(171 days)
Not Found
No
The description focuses on standard AED functionality, ECG analysis, and user interface features. There is no mention of AI, ML, or related technologies.
Yes
The device is an Automated External Defibrillator (AED) used to deliver an electrical shock to victims of sudden cardiac arrest, which is a therapeutic intervention.
Yes
The device is primarily a therapeutic device (defibrillator), but it explicitly states that it has a "non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring". It also notes that in AED mode, it "automatically analyzes the patient's electrocardiogram (ECG)", and the DDU-2400 model in manual mode "provides a display of the patient's ECG trace". These functions involve the analysis and display of physiological data to assess a patient's condition, which are diagnostic activities, even if some modes are explicitly labeled as "non-diagnostic".
No
The device description clearly outlines hardware components such as a portable unit, battery, electrode pads, LCD display, and buttons, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat sudden cardiac arrest by delivering an electrical shock. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device analyzes the patient's ECG (electrical activity of the heart) to determine if a shock is needed. While it involves analyzing a physiological signal, it's for the purpose of guiding a therapeutic action (defibrillation), not for diagnosing a disease or condition based on in vitro analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
The device is a therapeutic medical device, specifically an Automated External Defibrillator (AED).
N/A
Intended Use / Indications for Use
The DDU-2400/2450 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 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2400/2450 AED must be used by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
The DDU-2400/2450 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 default mode of operation for the DDU-2400/2450 AED is Semiautomatic External Defibrillator (AED mode). In AED mode, after applying the defibrillation pads to the patient's chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and, if needed, advises the operator to push the button and deliver a shock. The AED guides the operator through the rescue protocol using a combination of voice and text prompts, audible alerts, and visible indicators. The LCD display shows instructional videos and text prompts.
The DDU-2400/2450 provides some optional features for the advanced user. When used in AED mode, the user can set the LCD display to show the patient's ECG trace. These models also provide a non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring using an optional 3-wire monitoring pads adaptor with standard ECG electrodes.
The DDU-2400 (only) supports a Manual override mode. Manual mode permits the user to override the AED features of the defibrillator. Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. Manual mode provides a display of the patient's ECG trace. operator-selected energy level along with charge, shock, and disarm functions.
The DDU-2400/2450 has a compact design and offers an easy-to-understand user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2400/2450 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
For patients under 8 years old, or less than 55 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
Intended User / Care Setting
The DDU-2400/2450 AED must be used by or on the order of a physician.
Manual mode is intended for use by personnel trained in ECG recognition.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing
The DDU-2400/2450 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. Testing demonstrates that the DDU-2400/2450 meets functional and performance specifications, and safety testing assures compliance with applicable industry safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
510(k) Summary
Date Summary Prepared: June 22, 2012
DEC 1 3 2012
510(k) Owner Information: Defibtech, LLC 741 Boston Post Road Guilford, CT 06437
Contact Information:
Mr. Ed Horton 203-453-6654, extension 138 (phone) 203-453-6657 (fax) ehorton(@defibtech.com (e-mail) ·
Common Name: Classification Name:
Trade (Proprietary) Name: DDU-2400/2450 Semiautomatic External Defibrillator Semiautomatic External Defibrillator Automated External Defibrillator (21 CFR 870.5310, Product Code MKJ)
Substantial Equivalence Model
The DDU-2400 and DDU-2450 products (DDU-2400/2450) represent modifications to the currently cleared Defibtech DDU-2300 AED. The DDU-2400/2450 is substantially equivalent to the DDU-2300 AED (K081259), with the exception of the optional ECG display/monitoring and manual override features that appear in the DDU-2400/2450 products. These features are substantially equivalent to the Heartstart FR2 AED. The defibrillation waveforms and energy used in manual mode are substantially equivalent to the Heartstart XLT Defibrillator/Monitor.
| Proprietary Name | Manufacturer | 510(k) Number |
|---|---|---|
| DDU-2300 Semiautomatic | ||
| External Defibrillator | Defibtech, LLC | K081259 |
| Heartstart FR2 AED | Philips Medical Systems | K013425 |
| Heartstart XLT | ||
| Defibrillator/Monitor | Agilent Technologies, Inc | K992543 |
The design and intended use of the DDU-2400/2450 AED is substantially equivalent in performance and safety to the devices listed above.
Defibrech, LLC DDU-2400/2450 510(k) Summary Page 1 of 3
1
Device Description
The DDU-2400/2450 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 default mode of operation for the DDU-2400/2450 AED is Semiautomatic External Defibrillator (AED mode). In AED mode, after applying the defibrillation pads to the patient's chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and, if needed, advises the operator to push the button and deliver a shock. The AED guides the operator through the rescue protocol using a combination of voice and text prompts, audible alerts, and visible indicators. The LCD display shows instructional videos and text prompts.
The DDU-2400/2450 provides some optional features for the advanced user. When used in AED mode, the user can set the LCD display to show the patient's ECG trace. These models also provide a non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring using an optional 3-wire monitoring pads adaptor with standard ECG electrodes.
The DDU-2400 (only) supports a Manual override mode. Manual mode permits the user to override the AED features of the defibrillator. Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. Manual mode provides a display of the patient's ECG trace. operator-selected energy level along with charge, shock, and disarm functions.
The DDU-2400/2450 has a compact design and offers an easy-to-understand user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2400/2450 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.
Intended Use
The DDU-2400/2450 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 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2400/2450 AED must be used by or on the order of a physician.
Defibtech, LLC DDU-2400/2450 510(k) Summary
2
Comparison of Technology Characteristics
The DDU-2400 and DDU-2450 represent modifications to the currently cleared Defibtech DDU-2300 AED, (K081259). They share a common hardware and software platform and employ the same cardiac rhythm analysis algorithm and defibrillation energy and waveform when used as an AED. The modifications provide some optional features for the advanced user such as ECG display, 3-wire ECG monitoring and Manual override, which are substantially equivalent to the Heartstart FR2 AED. The selectable energy and waveforms used in Manual mode are substantially equivalent to waveforms used by the Heartstart XLT.
Performance testing
The DDU-2400/2450 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. Testing demonstrates that the DDU-2400/2450 meets functional and performance specifications, and safety testing assures compliance with applicable industry safety standards.
Conclusion Summary of Safety and Effectiveness
Testing and performance evaluations demonstrate that the Defibtech DDU-2400/2450 AED is substantially equivalent to the predicate devices. The introduction of the DDU-2400/2450 AED does not present new issues of safety or effectiveness.
Page 3 of 3
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 1 3 2012
Defibtech LLC c/o Mr. Ed Horton 7 41 Boston Post Road, Suite 201 Guilford, CT 06437
Re: K121853
Trade/Device Name: DDU-2400/2450 Semiautomatic External Defibrillator and Accessories
Regulation Number: 21 CFR 870.5310
Regulation Name: Automated External Defibrillator
Regulatory Class: Class III (three)
Product Code: MKJ
Dated: November 23, 2012
Received: November 28, 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. Iisting 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.
4
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 (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 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, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
Indications for Use
510(k) Number: K121853
Device Name: DDU-2400/2450 Semiautomatic External Defibrillator and Accessories
Indications for Use:
The DDU-2400/2450 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-2400/2450 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) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Cardiovascular Devices
| Proprietary & Confidential Information | Page 1 of 1 |
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Defibrech LLC DDU 2400/2450 510(k) Indications for Use
510(k) Number