(64 days)
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.
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. 104 cm² (16.1 in²) They are radiotranslucent. 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ECG ELECTRODES) was tested against the AAMI Standard ANSI/AAMI DF80:2003.
| Test | Acceptance Criteria (Pre-Pacing Limits) | Acceptance Criteria (Post-Pacing Limits) | Reported Device Performance |
|---|---|---|---|
| DC Offset | ≤100 mV | ≤650 mV | All units passed |
| Offset Instability and Noise | ≤100 μV | ≤100 μV | All units passed |
| AC Small Signal Impedance (10 Hz) | ≤3,000 Ohms | ≤3,000 Ohms | All units passed |
| AC Small Signal Impedance (30 kHz) | ≤5 Ohms | ≤5 Ohms | All units passed |
| AC Large Signal Impedance | ≤3 Ohms | ≤3 Ohms | All units passed |
| Defib Overload Recovery (At 4 seconds) | ≤400 mV | ≤650 mV | All units passed |
| Defib Overload Recovery (At 60 seconds) | ≤300 mV | ≤500 mV | All units passed |
Additionally, the device was subjected to an accelerated age shelf life test:
- Acceptance Criteria: Maintain compliance with the above AAMI tests after 36 months of accelerated aging.
- Reported Device Performance: All units passed the tests after the accelerated age shelf life test.
Furthermore, Biocompatibility testing was performed on the patient contact material Hydrogel, and the material passed.
Finally, Compliance with the FDA performance standard for touch-proof ECG connectors was verified by inspection.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the AAMI electrical performance tests: Three different lots, with six samples each (total of 18 samples).
- For the 36-month accelerated age shelf life test: Three different lots, with two samples each (total of 6 samples).
- For Biocompatibility testing: Not specified, but performed on the patient contact material (hydrogel).
- For Connector compliance: Verified by inspection of the connectors (number of units not specified).
- Data Provenance: The nature of these tests (bench testing, accelerated aging, biocompatibility) indicates that the data is prospective and generated in a laboratory setting, rather than being collected from patients. The country of origin for the data is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission is for a medical device (defibrillator electrodes) and primarily relies on bench testing against established industry standards (AAMI Standard ANSI/AAMI DF80:2003) and conformance to FDA performance standards for connectors.
- Experts for Ground Truth: There is no mention of human expert consensus being used to establish a "ground truth" for the performance of these basic electrical and material properties tests. The "ground truth" is defined by the objective, quantifiable limits set forth in the AAMI standard itself and FDA regulations for connectors. The testing would be conducted by qualified laboratory personnel, but their role is to measure and report, not to interpret complex clinical data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. As described above, the determination of "passing" is based on objective measurements against pre-defined numerical limits in a standard, not on the subjective interpretation of expert reviewers that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No. This submission is for a physical medical device (defibrillator electrodes), not an AI algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is based on:
- Industry Standards: Specifically, the AAMI Standard ANSI/AAMI DF80:2003 for electrical performance characteristics of defibrillator electrodes.
- FDA Regulations/Performance Standards: For "touch-proof" ECG connectors and biocompatibility.
- Objective Measurements: These standards define quantifiable limits (e.g., ≤100 mV for DC Offset, ≤3,000 Ohms for AC Small Signal Impedance) against which the device's measured performance is compared.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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510(k) Summary K10 3334
JAN 1 8 2011
(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: 9 November 2010
(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. 104 cm² (16.1 in²) They are radiotranslucent. 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.
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(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 | ≤100 mV | ≤650 mV |
| Offset Instability and Noise | ≤100 μV | ≤100 μV |
| AC Small Signal Impedance | ||
| 10 Hz | ≤3,000 Ohms | ≤3,000 Ohms |
| 30 kHz | ≤5 Ohms | ≤5 Ohms |
| AC Large Signal Impedance | ≤ 3 Ohms | ≤ 3 Ohms |
| Defib Overload Recovery | ||
| At 4 seconds | ≤ 400 mV | ≤ 650 mV |
| At 60 seconds | ≤ 300 mV | ≤ 500 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
JAN 18 2011
Cardio Medical Products, Inc. Mr. Nick Mendise Vice President Sales 385 Franklin Ave. Ste. L Rockaway, NJ 07866
Re: K103334
Trade/Device Name: Cardio Med Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrodes Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (including paddles) Regulatory Class: Class II (two) Product Code: LDD Dated: October 19, 2010 Received: November 15, 2010
Dear Mr. 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.
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Page 2 – Mr. Nick Mendise
Enclosure
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 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,
W.W.S.
T.-CBram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number(if known): K10
Device Name: Cardio Med DEFIBRILLATION/CARDIOVERSION/MONOPHASIC OR BIPHASIC PACING/ECG ELECTRODES, Various Models
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
W.M.C.
Jivision of Cardiovascular Devices
§ 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.