(77 days)
Not Found
No
The summary describes a passive electrode device and its performance characteristics related to electrical conductivity and biocompatibility. There is no mention of any computational processing, algorithms, or learning capabilities.
Yes
Explanation: The device is indicated for use in external pacing, defibrillation, and cardioversion applications, which are therapeutic interventions. It provides a conductive interface to deliver electrical impulses for these medical treatments.
No
Explanation: The device is described as electrodes for defibrillation, cardioversion, and pacing. Its function is to provide a conductive interface for these treatments, not to diagnose medical conditions.
No
The device description explicitly states it is a physical, disposable electrode with specific materials and construction, intended for direct patient contact and connection to hardware defibrillators/pacemakers. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "external pacing, defibrillation and monitoring applications" and provides a "conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin." This describes a device used on the patient's body for therapeutic and monitoring purposes, not for testing samples from the body in a lab setting.
- Device Description: The description focuses on the physical characteristics of the electrodes and their function in conducting electrical signals to the patient's skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation; cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.
Product codes
LDD
Device Description
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various connector styles to match the specific defibrillator. The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
adult patients
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
Bench testing summary: Three different lots containing six samples each were subjected to the AAMI tests: DC Offset, Offset Instability and Noise, AC Small Signal Impedance (10 Hz and 30 kHz), AC Large Signal Impedance, and Defib Overload Recovery (At 4 seconds and At 60 seconds). All units passed these tests. The same testing routine (three lots, 2 samples each) was applied to a 36 month accelerated age shelf life test. All units passed the tests. Biocompatibility testing was performed on the patient contact material Hydrogel. The material passed biocompatibility testing. Compliance with the FDA performance standard was verified by inspection of the connectors.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
510(k) Summary K103154
(1) Submitter: Cardio Medical Products, Inc. 385 Franklin Avenue - Suite L Rockaway, NJ. 07866 Phone: 973-586-9500 Toll Free: 800-227-3633 Fax: 973-586-9624 Contact: Nick Mendise, V.P. Sales Date prepared: 19 October 2010
JAN 1 1 2011
(2) The name of the device: DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODE (Various Models) Common or usual name: Defibrillator Pad Classification name: 870.5300 DC-defibrillator (including paddles).
(3) Predicate devices: Identical in function and construction to the Heart Sync Electrodes described in K080421, as well as PadPro (K020203), and Katecho (K981737).
(4) Description of the device: These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = 98 cm2 (15.2 in2). They are radiotransparent. They come in various connector styles to match the specific defibrillator. (See intended use statement below.) The construction and materials employed are identical to the predicate. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
(5) Statement of the intended use of the device: The Cardio Med
DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation; cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIO-CONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.
(6) This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. The defibrillator pads meet the AAMI and FDA performance standards for this type of device.
1
(7) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence:
Bench testing summary: Three different lots containing six samples each were subjected to the AAMI tests:
| Test | Pre-Pacing Limits | Post-Pacing Limits |
|---|---|---|
| DC Offset | $\leq$ 100 mV | $\leq$ 100 mV |
| Offset Instability and Noise | $\leq$ 150 μV | $\leq$ 150 μV |
| AC Small Signal Impedance | ||
| 10 Hz | $\leq$ 2,000 Ohms | $\leq$ 2,000 Ohms |
| 30 kHz | $\leq$ 5 Ohms | $\leq$ 5 Ohms |
| AC Large Signal Impedance | $\leq$ 2 Ohms | $\leq$ 2 Ohms |
| Defib Overload Recovery | ||
| At 4 seconds | $\leq$ 400 mV | $\leq$ 400 mV |
| At 60 seconds | $\leq$ 300 mV | $\leq$ 300 mV |
All units passed these tests. The same testing routine (three lots, 2 samples each) was applied to a 36 month accelerated age shelf life test. All units passed the tests.
Biocompatibility testing was performed on the patient contact material Hydrogel. The material passed biocompatibility testing.
Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof.")
(8) Conclusion: Based on the results of the nonclinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices) we conclude that these defibrillator pads are as safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are identical to the predicates.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardio Medical Products, Inc. C/O Nick Mendise V.P. Sales 385 Franklin Avenue- Suite L Rockaway, NJ 07866
JAN 1 1 201
Re: K103159
Trade/Device Name: Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes Regulation Number: 21 CFR 870.5300 Regulation Name: Cardiovascular Regulatory Class: Class II Product Code: LDD Dated: October 19, 2010 Received: October 26, 2010
Dear Mr. Nick Mendise:
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 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. Nick Mendise
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 Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3-Mr. Nick Mendise
Indications for Use
JAN 1 1 2011
510(k) Number: K103159
Device Name: Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes
Indications For Use: The Cardio Med
DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ ECG ELECTRODES are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Cardiac Science (ANDERSON connectors), PHILIPS MEDICAL, PHYSIOCONTROL, and ZOLL MEDICAL models of monophasic and bi-phasic defibrillators, external pacemakers.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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Division of Cardiovascular Devices
510(k) Number