(29 days)
Not Found
No
The description focuses on standard signal analysis (ECG rhythm detection) and sensor-based feedback (accelerometer for CPR depth), which are typical functions of traditional medical devices and do not inherently indicate the use of AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond basic rhythm analysis.
Yes
The device delivers defibrillation energy to the patient for the treatment of 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 diagnostic function.
No
The device description clearly outlines hardware components such as a portable, battery-powered unit, electrodes with an accelerometer, and a display, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- Device Function: The description clearly states that this device is an external defibrillator used to analyze the patient's electrocardiographic (ECG) rhythm and deliver electrical therapy directly to the patient's body. It also provides feedback on CPR compressions.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens derived from the human body. Its function is based on analyzing electrical signals from the heart and providing physical therapy and feedback.
Therefore, this device falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic.
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 thank 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 (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The ZOLL AEDPlus was cleared by the agency under 510(k) application K033474. 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 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, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures 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 American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth). The recent American Heart Association (AHA) 2010 Guidelines (see attached) changed it's previous recommendation for a minimum depth of CPR compressions from 1.5 inches to a depth of at least 2.0 inches. The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result we are modifying the device's software from it's current CPR depth monitoring of 1.5" to at least 2.0" and provide an additional text user prompt to remind users to fully release the patient's chest during CPR. 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 user 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
When a victim is less than 8 years of age, or weighs less thank 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes.
Intended User / Care Setting
Not Found
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 2010 AHA Guidelines software update) 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 AED Plus (with 2010 AHA · Guidelines software update) 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for ZOLL Medical Corporation. The logo features the word "ZOLL" in large, bold, black letters. Below the word "ZOLL" is the tagline "Advancing Resuscitation. Today." in a smaller font. There is a curved line below the tagline.
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A
FFB 17 201
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) 421-9171
Date Summary Prepared:
January 14, 2011
Device:
ZOLL AED Plus with 2010 AHA Guidelines Software Update
Classification:
Automatic External Defibrillators: Class III (21 CFR 870,5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)
Description:
The ZOLL AEDPlus was cleared by the agency under 510(k) application K033474. 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 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, enables the treatment button and prompt the user to deliver the defibrillation energy to the patient. If the device detects a non-shockable rhythm, the device will prompt the user to begin CPR. The electrodes used with the device incorporates an accelerometer that mesures the depth of CPR compressions. This information is used by the device to provide feedback to the user and encourage
1
the user to administer CPR in compliance with the American Heart Association (AHA) Guidelines. The device provides feedback in the form of a metronome (to encourage the proper CPR frequency of 100 compressions per minute) and a visual depth indicator on the display (to encourage the recommended compression depth).
The recent American Heart Association (AHA) 2010 Guidelines (see attached) changed it's previous recommendation for a minimum depth of CPR compressions from 1.5 inches to a depth of at least 2.0 inches. The Guidelines also advise caregivers to allow full recoil of the patient's chest during CPR. As a result we are modifying the device's software from it's current CPR depth monitoring of 1.5" to at least 2.0" and provide an additional text user prompt to remind users to fully release the patient's chest during CPR.
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 user to "Fully Release" the patient's chest . during CPR
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 thank 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 2010 AHA Guidelines for CPR software update) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 5/21/2004).
Comparison of Technological Characteristics
The technological characteristics of the proposed ZOLL AED Plus (with 2010 AHA Guidelines software update) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 5/21/2004).
Performance Testing:
Extensive performance testing ensures that the ZOLL AED Plus (with 2010 AHA Guidelines software update) 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:
2
Conclusion
Performance and safety testing of the ZOLL AED Plus (with 2010 AHA · Guidelines software update) 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.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Eileen M. Boyle Regulatory Affairs Specialist Zoll Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105
FEB 17 20:1
Re: K110154
Trade/Device Name: Zoll AED Plus with 2010 AHA Guidelines Software Update Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: January 14, 2011 Received: January 19, 2011
Dear Ms. Boyle:
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 omrois:
4
Page 2 - Ms. Eileen M. Boyle
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/ReportalProblem/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,
W.M.
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
KITOS
510(k) Number (if known): Device Name: ZOLL AED Plus
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 thank 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)
W.Moe
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K110154