The Target Sterile Electrodes are intended for use as a single patient, sterile, disposable, adhesive conductive interface between the patient's skin and the electromedical stimulator as ordered by a physician.

AI/ML Overview

This 510(k) summary describes a new medical device, the Target Sterile Electrode, and compares it to a predicate device, the Surgi-Stim Sterile Electrode, to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device, Surgi-Stim Sterile Electrode. The study aims to demonstrate that the new Target Sterile Electrode performs equivalently or better than the predicate for these properties.

Properties or Performance Characteristics	Acceptance Criteria (Predicate: Surgi-Stim Sterile Electrode)	Reported Device Performance (Target Sterile Electrode)
Electrode Backing Material	Non-woven	Non-woven
Method of attaching wire to electrode	Polyester Circular Disk	Polyester Circular Disk
Release liner card the electrode is stored on	Silicone Coated Paper	Silicone Coated Paper
Conductive Electrode Element	2 Mil Vinyl With Carbon Loaded Pigment Coated With Silver / Silver chloride Ink	2 Mil Vinyl With Carbon Loaded Pigment Coated With Silver / Silver chloride Ink
Hydrogel	Promeon RG 63B Formulation Thickness .032"	Comfort Gel A (Promeon RG 63B Formulation) Thickness .032"
Electrode Leadwire	Leadwire connector .080" or .059"	Leadwire connector .080" or .059"
Labeling	Sterile for Single Patient Use	Sterile for Single Patient Use
Labeling	States Potential Adverse Reactions is Skin Irritation	States Potential Adverse Reactions is Skin Irritation
Electrode Impedance @ 1000 Hertz	Less Than 100 Ohms	Less Than 100 Ohms
Force Required to Remove Wire From Electrode	More Than 5 Pounds of Force	More Than 6 Pounds of Force

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

The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The comparison is based on material specifications and performance characteristics, suggesting laboratory testing rather than clinical study on patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document does not describe the use of experts to establish ground truth. The comparison is based on objective material and physical property evaluations.

4. Adjudication Method

This document does not describe any adjudication method as it's not a study involving subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe a multi-reader multi-case comparative effectiveness study. The device is a cutaneous electrode, not an imaging or diagnostic device requiring human interpretation of results.

6. Standalone (Algorithm Only) Performance Study

No. This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation is based on objective physical and material properties and performance specifications of the predicate device. For instance, the "ground truth" for impedance is "Less Than 100 Ohms," and for wire removal force, it's "More Than 5 Pounds of Force."

8. Sample Size for the Training Set

This document does not specify a training set sample size. The comparison is based on characterization of the new device against an existing predicate.

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

This document does not describe a training set or how its ground truth was established, as this is a device equivalence submission based on material and performance comparison rather than an AI/machine learning model. The 'ground truth' for comparison purposes is the established specifications and performance of the predicate device.

Summary

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510(k) SUMMARY

APR 2 4 2008

Statement:	This summary of 510(k) substantial equivalence is being submittedin accordance with the requirements of 21 CFR 807.92.K072799
Submitter's Identification:	Vision Quest Industries, Inc.18011 Mitchell SouthIrvine, CA 92614Contact Person: Jaime Pulley, V.P. of Quality Assurance/Regulatory AffairsPhone: (760) 477-8201Fax: (760) 734-1577
Date Summary Prepared:	September 29, 2007
Name of Device:	Proprietary Name: Target Sterile ElectrodeCommon Name: Cutaneous Electrode
Classification Name:	(GXY)
Predicate Device Name:	Surgi-Stim Sterile Electrodes510(k) # K041953ConMed Corporation525 French Rd.Utica, NY 13502

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Description and Intended use:

Device Dimensions

Image /page/1/Figure/3 description: This image shows a technical drawing of a sensor. The sensor has a circular head with a diameter of 3.0 inches and is connected to a wire that is 18 inches long. The connector has an inner diameter of 0.059 inches. The drawing also shows an edge view of the sensor, which indicates that the overall thickness is less than 1/16 inch. The file name is 1222B07.

Sterilization Methods: 25kGy Gamma Radiation

For predicate device comparison performance comparison was based on the following properties.

1. Measurement of conductivity of the total electrode circuit from wire connector to the hydrogel
1. The strength of the electrode wire and the integrity of wire attachment.
1. The type of materials used in each of the electrode components.
The thickness of the hydrogel 4.
క. Leadwire connector
Labeling information 6.

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Properties orPerformanceCharacteristics	Target SterileElectrode	Surgi-StimSterile Electrode	Reason forSubstantialEquivalence
Electrode BackingMaterial	Non-woven	Non-woven	Using the sametype of material
Method ofattaching wire toelectrode	Polyester CircularDisk	Polyester CircularDisk	Using similarstrain relief madeof the samematerial
Release liner cardthe electrode isstored on	Silicone CoatedPaper	Silicone CoatedPaper	Using the sametype of material
ConductiveElectrode Element	2 Mil Vinyl WithCarbon LoadedPigment CoatedWith Silver / Silverchloride Ink	2 Mil Vinyl WithCarbon LoadedPigment CoatedWith Silver / Silverchloride Ink	Using the sametype of material
Hydrogel	Comfort Gel A(Promeon RG 63BFormulation)Thickness .032"	Promeon RG 63BFormulationThickness .032"	The Comfort GelA and the RG 63Bformulation arealmost identical
ElectrodeLeadwire	Leadwireconnector .080" or.059"	Leadwireconnector .080" or.059"	Using the sametype of connector
Labeling	Sterile for SinglePatient Use	Sterile for SinglePatient Use	Descriptivewording verysimilar
Labeling	States PotentialAdverseReactions is SkinIrritation	States PotentialAdverseReactions is SkinIrritation	Descriptivewording verysimilar
ElectrodeImpedance @1000 Hertz	Less Than 100Ohms	Less Than 100Ohms	Similar conductiveproperties
Force Required toRemove WireFrom Electrode	More Than 6Pounds of Force	More The 5Pounds of Force	Exceeds Surgi-Stim Electrode

Indications for Use:

The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.

Comparison to Predicate:

This device is substantially equivalent to its predicate device, the Surgi-Stim sterile electrodes. They provide similar indications for use and are all derived from similar materials, except the hydrogel.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2008

Vision Quest Industries, Inc. c/o Ms. Jaime Pulley 18011 Mitchell South Irvine, CA 92614

Re: K072799 Trade/Device Name: Target Sterile Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: April 18, 2008 Received: April 22, 2008

Dear Ms. Pulley:

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. Iisting 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.

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.

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Page 2 - Ms. Jaime Pulley

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Murli N. Melkote

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: TARGET STERILE ELECTRODE

Indications for Use:

Sterile - Single Patient Use Only - Disposable

The sterile Target electrode is intended for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation.

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

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)

Nil R.P. Ogl
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K072799

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).