The 700-F series 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 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. The duration for use is to 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

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.

AI/ML Overview

The provided text is a 510(k) summary for the Cardiotronics Systems 700-F Series Disposable Cardiac Stimulation/Monitoring Electrodes. This document describes the device, its intended use, and substantial equivalence to a predicate device, focusing on bench testing, biocompatibility, and limited animal testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that the device's performance was evaluated against specific standards and general suitability.

Acceptance Criteria Category	Reported Device Performance
Electrical Performance	Conformance to ANSI/AAMI DF-39 subsection 3.3.19. The text states: "These test show the 700-F series electrodes to be suitable for the uses and environment specified." and "Substantial equivalence has been determined primarily on the basis of electrical performance results in conformance to the AAMI standard DF39 (Subsection 3.3.19)".
Mechanical Performance	"A number of mechanical performance parameters developed by the manufacturer." The text states: "These test show the 700-F series electrodes to be suitable for the uses and environment specified."
Biocompatibility (Hydrogel)	Cytotoxicity: Passed. Primary Skin Irritation: Passed. Delayed Contact Sensitization: Passed. The text states: "These tests showed all materials which contact the skin to be biocompatible."
Biocompatibility (Foam Ring)	Primary Skin Insult Patch test: Passed. The text states: "These tests showed all materials which contact the skin to be biocompatible."
Animal Study (Live Pigs)	Effectiveness at delivering energy: Demonstrated. Ability to sense clear ECG signal: Demonstrated. No significant skin changes during or after energy delivery: Ensured. The text states: "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."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "a limited number of electrodes were tested on live pigs" for the animal study. For bench testing (electrical and mechanical), biocompatibility, the specific number of units tested is not provided.
Data Provenance: The animal study was conducted on "live pigs." The location (country of origin) is not specified. The studies appear to be prospective, specifically designed to test the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable and therefore not provided in the document. The studies described are technical performance evaluations (bench and animal) rather than human-expert-driven evaluations requiring ground truth establishment by experts in the context of diagnostic interpretations.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As described above, the studies involve direct measurement of device performance, not interpretation by human experts.

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

Not applicable. The device is a physical electrode, not an AI or diagnostic tool that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an electrode, not an algorithm. However, the bench and animal tests can be considered "standalone" in the sense that they evaluate the device's technical performance directly, without human "in-the-loop" interpretation for the ground truth establishment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these studies is based on:

Established Standards: Conformance to ANSI/AAMI DF-39 for electrical performance.
Manufacturer-Developed Parameters: For mechanical performance.
Biocompatibility Standards: Implicitly, standard methods for cytotoxicity, irritation, and sensitization tests.
Direct Observation/Measurement: In the animal study, effectiveness in energy delivery, ECG signal sensing, and absence of skin changes would be directly observed or measured against expected physiological responses.

8. The Sample Size for the Training Set

Not applicable. This device is an electrode, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as point 8.

Summary

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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:

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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.

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.