(93 days)
Not Found
No
The document describes a reusable defibrillation electrode with a CPR sensor. The focus is on the hardware and its intended use with specific defibrillators, not on any AI/ML algorithms for data analysis or decision support. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as electrodes for defibrillation and cardioversion, which are therapeutic medical procedures that treat heart conditions.
Yes
The device is used for "ECG Monitoring," which is a diagnostic function.
No
The device is a physical electrode with a CPR sensor, intended for use with specific defibrillators and gel. It is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is a defibrillation electrode used for direct patient contact for procedures like defibrillation, ECG monitoring, cardioversion, and CPR feedback. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device's function is therapeutic and diagnostic in a clinical setting. While it performs ECG monitoring (a diagnostic function), this is done directly on the patient's body, not through the analysis of an in vitro specimen. The primary functions of defibrillation and cardioversion are therapeutic.
Therefore, the CPR Dura-padz Reusable Defibrillation Electrode 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
- Defibrillation
- ECG Monitoring
- Cardioversion
- CPR Feedback
The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:
- AED Pro
- M Series
- E Series
- R Series
Product codes
MKJ, LIX
Device Description
As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.
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
The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).
Intended User / Care Setting
The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:
- Physicians
- Nurses
- Paramedics
- Emergency Medical Technicians
- Cardiovascular Laboratory Technicians
- First 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
The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission.
N/A - Clinical evidence was not necessary to show substantial equivalence.
Key Metrics
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
Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2015
Bio-Detek, Inc. % Shannon Duhamel Regulatory Affairs Specialist Zoll Medical Corporation 269 Mill Road Chelmsford, Massachusetts 01824-4105
Re: K150198
Trade/Device Name: CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, LIX Dated: April 13, 2015 Received: April 14, 2015
Dear Shannon Duhamel,
We have reviewed vour 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 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
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): K150198
Device Name: CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel
Intended Use:
- Defibrillation
- ECG Monitoring
- Cardioversion ●
- CPR Feedback ●
The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:
- AED Pro
- M Series ●
- E Series ●
- R Series ●
The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:
- . Physicians
- Nurses
- Paramedics
- Emergency Medical Technicians ●
- Cardiovascular Laboratory Technicians
- First Responders
The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.
The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).
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 IF NEEDED)
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510(k) Summary:
| Submitter's Name and Address: | Bio-Detek, Inc.
525 Narragansett Park Drive
Pawtucket, RI 02861 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Correspondent: | Shannon Duhamel
RA Specialist
(978) 421-9574
sduhamel@zoll.com |
| Date Summary Prepared: | July 9, 2014 |
| Classification: | Class III |
| Device Name | CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel |
| Common Name | Automated External Defibrillator Multi-Function Electrodes |
| Classification Name | Automated External Defibrillators (MKJ;
21 CFR 870.5310)
Cardiopulmonary Resuscitation Aid (LIX;
21 CFR 870.5200) |
| Predicate Devices | K100565 - Dura-padz Reusable Defibrillation Electrode used in conjunction with Dura-padz Gel
K110742 - ZOLL OneStep Adult Multi-Function Electrode |
Substantial Equivalence - Non-Clinical Evidence:
The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. As with the cleared predicate (K100565), the subject device is intended for use on adult patients with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series. The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742. Safety, efficacy and substantial equivalence was shown through verification and validation testing.
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Substantial Equivalence - Clinical Evidence:
N/A - Clinical evidence was not necessary to show substantial equivalence.
Description:
As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses. The device Indications For Use are as follows:
- Defibrillation ●
- ECG Monitoring
- Cardioversion ●
- CPR Feedback ●
The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:
- AED Pro
- M Series ●
- E Series ●
- R Series
The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:
- Physicians ●
- Nurses ●
- Paramedics ●
- Emergency Medical Technicians
- Cardiovascular Laboratory Technicians
- First Responders
The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.
The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).
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Comparison of Technological Characteristics:
The CPR Feedback, ECG monitoring, defibrillation and cardioversion functions of the CPR Dura-padz electrode cleared with the predicate devices K110742 and K100565 have remained unchanged in the proposed version of the device.
Performance Testing:
The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission.
Conclusion:
The information provided in this 510(k) demonstrates that the CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.