The LONG LIFE PAD™ is intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. These pads should be used only with the Omron Electrotherapy Pain Relief Unit, (PM3030) and applied on normal, healthy, dry, clean skin of adults.

Device Description

The LONG LIFE PADs™ are non-sterile, disposable, laminated, flexible structures composed of the following three main construction layers from bottom to top:
. Polyester protective film,
. gel,
. carbon layer,
. non-skin contact polyethylene lamination layer
. snap connection

The electrodes are designed for single-patient/multiple application use. Because of the Adhesive's nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin.

The pad patient contacting surface is a biocompatible hydrogel. The electrode has one connection point that is used to connect the stimulation device to the electrodes. This connection point is compatible only with the Omron PM3030.

AI/ML Overview

The information provided is about a 510(k) premarket notification for a medical device called "LONG LIFE PAD™," which is a cutaneous electrode. This document details the device's comparison to a predicate device and bench testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary states that the Long Life Pads met all requirements, specifications, and the "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode." While specific numerical acceptance criteria are not explicitly detailed in the provided text, the document indicates compliance with the following types of tests:

Acceptance Criteria Category	Reported Device Performance
Compliance with Guidance	Met all requirements, specifications, and "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode." (Implies compliance with electrical safety, biocompatibility, performance, and labeling standards.)
Material Biocompatibility	Patient contacting materials of the electrode tested in accordance with ISO 10993-1 and FDA Guidance.
Dispersion	Passed Dispersion Test Protocol Report Summary. (Implies satisfactory electrical current distribution and minimization of hot spots.)
Adhesion	Passed Adhesion Test Protocol Report Summary. (Implies satisfactory adherence to skin over the intended use period without premature detachment or excessive residue.)
Stability (Storage Conditions)	Passed Stability Testing (Storage Conditions). (Implies the device maintains its performance and integrity under specified storage conditions.)
Shelf Life	Passed Stability Test Protocol Report (Shelf life). (Implies the device maintains its performance and integrity over its stated shelf life.)
Shipment Stability	Passed Stability Shipment Test Report Summary. (Implies the device maintains its performance and integrity during shipping and handling.)
Substantial Equivalence (General)	Found substantially equivalent to the predicate (Well-Life Self Adhesive Electrodes K082065) in indications for use, patient population, environment for use, technology characteristics, specifications, and performance.

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

The document mentions "bench tests" but does not specify the sample sizes (number of pads tested) or the provenance (country of origin, retrospective/prospective) of the data for these tests. It only states that the tests were performed.

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

This information is not applicable to the provided document. The performance evaluation presented is based on bench testing of the device's physical and electrical properties, not on clinical assessment or interpretation by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically associated with clinical studies involving human interpretation or outcomes, not bench testing of device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission is for a cutaneous electrode and relies on bench testing to demonstrate substantial equivalence to a predicate device, not a comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to the device described. The "LONG LIFE PAD™" is a physical medical device (cutaneous electrode), not an algorithm or AI system. Its performance is inherent to its physical properties and design, not an "algorithm only" performance.

7. The Type of Ground Truth Used:

For the bench tests, the "ground truth" would be the established scientific and engineering standards and specifications (e.g., electrical resistance limits, adhesion strength targets, material biocompatibility standards as per ISO 10993-1) against which the device's performance was measured. It is not an expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.

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

This information is not applicable as there is no training set for this device.

Summary

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K120516

MAY 1 7 2012

510(k) Summary Page 1 of 5 May 9, 2012

Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045	Tel - 847-247-5625Fax - 847-680-6911
Official Contact:	Mirna DiPano- Director, Quality & Regulatory
Proprietary or Trade Name:	LONG LIFE PADTM
Common/Usual Name:	Cutaneous electrode
Classification Name/Code:	GXY – electrode, cutaneousCFR 882.1320Class 2
Device:	Long Life PadTM
Predicate Device:	Well Life Healthcare Limited – Well-Life SelfAdhesive Electrodes K082065

Device Description:

The LONG LIFE PADs™ are non-sterile, disposable, laminated, flexible structures composed of the following three main construction layers from bottom to top:

. Polyester protective film,
. gel,
. carbon layer,
. non-skin contact polyethylene lamination layer
. snap connection

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510(k) Summary Page 2 of 5 May 9, 2012

Indications for Use:

Environment of Use:

Clinics, hospital and home use environments

Contraindications

Do not use these pads for stimulation if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

Summary of substantial equivalence

The LONG LIFE PAD™ was compared to the predicate Well-Life Self Adhesive Electrodes (K082065) as in the device comparison table below.

