(48 days)
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No
The device description and performance studies focus on the physical and electrical properties of the electrodes, with no mention of AI or ML algorithms for data processing or decision making.
Yes
The device is described as being suitable for "external pacing, external defibrillation, synchronized cardioversion," which are all therapeutic interventions for cardiac rhythm management. It provides an interface from the skin to these "diagnostic or therapeutic devices."
Yes
The device's intended uses include "ECG Monitoring" and "ability to sense clear ECG signal," which are diagnostic functions. It is also labeled as providing an interface to "a number of diagnostic or therapeutic devices," explicitly mentioning diagnostic capabilities.
No
The device description clearly outlines physical components like foam backing, metallic substrate, conductive adhesive, and integral lead wires, indicating it is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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.
- Device Function: The 700-MP Series Radiolucent Multi-pad electrodes are designed for external cardiac stimulation and monitoring. They are applied to the patient's skin to deliver electrical energy for pacing, defibrillation, and cardioversion, and to pick up electrical signals for ECG monitoring.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from the patient. It interacts directly with the patient's body surface.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics. It is a medical device used for direct patient intervention and monitoring.
N/A
Intended Use / Indications for Use
The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses:
- External Defibrillation External Pacing ECG Monitorina Synchonized Cardioversion
Product codes (comma separated list FDA assigned to the subject device)
74LDD, 74DRO, 74DRX
Device Description
The 700-MP Radiolucent Multi-Pad electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. In addition, the 700-MP electrodes provide separate ECG monitoring elements on the same foam backing material for the attachment of standard ECG leadwires.
Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is performed in accordance with established protocols. Optionally, the separate leadwires may be attached to the ECG monitoring elements provided on the foam back area.
The 700-MP Radiolucent Multi-Pad electrodes are produced only in the Adult configuration. Leadwire sets having various lengths and interface connectors are added to the basic electrode style and may result in different catalog numbers to obtain combinations of end product design. The product line is further differentiated through trade name identification.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's chest
Indicated Patient Age Range
primarily adults
Intended User / Care Setting
all areas of the hospital, ambulance, and prehospital (paramedic) situations.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing of the 700-MP Series radiolucent Multi-pad electrodes consisted of a battery of both electrical and mechanical tests. These tests include electrical performance parameters as indicated in ANSI/AAMI DF-39 subsection 3.3.19 as well as a number of mechanical performance parameters developed by the manufacturer. These test show the 700-MP series electrodes to be suitable for the uses and environment specified.
Biocompatibility studies were conducted on the hydrogel conductive adhesive and the adhesive foam ring. The tests on the hydrogel consisted of Cytotoxicity. Primary Skin Irritation, and Delayed Contact Sensitization. Tests on the adhesive foam ring consisted of Primary Skin Insult Patch test. These tests showed all materials which contact the skin to be biocompatible.
In addition to the mechanical, electrical, and biocompatibility tests, a limited number of electrodes of similar construction were tested on live pigs over a twenty four hour period to demonstrate effectiveness at delivering energy, ability to sense clear ECG signal and to ensure that these electrodes do not contribute to any significant skin changes during or after the delivery of energy. Additional electrodes of similar construction were tested on live pigs over an eight hour period to demonstrate effectiveness at delivering energy. ability to sense clear ECG signals and to ensure that these electrodes do not contribute to any significant skin changes during or after delivery of energy.
The results of the aforementioned battery of tests demonstrate that the 700-MP series electrodes are substantially equivalent to the 600 series electrodes and are suitable for the specified intended uses in the environment for use indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
Image /page/0/Picture/0 description: The image shows the word "CARDIOTRONICS" in a bold, stylized font. Below the main word, the word "SYSTEMS" is spelled out with a space between each letter. The font used for "SYSTEMS" is much smaller and simpler than the font used for "CARDIOTRONICS".
Corporate Office 5966 LaPlace Court Carlsbad, CA 92008
(619) 431-9446 (800) 441-9446 lax (619) 431-1805
510(k) Summary
Summary of information contained in the 510(k) Premarket Notification
PR 1 6 1997
Date:
February 15, 1997
Submitter:
Cardiotronics Systems, Inc. 5966 La Place Court Carlsbad, California 92008
Contact Person
Tim J. Way Business Unit Manager Telephone (619) 431-9446 Facsimile (619) 431-1805
Tradename:
700-MP Series Multi-pad Electrodes
Classification:
These electrodes are disposable accessories to the following products.
| Product | Code | Class | CFR Section |
|---|---|---|---|
| DC-Defibrillator, Low Energy (including paddles) | 74LDD | II | 870.530 |
| Pacemaker, Cardiac, External Transcutaneous | 74DRO | III | 870.555 |
or under specific classification related to ECG monitoring would be considered:
| Electrode, Electrocardiographic | 74DRX II | 870.230 |
|---|---|---|
| --------------------------------- | ---------- | --------- |
The 700-MP series electrodes are substantially equivalent to the R2 Medical Systems 600 Series electrode and the Cardiotronics #918 Multi-pad Electrodes.
Description:
The 700-MP Radiolucent Multi-Pad electrodes consist of a foam backing material, a laminated metallic substrate which is covered by a conductive adhesive (hydrogel). This hydrogel is then surrounded by an adhesive coated foam ring and covered by a removable release liner. The electrodes have an integral lead wire for attachment to the interface cable of the defibrillator/pacemaker/monitor. In addition, the 700-MP electrodes provide separate ECG monitoring elements on the same foam backing material for the attachment of standard ECG leadwires.
