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
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.

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.
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.

AI/ML Overview

This appears to be a 510(k) summary for the Defibtech AED with Attenuated Defibrillation/Monitoring Pads (Model DDU-100 with DDP-200P), intended for pediatric use.

Based on the provided text, there is no detailed study described that establishes specific acceptance criteria and then proves the device meets those criteria with statistical data. Instead, the document makes a general statement about safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, with notes on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
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." (General statement, no specific metrics or thresholds provided.)
Energy Delivery (Pediatric)	The device is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms. (This is a design specification, not a performance outcome from a study.)
Energy Attenuation	"Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules." (This is a design feature, not a performance metric from a study.)

Explanation: The document focuses on demonstrating substantial equivalence to a predicate device (Heartstream Attenuated Defibrillation Pads, K003819) rather than presenting a standalone clinical study with predefined acceptance criteria and performance outcomes. The "Conclusion Summary of Safety and Effectiveness" explicitly states this.

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

Sample Size: Not specified.
Data Provenance: Not specified. The document does not describe a clinical test set or its origin. It refers to "testing and performance evaluations," which could mean bench testing, animal studies, or internal verification, but no details are given.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as no clinical study with ground truth establishment is described.

4. Adjudication Method

Not applicable as no clinical study requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study is not described. The device is a physical medical device (defibrillator pads) that works in conjunction with an AED. Performance evaluations mentioned are likely related to its physical and electrical characteristics.

7. Type of Ground Truth Used

Not applicable as no clinical study with ground truth is described. The assessment is based on "substantial equivalence" to a predicate device, implying that the predicate's established safety and effectiveness serve as a benchmark.

8. Sample Size for the Training Set

Not applicable as no machine learning algorithm development (which would involve a training set) is described.

9. How Ground Truth for the Training Set was Established

Not applicable as no training set or machine learning algorithm is described.

Summary of the Document's Approach:

The provided 510(k) summary primarily asserts substantial equivalence to a legally marketed predicate device (Heartstream Attenuated Defibrillation Pads, K003819). It states that "Testing and performance evaluations demonstrate that the safety and effectiveness" are equivalent. This type of submission often relies on a combination of:

Bench testing: To confirm electrical characteristics, energy attenuation, impedance ranges, etc.
Design specifications: Highlighting how the device's design meets the intended function (e.g., delivering 50J into a specific impedance range).
Comparison to predicate device's established performance: Assuming the predicate device is safe and effective, the new device needs to demonstrate it functions similarly for the same indications.

It does not present a detailed clinical trial with specific acceptance criteria, statistical performance metrics, or a described ground truth methodology.

Summary

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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:	(203) 453-6654 x13
Facsimile:	(203) 453-6657
Trade (Proprietary) Name	Defibtech AED with Attenuated Defibrillation/MonitoringPads
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 AttenuatedDefibrillation 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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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:
Unconscious and unresponsiveNot breathingLess than eight years old
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

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.