(206 days)
Not Found
No
The description focuses on standard AED functionality, ECG analysis, and CPR feedback based on compression performance. There is no mention of AI or ML algorithms for rhythm analysis, CPR feedback, or any other function. The analysis is described as "acquires and analyzes an adult or pediatric patient's ECG signal," which is typical for non-AI/ML AEDs.
Yes
The device is an automated external defibrillator (AED) used for delivering an electrical shock (defibrillation) to victims of cardiac arrest, which is a therapeutic intervention.
Yes
The device is intended to acquire and analyze an adult or pediatric patient's ECG signal to detect a shockable rhythm, which is a diagnostic function. Additionally, it has a "non-diagnostic ECG monitoring feature" but the primary function of analyzing the ECG for shockable rhythms still qualifies it as a diagnostic device based on its intended use for decision-making regarding defibrillation.
No
The device description clearly states it is a "portable, battery powered, automated external defibrillator (AED)" and mentions hardware components like electrodes, an LCD screen, and an ECG cable.
Based on the provided information, 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 ZOLL AED Pro is an external defibrillator. Its primary function is to analyze the electrical activity of the heart (ECG signal) and deliver an electrical shock to restore a normal heart rhythm in cases of cardiac arrest.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the patient's body surface via electrodes to acquire the ECG signal.
- Intended Use: The intended use is for defibrillation and monitoring of the patient's ECG and CPR performance, not for diagnosing a condition based on analysis of a biological sample.
Therefore, the ZOLL AED Pro falls under the category of a therapeutic and monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- Unconsciousness, and .
- Absence of normal breathing, and .
- Absence of a pulse or signs of circulation. .
When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should with the with ZOLL pedi-padz™ II defibiliation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable At the ulscretion of the resource and meathing or responsive patient's ECG rhythm, regardless of their to provide a not-olaghostic display of a breaking of Nosperiorms a background analysis of the patient's rhythm and disables its defibrillator feature.
Product codes
MJK
Device Description
The ZOLL AED Pro External Defibrillator 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.
Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts.
The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.
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
Adult or pediatric patient. Less than 8 years of age, or weighs less than 55 lbs (25 kg).
Intended User / Care Setting
personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations.
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)
The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards.
Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated that its features, functions and incorporated interpretive algorithm are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
FEB - 4 2005
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:
June 28, 2004
Device:
ZOLL AED Pro External Defibrillator
Classification:
Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)
Automatic External Defibrillators; Class III (21 CFR 870.5310)
Cardiac Monitors (including Cardiotachometers and Rate Alarms): Class II (21 CFR 870.2300
Substantial Equivalence:
The features and functions of the ZOLL AED Pro External Defibrillator are substantially equivalent to those of the ZOLL AED Plus with CPR Aid: 510(k) No. K011541, cleared 4/11/2002, the ZOLL AED Plus: 510(k) No. K033474, cleared 5/21/2004 and the Philips Medical Systems, Heartstart FR2+ (formerly Heartstream ForeRunner), 510(k) No. K013425, cleared 1/14/2002.
Description:
The ZOLL AED Pro External Defibrillator 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
510(k) Summarv
Defibrillation therapy is provided by using defibrillation electrode products specifically designed to be attached to the ZOLL AED Pro. ZOLL pedirpadz™ II defibrillation electrodes enable users to provide therapy to children less than 8 years of age. When used in conjunction with ZOLL CPR-D-padz™, the AED Pro provides CPR compression performance feedback to the user through voice prompts.
The ZOLL AED Pro also provides a non-diagnostic ECG monitoring feature and manual override capabilities for physicians and appropriately trained healthcare providers. A high-resolution LCD Screen will display ECG Data, Visual Prompts, Shock Count and CPR compression performance.
Intended Use
The ZOLL AED Pro External Defibrillator is a portable, ruggedized, automated external defibrillator intended for use by personnel who are trained in basic life support, advanced life support, or other physician-authorized emergency medical response who must respond to emergency situations, to deliver defibrillation therapy and to display ECG rhythms of patients during treatment.
Comparison of Technological Characteristics:
The ZOLL AED Pro design characteristics are the same as those of the indicated predicate devices; the technology is very similar to that of the ZOLL AED Plus. The ZOLL AED Pro acquires and analyzes ECG signals and provides shock advisory determinations for adult and pediatric patients. The ZOLL AED Pro advises users to deliver a shock, perform CPR or conduct patient assessment through audible and visual prompts identical to those used by the ZOLL AED Plus. The AED Pro ECG monitoring feature and manual override capability are substantially equivalent to that of the Philips Heartstart FR2+ defibrillator.
Performance Testing:
The ZOLL AED Pro External Defibrillator has been subjected to extensive performance testing to ensure that the device meets all of its functional requirements and performance specifications. Safety testing was performed to assure the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Based on the results of the performance and safety testing, the ZOLL AED Pro has demonstrated 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. 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.
Public Health Service
FEB - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sean Reynolds Regulatory Affairs Engineer Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105
K041892 Re:
Trade/Device Name: ZOLL AED Pro External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automatic External Defibrillator Regulatory Class: III Product Code: MJK Dated: December 3, 2004 Received: December 6, 2004
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 ass ontale an 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
3
Page 2 - Mr. Sean Reynolds
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 DX 3 issumost of our device complies with other requirements of the Act or that FDA nas mude a determilations administered by other Federal agencies. You must comply with all 1 Coords statutes and regendating, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) incolares, none manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Connor provisions (Socure to begin marketing your device as described in your Section 510(k) This letter will and in yours Finding of substantial equivalence of your device to a legally prematics notification: "The PDF missing site and thus, permits 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 in you attire Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Echeral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimnica for
Bram D. Zuckerman, M.D. Division of Cardiovacsular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K041892
Device Name: ZOLL AED Pro External Defibrillator
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, and .
- Absence of normal breathing, and .
- Absence of a pulse or signs of circulation. .
When the victim is less than 8 years of age or weighs less than 55 lbs (25 kg), the AED Pro unit should with the with ZOLL pedi-padz™ II defibiliation electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
At the discretion of the rescuer, the Monitoring Mode feature can be used with the AED Pro ECG Cable At the ulscretion of the resource and meathing or responsive patient's ECG rhythm, regardless of their to provide a not-olaghostic display of a broaking of Nosperiorms a background analysis of the patient's rhythm and disables its defibrillator feature.
Contraindications for Use - Defibrillation
Do not use the AED Pro unit for defibrillation when the patient
- . ls conscious; or
- Is breathing; or .
- Has a detectable pulse or other signs of circulation. .
Contraindications for Use - CPR Monitoring
The CPR monitoring function is not intended for use on patients under 8 years of age.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ummuma Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number k 041892
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