DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

K113787 · Defibtech, LLC · MKJ · Jan 4, 2013 · Cardiovascular

Device Facts

• Record ID: K113787
• Device Name: DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
• Applicant: Defibtech, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Jan 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The DDU-120 AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is: Unconscious and unresponsive. Not breathing. For patients under 8 years old, use child/infant electrode pads. Do not delay therapy to determine exact age. The DDU-120 AED must be used by or on the order of a physician.

Device Story

Portable Automated External Defibrillator (AED) for sudden cardiac arrest (SCA) victims. Inputs: ECG signals via patient-applied pads. Operation: Patient Analysis System ensures pad contact; analyzes ECG rhythm; delivers 150J (adult) or 50J (pediatric) impedance-compensated, biphasic truncated exponential shock automatically if indicated. Used in clinical or emergency settings by or under physician order. Provides voice prompts for operator guidance. Records event data (ECG, audio, shock recommendations). Benefits: Automated shock delivery without user intervention for rapid life-saving therapy.

Clinical Evidence

Bench testing only. Performance evaluations demonstrated that the DDU-120 meets functional and performance specifications and is equivalent to the predicate device.

Technological Characteristics

Portable AED; impedance-compensated, biphasic truncated exponential waveform; user-replaceable battery; single-use adult/pediatric pads. Fully-automatic shock delivery. Voice prompt interface. No specific material standards or software architecture details provided.

Indications for Use

Indicated for victims of sudden cardiac arrest (SCA) who are unconscious, unresponsive, and not breathing. For patients <8 years old, use child/infant electrode pads.

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

• Sentry Semi-automatic External Defibrillator, DDP-100 Defibrillation Pads (K013896)
• Defibtech AED with Attenuated Defibrillation/Monitoring Pads (K033896)

Submission Summary (Full Text)

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#### Section 2

510(k) Summary

JAN

4 2013

# K113787

### 510(k) Summary

Date Summary Prepared: D December 20, 2011

## 510(k) Owner Information: Defibtech, LLC 741 Boston Post Road Guilford, CT 06437 Contact Information: Mr. Ed Horton 203-453-6651, extension 138 (phone) 203-453-6657 (fax) [e-mail] (e-mail)

Trade (Proprietary) Name: DDU-120 Fully-Automatic External Defibrillator Automatic External Defibrillator Common Name: Automated External Defibrillator (21 CFR 870.5310, Classification Name: Product Code MKJ)

#### Predicate Device

The DDU-120 is a modification to the DDU-100 predicate device. The design and intended use of the DDU-120 AED is substantially equivalent in performance and safety to the Sentry (DDU-100) AED with Adult and Attenuated Pediatric Pads cleared under the following Proprietary Names:

| Proprietary Name | Manufacturer | 510(k) Number |
|---------------------------------------------------------------------------------|----------------|---------------|
| Sentry Semi-automatic External<br>Defibrillator, DDP-100<br>Defibrillation Pads | Defibtech, LLC | K013896 |
| Defibtech AED with Attenuated<br>Defibrillation/Monitoring Pads | Defibtech, LLC | K033896 |

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#### Device Description

The DDU-120 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads.

The DDU-120 employs a Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required. If needed, the DDU-120 delivers a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.

Voice prompts provide simple instructions for the operator. The DDU-120 AED is capable of recording event information including ECG, audio data and SHOCK NO SHOCK recommendations.

#### Intended Use

The DDU-120 AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is:

- Unconscious and unresponsive.
- . Not breathing.

For patients under 8 years old, use child/infant electrode pads. Do not delay therapy to determine exact age.

The DDU-120 AED must be used by or on the order of a physician.

#### Comparison of Technology Characteristics

The DDU-120 AED design characteristics are the same as those of the predicate device. Both devices employ the same underlying scientific technology for patient analysis and defibrillation therapy. Both user interface designs guide the user with voice prompts and visual guidance. DDU-120 is the fully-automatic version of the semi-automatic DDU-100.

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KII 3787

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#### Performance testing

The DDU-120 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. Testing demonstrates that the DDU-120 meets functional and performance specifications. Safety testing assures compliance with applicable industry safety standards.

#### Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the Defibtech DDU-120 AED is substantially equivalent to the predicate device. The introduction of the DDU-120 AED does not present new issues of safety or effectiveness.

K113787

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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 a person with outstretched arms, representing the department's mission to protect the health of all Americans.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

> JAN 4 2013

Defibtech. LLC c/o Mr. Ed Horton VP, Quality Assurance & Regulatory Affairs 741 Boston Post Road, Suite 201 Guilford, CT 06437

Re: K113787

Trade/Device Name: DDU -120 Fully Automatic External Defibrillator and Accessories Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: December 20, 2012 Received: December 26, 2012

Dear Mr. Horton:

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.

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.

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#### Page 2 - Mr. Ed Horton

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 (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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Bram D. Zuckerman

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

510(k) Number (if known): K113787

Device Name: DDU-120 Automatic External Defibrillator and Accessories

Indications For Use:

#### 1.3 Indications

The DDU-120 AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is.

- · Unconscious and unresponsive.
- · Not breathing.

For patients under 8 years old, use childinfant electrode pads. Do not delay therapy to determine exact age.

The DDU-120 AED must be used by or on the order of a physician.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------|----------|
| Division: Cardiovascular Devices | |
| K Number | K11 3787 |

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