(44 days)
FOR USE WITH DEFIBTECH ELECTRODES FOR AUTOMATIC AND MANUAL EXTERNAL DEFIBRILLATORS FOR MONITORING, PACING AND DEFIBRILLATION UP TO 360 JOULES.
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.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics in the format requested. The document is a 510(k) summary for the Defibtech Electrode Adapter, focusing on establishing substantial equivalence to a predicate device.
However, based on the limited information available, I can extract and infer the following:
Device: Defibtech Electrode Adapter (Model DAC-300 Series)
Intended Use: For use with Defibtech electrodes to monitor, pace, and defibrillate (up to 360 Joules) with automatic and manual defibrillators.
Overall Conclusion: "Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices." This implies that the device met the implicit acceptance criteria based on its equivalence to the predicate device.
Here's an attempt to structure the answer based on the provided text, with significant limitations due to the lack of explicit details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds). The primary "acceptance criterion" described is substantial equivalence to the predicate device. The performance is reported implicitly as meeting this equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Heartstream Electrode Adapter, K972418) for monitoring, pacing, and defibrillation (up to 360 Joules). | "Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Electrode Adapter is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The statement refers generally to "testing and performance evaluations," suggesting various tests were conducted, but specifics are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or how ground truth was established for any test set. This type of information is typically associated with clinical studies involving human interpretation or pathology, which are not described here.
4. Adjudication method for the test set
No information is provided regarding adjudication methods.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging AI algorithms, and the Defibtech Electrode Adapter is a hardware accessory, not an AI diagnostic tool. Therefore, human reader improvement with/without AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device is an "Electrode Adapter," an interface between electrodes and defibrillators. It is not an algorithm that performs standalone analysis or diagnosis. The "performance evaluations" would likely focus on electrical parameters, safety, durability, and functionality when connected to other devices, rather than algorithmic performance in a diagnostic sense.
7. The type of ground truth used
The concept of "ground truth" (expert consensus, pathology, outcomes data) is not explicitly discussed in the context of specific performance measurements for the electrode adapter. Given the device's function, ground truth would likely relate to objective measurements of electrical conductivity, energy delivery accuracy, signal integrity for monitoring, and safety standards compliance.
8. The sample size for the training set
The document does not mention a "training set." This term is typically used in the context of machine learning or AI algorithm development. The Defibtech Electrode Adapter is a hardware accessory, not an AI system that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, the method for establishing its ground truth is also not applicable or mentioned.
Summary of Limitations:
The provided document (a 510(k) summary) is primarily focused on demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include detailed technical performance study reports with explicit acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would be typical for a comprehensive description of algorithmic or diagnostic device performance. The "performance evaluations" are broadly stated as demonstrating safety and effectiveness equivalent to the predicate.
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NOV 1 3 2003
Section E - 510(k) Summary
Date of Submission: September 26, 2003
| Establishment Registration | ||
|---|---|---|
| LocationCompany 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
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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.
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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
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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
§ 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.