external defibrillation
synchronized cardioversion
cardiac stimulation
ECG monitoring
EURO DEFI PADS series of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.
The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule.
The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule.
The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

Device Description

FIAB EURO DEFI PADS series of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type electrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market.
The products are packaged in pairs inside water-vapor proof, heat sealed, non-transparent, aluminum/PE pouches.
FIAB EURO DEFI PADS series of disposable multi-function electrodes are available in the following versions: adult, adult radiotransparent, pediatric.

AI/ML Overview

This submission is for a medical device that is substantially equivalent to existing predicate devices, rather than a diagnostic AI algorithm. Therefore, the questions related to AI performance metrics, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies are not applicable in this context. The acceptance criteria and study detailed below refer to the substantial equivalence requirements for traditional medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	FIAB EURO DEFI PADS Performance
Intended Use	Same as predicate devices: external defibrillation, synchronized cardioversion, cardiac stimulation, ECG monitoring.	Meets: "FIAB EURO DEFI PAD electrodes have the same intended use as the predicate device."
Design, Materials, Packaging, Labeling	No technical differences compared to predicate devices.	Meets: "There are no technical differences in the design, materials, packaging, and labeling compared to the predicate."
Defibrillation Performance Standards	Meet 21 CFR 898.12 and ANSI/AAMI DF80:2003 standards.	Meets: "The defibrillation pads meet the standards referenced above." and "Testing was conducted to meet AAMI/ANSI standard DF80:2003. The FIAB Euro Defi Pads passed the tests related to defibrillation pads."
Biocompatibility	Pass ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and delayed-type hypersensitivity).	Meets: "The results were reported as passing by the NAMSA organization and are congruent with the predicate device."
Component Compatibility	Ensure interoperability with listed defibrillators, pacers, and monitors (assessment of insertion/extraction forces, energy delivery, simulated heartbeat monitoring).	Meets: "Compatibility testing was conducted to ensure interoperability between the FIAB Euro Defi Pads and the listed defibrillators, pacers, and monitors."
Risk-Benefit Analysis	Risk must be deemed acceptable according to ISO 14971 standards.	Meets: "According to the risk-benefit analysis (ISO 14971 standards), the risk has been deemed acceptable."
Shelf-Life	Assure a shelf life of 30 months.	Meets: "Accelerated age testing was conducted to assure a shelf life of 30 months."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not specify a "test set" in the context of an AI algorithm or a clinical trial with a defined patient population. Rather, the "tests" refer to engineering and biological evaluations performed on the device itself.

Sample size: Not explicitly stated for each test, but standard procedures for medical device testing within ISO and AAMI standards would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., adequate electrodes for biocompatibility, multiple units for electrical or compatibility testing).
Data provenance: The testing was conducted by NAMSA (for biocompatibility) and likely by FIAB SpA or a contracted laboratory for other tests. The manufacturer is FIAB SpA, located in Florence, Italy. The data is prospective for these specific tests as they were performed to validate the device for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI diagnostic device where expert ground truth is established for image/data interpretation. Ground truth for device performance is established by adherence to recognized national and international standards (e.g., AAMI/ANSI, ISO) and laboratory testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI diagnostic device requiring human adjudication of performance outcomes. Device performance is determined by meeting predefined technical specifications and standards (e.g., passing electrical tests, biocompatibility results).

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. This is not an AI diagnostic device. No human-in-the-loop performance or MRMC study was conducted.

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

Not applicable. This is not an AI algorithm. The device, when used, is always "human-in-the-loop" as it requires a medical professional to apply and operate it with a defibrillator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device's performance is its adherence to established engineering, safety, and biocompatibility standards, and its functional equivalence to legally marketed predicate devices. This includes:

Standard adherence: Compliance with 21 CFR 898.12, ANSI/AAMI DF80:2003, and ISO 10993 (biocompatibility).
Predicate device comparison: Demonstrating that the device has the "same intended use," "no technical differences in the design, materials, packaging, and labeling" to the predicate, and performs as expected for its clinical applications.
Laboratory testing results: Objective measurements from tests like biocompatibility, component compatibility (e.g., insertion/extraction forces, energy delivery), and electrical standards compliance.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical device, not an AI algorithm that requires a training set.

