GUARDIAN 150 ELECTRODE

K083756 · Selectivemed Components, Inc. · GXY · Jun 26, 2009 · Neurology

Device Facts

• Record ID: K083756
• Device Name: GUARDIAN 150 ELECTRODE
• Applicant: Selectivemed Components, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.

Device Story

Guardian 150 electrode is a single-patient, single-use, self-adhering cutaneous electrode. It interfaces with TENS and NMES devices to deliver electrical stimulation to muscles, specifically for pharyngeal contraction and muscle re-education. Available in cloth, pre-wired, snap, and pin configurations. The device is latex-free. It is used in clinical or home settings as prescribed, functioning as a passive conductive interface between the stimulation device and the patient's skin.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous electrode; self-adhering; latex-free; cloth backing; configurations include pre-wired, snap, and pin styles. Passive conductive interface for TENS/NMES devices.

Indications for Use

Indicated for use with TENS and NMES, including muscle re-education via external stimulation of muscles required for pharyngeal contraction.

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

• Chattanooga VitalStim (K023347)
• Guardian disposable TENS and TENS/NMES electrodes (K945676)
• Columbia 600 Electrode (K080386)

Submission Summary (Full Text)

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ATTACHMENT 13

# 510(k) Summarv As Required by 21 section 807.92 ( c )

KC083756

1-Submitter Name: SelectiveMed™ Components, Inc 2-Address: 564 Harcourt Road Mount Vernon, OH 43050 3-Phone: [phone] 397 6112 4-Fax: 5-Contact Person: Mr Rick Fisher (President) 6-Date summary prepared: June 11th, 2009 7 - Official Correspondent: Mansour Consulting LLC 8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA 9- Phone: [phone]

10- Fax: [phone]

11- Contact Person: Jay Mansour, President

JUN 2 6 2009

12-Device Trade or Proprietary Name: Guardian 150 electrode. Model Numbers 150, 151, 152 and 3637

13-Device Common or usual name: Electrode for TENS, TENS/NMES including for muscles necessary for pharyngeal contraction

### 14-Device Classification Name: Electrode, cutaneous

#### 15-Substantial Equivalency is claimed against

The electrode of the Chattanooga VitalStim, cleared under K023347 (Chattanooga group)

Guardian disposable TENS and TENS/NMES electrodes cleared under K945676 (SelectiveMed TM Components, Inc)

Columbia 600 Electrode cleared under K080386 (Columbia Scientific Development, LLC)

### 16-Description of the Device:

Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.

#### 17-Intended use of the device: (refer to FDA form attached)

Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.

#### 18-Safety and Effectiveness of the device:

Guardian 150 electrode is safe and effective as the predicate devices cited above.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three overlapping strokes, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.

JUN 26 2009

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SelectiveMed Components, Inc. % Mansour Consulting Inc. Mr. Jay Mansour President 845 Aronson Lake Court Roswell, Georgia 30075

Re: K083756

Trade/Device Name: Guardian 150 electrode- Models 150, 151, 152 and 3637 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 11, 2009 Received: June 17, 2009

Dear Mr. Mansour:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jay Mansour

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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 14

# Indications for Use

510(k) Number (if known):

Device Name: Guardian 150 electrode- Models 150, 151, 152 and 3637

Indications For Use:

Guardian 150 electrode is indicated for use with TENS and NMES, including for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

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

Over-The-Counter Use (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)

Haywood S. Gill

K083756

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number ***_***