(34 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 capabilities.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the electrodes are suitable for "external pacing, external defibrillation, synchronized cardioversion," which are all therapeutic interventions for cardiac conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are labeled with "ECG Monitoring," which is a diagnostic function. Additionally, the text mentions providing an interface to "a number diagnostic or therapeutic devices."
No
The device description clearly outlines physical components like foam backing, metallic substrate, hydrogel, adhesive foam ring, and lead wires, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The 700-F series electrodes are described as disposable electrodes for external cardiac stimulation and monitoring. They provide an interface from the skin to external devices like defibrillators, pacemakers, and monitors. Their function is to deliver electrical energy to the body or sense electrical signals from the body, not to analyze samples taken from the body.
- Intended Use: The stated intended uses are External Defibrillation, External Pacing, ECG Monitoring, and Synchronized Cardioversion. These are all procedures performed on the patient's body, not tests performed on samples from the patient's body.
- Device Description: The description details the physical components of the electrode and how it is applied to the patient's skin. There is no mention of collecting or analyzing biological samples.
Therefore, the 700-F series electrodes fall under the category of medical devices used for external therapeutic and diagnostic procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. 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 of 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 Monitoring
Synchonized Cardioversion
Product codes
74LDD, 74DRO, 74DRX, LDD
Device Description
The 700-F Series 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.
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 new accordance with established protocols.
The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.
Mentions image processing
Not Found
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
Adults and children
Intended User / Care Setting
Environment for use includes 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-F Series 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-F 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 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 ofter the delivery of energy.
The results of the aforementioned battery of tests demonstrate that the 700-F 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.)
Not Found
Predicate Device(s)
R2 Medical Systems 600 Series electrode.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section 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 it, the word "SYSTEMS" is spelled out with individual letters spaced apart. The font is black and the background is white.
510(k) Summary
Summary of information contained in the 510(k) Premarket Notification
Date:
November 5, 1996
Submitter:
Cardiotronics Systems, Inc. 5966 La Place Court Carlsbad, California 92008
Contact Person
Tim J. Way Vice President - Regulatory Affairs Telephone (619) 431-9446 Facsimile (619) 431-1805
Tradename:
700-F Series Disposable Cardiac Stimulation/ Monitoring Electrodes (a number of end products, including those manufactured under private label)
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-F series electrodes are substantially equivalent to the R2 Medical Systems 600 Series electrode.
Description:
The 700-F Series 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.
2.35
1
Image /page/1/Picture/0 description: The image shows the word "CARDIOTRONICS" in large, bold, black letters. Below the word, the word "SYSTEMS" is spelled out with a single letter underneath each letter of the word. The letters of the word "SYSTEMS" are smaller and thinner than the letters of the word "CARDIOTRONICS".
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 new accordance with established protocols.
The 700-F Series electrodes are produced in two basic styles; Adult and Child. Leadwire sets having various lengths and interface connectors are added to the basic electrode styles to obtain many combinations of end product design. The product line is further differentiated through trade name and OEM identification.
Intended Use:
The 700-F series electrodes are disposable electrodes for external cardiac stimulation and monitoring. Electrodes of this design are suitable for external pacing, external pacing, external defibrillation, synchronized cardioversion and ECG monitoring. The expected patient population for the use of these devices includes adults and children. 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 of 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 Monitoring Synchonized Cardioversion
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-F series electrodes are equivalent to the those of the R2 Medical Systems 600 Series electrodes. As in the 600 Series, the 700-F series are considered to be low impedance, large surface electrodes suitable for external defibrillation, ECG montoning, 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.
The 700-F series 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-F 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 primers and methods of manufacture are equivalent to the 600 series electrodes.
2
Image /page/2/Picture/0 description: The image shows the word "CARDIOTRONICS" in a bold, stylized font. Below the main word, there is the word "SYSTEMS" with each letter separated by a space. The font used for "SYSTEMS" is smaller and simpler compared to the main word. The overall design appears to be a logo or branding element.
Performance Evaluation
Bench testing of the 700-F Series 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-F 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 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 ofter the delivery of energy.
The results of the aforementioned battery of tests demonstrate that the 700-F series electrodes are substantially equivalent to the 600 series electrodes and are suitable for the specified intended uses in the environment for use indicated.
2.37
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 26 2011
Cardiotronics Systems. Inc. c/o Mr. Tim J. Way 5966 La Place Court Carlsbad, CA 92008
K96469 Re:
700-FR Series Stimulation Electrodes Regulation Number: 21 CFR 870. 5300 Regulation Name: DC-Defibrillator (Including paddles) Regulatory Class: Class II (two) Product Code: LDD Dated: November 5, 1996 Received: December 7, 1996
Dear Mr. Way:
This letter corrects our substantially equivalent letter of December 11, 1996.
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 (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. Tim J. Way
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 (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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
for
5
Indications for use Statement
510(k) Number K9644
Device Name : 700-F Series Disposable Stimulation Electrodes
Indications for Use:
The 700-F series electrodes are disposable electrodes for external cardiac stimulation and succhination and humanian and ECC more sitemal pacing, external pacing, external defibiliation, synchronized can'includes and ECG monitoring. The expected patient population for the use of these devices includes and children. The expected pattern population for the use of the hospital, and prehespital (paramedic) situations. The duration for use in ineas of the be less than 24 hours. 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 labels with one or more of the following intended uses:
External Defibrillation
External Pacing
ECG Monitoring
Synchonized Cardioversion
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
Over the Counter
Richard Phillips
003
C A