(44 days)
Not Found
No
The summary describes a simple electrode adapter, a passive component, and there is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No
The device is described as an adapter for electrodes used with defibrillators for monitoring, pacing, and defibrillation. It facilitates the use of other therapeutic devices (defibrillators) but does not directly provide a therapeutic effect itself.
No
The device is an electrode adapter for defibrillators, used for monitoring, pacing, and defibrillation. While monitoring can involve gathering data, the primary function of this device is to facilitate therapeutic interventions (pacing and defibrillation) rather than to diagnose a condition. The description does not mention any analytical or interpretative functions that would classify it as diagnostic.
No
The device description explicitly states it is a "reusable" "adapter" that provides an "interface" between electrodes and defibrillators. This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "MONITORING, PACING AND DEFIBRILLATION" using external defibrillators. These are procedures performed directly on a patient's body, not on samples taken from the body.
- Device Description: The description reinforces its role as an "interface between Defibtech electrodes and various automatic and manual external defibrillators." This is a physical connection for delivering electrical therapy, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or diagnostic testing performed in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering electrical therapy to a patient.
N/A
Intended Use / Indications for Use
FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES.
Product codes
MKJ
Device Description
The Defibtech Electrode Adapter provides an interface between Defibtech electrodes and various automatic and manual external defibrillators. Each adapter is reusable and is either a stand-alone accessory or can be preattached to a Defibtech electrode package.
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
Not Found
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)
Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 3 2003
Section E - 510(k) Summary
Date of Submission: September 26, 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 Electrode Adapter | |
| Model Number | DAC-300 Series | |
| Common Name | Defibrillation Electrode Adapter | |
| Classification | ||
| FDA Panel | Cardiovascular | |
| Class | Class III | |
| Regulation | 21 CFR 870.1025 - Arrhythmia detector and alarm | |
| Substantial Equivalence | ||
| Model | Manufacturer | 510(k) Number |
| Heartstream Electrode Adapter | Heartstream, Inc. | K972418 |
Device Description
The Defibtech Electrode Adapter provides an interface between Defibtech electrodes and various automatic and manual external defibrillators. Each adapter is reusable and is either a stand-alone accessory or can be preattached to a Defibtech electrode package.
Intended Use
Intended for use with Defibtech electrodes to monitor, pace and defibrillate (up to 360 Joules) with automatic and manual defibrillators.
Conclusion Summary of Safety and Effectiveness
Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices.
(0331444
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing segments and a flowing tail.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Defibtech, LLC c/o Mr. John L. Rogers Director, Medical Device Compliance 753 Boston Post Road, Suite 102 Guilford, CT 06437
Re: K033144
Trade Name: Defibtech Electrode Adapter Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MKJ Dated: September 26, 2003 Received: September 30, 2003
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.
2
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 (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. 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) 594-4646. 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 vours.
Diva Reinber
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section D - Statement of Indications of Use
| Ver/ 3 - 4/24/96 | Page 1 of 1 |
|---|---|
| ------------------ | ------------- |
| Applicant: | Defibtech, LLC |
|---|---|
| 510(k) Number (if known): | Not Applicable |
| Device Name: | Defibtech Electrode Adapter |
| Indications For Use: | FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES. |
(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)
(Optional Format 1-2-96)
Division Sign-Off
Division of Cardiovascular Devices
| 510(k) Number | K033144 |
|---|---|
| --------------- | --------- |
Defibtech LLC Electrode Adapter 510(k)
Proprietary & Confidential
9/26/03