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

The DDU-1000 AED must be used by or on the order of a physician.

Device Description

The DDU-1000 is a portable, Semiautomatic External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery pack and supports both adult and pediatric user-replaceable singleuse defibrillation/monitoring pads.

The DDU-1000 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-1000 provides 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 the predicate device.

Voice prompts provide simple instructions for the operator. The DDU-1000 AED is capable of recording event information including electrocardiogram (ECG), audio data and SHOCK/NO SHOCK recommendations.

AI/ML Overview

The provided document, a 510(k) summary for the DDU-1000 Semiautomatic External Defibrillator and Accessories (K131525), focuses on demonstrating substantial equivalence to a predicate device (DDU-2300, K081259) rather than presenting a standalone study with explicit acceptance criteria and detailed performance metrics of the DDU-1000 against those criteria.

The core argument is that the DDU-1000 uses the "same underlying technologies to provide functionally equivalent performance characteristics as the predicate device." Therefore, the "acceptance criteria" for the DDU-1000 implicitly align with meeting the established safety and performance of the predicate device, as confirmed through various tests.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance numbers for the DDU-1000 in a standalone context. Instead, it asserts functional equivalence to a predicate device (DDU-2300, cleared under K081259).

The performance testing listed focuses on demonstrating this equivalence and compliance with general safety and performance standards.

Acceptance Criteria (Inferred from Equivalence Claim & Standards)	Reported Device Performance (Summary)
Patient Analysis System: Ensure proper pad/patient connection and accurate ECG rhythm analysis for shock determination.	"The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device."
Defibrillation Therapy: Deliver appropriate impedance-compensated, biphasic truncated exponential shock (150 J adult, 50 J pediatric).	"If needed, the DDU-1000 provides 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 the predicate device."
Hardware Verification:	Device meets functional and/or performance specifications.
Software Validation:	Device meets functional and/or performance specifications.
Design Validation:	Device meets functional and/or performance specifications.
Defibrillation Waveform Comparison:	Demonstrates equivalence to predicate device.
Safety Compliance (IEC 60601-2-4): Particular requirements for cardiac defibrillators.	Assures compliance with applicable industry safety standards.
EMC Compliance (IEC 60601-1-2): General requirements for safety - electromagnetic compatibility.	Assures compliance with applicable industry safety standards.
ECG analysis and shock advisory system performance per AHA recommendations:	Assures compliance with applicable industry safety standards ("American Heart Association's Automatic External Defibrillators for Public Access Defibrillation: Recommendation for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety").

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

The document mentions "Performance testing, including hardware verification, software validation, design validation and defibrillation waveform comparison," but does not specify the sample size for any test set.

Data Provenance: Not explicitly stated, but the focus on equivalence to a previously cleared device (predicate) suggests that the underlying algorithm and waveform performance data would likely originate from the studies supporting the predicate device (K081259). If new data was generated for the DDU-1000, its provenance is not detailed here.

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

This information is not provided in the document. Given the nature of the device (AED) and the assertion that the "cardiac rhythm analysis algorithm... are the same as the predicate device," it's highly probable that ground truth establishment for the algorithm's performance would have been done for the predicate device. However, details are absent for the DDU-1000 submission itself.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The submission focuses on device equivalence and compliance with standards, not on the comparative effectiveness of human readers with or without AI assistance for this specific device. AEDs are designed for automated analysis and shock delivery, reducing the human interpretation component compared to diagnostic imaging AI.

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

The document states, "The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device." It also mentions compliance with "the American Heart Association's Automatic External Defibrillators for Public Access Defibrillation: Recommendation for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety."

This strongly implies that standalone algorithm performance testing (likely without human-in-the-loop) was performed to ensure the rhythm analysis algorithm meets established standards. However, specific details of this testing (e.g., dataset size, metrics) are not presented in this 510(k) summary for the DDU-1000, relying instead on its identity with the predicate's algorithm.

