CARDIO MED

K103334 · Cardio Medical Products, Inc. · LDD · Jan 18, 2011 · Cardiovascular

Device Facts

• Record ID: K103334
• Device Name: CARDIO MED
• Applicant: Cardio Medical Products, Inc.
• Product Code: LDD · Cardiovascular
• Decision Date: Jan 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use, non-sterile, self-stick defibrillator electrodes; 104 cm² surface area; radiotranslucent. Provides conductive interface between patient skin and external defibrillator/pacemaker. Used in clinical settings for adult patients requiring defibrillation, cardioversion, or pacing. Connects to various monophasic/biphasic defibrillator models via specific connectors. Healthcare providers apply pads to patient; device facilitates energy delivery from instrument to patient. Benefits include enabling life-saving cardiac therapy and continuous ECG monitoring.

Clinical Evidence

Bench testing only. Testing included DC offset, offset instability/noise, AC small/large signal impedance, and defib overload recovery across three lots. Accelerated 36-month shelf-life testing performed. Biocompatibility testing conducted on patient-contact hydrogel material. All units passed performance and safety specifications.

Technological Characteristics

Single-use, self-stick electrodes; 104 cm² area; radiotranslucent. Conductive adhesive hydrogel patient interface. Complies with ANSI/AAMI DF80:2003. Connectors meet FDA performance standards for touch-proof ECG connectors. Passive device; no internal energy source or software.

Indications for Use

Indicated for adult patients requiring external cardiac pacing, defibrillation, cardioversion, or ECG monitoring. Used as a conductive interface between the patient's skin and external defibrillators or transcutaneous pacemakers (max 360 joules).

Regulatory Classification

Identification

Low-energy DC-defibrillator: 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. High-energy DC-defibrillator: 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.

Predicate Devices

• Heart Sync Electrodes (K080421)
• PadPro (K020203)
• Katecho (K981737)

Submission Summary (Full Text)

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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: [phone] Toll Free: 800-227-3633 Fax: [phone] 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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 [phone] or [phone] 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)

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W.M.C.

Jivision of Cardiovascular Devices