DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

K081259 · Defibtech, LLC · MKJ · Jun 15, 2009 · Cardiovascular

Device Facts

• Record ID: K081259
• Device Name: DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
• Applicant: Defibtech, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are: - · Unconscious and unresponsive - · Not breathing For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight. The DDU-2300 AED must be used by or on the order of a physician.

Device Story

Portable AED for sudden cardiac arrest (SCA) victims; operates via user-replaceable battery and single-use defibrillation/monitoring pads. Patient Analysis System monitors pad connection and ECG rhythm; delivers 150J (adult) or 50J (pediatric) impedance-compensated, biphasic truncated exponential shock if indicated. Features LCD display, voice prompts, and graphical user interface for operator guidance. Records event data including ECG, audio, and shock recommendations. Used by or on order of physician.

Clinical Evidence

Bench testing and performance evaluations only; no clinical data presented. Testing confirmed device meets functional and performance specifications and complies with industry safety standards.

Technological Characteristics

Portable AED; impedance-compensated, biphasic truncated exponential waveform; user-replaceable battery; adult/pediatric pads. LCD display interface. Software-based ECG analysis algorithm.

Indications for Use

Indicated for victims of sudden cardiac arrest (SCA) who are unconscious, unresponsive, and not breathing. Pediatric patients defined as under 8 years old or less than 55 lbs (25 kg) require 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 Semiautomatic External Defibrillator, DDP-100 Defibrillation Pads (K013896)
• Defibtech AED with Attenuated Defibrillation/Monitoring Pads (K033896)

Submission Summary (Full Text)

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K081259

# Section 5

# 10202 rev B

510(k) Summary

# 510(k) Summary

Date Summary Prepared: April 30, 2008

JUN 1 5 2009

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-2300 Semiautomatic External Defibrillator Common Name: Semiautomatic External Defibrillator Classification Name: Automated External Defibrillator (21 CFR 870.5310, Product Code MKJ)

### Substantial Equivalence Model

The design and intended use of the DDU-2300 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 Semiautomatic External<br>Defibrillator, DDP-100<br>Defibrillation Pads | Defibtech, LLC | K013896 |
| Defibtech AED with Attenuated<br>Defibrillation/Monitoring Pads | Defibtech, LLC | K033896 |

Defibtech, LLC DDU-2300 510(k) Summary Page I of 3

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# Section 5

#### 10202 rev B 510(k) Summary

# Device Description

The DDU-2300 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-2300 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-2300 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.

The DDU-2300 has a compact design and offers an improved user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2300 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.

### Intended Use

The DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

- · Unconscious and unresponsive
- · Not breathing

For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-2300 AED must be used by or on the order of a physician.

# Comparison of Technology Characteristics

The DDU-2300 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. The DDU-2300 replaces the LED/text display with an LCD display.

Defibtech, LLC DDU-2300 510(k) Summary

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### 10202 rev B 510(k) Summary

202 REV D 510(K) Summary

K081259

The DDU-2300 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. Testing demonstrates that the DDU-2300 meets functional and performance specifications. Safety testing assures complance with applicable industry safety standards.

# Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the Defibtech DDU-2300 AED is substantially equivalent to the predicate device. The introduction of the DDU-2300 AED does not present new issues of safety or effectiveness.

Defibtech, LLC DDU-2300 510(k) Summary

Page 3 of 3

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2009

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

Re: K081259

Trade/Device Name: DDU-2300 Semiautomatic Defibrillator and Accessories Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: June 8, 2009 Received: June 9, 2009

### 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. .

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number: Ju81259

Device Name: DDU-2300 Semiautomatic External Defibrillator and Accessories

# Indications for Use:

The DDU-2300 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:

- · Unconscious and unresponsive
- · Not breathing

For patients under 8 years old, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-2300 AED must be used by or on the order of a physician.

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)

Defibtech LLC
DDU 2300 510(k) Indications for Use

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) Confidential Information | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K081259 |

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