SAMARITAN AED, MODEL SAM-01

K023854 · Heartsine Technologies, Inc. · MKJ · Feb 14, 2003 · Cardiovascular

Device Facts

• Record ID: K023854
• Device Name: SAMARITAN AED, MODEL SAM-01
• Applicant: Heartsine Technologies, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs: . Unconscious . Not breathing . Without circulation . The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

Device Story

Portable, battery-operated AED for cardiac arrest treatment. Inputs: patient ECG rhythm via two self-adhesive, single-use, conductive gelled electrodes. Operation: proprietary ECG analysis algorithm determines shock/no-shock; if shock indicated, device charges to 100J, 150J, or 200J escalating energy levels. Output: truncated exponential biphasic waveform pulse delivered via user-activated shock button. Features: voice/text prompts, backlight LCD, manual override, event/audio recording on battery memory chip. Used by trained responders in emergency settings. Output guides clinical decision-making by automating rhythm analysis and defibrillation therapy, potentially restoring circulation.

Clinical Evidence

Bench testing performed per ANSI/AAMI DF2-1996 and ANSI/AAMI DF39-1993. Efficacy of the biphasic waveform supported by animal and human clinical trials.

Technological Characteristics

Portable AED; lithium manganese dioxide battery; truncated exponential biphasic waveform; 100J/150J/200J escalating energy; ECG monitoring; LCD display; voice/text prompts; event/audio data logging. Complies with ANSI/AAMI DF2-1996 and ANSI/AAMI DF39-1993.

Indications for Use

Indicated for cardiac arrest victims (unconscious, apneic, pulseless). Intended for trained BLS/AED, ALS, or emergency medical response personnel. Contraindicated for children < 8 years old.

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

• Phillips Heartstream FR2 (K003565)

Submission Summary (Full Text)

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# 510(k) Summary

### Date Summary Prepared:

K023854

November 15, 2002

#### Submitter's Name and Address:

HeartSine Technologies, Inc. 25892 Jamon Lane Mission Viejo, CA 92691

#### Contact Person:

William J. Smirles, EMT-P Telephone: [phone] Facsimile: 1.517.809.6748

#### Device Name:

Proprietary Name: HeartSine Samaritan® AED Common Name: Automated External Defibrillator Classification Names: DC-Defibrillator, Low Energy

#### Predicate Device:

The features and functions of the HeartSine Samaritan® AED are substantially equivalent to those of the Phillips Heartstream FR2 (K003565).

#### Device Description:

The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.

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The Samaritan® AED incorporates the following features:

- . Backlight LCD display providing text prompts and ECG display
- Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
- Automated self tests with a separate status indicator display .
- . Controls for Power On/Off, Shock, Backlight, Contrast & manual override
- Integral event data recording incorporated in the removable battery .

A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.

### Indications for Use:

The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

- . Unconscious
- Not breathing .
- Without circulation .

The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

#### Summary of Performance Information:

Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® AED complies with the applicable sections of ANSI / AAMI DF2- 1996 (Cardiac Defibrillator Devices) and ANSI / AAMI DF39 - 1993 Automatic External Defibrillators & Remote Controlled Defibrillators. The efficacy of the biphasic waveform in this device has been demonstrated in animal and human clinical trials.

The information in this 510(k) submission demonstrates that the HeartSine Samaritan® AED is substantially equivalent to the predicate device with respect to safety. effectiveness and performance.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 1 4 2003

Heartsine Technologies, Inc. Mr. William J. Smirles Senior Vice President 25892 Jamon Lane Mission Viego, CA 92691

Re: K023854

> Trade/Device Name: Samaritan® AED Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III Product Code: MKJ Dated: November 15, 2002 Received: November 19, 2002

Dear Mr. Smirles:

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 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

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Page 2 - Mr. William J. Smirles

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. 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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

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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### Section

# Indications for Use

510(k) Number (if known):

KO23854

Device Name: HeartSine Technologies, Inc. Samaritan® AED

Indications for Use: The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

- Unconscious .
- Not breathing .
- Without circulation .

The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Num

Prescription Use:

Over-the-Counter Use: or