(69 days)
K915159A, K022929
Not Found
No
The document mentions an "interpretive algorithm" for ECG analysis, which is a common feature in medical devices and does not necessarily imply the use of AI or ML. There are no mentions of AI, ML, deep learning, or related terms.
Yes
The device is intended for defibrillation, ECG monitoring, and noninvasive pacing, all of which are therapeutic interventions aimed at treating medical conditions.
Yes
The device (ZOLL M Series and ZOLL E Series AED Defibrillator products, used with the pedrpadz™ electrodes) is diagnostic because it performs ECG monitoring and utilizes an interpretive algorithm to analyze a patient's heart-rhythm to detect shockable rhythms. It also monitors other vital signs like Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, and Non Invasive Blood Pressure measurement.
No
The device described is a disposable electrode, which is a hardware component used with a defibrillator. The summary focuses on the physical electrode and its function in reducing energy delivery, not on software.
Based on the provided information, the ZOLL pedirpadz™ Reduced Energy Electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ZOLL pedirpadz™ is an electrode used for external defibrillation, ECG monitoring, and noninvasive pacing. It directly interacts with the patient's body to deliver electrical energy or monitor electrical signals. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states its purpose is for defibrillation, ECG monitoring, and noninvasive pacing of pediatric patients. These are all direct patient interventions or monitoring activities, not laboratory-based diagnostic tests.
Therefore, the ZOLL pedirpadz™ falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg).
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- Unconsciousness
- Absence of breathing
- Absence of pulse.
Product codes
MLN
Device Description
The disposable ZOLL pedrpadz™ Reduced Energy Electrode is specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population.
The ZOLL M Series and ZOLL E Series Defibrillator products are portable, batterypowered devices indicated for the defibrillation (manual and AED), Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non- Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport.
When analyzing a patient's heart-rhythm using the incorporated interpretive algorithm, the device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
When analyzing a patient's heart-rhythm using the incorporated interpretive algorithm, the device 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.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg).
Intended User / Care Setting
personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
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 testing of the ZOLL pedrpadz™ Reduced Energy Electrode with the ZOLL M Series and ZOLL E Series AED ensures that these products meet all functional requirements and performance specifications with regard to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ZOLL pedirpadz™ Multifunction Electrode K915159A, Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes K022929
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
ZOLL Medical Corporation
Image /page/0/Picture/1 description: The image shows the address of a company's worldwide headquarters. The address is 269 Mill Road, Chelmsford, Massachusetts 01824-4105. The country is the U.S.A.
978 421-9655 978 421-0025 Main Fax
Image /page/0/Picture/3 description: The image shows the logo for ZOLL Medical Corporation. The word "ZOLL" is written in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today."
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
NOV 0 6 2007
Contact Person:
Sean Reynolds (978) 421-9386
Date Summary Prepared:
August 23, 2007
Device:
ZOLL pedirpadz™ Reduced Energy Electrode
Classification:
Electrode, Electrodcardiograph, Multi-Function; Class II (21 CFR 870.2360)
Substantial Equivalence:
The features and functions of the ZOLL pedirpadz™ Reduced Energy Electrode are substantially equivalent to those of the ZOLL pedirpadz™ Multifunction Electrode K915159A, cleared 02/07/1992, and the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes K022929, cleared 01/27/2003.
Description:
The disposable ZOLL pedrpadz™ Reduced Energy Electrode is specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population.
The ZOLL M Series and ZOLL E Series Defibrillator products are portable, batterypowered devices indicated for the defibrillation (manual and AED), Noninvasive Transcutaneous Pacing, and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, End Tidal CO2, 12-Lead ECG Monitoring, Non
1
Invasive Blood Pressure measurement and data printing and recording for resting patients in critical care and transport.
When analyzing a patient's heart-rhythm using the incorporated interpretive algorithm, the device 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.
Indications for Use
The ZOLL pedroadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 lbs (25 kg).
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- . Unconsciousness
- Absence of breathing
- . Absence of pulse.
Comparison of Technological Characteristics
The ZOLL pedirpadz™ Reduced Energy Electrode in conjunction with ZOLL E Series or ZOLL M Series AED products maintain performance characteristics, features and functions that are very similar to those of the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with the Cardiac Science PowerHeart® Automated External Defibrillator, Model 9200/9210.
Testing
Extensive testing of the ZOLL pedrpadz™ Reduced Energy Electrode with the ZOLL M Series and ZOLL E Series AED ensures that these products meet all functional requirements and performance specifications with regard to safety and effectiveness.
Conclusion
Based on the results of the usability testing, the ZOLL pedirpadz™ Reduced Energy Electrode has demonstrated that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2007
ZOLL Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer 269 Mill Road Chelmsford, MA 01824
Re: K072430
ZOLL pedi·padz™ Reduced Energy Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: MLN Dated: August 28, 2007 Received: August 29, 2007
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 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.
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.
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Page 2 - Mr. Sean Reynolds
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
.S.U
For 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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INDICATIONS FOR USE
| 510(k) Number (if known): | K072430 |
|---|---|
| --------------------------- | --------- |
ZOLL pedi•padz™ Reduced Energy Electrode Device Name:
Indications for Use
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 Ibs (25 kg).
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- . Unconsciousness
- Absence of breathing .
- Absence of pulse. .
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)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko 72430