Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and electrical properties of the electrode pads, with no mention of AI or ML.

Therapeutic

No
The device, LONG LIFE PAD™, is described as a "disposable, conductive adhesive interface" intended for use with an Electrical Stimulator (Omron Electrotherapy Pain Relief Unit, PM3030), not as a therapeutic device itself. Its purpose is to connect the stimulator to the patient's skin.

Diagnostic

No

The device is described as a "conductive adhesive interface" for an electrical stimulator, indicating its role in therapy delivery rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components including a polyester protective film, gel, carbon layer, polyethylene lamination layer, and a snap connection, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is as a conductive adhesive interface between the patient's skin and an electrical stimulator for pain relief. This is a therapeutic application, not a diagnostic one.
Device Description: The description details the physical components and function of the pads for electrical stimulation, not for analyzing biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is the core function of an IVD.
Performance Studies: The performance studies focus on physical properties like dispersion, adhesion, and stability, which are relevant to the function of an electrode pad, not the accuracy of a diagnostic test.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate electrical stimulation for pain relief, which falls under the category of a therapeutic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

GXY

Device Description

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's skin

Indicated Patient Age Range

Adults

Intended User / Care Setting

Clinics, hospital and home use environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench tests were performed and 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 .

Key Metrics

Not Found

Predicate Device(s)

K082065

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

K120516

MAY 1 7 2012

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

| Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 | Tel - 847-247-5625
Fax - 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, cutaneous
CFR 882.1320
Class 2 |
| Device: | Long Life PadTM |
| Predicate Device: | Well Life Healthcare Limited – Well-Life Self
Adhesive Electrodes K082065 |

Device Description:

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.

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.

1

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

Indications for Use:

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.

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.

2

Device Comparison
Indications for Use	Well-Life Pad
510(k) K082065
The Well Life Self Adhesive
Electrode/CM, FA, PU and SP
series are intended for use as a
disposable, conductive adhesive
interface between the patient's
skin and the Electrical
Stimulator. Well Life Self
Adhesive Electrode / AP, CM,
FA, PU and SP series are
designed and intended to be
used With marketed Electrical
Stimulators, i.e. TENS
(Transcutaneous Electrical
Nerve Stimulation), MENS
(Microcurrent Electrical Nerve
Stimulation), EMS (Electrical
Muscular Stimulation), IF
(Interferential) and PGS (Pulsed
Galvanic Stimulation)	May 9, 2012
Long Life Pad
The LONG LIFE PADTM 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.	Comparison
Similar indications. The Long
Life Pad is restricted to the
Omron PM3030 stimulator
(K110068)
Product Code
Prescriptive or
OTC	GXY	GXY	Identical
	Both	OTC	Similar
Environment Of
use	Clinics, hospital and home use
environments	Clinics, hospital and home use
environments	Identical
	Well-Life Pad
510(k) K082065	Long Life Pad
510(k) TBD	Comparison
Patient
Population	Adult	Adult
Conductive
Interface	Biocompatible hydrogel	Biocompatible hydrogel	Identical
Construction &
Materials	Bottom to top:
• PET protective layer,
• gel,
• scrim layer,
• carbon layer,
• non-skin contact white
foam layer
• with snap connection	Bottom to top:
• Polyester protective film,
• gel,
• carbon layer,
• non-skin contact
polyethylene lamination
layer
• with snap connection	Identical

Construction layers and materials
are very similar. |

510(k) Summary

3

510(k) Summary

:

、一

4

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.

5

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

6

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

7

Indications for Use Statement

Page 1 of 1

510(k) Number:

LONG LIFE PAD™

K120516

Device Name:

Indications for Use:

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.

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