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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DDU-120 Fully-Automatic External Defibrillator, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria or detailed reported device performance values for the DDU-120. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implied):

Functional Equivalence: The DDU-120 must provide functionally equivalent performance characteristics to the predicate device (DDU-100).
Safety Standards: The DDU-120 must comply with applicable industry safety standards.
No New Issues: The DDU-120 must not present new issues of safety or effectiveness compared to the predicate.
Patient Analysis System: The Patient Analysis System must properly ensure pad/patient connection and accurately analyze the patient's ECG rhythm to determine if a shock is required.
Defibrillation Delivery: If needed, the device must deliver a 150 J (adult) / 50 J (pediatric) impedance-compensated, biphasic truncated exponential defibrillation shock.
Algorithm and Waveform: The cardiac rhythm analysis algorithm and defibrillation energy/waveform must be the same as previous Defibtech AEDs.

Reported Device Performance:
The document states:

"Testing demonstrates that the DDU-120 meets functional and performance specifications."
"Safety testing assures compliance with applicable industry safety standards."
"The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs."
"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."

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, shock success rates), a table with numerical values cannot be created from this text. The core of the acceptance is based on demonstrating equivalence, not on hitting specific new, quantified performance targets.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the context of algorithm performance or clinical trials. The performance testing mentioned is general and appears to be bench/functional testing rather than a separate clinical validation dataset for the algorithm. The data provenance is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission focuses on substantial equivalence based on technical aspects and safety standards, rather than a de novo clinical ground truth establishment study.

4. Adjudication Method for the Test Set

Since no specific test set or expert ground truth establishment is described, the adjudication method is not applicable/not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in the document. The device is an Automated External Defibrillator (AED), which automates the analysis and shock delivery, rather than acting as an AI assistant for human readers/operators in a diagnostic context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a standalone device in the context of its primary function: it employs a "Patient Analysis System" that "analyzes the patient's ECG rhythm to determine whether a shock is required" and "delivers a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient without user intervention."

The document states, "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs." This implies the algorithm's standalone performance was established previously or is considered equivalent to existing cleared algorithms. No new standalone study specific to the DDU-120's algorithm performance is detailed here beyond its functional equivalence to the predicate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for validating the cardiac rhythm analysis algorithm. It only mentions that the algorithm is the "same as previous Defibtech AEDs," suggesting that its validation was performed for prior submissions. For AED algorithms, ground truth typically involves expert-labeled ECG rhythms (e.g., shockable vs. non-shockable), sometimes correlated with patient outcomes in clinical studies, but this specific information is absent from this submission.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. Given that the algorithm is stated to be the "same as previous Defibtech AEDs," any training would have occurred during the development of those previous devices.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the document. As with the training set size, this would relate to the development of the existing algorithm from previous devices.

Summary

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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) ehorton@defibtech.com (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 ExternalDefibrillator, DDP-100Defibrillation Pads	Defibtech, LLC	K013896
Defibtech AED with AttenuatedDefibrillation/Monitoring Pads	Defibtech, LLC	K033896

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Device Description

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.

Page 2 of 3

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of ____

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.