardiac pacing is pating, as an alternatious or unconscious patients in asystole, profound indical for 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 the 5 of 5 lead pation. Salian cardiac rhythms and dysrhythmias and calculating heart rate.
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# 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.
# 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.
## Comparison of Technological Characteristics
The ZOLL R Series design characteristics are fundamentally the same scientific technologies as those of the indicated predicate devices; the technology is very similar to that of the ZOLL E Series. The ZOLL R Series provides monitoring of patient vital signs, including: ECG Monitoring and Pulse Oximetry, using technology very similar to that of the predicate ZOLL E Series.
The ZOLL R Series advises users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts nearly identical to those used by the indicated predicate devices. The ZOLL R Series acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients, utilizing the identical ECG Analysis Algorithms that are incorporated into the predicate ZOLL AED Pro Defibrillator. ZOLL's proprietary CPR Aid feature provides users with performance feedback for compression depth and rate similar to the ZOLL AED Pro.
Performance Testing:
Extensive performance and software testing ensures that the ZOLL R 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 R 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2006
ZOLL Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105
Re: K060559
TradeDevice Name: Zoll R Series Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators Regulatory Class: Class III (three) Product Code: MKJ, LDD, DRO, DQA, LIX Dated: August 10, 2006 Received: August 14, 2006
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.
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Page 2 -- Mr. Sean Reynolds
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised frat FDA s issualtes or a succession of the requirements of the Act
that FDA has made a determination that your device complies with of any must that FDA has made a determination that your as resear agencies. You must and or any Federal statues and regulations administered of other to: registration and listing (21 l
eomply with all the Act's requirements, including, but not limited to: repiram comply with an the Act S requiremont, me; good manufacturing practice requirements as sett CFR Part 807), labeling (21 CFR 1 at 607), good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Rates (2) 11 CFR 1000 1 forth in the quanty systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections of I stills) in your Section 100(k)
This letter will allow you to begin marketing your device of your davice to 1egal This letter will allow you to begin makemig of substantial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA inding of substantal equive 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
rs of the many of the many on 1000 - All any also regulation entitled If you desire specific advice ion your de vice of an also, please note the regulation entitled. contact the Office of Compilance at (217) 276 - 12 - 17 - 17 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - "Misbranding by relefence to premarket tionneation" (1) 35 oct from the Division of Small other general information on your responsionals at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance as to too working to word index.html.
Sincerely yours,
Q.S.U
Con Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Section 4 - Indications for Use
# 510(k) Number (if known):
Device Name: ZOLL R Series
# Defibrillator Function
#### 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 This product should be used only by qualified percently the 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 in manual noot, the unt our also by ician must decide when synchronized cardioversion is appropriate.
The advisory function should be used to confirm ventricular fibrillation and wide complex ventricular The advisory function should be about to somments meeting the three conditions indicating lack of circulation (listed above).
# Intended Use - Semiautomatic Operation (AED)
The R Series products are designed for use by emergency care personnel who have completed THE IT Series produces are doolghed for ass 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 r ricy are spoolingally coorgesuscitation 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 000 or there there is apparent lack of circulation as indicated by:
- Unconsciousness .
- Absence of breathing .
- . Absence of pulse.
#### (continued on next page)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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) | |
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| <i>(Division Sign-Off)</i> | |
| Division of Cardiovascular Devices | Page 1 of 3 |
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## Indications for Use (continued from previous page)
Specifications for the ECG rhythm analysis function are provided in the section, "ECG Rhythm Analysis Algoirhtm Accuracey" on page A-26.
When the patient is less than 8 years of age or weighs less than 55 lbs. (25 Kg), you must use ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine the 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.
# External Pacemaker (Pacer Version Only)
#### 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 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 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.
(continued on next page)
S.M.
(DIVision Sign-Off)
Division of Cardiovascular Devices
510(k) Number K060559
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## Indications for Use (continued from previous page)
#### Pediatric Pacing
Pacing can be performed on pediatric patients weighing 33lb. (15kg) or less using ZOLL pediatric hands-free therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could 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 pediatric and neonatal patients in a hospital environment.
QSSM
f Cardiovascular Devices 510(k) Numb