Summary

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Section 05

K103783 - Additional Information

Pad-type electrodes

Submitter Information

FIAB SpA Via P. Costoli, 4 50039 Vicchio Florence - Italy

Phone: +39 055 8497916 Fax: +39 055 8497987 Contact person: Silvia Calabrò, Official Correspondent E-mail: regulatory@fiab.it

Device name and classification

Trade name: EURO DEFI PADS series of disposable multi-function electrodes

Common name: defibrillation electrodes

Classification name: Electrode, Electrocardiograph, Multi-Function (21 CFR 870.2360, Product code MLN)

Predicate device

Lawfully marked devices to which it is claimed equivalence:

Trade name	510(K) holder	510(K) number
Adult Radiotranslucent Multi-function Electrodes	Heart Sync LLC	K080421
Adult Radiotransparent Multi-function Electrodes	Heart Sync LLC	K080421
Pediatric Radiotranslucent Multi-function Electrodes	Heart Sync LLC	K081442

Device description

FIAB EURO DEFI PADS scries of disposable multi-function electrodes are made by a couple of pre-gelled self-adhesive pad-type clectrodes consisting of foam backing, laminated metallic substrate, conductive hydrogel, cabling and molded connector. The electrodes are passive devices providing the conductive interface between the defibrillator and the patient's skin. Each couple of electrodes is permanently attached with lead wires that join together in a safety connector suitable for direct connection to devices - both monophasic and biphasic of the main defibrillators brands nowadays present on the market.

The products are packaged in pairs inside water-vapor proof, heat scaled, non-transparent, aluminum/PE pouches.

FIAB EURO DEFI PADS scries of disposable multi-function clectrodes are available in the following versions: adult, adult radiotransparent, pediatric.

2011/05/10

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Section 05

K103783 - Additional Information

Pad-type electrodes

All products are intended to be used by mcdical staff only in not-sterile environment. All disposable devices are not-sterile and for single patient use only.

Intended use

EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications:

external defibrillation -
synchronized cardioversion +
cardiac stimulation
ﺳ ECG monitoring

EURO DEFI PADS scries of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin.

These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.

The pediatric model of EURO DEFI PADS disposable multi-function electrodes is intended for use on pediatric patient under eight years of age, or weighting less than 25 kg, the device is designed to deliver a maximum of 100 joule.

The adult model of EURO DEFI PADS disposable multi-function electrodes is intended for use on adult patients and children older than eight years or greater than 25 kg, the device is designed to deliver a maximum of 360 joule.

The radio-transparcnt adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

Comparison to predicate

Safety and effectiveness of adult version:

COMPARISON	HEART SYNC Adult Radiotranslucent	FIAB EURO DEFI PADS
AREAS	Electrodes (K080421)	Adult Electrodes
Indication for	For use as disposable electrodes onexternal defibrillators for monitoring,pacing, cardioversion and defibrillation	SAME
use
Where used	Hospitals and paramedic situation	SAME
Basic features	Radiotranslucent, non sterile, latex free,single use, self adhesive, in sealed foilpouch	Radiopaque, non sterile, latexfree, single use, self adhesive,in sealed foil pouch
Targetpopulation	Adult patients	SAME
Energy usedand/or delivered	For use on defibrillators whose output isclassified as low power (360 joulemaximum)	SAME
Standard met	21 CFR 898.12 performance standard;ANSI/AAMI DF80:2003 standard	SAME
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Section 05

K103783 - Additional Information

Pad-type electrodes

Safety and effectiveness of adult radiotransparent version:

COMPARISONAREAS	HEART SYNC AdultRadiotransparent Electrodes(K080421)	FIAB EURO DEFI PADSAdult RadiotransparentElectrodes
Indication foruse	For use as disposable electrodes onexternal defibrillators for monitoring,pacing, cardioversion and defibrillation	SAME
Where used	Hospitals and paramedic situation	SAME
Basic features	Radiotransparent, non sterile, latex free,single use, self adhesive, in sealed foilpouch	Radiotransparent except for wire-pad connection, non sterile, latexfree, single use, self adhesive, insealed foil pouch
Targetpopulation	Adult patients	SAME
Energy usedand/or delivered	For use on defibrillators whose output isclassified as low power (360 joulemaximum)	SAME
Standard met	21 CFR 898.12 performance standard;ANSI/AAMI DF80:2003 standard	SAME

