DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

K033896 · Defibtech, LLC · MKJ · Jun 16, 2004 · Cardiovascular

Device Facts

• Record ID: K033896
• Device Name: DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
• Applicant: Defibtech, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is: -Unconscious and unresponsive - Not breathing - Less than eight years old - Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician. Do not delay therapy to determine exact age or weight.

Device Story

Device consists of self-adhesive defibrillation/monitoring pads for use with Defibtech DDU-100 Series AEDs; pads incorporate energy attenuator to reduce nominal 150J defibrillation energy to 50J for pediatric patients. Input: ECG signals from patient; device monitors impedance between pads to ensure contact. Operation: AED analyzes ECG; if shock advised, delivers biphasic truncated exponential waveform. Output: Voice/visual prompts for operator; 50J energy delivery. Used by trained emergency personnel (ALS/BLS) or physician-authorized responders in clinical or emergency settings. Benefit: Enables safe defibrillation therapy for pediatric patients by reducing energy levels to appropriate pediatric range (25-175 ohms impedance).

Clinical Evidence

Bench testing only. Performance evaluations confirmed energy attenuation from 150J to 50J and proper impedance monitoring functionality.

Technological Characteristics

Self-adhesive disposable pads; integrated energy attenuator; biphasic truncated exponential waveform; pediatric impedance range 25-175 ohms; energy output 50J; ECG monitoring capability; visual/audio prompt interface.

Indications for Use

Indicated for pediatric patients under eight years of age who are unconscious, unresponsive, and not breathing due to sudden cardiac arrest. Must be used by or on the order of a physician.

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

• Heartstream Attenuated Defibrillation Pads (K003819)

Submission Summary (Full Text)

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# JUN 1 6 2004

## Section E – 510(k) Summary

Date of Submission: December 12, 2003

| Establishment Registration | |
|----------------------------|-----------------------------------------------------------------|
| Location | |
| Company Name: | Defibtech, LLC |
| Address 1: | 753 Boston Post Road |
| Address 2: | Suite 102 |
| City, State, and Zip Code: | Guilford, CT 06437 |
| Contact Information | |
| Name: | Mr. John L. Rogers |
| Telephone: | [phone] x13 |
| Facsimile: | [phone] |
| Trade (Proprietary) Name | Defibtech AED with Attenuated Defibrillation/Monitoring<br>Pads |
| Model Number | DDU-100 with DDP-200P |
| Common Name | Automatic External Defibrillator with Pediatric Electrodes |
| Classification | |
| FDA Panel | Cardiovascular |
| Class | Class III |
| Regulation | 21 CFR 870.1025 - Arrhythmia detector and alarm |
| Substantial Equivalence | |

| Model | Manufacturer | 510(k) Number |
|-----------------------------------------------|----------------------------|---------------|
| Heartstream Attenuated<br>Defibrillation Pads | Agilent Technologies, Inc. | K003819 |

#### Device Description

Defibtech Attenuated Defibrillation/Monitoring Pads are intended for use only with Defibtech DDU-100 Series AEDs or compatible Defibtech AEDs, on patients who are less than eight years of age.

Attenuated Defibrillation/Monitoring Pads are indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:

- Unconscious and unresponsive -
- ・ Not breathing
- -Less than eight years old

A pulse check is not required based on the recommendations of the American Heart Association Guidelines 2000 for CPR and ECC.

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## Section E- 510(k) Summary

Only people trained in its use should operate the Defibtech Series AEDs. This may include emergency care personnel specifically trained on Defibtech AED's or one of the following:

- People with training in advanced life support (ALS) -
- People with training in basic life support (BLS) -
- People filling other physician-authorized emergency medical response role -

Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician.

Attenuated Defibrillation/Monitoring Pads consist of two self-adhesive defibrillation/ monitoring pads used to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules. They are provided as a packaged, single-use disposable assembly.

The impedance between the two pads is monitored to ensure proper pad-to-patient contact. 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.

Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. The pads incorporate an attenuator that decreases the energy delivered to the patient to 50 Joules. Delivered energy does not change significantly with patient impedance, although the duration of the generated waveform will vary. The Defibtech Series AED is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms.

#### Intended Use

The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is:

- -Unconscious and unresponsive
- ﮯ Not breathing
- Less than eight years old -

Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician.

Do not delay therapy to determine exact age or weight.

#### Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the safety and effectiveness of the Attenuated Defibrillation/Monitoring Pads is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a wavy line representing the body. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 2004

Defibtech, LLC c/o Mr. John L. Rogers Director Medical Device Compliance 753 Boston Post Rd., Suite 102 Guilford, CT 06437

Re: K033896

Trade Name: Defibtech AED with Attenuated Defibrillation/Monitoring Pads Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: III (three) Product Code: MKJ Dated: March 18, 2004 Received: March 19, 2004

Dear Mr Rogers:

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. John L. Rogers

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), 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 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 D - Statement of Indications of Use

.

| Applicant: | Defibtech, LLC |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) Number (if known): | K033896 |
| Device Name: | Defibtech DDU-100 AED with DDP-200P Attenuated Defibrillation/Monitoring Pads |
| Indications For Use: | |
| The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is: | |
| <ul><li>Unconscious and unresponsive</li><li>Not breathing</li><li>Less than eight years old</li></ul> | |
| Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician. | |
| Do not delay therapy to determine exact age or weight. | |
| Prescription Use (Part 21 CFR 801 Subpart D) | _YES_ AND/OR Over-The-Counter Use_NO_ (Part 21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

*for BD2*

(Division Sign-Off)

on of Cardiovascular Devices

Number K033896

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