TARGET STERILE ELECTRODE

K072799 · Vision Quest Industries, Inc. · GXY · Apr 24, 2008 · Neurology

Device Facts

• Record ID: K072799
• Device Name: TARGET STERILE ELECTRODE
• Applicant: Vision Quest Industries, Inc.
• Product Code: GXY · Neurology
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Target Sterile Electrode is a single-patient, disposable, adhesive conductive interface; connects patient skin to electromedical stimulator. Device consists of circular sensor head (3.0 inch diameter), 18-inch wire, and connector (0.059 or 0.080 inch). Construction includes non-woven backing, silicone-coated paper release liner, and conductive element (vinyl with carbon-loaded pigment and silver/silver chloride ink). Hydrogel (Comfort Gel A) provides conductive interface. Used in clinical settings for neuromuscular and nerve stimulation; operated by healthcare professionals. Device delivers electrical stimulation to patient; output impedance <100 Ohms at 1000 Hz. Benefits include safe, sterile electrical signal transmission for therapeutic stimulation. Sterilized via 25kGy Gamma Radiation.

Clinical Evidence

Bench testing only. Performance characteristics compared to predicate included conductivity of total electrode circuit, wire strength/attachment integrity, material composition, hydrogel thickness, and impedance. Impedance measured <100 Ohms at 1000 Hz; wire pull-force exceeded 6 pounds.

Technological Characteristics

Non-woven backing; silicone-coated paper release liner; conductive element: 2 mil vinyl with carbon-loaded pigment and silver/silver chloride ink; hydrogel: Comfort Gel A (Promeon RG 63B formulation, 0.032" thick); leadwire connector: 0.059" or 0.080"; sterilization: 25kGy Gamma Radiation.

Indications for Use

Indicated for use in Electrical Neuromuscular and Transcutaneous Electrical Nerve Stimulation. Single patient, disposable use.

Regulatory Classification

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.

Predicate Devices

• Surgi-Stim Sterile Electrodes (K041953)

Submission Summary (Full Text)

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# 510(k) SUMMARY

APR 2 4 2008

| Statement: | This summary of 510(k) substantial equivalence is being submitted<br>in accordance with the requirements of 21 CFR 807.92.<br>K072799 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Identification: | Vision Quest Industries, Inc.<br>18011 Mitchell South<br>Irvine, CA 92614<br>Contact Person: Jaime Pulley, V.P. of Quality Assurance/<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | September 29, 2007 |
| Name of Device: | Proprietary Name: Target Sterile Electrode<br>Common Name: Cutaneous Electrode |
| Classification Name: | (GXY) |
| Predicate Device Name: | Surgi-Stim Sterile Electrodes<br>510(k) # K041953<br>ConMed Corporation<br>525 French Rd.<br>Utica, NY 13502 |

:

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Description and Intended use:

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.

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
- 2. The strength of the electrode wire and the integrity of wire attachment.
- 3. 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 or<br>Performance<br>Characteristics | Target Sterile<br>Electrode | Surgi-Stim<br>Sterile Electrode | Reason for<br>Substantial<br>Equivalence |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Electrode Backing<br>Material | Non-woven | Non-woven | Using the same<br>type of material |
| Method of<br>attaching wire to<br>electrode | Polyester Circular<br>Disk | Polyester Circular<br>Disk | Using similar<br>strain relief made<br>of the same<br>material |
| Release liner card<br>the electrode is<br>stored on | Silicone Coated<br>Paper | Silicone Coated<br>Paper | Using the same<br>type of material |
| Conductive<br>Electrode Element | 2 Mil Vinyl With<br>Carbon Loaded<br>Pigment Coated<br>With Silver / Silver<br>chloride Ink | 2 Mil Vinyl With<br>Carbon Loaded<br>Pigment Coated<br>With Silver / Silver<br>chloride Ink | Using the same<br>type of material |
| Hydrogel | Comfort Gel A<br>(Promeon RG 63B<br>Formulation)<br>Thickness .032" | Promeon RG 63B<br>Formulation<br>Thickness .032" | The Comfort Gel<br>A and the RG 63B<br>formulation are<br>almost identical |
| Electrode<br>Leadwire | Leadwire<br>connector .080" or<br>.059" | Leadwire<br>connector .080" or<br>.059" | Using the same<br>type of connector |
| Labeling | Sterile for Single<br>Patient Use | Sterile for Single<br>Patient Use | Descriptive<br>wording very<br>similar |
| Labeling | States Potential<br>Adverse<br>Reactions is Skin<br>Irritation | States Potential<br>Adverse<br>Reactions is Skin<br>Irritation | Descriptive<br>wording very<br>similar |
| Electrode<br>Impedance @<br>1000 Hertz | Less Than 100<br>Ohms | Less Than 100<br>Ohms | Similar conductive<br>properties |
| Force Required to<br>Remove Wire<br>From Electrode | More Than 6<br>Pounds of Force | More The 5<br>Pounds of Force | Exceeds Surgi-<br>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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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