(260 days)
No
The description focuses on standard ECG analysis and accelerometer-based feedback, with no mention of AI or ML algorithms.
Yes
The device is described as a "semi-automatic external defibrillator" and its purpose is to deliver defibrillation energy to treat cardiac arrest, which is a therapeutic intervention.
Yes
The device analyzes the electrocardiographic (ECG) rhythm of the patient to detect whether the rhythm is shockable or non-shockable, which is a form of diagnosis.
No
The device description clearly states it is a "lightweight, portable, battery-powered semi-automatic external defibrillator" and mentions hardware components like electrodes with an accelerometer and a capacitor.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an external defibrillator. Its primary function is to analyze the patient's ECG rhythm and deliver an electrical shock to treat cardiac arrest. It interacts directly with the patient's body (via electrodes) and does not analyze samples taken from the body.
- Intended Use: The intended use is to treat suspected cardiac arrest by analyzing the patient's circulation and delivering defibrillation if necessary. This is a therapeutic intervention, not a diagnostic test performed on a sample.
While the device analyzes the patient's ECG rhythm, this analysis is done in vivo (within the living body) and is part of the process of determining whether to deliver therapy, not a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
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 less than 8 years of age, or weighs 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 predicate ZOLL AED Plus with 2010 AHA Guideline software update was cleared by the agency under 510(k) application K110154. The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest. When connected with ZOLL AED Plus defibrillation electrodes to a patient, the predicate device will analyze the electrocardiographic (ECG) ihythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a nonshockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that measures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the 2010 American Heart Association (AHA) Guidelines. If the device detects a shockable rhythm, the semiautomatic configuration of the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. The user would then press the treatment (shock) button to deliver the defibrillation shock to the patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button. The following is a comparison summary of the new Fully Automatic AED Plus when compared to the predicate device: - When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone. - All other functions of the device and its Indications for Use have remained . unchanged. - . The proposed change is implemented in the device through software.
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
less than 8 years of age
Intended User / Care Setting
trained responders
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 Fully Automatic AED Plus performs as well as the indicated 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 Fully Automatic AED Plus demonstrates that its features and functions are substantially equivalent to those of 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 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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510(k) Summary:
OCT 2 6 2012
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford. MA 01824-4105 (978) 421-9655
Contact Person:
Tanmay B. Shukla (978) 421-9171
Date Summary Prepared:
February 8, 2012
Device:
ZOLL Fully Automatic AED Plus
Classification:
Automatic External Defibrillators: Class III (21 CFR 870.5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
Description:
The predicate ZOLL AED Plus with 2010 AHA Guideline software update was cleared by the agency under 510(k) application K110154. The device is a lightweight, portable, battery-powered semi-automatic external defibrillator that uses voice prompts and visual icons to guide a user through a cardiac arrest rescue. The device utilized the ZOLL Rectilinear Bi-Phasic defibrillation waveform. The device is designed to be used by trained responders for the treatment of cardiac arrest.
When connected with ZOLL AED Plus defibrillation electrodes to a patient, the predicate device will analyze the electrocardiographic (ECG) ihythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a nonshockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that measures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage the user to administer CPR in compliance with the 2010 American Heart Association (AHA) Guidelines. If the device detects a shockable rhythm, the semiautomatic configuration of the device charges the capacitor, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. The user would then press the treatment (shock) button to deliver the defibrillation shock to the
1
patient. The new fully automatic configuration would deliver the shock to the patient without the need for the user (rescuer) to press the shock button.
The following is a comparison summary of the new Fully Automatic AED Plus when compared to the predicate device:
- When a shockable rhythm has been detected defibrillation energy is delivered by the device without the need for the user (rescuer) to depress the treatment (shock) button following a sequence of appropriate prompts and a warning tone.
- All other functions of the device and its Indications for Use have remained . unchanged.
- . The proposed change is implemented in the device through software.
Intended Use:
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 less than 8 years of age, or weighs 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 new ZOLL Fully Automatic AED Plus are substantially equivalent to the predicate ZOLL AED Plus (K110154, cleared for use on 2/17/2011).
Comparison of Technological Characteristics
The technological characteristics of the new ZOLL Fully Automatic AED Plus are substantially equivalent to the predicate ZOLL AED Plus (K110154, cleared for use on 2/17/2011).
Performance Testing:
Extensive performance testing ensures that the ZOLL Fully Automatic AED Plus performs as well as the indicated 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 Fully Automatic AED Plus demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2012
Zoll Medical Corporation c/o Mr. Tanmay Shukla Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824
Re: K120406
Trade/Device Name: Zoll AED Plus Fully Automatic Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: October 17, 2012 Received: October 18, 2012
Dear Mr. Shukla:
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.
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
3
Page 2 - Mr. Tanmay Shukla
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 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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Section 4 - Indications for Use
510(k) Number (if known): ZOLL Fully Automatic AED Plus Device Name:
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 less than 8 years of age, or weighs 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 _ 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
non
(Division/Sign-Off) Division of Cardiovascular Devices 510/k) Numb