(29 days)
No
The device description focuses on standard ECG analysis and CPR feedback based on pre-defined guidelines, with no mention of AI or ML algorithms. The software updates are related to changing thresholds and prompts based on updated guidelines, not learning or adaptive capabilities.
Yes
The device is described as an automated external defibrillator (AED) used for defibrillation, which is a therapeutic intervention for victims of cardiac arrest.
Yes
The device is described as acquiring and analyzing an ECG signal and using ECG monitoring to evaluate a patient's heart rate or ECG morphology, which are diagnostic functions.
No
The device description explicitly states it is a "portable, battery powered automated external defibrillator (AED)" and mentions hardware components like electrodes. While it includes software updates, the core device is a hardware-based defibrillator.
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 description clearly states the device is a portable automated external defibrillator (AED) used for defibrillation and ECG monitoring. It analyzes the patient's ECG signal and delivers electrical shocks to the chest. It also provides feedback for CPR.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body (via electrodes on the chest) to acquire and analyze electrical signals (ECG).
The device is a therapeutic and monitoring device, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome 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 at least 2 inches (5 cm) for adult patients.
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by
- Unconsciousness
- · Absence of breathing, and
- · Absence of pulse and other signs of circulation.
When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedirpadz® II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Product codes
MKJ
Device Description
The ZOLL AED Pro® is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.
The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:
- changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
- prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
- adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR
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
The device is indicated for use on patients 8 years old or older and weighing 55 lb. (25 kg) or more for defibrillation. ZOLL pedirpadz® II pediatric defibrillation electrodes can be used for patients less than 8 years old or weighing less than 55 lb. (25 kg). The CPR monitoring function is not intended for use on patients under 8 years of age.
Intended User / Care Setting
In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient. In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills.
In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device, basic life and/or advanced life support, or other physician-authorized emergency medical training.
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 Testing: Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications.
Conclusion: Performance testing of the ZOLL AED Pro Defibrillator demonstrates that its features and functions 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)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the company name in bold, black letters. Below the name is the tagline "Advancing Resuscitation. Today."
K 110526
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
Contact Person:
Eileen M. Boyle
(978) 421-9655, Ext. 9171
Date Summary Prepared:
February 11, 2011
Device:
ZOLL AED Pro® with 2010 AHA Guidelines Software Update
Classification:
Defibrillator, Low-energy - DC: Class III (21 CFR 870.5310)
Automatic External Defibrillators have been considered Class III devices by FDA.
Cardiac Monitors (including Cardiotachometers and Rate alarms): Class II (21 CFR 870.2300)
Description:
The ZOLL AED Pro® is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AED Pro acquires and analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.
1
K110526
The recent 2010 American Heart Association Guidelines for CPR and ECC changed previous recommendations from 1.5"-2.0" inches compression depth of a depth of at least 2.0". The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result, we are proposing modifying the device's software to prompt caregivers to perform CPR in accordance with the new AHA quidelines.
Description of Software Changes
The ZOLL AED Pro software, which currently supports the 2005 American Heart Association Guidelines for CPR and ECC, has been revised to optionally support the 2010 American Heart Association Guidelines for CPR and ECC. The specific changes include:
The specific changes include:
- changing the depth indicator on the device screen from 1.5 inches to 2.0 inches .
- prompting the user to "push harder" when compressions are less than 2.0 inches . instead of less than 1.5 inches in the previous release
- adding a text prompt to remind the rescuer to "Fully Release" the patient's . chest during CPR
Intended Use
The AED Pro unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome 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 at least 2 inches (5 cm) for adult patients.
Indications for Use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by
- Unconsciousness
- · Absence of breathing, and
- · Absence of pulse and other signs of circulation.
When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pedirpadz® II pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
2
Never use the AED Pro unit for defibrillation when the patient
- Is conscious
- · Is breathing, or
- · Has a detectable pulse or other sign of circulation.
CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
Intended Users
In semiautomatic mode, the AED Pro unit is intended to be used by rescuers and emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator controls delivery of shocks to the patient. In manual mode, the AED Pro unit is intended to be used only by qualified medical personnel trained in Advanced Life Support skills.
In ECG monitoring mode, the AED Pro unit is intended to be used by personnel who are qualified by training in the use of the AED Pro device, basic life and/or advanced life support, or other physician-authorized emergency medical training.
Substantial Equivalence:
The features and functions of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).
Comparison of Technological Characteristics
The technological characteristics of the proposed ZOLL AED Pro (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Pro (K041892, cleared for use on 2/4/2005).
Performance Testing:
Extensive performance testing ensures that the ZOLL AED Pro Defibrillator meets all of its functional requirements and performance specifications.
Conclusion
. Performance testing of the ZOLL AED Pro Defibrillator demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ZOLL Medical Corporation c/o Mr. Chuck Kolifrath Regulatory Affairs Manager Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105
MAR 2 5 2011
Re: K110526
Trade/Device Name: ZOLL AED Pro with 2010 AHA Guidelines Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 26, 2011 Received: February 24, 2011
Dear Mr. Kolifrath:
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. Please note: CDRH does not evaluate information related to contract hability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Mr. Chuck Kolifrath
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.
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 vours,
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4-INDICATIONS FOR USE
510(k) Number (if known): K110526
Device Name: ZOLL AED Pro with 2010 AHA Guideline Update
Indications for Use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by
- Unconsciousness .
- Absence of breathing, and .
- Absence of pulse and other signs of circulation. .
When the victim is less than 8 years old or weighs less than 55 lb. (25 kg), use ZOLL pediatric defibrillation electrodes: Do not delay therapy to determine the patient's exact age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Contraindications for Use Defibrillation
Never use the AED Pro unit for defibrillation when the patient
- ls conscious
- . Is breathing, or
- Has a detectable pulse or other sign of circulation.
CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
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)
Page 1 of 1
BDZ
lovascular Devices
510(k) Number K110526