7. The Type of Ground Truth Used

Based on the nature of a cardiac rhythm analysis algorithm, the ground truth would typically be established by expert consensus of cardiologists or electrophysiologists reviewing ECG recordings, potentially alongside clinical outcomes if such data was integrated. However, the document does not explicitly state the type of ground truth used for this specific submission, only that the algorithm is the same as the predicate.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for any training set. As the algorithm is stated to be the same as the predicate, any training would have occurred during the development of the predicate device (DDU-2300, K081259).

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

The document does not provide information on how the ground truth for the training set (if any, related to the original algorithm development) was established for this submission. This would likely have been detailed in the predicate device's submission.

Summary

{0}------------------------------------------------

Attachment 3

510(k) Summary

# K131525

Page 1 of 3

510(k) Summary

APR 2 4 2014

Date Summary Prepared: April 22, 2014

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-1000 Semiautomatic External Defibrillator and Accessories

Common Name: Semiautomatic External Defibrillator

Classification Name: Automated External Defibrillator (21 CFR 870.5310, Product Code MKJ)

Predicate Device

The DDU-1000 is a modification to the DDU-2300 predicate device. The design and intended use of the DDU-1000 AED is substantially equivalent in performance and safety to the DDU-2300 AED and accessories cleared under the following Proprietary Name:

Proprietary Name	Manufacturer	510(k) Number
DDU-2300 SemiautomaticExternal Defibrillator andAccessories	Defibtech, LLC	K081259

{1}------------------------------------------------

# K131525

Page 2 of 3

Device Description

Intended Use

The DDU-1000 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 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-1000 AED must be used by or on the order of a physician.

Comparison of Technology Characteristics

The DDU-1000 AED design characteristics are the same as those of the predicate device including the same battery and pads. 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-1000 AED user interface includes a simple stationary pictogram, which is illuminated with light emitting diodes (LEDs) to guide the user. In comparison, the user interface of the DDU-2300

{2}------------------------------------------------

Attachment 3

510(k) Summary

# K131525

Page 3 of 3

AED (predicate device), which consists of a color liquid crystal display (LCD) screen that displays dynamic imagery and text prompts to guide the user through the event. In addition, the intended users are the same for both AEDs.

Performance testing

The DDU-1000 AED uses the same underlying technologies to provide functionally equivalent performance characteristics as the predicate device. Testing, including hardware verification, software validation, design validation and defibrillation waveform comparison, demonstrates that the DDU-1000 meets functional and/or performance specifications. Safety testing, including IEC 60601-2-4 for the "Particular Requirements for the Safety of Cardiac Defibrillators," IEC 60601-1-2 for "General Requirements for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and Tests" and the ECG analysis and shock advisory system to the "American Heart Association's Automatic External Defibrillators for Public Access Defibrillation: Recommendation for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety," assures compliance with applicable industry safety standards.

Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the Defibtech DDU-1000 AED is substantially equivalent to the predicate device. The introduction of the DDU-1000 AED does not present new issues of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the HHS symbol, which is a stylized representation of a person embracing another person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 24, 2014

Defibtech, LLC c/o Mr. Ed Horton Vice President, Quality and Regulatory 741 Boston Post Road Guilford, CT 06437

Re: K131525

Trade/Device Name: DDU-1000 Semiautomatic External Defibrillator and Accessories , Regulatory Number: 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: II (two) Product Code: MKJ Dated: March 11, 2014 Received: March 12, 2014

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.

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

. . .:

{4}------------------------------------------------

Page 2 - Mr. Ed Horton

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.html

. .

Image /page/4/Picture/7 description: The image shows the phrase "Sincerely yours," followed by a logo. The logo appears to be for the FDA, but it is crossed out with black lines. The logo is a stylized version of the letters FDA.

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K131525

Indications for Use

510(k) Number (if known):

Device Name: DDU-1000 Semiautomatic External Defibrillator and Accessories

Indications For Use:

The DDU-1000 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 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.

The DDU-1000 AED must be used by or on the order of a physician.

Prescription Use X (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)

Date
2014.04.24
07:38:46 -04'00'

Page 1 of 1

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.