(379 days)
Not Found
No
The description mentions a "cardiac rhythm analysis algorithm" but explicitly states it is the "same as previous Defibtech AEDs," suggesting a traditional, rule-based algorithm rather than AI/ML. There are no mentions of AI, ML, training data, or performance metrics typically associated with AI/ML models.
Yes
The device is an Automated External Defibrillator (AED) that delivers an electrical shock to the heart to treat sudden cardiac arrest, which is a therapeutic intervention.
Yes
The device explicitly states that it "analyzes the patient's ECG rhythm to determine whether a shock is required," which is a diagnostic function to assess the patient's condition.
No
The device description explicitly states it is a "portable, Automated External Defibrillator (AED)" and mentions hardware components like a battery, electrode pads, and a Patient Analysis System.
Based on the provided text, the DDU-120 AED is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- DDU-120 Function: The DDU-120 AED is a device that analyzes the patient's ECG rhythm and delivers an electrical shock directly to the patient's body to treat sudden cardiac arrest. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for use on victims of sudden cardiac arrest, not for analyzing samples from them.
- Device Description: The description focuses on its function as a defibrillator, analyzing the patient's ECG rhythm in vivo (within the living body).
Therefore, the DDU-120 AED falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For patients under 8 years old, use child/infant electrode pads.
Intended User / Care Setting
Not Found
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-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.
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
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 External | ||
| Defibrillator, DDP-100 | ||
| Defibrillation Pads | Defibtech, LLC | K013896 |
| Defibtech AED with Attenuated | ||
| Defibrillation/Monitoring Pads | Defibtech, LLC | K033896 |
1
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.
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
2
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.
3
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.
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 (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
5
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 |
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