SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA

K013896 · Defibtech, LLC · MKJ · Jun 19, 2002 · Cardiovascular

Device Facts

• Record ID: K013896
• Device Name: SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA
• Applicant: Defibtech, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 19, 2002
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Sentry AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is: - Unconscious and unresponsive . - Not breathing ● - At least eight vears old . The Sentry AED must be used by or on the order of a physician. The DDP-100 defibrillation pads are used in conjunction with the Defibtech Sentry semiautomatic external defibrillator and act as a conductive interface between the Sentry and the patient's skin. The disposable electrodes are non-sterile and for single patient use only. The pads are intended for external defibrillation and ECG monitoring in combination with a Defibtech defibrillator.

Device Story

Portable, battery-powered semiautomatic external defibrillator (AED) for use by or on order of physician. Inputs: ECG signals via two non-sterile, self-adhesive disposable defibrillation/monitoring pads. Device monitors pad-to-patient impedance to ensure contact. Operation: Device analyzes ECG to detect shockable rhythms; charges capacitor automatically if shockable rhythm identified; prompts operator via voice/visual indicators to press SHOCK button. Device does not shock automatically. Output: Biphasic truncated exponential waveform (150J into 50-ohm load). Records event data (ECG, audio) internally or on optional Defibtech Data Card (DDC). Benefits: Facilitates rapid defibrillation for SCA victims. Operator uses two buttons (ON/OFF, SHOCK) and LED indicators to manage therapy.

Clinical Evidence

Bench testing only. Performance evaluations conducted per ANSI/AAMI DF39 (1993) and American Heart Association recommendations for arrhythmia analysis algorithm performance. No clinical trial data presented.

Technological Characteristics

Biphasic truncated exponential waveform; 150J energy output. Power: Lithium/Manganese Dioxide battery. Connectivity: Optional Defibtech Data Card (DDC) for event/audio recording. Interface: Voice prompts, visual LED indicators, two-button control. Electrodes: Non-sterile, single-use, self-adhesive pads. Standards: ANSI/AAMI DF39.

Indications for Use

Indicated for victims of sudden cardiac arrest (SCA) who are unconscious, unresponsive, not breathing, and at least 8 years old. Contraindicated for patients who are conscious, responsive, breathing, have a detectable pulse, or are younger than 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

• ForeRunner (Heartstream, Inc.) (K955628)
• KDP-60 (Katecho, Inc.) (K981737)

Submission Summary (Full Text)

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510(k) Summary

Date Summary Prepared: June 18, 2002

| Establishment Registration<br>Location | |
|----------------------------------------|---------------------------------------------|
| Company Name: | Defibtech, LLC |
| Address 1: | 1200 Boston Post Road |
| Address 2: | Suite 207 |
| City, State, and Zip Code: | Guilford, CT 06437 |
| Contact Information | |
| Name: | Mr. Gintaras Vaisnys |
| Telephone: | [phone] x17 |
| Facsimile: | [phone] |
| Trade (Proprietary) Name | Sentry Semiautomatic External Defibrillator |
| Model Number | Defibtech Sentry |
| Common Name | DC-Defibrillator, Low Energy |
| Trade (Proprietary) Name | Defibrillation Pads or Electrodes |
| Model Number | DDP-100 Defibrillation Pads |
| Common Name | External Defibrillation Pads |

# Substantial Equivalence

| Model | Manufacturer | 510(k) Number |
|------------|-------------------|---------------|
| ForeRunner | Heartstream, Inc. | K955628 |
| KDP-60 | Katecho, Inc. | K981737 |

## Device Description

The Sentry is a semiautomatic external defibrillator (AED) designed to be portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The Sentry AED is capable of recording event information including ECG, audio data (optional) and SHOCK/NO SHOCK recommendations.

When connected to a patient who is unconscious and not breathing the Sentry AED performs the following tasks:

- . Prompts the operator to take necessary actions to enable analysis
- Automatically analyzes the patient's ECG ●
- Determines whether a shockable rhythm is present ●
- Charges the defibrillation capacitor if the rhythm is shockable .

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- . Arms the SHOCK button and prompts the operator to press the SHOCK button when the device is ready and a shock is recommended
- Delivers a shock if the user presses the SHOCK button and the device has . determined that a shock is required

The Sentry AED will NOT shock a patient automatically; it will only advise the operator. The SHOCK button is only enabled when a shockable rhythm is detected and the device is charged and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must press the SHOCK button to initiate deffbrillation.

The Sentry AED uses two non-sterile self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are provided as a single patient use, packaged, disposable assembly.

The Sentry AED determines proper pad-to-patient contact by monitoring the impedance between the two pads. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The Sentry AED has two pushbutton controls and several LED indicators.

Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. Energy delivered does not change significantly with patient impedance. although the duration of the generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 - 150 ohms.

Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) Lithium/Manganese Dioxide Battery Pack. Battery Packs are available in several configurations that are optimized for use in specific applications. Each Pack is marked with an expiration date.

The Sentry AED records event documentation internally and optionally, on Defibtech Data Cards (DDC). The optional DDC enables the AED to record event documentation. and audio, if enabled. Audio recording is available only for units with Defibtech Data Cards installed. Event documentation stored internally can be downloaded onto a DDC for review.

## Intended Use

The Sentry AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:

- Unconscious and unresponsive .
- Not breathing ●
- At least eight vears old .

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The Sentry AED must be used by or on the order of a physician.

The DDP-100 defibrillation pads are used in conjunction with the Defibtech Sentry semiautomatic external defibrillator and act as a conductive interface between the Sentry and the patient's skin. The disposable electrodes are non-sterile and for single patient use only. The pads are intended for external defibrillation and ECG monitoring in combination with a Defibtech defibrillator.

#### Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Sentry is substantially equivalent to the predicate device. Performance testing was performed in accordance with established industry standards (ANSI/AAMI DF39 -Automatic external defibrillators and remote-control defibrillators: 1993) and recommendations (American Heart Association - Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety: October 1996).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Defibtech, LLC c/o Mr. Gintaras Vaisnys 1200 Boston Post Road Suite 207 Guilford, CT 06437

Re: K013896

Sentry Semiautomatic External Defibrillator (AED) Regulation Number: 870.1025 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: March 20, 2002 Received: March 21, 2002

Dear Mr. Vaisnys:

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.

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Page 2 - Mr. Gintaras Vaisnys

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.

Doug Tull

na-Bea Tillman, Ph.D. Do Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ver/ 3 - 4/24/96

Page 1 of 1

Applicant: Defibtech, LLC

510(k) Number (if known): K013896

Device Name: Sentry Semiautomatic External Defibrillator ("AED")

Indications For Use:

The Sentry AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is:

- Unconscious and unresponsive -
- Not breathing -
- At least eight years old -

The Sentry AED must be used by or on the order of a physician.

Contraindications For Use:

The Sentry AED should not be used if the patient shows any of the following signs:

- Conscious and/or Responsive =
- Breathing
- Has a detectable pulse
- Is younger than eight years old

Refer to Üser's Manual for Operator Training Requirements.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dell

Ivision of Cardiovascular & Respiratory Desviors 801.109)

Gy-45

(Quiz 1B - 1006)

(Optional Format 1-2-96)