(483 days)
Not Found
No
The description focuses on standard ECG analysis and detection of shockable rhythms, which are typical functions of AEDs and do not inherently require AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
Yes.
The device delivers defibrillation therapy to patients experiencing cardiac arrest.
Yes
The device analyzes the electrocardiographic (ECG) rhythm of the patient to detect whether the rhythm is shockable or non-shockable, which is a diagnostic function.
No
The device description clearly states it is a "lightweight, portable, battery-powered semi-automatic external defibrillator" and mentions hardware components like electrodes and a "Shock Button," indicating it is a physical device with integrated software, not software only.
Based on the provided text, the ZOLL AED Plus external defibrillator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ZOLL AED Plus Function: The ZOLL AED Plus analyzes the electrical activity of the heart (ECG rhythm) directly from the patient's body through electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is to defibrillate victims of cardiac arrest by delivering an electrical shock, not to diagnose a condition based on laboratory analysis of a specimen.
Therefore, the ZOLL AED Plus falls under the category of a therapeutic device, specifically an external defibrillator, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by: Unconsciousness and . Absence of normal breathing and Absence of a pulse or signs of circulation . When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Product codes
MKJ
Device Description
The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external defibrillator that automatically analyzes the electrocardiographic (ECG) rhythm to guide a user through a cardiac arrest event. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, issues the warning "Don't Touch Patient," and enables the "Shock Button". The user can then press the shock button to deliver defibrillation therapy to the patient. If the patient is not in a shockable rhythm, or if cardioversion-defibrillation therapy has been delivered, CPR (Cardiopulmonary Resuscitation) may be advised and administered after automatically repeated analyses of the patient's heart rhythm. The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is extremely rugged, and ready to use at a moment's notice. The device automatically performs a periodic self-test and continually indicates its state of readiness to the user. When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes, the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.
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
patients less than 8 years of age, or less than 55 lbs (25kg)
Intended User / Care Setting
personnel who are qualified by training in basic life support, or advanced life support, or other physician-authorized emergency medical response
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 ZOLL AED Plus (with software version 5.32) performs as well as the indicated predicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards. Performance and safety testing of the ZOLL AED Plus (with software version 5.32) demonstrates the functions are substantially equivalent to the indicated commercially distributed predicate 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.
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૪૯9156
510(k) Summary:
SEP 2 3 2010
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Charles W. Kolifrath (978) 421-9786
Date Summary Prepared:
May 22, 2009
Device:
ZOLL AED Plus (V5.32 Software Release)
Classification:
Automatic External Defibrillators: Class III (21 CFR 870.5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
Description:
The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external The ZOLL AED Fids is a lightwolght, portually cons to guide a user through a cardiac ochbhilator that about willized the ZOLL Rectilinear Bi-Phasic defibrillation arrest reseat. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.
When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the will analyze the clestroomale. If the device detects a shockable rhythm, the rifythin is shockable of non onbonable." device charges the oupdoiter, chables in the ment Button". The user can then press the warning "Dort Frodor Fration," Toution therapy to the patient. If the patient is not treathent button to dolliver donamalism may be advised and administered after automatically repeated analyses of the patient's heart rhythm.
The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is The ZOLL AED Plus is lightweight. Tt our outly bo transported in and ready to use at a
1
K091561 pg 2 of 2
moment's notice. The device automatically performes a periodic self-test and continually indicates its state of readiness to the user.
When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes, the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.
Intended Use:
The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physicianauthorized emergency medical response to defibrillate victims of cardiac arrest.
Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:
- Unconsciousness and .
- Absence of normal breathing and .
- Absence of a pulse or signs of circulation ●
When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Substantial Equivalence:
The features and functions of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).
Comparison of Technological Characteristics
The technological characteristics of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).
Performance Testing:
Extensive performance testing ensures that the ZOLL AED Plus (with software version 5.32) performs as well as the indicated predicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Performance and safety testing of the ZOLL AED Plus (with software version 1 enomance and bullety tooling on the functions are substantially equivalent to 5.02) domonotices the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a bird or eagle in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zoll Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824
SEP 2 3 2010
Re: K091561
Trade/Device Name: Zoll AED Plus Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 3, 2010 Received: September 8, 2010
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 liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
3
Page 2 - Mr. Charles W. Kolifrath
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K09 1561 as.1 ofl
Indications for Use
510(k) Number (if known):
2 3 2010 SEP
Device Name: ZOLL AED Plus
Indications For Use:
The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:
- Unconsciousness and .
- Absence of normal breathing and ●
- Absence of a pulse or signs of circulation .
When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091561
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