PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000

K081279 · Transfer Technology · GXY · Jan 23, 2009 · Neurology

Device Facts

• Record ID: K081279
• Device Name: PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
• Applicant: Transfer Technology
• Product Code: GXY · Neurology
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transfer Technology PRO-TECH Delivery System electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator Transfer Technology's reusable electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), and MANS (Muscle and Neurological Stimulators)

Device Story

PRO-TECH Delivery System Electrodes are reusable, laminated neurostimulation electrodes. They function as a conductive interface between patient skin and electrical stimulators (TENS, EMS, MANS). Construction includes a top layer of vinyl tape or non-woven fabric, a conductive layer (pure tin or carbon with Ag/AgCl), a flexible vinyl tape perimeter, and a conductive hydrogel patient layer. A silicone-insulated stainless steel lead wire with a recessed female contact connects the electrode to the stimulator. Used in clinical or home settings under the direction of a healthcare provider. The device facilitates the delivery of electrical stimulation to the patient for therapeutic purposes.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and component comparison to predicate devices.

Technological Characteristics

Laminated flexible construction. Materials: Vinyl tape/non-woven fabric, pure tin or carbon with Ag/AgCl conductive layer, Amgel AG703 hydrogel. Lead wire: Silicone-insulated stainless steel yarn. Compliance: IEC 60601-1 Subclause 56.3(c) for insulated contacts; 21 CFR Part 898 for lead wire assembly.

Indications for Use

Indicated for use as a conductive adhesive interface between patient skin and electrical stimulators (TENS, EMS, MANS). No specific patient population, age, or gender restrictions provided.

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

• K000870 (Katecho Inc)
• K970426 (Axelgaard Manufacturing)
• K875284 (Medtronic Inc)

Submission Summary (Full Text)

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JAN 2 9 2009

Koss1279

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## 510(k) Summary

| Submitter's Information | Joseph J Arbour<br>Transfer Technology<br>37822 Oxford Drive<br>Murrieta, CA 92562<br>Phone [phone]<br>Fax [phone] | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date of Preparation | May 6, 2008 | |
| Proprietary Name | PRO-TECH Delivery System Electrodes | |
| Common Name | Neurostimulation Electrodes | |
| Classification Name | Electrodes, Cutaneous | |
| Predicate Device | K000870 (Katecho Inc )<br>K970426 (Axelgaard Manufacturing)<br>K875284 (Medtronic Inc ) | |
| Description of Device | Electrodes, Cutaneous | |
| Intended Use | The Transfer Technology PRO-TECH Delivery System<br>electrodes are intended for use as a disposable, conductive<br>adhesive interface between the patient's skin and the Electrical<br>Stimulator Transfer Technology's reusable electrodes are<br>designed and intended to be used with marketed Electrical<br>Stimulators, i.e. TENS (Transcutaneous Electrical Nerve<br>Stimulation), EMS (Electrical Muscular Stimulation), and MANS<br>(Muscle and Neurological Stimulators) | |
| Technological Comparison | The Transfer Technology PRO-TECH Delivery System<br>electrodes exhibit technological characteristics that are<br>substantially equivalent to those of the predicate device, as<br>determined by both component usage and physical testing | |
| Labeling Comparison | The labeling of Transfer Technology PRO-TECH Delivery<br>System electrodes substantially equivalent to those of the<br>predicate devices | |
| Device Description | Transfer Technology reusable neurostimulator electrodes are<br>laminated flexible materials widely used in this application | |
| | Top layer Vinyl tape or non-woven fabrics with biocompatible<br>adhesive | |
| | Second layer Grade "A" pure tin or electrically conductive<br>carbon with Ag or Ag/AgCl | |
| | Third layer 1.25" flexible vinyl tape with biocompatible adhesive<br>laminated around the outer perimeter of electrode | |
| | Patient layer Conductive hydrogel Amgel AG703 | |
| Device Description<br>(continued) | Lead Wire Constructed of a silicone-insulated stainless steel<br>yarn wire with a standard 080" recessed female contact<br>crimped and then insulated to one end By design, the insulated<br>contact prevents the conductive connection to earth or<br>hazardous voltages as required in IEC 60601-1 Subclause<br>56 3(c) Wire assembly is in compliance with FDA performance<br>standard 21 CFR Part 898 | |
| Non-clinical Testing | The critical components used in Transfer Technology<br>PRO-TECH Delivery System electrodes<br>(Amgel AM703 K983741) are the same as used in the<br>predicate devices Therefore there is no reason to believe that<br>the Transfer Technology PRO-TECH Delivery System electrodes<br>will perform any different than the predicate device | |
| Clinical Testing | Not Applicable | |
| Packaging | Electrodes are stored in a 2-mil poly re-sealable bag to comply<br>with the shelf life specifications of the hydrogel manufacturer<br>Labeling is compliant to 21CFR Part 801 | |
| Conclusion | The Transfer Technology PRO-TECH Delivery System<br>electrodes are substantially equivalent to those of the submitted<br>predicate devices and any difference between the devices do not<br>pose new questions of safety and effectiveness | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized strokes forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Transfer Technology % Mr Joseph J Arbour 37822 Oxford Drive Murrieta, California 92562

JAN 2 3 2009

Re K081279

Trade/Device Name PRO-TECH Delivery System Electrodes Regulation Number 21 CFR 882 1320 Regulation Name Cutaneous electrode Regulatory Class II Product Code GXY Dated November 17, 2008 Received November 17, 2008

Dear Mr Arbour

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 pror 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 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 - Mr Joseph J Arbour

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 Brometric'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 Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours,

Mark N Milham

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) | K081279 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | PRO-TECH Delivery System Electrodes |
| Indications For Use | The Transfer Technology PRO-TECH Delivery<br>System electrodes are intended for use as a<br>disposable, conductive adhesive interface<br>between the patient's skin and the Electrical<br>Stimulator Transfer Technology's reusable<br>electrodes are designed and intended to be used<br>with marketed, Electrical Stimulators, i.e. TENS<br>(Transcutaneous Electrical Nerve Stimulation),<br>EMS (Electrical Muscular Stimulation), and MANS<br>(Muscle and Neurological Stimulators) |

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)

David Keane by MKM 1/23/2009
Division Sign-Off

Jivision of General, Restorative. and Neurological Devices

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~~(k) Number K081279