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Device Comparison
Indications for Use	Well-Life Pad510(k) K082065The Well Life Self AdhesiveElectrode/CM, FA, PU and SPseries are intended for use as adisposable, conductive adhesiveinterface between the patient'sskin and the ElectricalStimulator. Well Life SelfAdhesive Electrode / AP, CM,FA, PU and SP series aredesigned and intended to beused With marketed ElectricalStimulators, i.e. TENS(Transcutaneous ElectricalNerve Stimulation), MENS(Microcurrent Electrical NerveStimulation), EMS (ElectricalMuscular Stimulation), IF(Interferential) and PGS (PulsedGalvanic Stimulation)	May 9, 2012Long Life PadThe LONG LIFE PADTM isintended for use as a disposable,conductive adhesive interfacebetween the patient's skin and theElectrical Stimulator. These padsshould be used only with theOmron Electrotherapy Pain ReliefUnit, (PM3030) and applied onnormal, healthy, dry, clean skin ofadults.	ComparisonSimilar indications. The LongLife Pad is restricted to theOmron PM3030 stimulator(K110068)
Product CodePrescriptive orOTC	GXY	GXY	Identical
	Both	OTC	Similar
Environment Ofuse	Clinics, hospital and home useenvironments	Clinics, hospital and home useenvironments	Identical
	Well-Life Pad510(k) K082065	Long Life Pad510(k) TBD	Comparison
PatientPopulation	Adult	Adult
ConductiveInterface	Biocompatible hydrogel	Biocompatible hydrogel	Identical
Construction &Materials	Bottom to top:• PET protective layer,• gel,• scrim layer,• carbon layer,• non-skin contact whitefoam layer• with snap connection	Bottom to top:• Polyester protective film,• gel,• carbon layer,• non-skin contactpolyethylene laminationlayer• with snap connection	IdenticalConstruction layers and materialsare very similar.

510(k) Summary

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510(k) Summary

、一

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510(k) Summary Page 5 of 5 May 9, 2012

Differences Between Other Legally Marketed Predicate Devices

The Omron Long Life Pad is viewed as substantially equivalent to the predicate device because: The Long Life Pad uses the same principal of operation as the predicate. The Long Life Pad uses similar materials. The Long Life Pad has approximately the same surface area. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Indications - The Long Life Pad and the predicate (Well-Life Self Adhesive Electrodes K 082065) are intended for use as disposable, conductive adhesive interfaces between the patient's skin and an electrical stimulator.

Prescriptive - The Long Life Pad TM is OTC as is the predicate.

Design and Technology - The Long Life Pad "M has equivalent design and features as the predicate and has the identical technology to the predicate.

Performance and Specifications - The Long Life Pad TM has equivalent specifications of performance as the predicate.

Materials - The patient contacting materials of the electrode has been tested in accordance to ISO 10993-1 and FDA Guidance as was the predicate.

Environment of Use - Same

Patient Population - The Long Life Pads are restricted to adults

Performance Testing -

We have performed bench tests and found that the Long Life Pads met all requirements specifications and "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode". The testing is comprised of

. Dispersion Test Protocol Report Summary
. Adhesion Test Protocol Report Summary
Stability Testing (Storage Conditions) .
Stability Test Protocol Report (Shelf life) .
Stability Shipment Test Report Summary .

Conclusion -

The LONG LIFE PAD™ is substantially equivalent to the predicate Well-Life Self Adhesive Electrodes (K082065) in indications for use, patient population, and environment for use, technology characteristics, specifications and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Omron HealthCare, Inc. c/o Mr. Paul E. Dryden President, Regulatory Consultant for Omron 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K120516

Trade/Device Name: Long Life Pad™ Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 15, 2012 Received: February 21, 2012

Dear Mr. Dryden:

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.

MAY 1 7 2012

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Page 2 - Mr. Paul E. Dryden

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 (OS) 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 yours,
Kevin Norouzi

for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

510(k) Number:

LONG LIFE PAD™

K120516

Device Name:

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) or

Over-the-counter use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MzLB Nicholas

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120516

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).