The PadPro Radiotranslucent (minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Device Description

The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "PadPro" 2516 Multifunction Electrodes. This submission aims to demonstrate substantial equivalence to an already legally marketed device, the Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737), rather than proving the device meets acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable in this context. The focus of a 510(k) is to show that the new device is as safe and effective as a predicate device, often through bench testing, design comparison, and adherence to recognized standards.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device and adherence to relevant industry standards, rather than specific performance metrics from a de novo clinical trial. The "reported device performance" is framed in terms of meeting these standards and being functionally similar to the predicate.

Acceptance Criteria (Standards and Equivalence)	Reported Device Performance ("PadPro" Electrodes)
Indications for Use: Disposable electrodes for automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation.	SAME as predicate device (Katecho KDP-60 K-Defib/Pace Adult Electrode).
Where Used: Hospitals and Paramedic situations.	SAME as predicate device.
Basic Features: Radiotranslucent, non-sterile, latex-free, single patient use, self-adhesive, in sealed foil pouch.	Radiotranslucent "minor shadowing" non-sterile, latex free, single patient use, self adhesive, in sealed foil pouch. (Nearly identical, difference noted as "minor shadowing" vs. "radiotranslucent")
Standard Met 1: International Electrotechnical Commission (IEC) 601-1: Medical Electrical Equipment 601-1 (1988) Part 1: General requirements for safety, Amendment No. 1 (1991), Amendment No. 2 (1995).	SAME as predicate device.
Standard Met 2: Sec. 898.12 Performance standard (implied for predicate, likely referring to general performance requirements).	SAME as predicate device.
Standard Met 3: ANSI/AAMI DF-39 (3.3.19) standard, self-adhesive electrodes for monitoring and defibrillation.	SAME as predicate device.
Overall Conclusion: Substantially equivalent to other legally marketed electrodes for this purpose.	In all respects, the PadPro System Defibrillator Electrodes are substantially equivalent. The device meets the standards referenced above.

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

Not applicable in the context of this 510(k) submission. The document focuses on demonstrating substantial equivalence through design and feature comparison, and adherence to performance standards, rather than a clinical "test set" from a prospective study. The data provenance is primarily the product specifications and testing results from the manufacturer to demonstrate compliance with standards and equivalence.

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

Not applicable. The ground truth in this context is established by the recognized industry standards (IEC, ANSI/AAMI) and the performance characteristics of the predicate device. Expert consensus for a "test set" as in a diagnostic study is not mentioned or required for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" requiring adjudication in the sense of a clinical trial or diagnostic accuracy study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is not mentioned or implied. The submission is for a medical device (defibrillator electrodes) and not a diagnostic AI system where reader performance with and without AI assistance would be evaluated.

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

Not applicable. This device is a passive component (electrodes), not an algorithm or AI system. Its function is to provide an interface for human-operated defibrillators/pacemakers.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Established Industry Standards: IEC 601-1 and ANSI/AAMI DF-39. The device's compliance with these standards serves as a benchmark for its safety and basic performance.
Predicate Device Characteristics: The features, indications for use, and performance claims of the legally marketed Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737). Substantial equivalence to this device is the primary "ground truth" for regulatory clearance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set mentioned or implied, the establishment of its ground truth is irrelevant to this submission.

Summary

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MAY 0 8 2002

EXHIBIT 2

PadPro LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 734-663-0132 Fax: 734-663-1306 Contact: Cliff Poppy, President December 12, 2000 510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: "PadPro" 2516 Multifunction Electrodes Classification Name: Electrode, Electrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode
1. Equivalent legally marketed device: This identical in function to the Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737) and nearly identical in design.
1. Indications for Use: The PadPro Radiotranslucent (minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
1. Description of the Devices: Features & Benefits:

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Comparison Areas	Katecho KDP-60 K-Defib/PaceAdult Electrode (K981737)	"PadPro" DefibrillatorElectrodes
Indications for use	For use as disposable electrodes forautomatic and manual externaldefibrillators for monitoring, pacing,cardioversion, and defibrillation	SAME
Where used	Hospitals and Paramedic situations	SAME
Basic features	Radiotranslucent, non sterile, latexfree, single patient use, self adhesive,in sealed foil pouch.	Radiotranslucent "minorshadowing" non sterile,latex free, single patient use,self adhesive, in sealed foilpouch.
Standard met	International ElectrotechnicalCommission (IEC) 601-1: MedicalElectrical Equipment 601-1 (1988) Part1: General requirements for safetyAmendment No. 1 (1991) AmendmentNo. 2 (1995 and Sec.898.12Performance standard;ANSI/AAMI DF-39 (3.3.19)standard, self adhesive electrodes formonitoring and defibrillation	SAME

Safety and Effectiveness, comparison to predicate device: 5.
1

Conclusion In all respects, the PadPro System Defibrillator Electrodes are substantially 6. equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 08 2002

PadPro LLC c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K020203

Trade Name: "PadPro" 2516 Multifunction Electrodes Regulation Number: 21 CFR 870.2360 Regulation Name: Electrode, Electrocardiograph, Multifunction Regulatory Class: Class II (two) Product Code: MLN Dated: February 25, 2002 Received: February 26, 2002

Dear Mr. Kamm:

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. Daniel Kamm

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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Dat Tuh
Dr. Dan Till, Ph.D.

onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number_

Device Name: "PadPro" 2516 Multifunction Electrodes

Indications for Use:

The PadPro non-radiotransparent (radiotranslucent with minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over the Counter Use
			(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number

Regulation Number and Section

§ 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.