1
Image /page/1/Picture/0 description: The image shows the word "CARDIOTRONICS" in a stylized, bold, black font. Below the main word, the word "SYSTEMS" is spelled out with a space between each letter. The font of the word "SYSTEMS" is a simple sans-serif font. The image appears to be a logo or brand name.
Comorate Office 5966 LaPlace Court Carlsbad, CA 92008
619 431-9446 (800) 441-9446 fax (619) 431-1805
Upon use, the release liner is removed from the electrode, exposing the hydrogel and adhesive areas. Each electrode of the set is then applied to the patient's chest in the selected set and pressed to ensure adhesion. The electrode is then attached to the host device via the interface cable and treatment is performed in accordance with established protocols. Optionally, the separate leadwires may be attached to the ECG monitoring elements provided on the foam back area.
The 700-MP Radiolucent Multi-Pad electrodes are produced only in the Adult configuration. Leadwire sets having various lengths and interface connectors are added to the basic electrode style and may result in different catalog numbers to obtain combinations of end product design. The product line is further differentiated through trade name identification.
Intended Use:
The 700-MP Series Radiolucent Multi-pad electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The MP designation refers to the multifunctionality of these electrodes wherein the separate ECG monitoring elements allow for continuous ECG monitoring through the attachment of separate ECG leadwires. The radiolucent substrate of these electrodes makes them particularly well suited for certain clinical applications involving radiographic viewing. The expected patient population for the use of these devices is primarily adults. The environment for use includes all areas of the hospital, ambulance, and prehospital (paramedic) situations. Individual catalog numbers are labeled for more specific use based primarily on the interface connector and cable system which defines the host external device, such as an external defibrillator.
The devices covered by this premarket notification provide an interface from the skin to a number diagnostic or therapeutic devices and are labeled with one or more of the following intended uses:
- External Defibrillation External Pacing ECG Monitorina Synchonized Cardioversion
As with all electrodes of this type, labeling indicates that separate ECG electrodes are required for monitoring during external pacing. In the case of 700-MP Radiolucent Multi-Pad Electrodes these separate ECG monitoring electrodes are provided on the same foam backing for the optional attachment of separate ECG leadwires.
/4-2
2
Image /page/2/Picture/0 description: The image shows the word "CARDIOTRONICS" in large, bold, black letters. Below this word, the word "SYSTEMS" is spelled out with a space between each letter. The font of the word "SYSTEMS" is smaller than the font of the word "CARDIOTRONICS".
porate Office
66 LaPlace Court
arlsbad, CA 92008
ax (619) 431-1805
Substantial Equivalence:
Note: As used herein, the term "substantial equivalence" is only as used in 21 CFR 807.81.
The design, materials, and intended uses of the 700-MP Series Radiolucent Multi-Pad electrodes are equivalent to the R2 Medical Systems 600 Series electrodes and the configuration of the 700-MP electrodes are equivalent to the Cardiotronics Systems #918 Multi-pad. As in the 600 Series, the 700-MP series are considered to be low impedance, large surface electrodes suitable for external defibrillation. ECG monitoring, and external pacing. Substantial equivalence has been determined primarily on the basis of electrical performance results in conformance to the AAMI standard DF39 (Subsection 3.3.19) and comparisons to materials and physical dimensions of the 600 Series and #918 Multi-pad.
The 700-MP Series Radiolucent Multi-pad electrodes differ from the 600-Series electrodes primarily in the conductive adhesive (hydrogel) material. While both hydrogels are of a similar chemical family, the 700-MP series utilize a cure-in-place hydrogel manufactured by Cardiotronics while the 600 series contain a commercially available hyrdrogel suitable for this application. All other primary components and methods of manufacture are equivalent to the 600 series electrodes.
Performance Evaluation
Bench testing of the 700-MP Series radiolucent Multi-pad electrodes consisted of a battery of both electrical and mechanical tests. These tests include electrical performance parameters as indicated in ANSI/AAMI DF-39 subsection 3.3.19 as well as a number of mechanical performance parameters developed by the manufacturer. These test show the 700-MP series electrodes to be suitable for the uses and environment specified.
Biocompatibility studies were conducted on the hydrogel conductive adhesive and the adhesive foam ring. The tests on the hydrogel consisted of Cytotoxicity. Primary Skin Irritation, and Delayed Contact Sensitization. Tests on the adhesive foam ring consisted of Primary Skin Insult Patch test. These tests showed all materials which contact the skin to be biocompatible.
In addition to the mechanical, electrical, and biocompatibility tests, a limited number of electrodes of similar construction were tested on live pigs over a twenty four hour period to demonstrate effectiveness at delivering energy, ability to sense clear ECG signal and to ensure that these electrodes do not contribute to any significant skin changes during or after the delivery of energy. Additional electrodes of similar construction were tested on live pigs over an eight hour period to demonstrate effectiveness at delivering energy. ability to sense clear ECG signals and to ensure that these electrodes do not contribute to any significant skin changes during or after delivery of energy.
The results of the aforementioned battery of tests demonstrate that the 700-MP series electrodes are substantially equivalent to the 600 series electrodes and are suitable for the specified intended uses in the environment for use indicated.