9131 DEFIBRILLATION ELECTRODES

K082090 · Cardiac Science Corporation · MKJ · Dec 12, 2008 · Cardiovascular

Device Facts

• Record ID: K082090
• Device Name: 9131 DEFIBRILLATION ELECTRODES
• Applicant: Cardiac Science Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

Device Story

Hydrogel polymeric self-adhesive electrode pads; 4.88in x 4.88in dimensions; conductive area ≥50cm2 per pad; total surface area ≥150cm2. Used with AEDs to monitor cardiac signals and deliver defibrillation energy. Packaged to maintain electrical contact between pads, allowing AED to perform diagnostic checks on inter-electrode impedance while stored. 9133 model includes brand-specific adapters for compatibility with Zoll or Physio-Control AEDs. Used in emergency settings by trained responders or lay users. Electrodes applied to patient skin after confirming unconsciousness, pulselessness, and apnea. Benefits include rapid delivery of life-saving defibrillation therapy.

Clinical Evidence

Bench testing only. Representative samples tested in accordance with system, safety, functional, and performance specifications; all samples passed.

Technological Characteristics

Hydrogel polymeric self-adhesive electrodes; dimensions 4.88in x 4.88in; conductive area ≥50cm2 per pad; total surface area ≥150cm2. Complies with AAMI DF-80 (AAMI DF-39) specifications. Single-use; short-term application (<8 hours). Inter-electrode impedance monitoring capability.

Indications for Use

Indicated for emergency treatment of cardiac arrest in patients >8 years of age or >55 lbs. Contraindicated for patients who are conscious, have a pulse, or are breathing.

Regulatory Classification

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.

Predicate Devices

• Survivalink-9130 Defibrillation Electrode (K971149)

Submission Summary (Full Text)

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## III. 510(k) Summary

| Submitter: | Cardiac Science Corporation<br>3303 Monte Villa Parkway<br>Bothell, WA 98021-8969 | DEC 1 2 2008 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Beverly Magrane<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared: | December 10, 2008 | |
| Trade Name: | 9131 Defibrillation Electrode<br>9133 Defibrillation Electrode | |
| Common Name: | External defibrillation electrodes | |
| Classification<br>Name and Number: | Automated External Defibrillator accessory (Electrode)<br>Class III, 21CFR 870.5310 | |
| Product Code: | MKJ | |
| Predicate<br>Device(s): | The 9131 and the 9133 Defibrillation Electrodes<br>manufactured by Cardiac Science, Inc are substantially<br>equivalent to the Survivalink-9130 Defibrillation Electrode,<br>K971149, (6/23/1997) | |
| Device<br>Description: | The model 9131 and the 9133 Defibrillation Electrodes<br>consists of a pair (2 each) of hydrogel polymeric self<br>adhesive electrode pads of equal dimension. The outer<br>dimension for each pad is 4.88in (12.4cm) by 4.88in (12.4<br>cm). Each electrode pad has a conductive hydrogel<br>polymeric area of at least 50cm2 to comply with the AAMI<br>DF-80 (AAMI DF-39) specifications. The total surface area<br>of the two electrodes is greater or equal to 150cm2. | |
| | The electrodes pads are packaged in such a way that the<br>two conductive hydrogel surfaces are in electrical contact.<br>This feature enables the Cardiac Science AED to run<br>diagnostic checks on the electrodes by checking the inter-<br>electrode impedance when the electrode package is<br>connected to and stored in the device. | |
| | The Cardiac Science 9133 defibrillation electrodes may<br>be used in conjunction with adaptor cables that allow the<br>electrodes to be used with compliant AEDs other than the<br>Cardiac Science brands. These adaptor cables are | |

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Indications For Use:

provided as accessories to the Cardiac Science defibrillation electrodes.

Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.

Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.

The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.

The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin. Representative samples of the electrodes were tested in accordance with the system, safety, functional and performance specifications. All samples successfully passed.

Based on the results of the testing described above, it is concluded that the modifications to the Cardiac Science, Defibrillation Electrode do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science 9131 and the 9133 Defibrillation Electrodes are substantially equivalent to the Defibrillation Electrode cleared in K971149 in terms of indications for use, features and functions.

Functional and Safety Testing:

Conclusion:

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 12 2008

Cardiac Science Corporation c/o Ms. Beverly Magrane Sr. Manager RA/RC 3303 Monte Villa Parkway Bothell, WA 98021-8969

Re: K082090

Trade/Device Name: 9131 and 9133 Defibrillation Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: November 10, 2008 Received: November 12, 2008

Dear Ms. Magrane:

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.

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

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### Page 2 - Ms. Beverly Magrane

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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

uma R.lo Ames

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 Statement

## 510(k) Number:

#### Device Name: 9131 Defibrillation Electrode

#### Indications for Use:

Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.

Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.

The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.

The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. la hines

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices

540/k) Number_KO82090

Confidential