(331 days)
Not Found
No
The description mentions a "Patient Analysis System" and a "cardiac rhythm analysis algorithm," but there is no mention of AI, ML, or any related terms. The device is described as using the "same underlying technologies" and "cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as the predicate device," suggesting a traditional algorithm rather than an AI/ML approach.
Yes
The device is described as an External Defibrillator (AED) and its intended use is to deliver a defibrillation shock to victims of sudden cardiac arrest, which constitutes a form of therapy.
Yes
The device employs a "Patient Analysis System" that "analyzes the patient's ECG rhythm to determine whether a shock is required," which is a diagnostic function.
No
The device description explicitly mentions hardware components such as a portable unit, battery pack, electrode pads, and includes hardware verification in the performance studies summary.
Based on the provided information, the DDU-1000 Semiautomatic External Defibrillator (AED) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The DDU-1000 directly interacts with the patient's body (applying electrode pads and delivering electrical shocks) and analyzes the patient's ECG rhythm in vivo (within the living body).
- The intended use is for treating sudden cardiac arrest. IVD devices are used for diagnosis, monitoring, or screening, not for direct therapeutic intervention like defibrillation.
- The device description focuses on external application and electrical therapy. It describes components like electrode pads, battery packs, and the delivery of a defibrillation shock. This is characteristic of a therapeutic medical device, not an IVD.
The DDU-1000 is clearly described as a therapeutic medical device used to treat a life-threatening condition by delivering an electrical shock.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
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.
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, or less than 55 pounds (25kg), use child/infant electrode pads.
Intended User / Care Setting
The DDU-1000 AED must be used by or on the order of a physician.
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-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.
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
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 Semiautomatic | ||
| External Defibrillator and | ||
| Accessories | Defibtech, LLC | K081259 |
1
# K131525
Page 2 of 3
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.
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