(409 days)
Not Found
No
The description mentions a "cardiac rhythm analysis algorithm" but does not use terms like AI, ML, deep learning, or neural networks. The algorithm is stated to be the same as previous devices, suggesting a more traditional, rule-based approach rather than a learning-based one.
Yes
The device is an Automated External Defibrillator (AED) that delivers an electrical shock to treat sudden cardiac arrest, which is a therapeutic intervention.
Yes
Explanation: The device is equipped with a "Patient Analysis System that ensures proper pad/patient connection and analyzes the patient's ECG rhythm to determine whether a shock is required." This analysis of ECG rhythm to determine a medical need (shock required) constitutes a diagnostic function.
No
The device description clearly states it is a portable, Automated External Defibrillator (AED) with physical components like a battery, electrode pads, an LCD display, and a speaker for voice prompts. It also mentions hardware functions like delivering a defibrillation shock.
Based on the provided information, the DDU-2300 Semiautomatic External Defibrillator (AED) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality. The DDU-2300 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 and device description clearly state its purpose is to treat sudden cardiac arrest by analyzing the patient's ECG and delivering a defibrillation shock. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- There is no mention of analyzing any biological samples or specimens.
Therefore, the DDU-2300 is a medical device, specifically a therapeutic device used for emergency treatment of sudden cardiac arrest, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DDU-2300 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 (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2300 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-2300 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-2300 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-2300 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.
The DDU-2300 has a compact design and offers an improved user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2300 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, or less than 55 pounds (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
Intended User / Care Setting
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)
Testing and performance evaluations demonstrate that the Defibtech DDU-2300 AED is substantially equivalent to the predicate device. The introduction of the DDU-2300 AED does not present new issues of safety or effectiveness.
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 5
10202 rev B
510(k) Summary
510(k) Summary
Date Summary Prepared: April 30, 2008
JUN 1 5 2009
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-2300 Semiautomatic External Defibrillator Common Name: Semiautomatic External Defibrillator Classification Name: Automated External Defibrillator (21 CFR 870.5310, Product Code MKJ)
Substantial Equivalence Model
The design and intended use of the DDU-2300 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 Semiautomatic External | ||
| Defibrillator, DDP-100 | ||
| Defibrillation Pads | Defibtech, LLC | K013896 |
| Defibtech AED with Attenuated | ||
| Defibrillation/Monitoring Pads | Defibtech, LLC | K033896 |
Defibtech, LLC DDU-2300 510(k) Summary Page I of 3
1
Section 5
10202 rev B 510(k) Summary
Device Description
The DDU-2300 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-2300 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-2300 provides a 150 J (50J pediatric) impedance compensated, biphasic truncated exponential defibrillation shock to the patient. The cardiac rhythm analysis algorithm and defibrillation energy and waveform utilized are the same as previous Defibtech AEDs.
The DDU-2300 has a compact design and offers an improved user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2300 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.
Intended Use
The DDU-2300 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 (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2300 AED must be used by or on the order of a physician.
Comparison of Technology Characteristics
The DDU-2300 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. The DDU-2300 replaces the LED/text display with an LCD display.
Defibtech, LLC DDU-2300 510(k) Summary
2
10202 rev B 510(k) Summary
202 REV D 510(K) Summary
The DDU-2300 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. Testing demonstrates that the DDU-2300 meets functional and performance specifications. Safety testing assures complance with applicable industry safety standards.
Conclusion Summary of Safety and Effectiveness
Testing and performance evaluations demonstrate that the Defibtech DDU-2300 AED is substantially equivalent to the predicate device. The introduction of the DDU-2300 AED does not present new issues of safety or effectiveness.
Defibtech, LLC DDU-2300 510(k) Summary
Page 3 of 3
3
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2009
DefibTech, LLC c/o Mr. Ed Horton VP, Quality Assurance & Regulatory Affairs 741 Boston Post Road, Suite 201. Guilford, CT 06437
Re: K081259
Trade/Device Name: DDU-2300 Semiautomatic Defibrillator and Accessories Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: June 8, 2009 Received: June 9, 2009
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. .
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: Ju81259
Device Name: DDU-2300 Semiautomatic External Defibrillator and Accessories
Indications for Use:
The DDU-2300 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 (25 kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2300 AED must be used by or on the order of a physician.
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)
Defibtech LLC
DDU 2300 510(k) Indications for Use
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Confidential Information | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K081259 |
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