Safety and effectiveness of pediatric version:

COMPARISONAREAS	HEART SYNC PediatricRadiotranslucent Electrodes (K081442)	FIAB EURO DEFI PADSPediatric Electrodes
Indication foruse	For use as disposable electrodes onexternal defibrillators for monitoring,pacing, cardioversion and defibrillation	SAME
Where used	Hospitals and paramedic situation	SAME
Basic features	Radiotranslucent, non sterile, latex free,single use, self adhesive, in sealed foilpouch	Radiopaque, non sterile, latexfree, single use, self adhesive,in sealed foil pouch
Targetpopulation	Pediatric patients whose weight is less than25 kg	SAME
Energy usedand/or delivered	Do not exceed a settings of 100 jouleswhile defibrillating	SAME
Standard met	21 CFR 898.12 performance standard;ANSI/AAMI DF80:2003 standard	SAME

The products covered by this submission are substantially equivalent to other disposable multi-function electrodes, that are legally marked for this purpose. Specifically FIAB EURO DEFI PADS series of disposable multi-function electrodes are substantially equivalent to HEART SYNC clectrodes.

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Section 05

K 103783 - Additional Information

Pad-type electrodes

FIAB EURO DEFI PAD clectrodes have the same intended use as the predicate device. There are no technical differences in the design, materials, packaging, and labeling compared to the predicate. The defibrillation pads meet the standards referenced above. They are produced and tested according to all requirements to guarantee safety and effectiveness (as shown in section 17 and 18 of the submission). According to the riskbenefit analysis (ISO 14971 standards), the risk has been decemed acceptable. The performance is expected to be the same as the predicate device (see section 12 of the submission). In addition to the descriptive characteristics the following tests were performed to establish substantial equivalence:

Biocompatibility - Biocompatibility testing of all patient contacting material was performed according to ISO10993-5 for cytotoxicity and 10993-10 for irritation and delayed-type hypersensitivity. The results were reported as passing by the NAMSA organization and are congruent with the predicate device.

Component Compatibility - Compatibility testing was conducted to ensure interoperability between the FIAB Euro Defi Pads and the listed defibrillators, pacers, and monitors. This included testing of the insertion and extraction forces of the physical connectors, amount of energy delivered through the pads, and the monitoring of a simulated heartbeat

Electrical Standards - Testing was conducted to mect AAMI/ANSI standard DF80:2003. The FIAB Euro Defi Pads passed the tests related to defibrillation pads

Shelf-Life Testing - Accolerated age testing was conducted to assure a shelf life of 30 months.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting a sense of unity and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FIAB SpA c/o Mr. Francesco Batistini Counsellor of the Board Via Costoli, 4 50039 Vicchio Florence - Italy

JUN 1 6 291

Re: K103783

Trade Name: FIAB Euro Defi Pads Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator Regulatory Class: Class II (two) Product Code: LDD Dated: May 10, 2011 Received: May 13, 2011

Dear Mr. Batistini:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Francesco Batistini

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

W.g. Hellebaum

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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Indications For Use Statement K103783 - Additional Information

Section 04

I. Life, Liberty, Happiness

Pad-type clectrodes

Indications for Use

510(K) Number: K103783

Device Name: EURO DEFI PADS series of disposable multi-function electrodes

Indications For Use:

EURO DEFI PADS series of disposable multi-function electrodes are indicated for the following clinical applications:

external defibrillation -
synchronized cardioversion
cardiac stimulation
ECG monitoring -

EURO DEFI PADS scries of disposable multi-function electrodes provide the conductive interface between the defibrillator and the patient's skin. These devices are available with different connectors compatible for use with different defibrillators. All devices are non-sterile and for single-use only.

The radio-transparent adult model EURO DEFI PADS disposable multi-function electrodes for adult patient use only, is well suited for certain clinical applications involving radiographic viewing.

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND /OR (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. A. Kilbourne

(Division Sign-Off)
Division of Cardiovascular Devices

K103783 510(k) Number

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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.