MYO-TRODE SG DISPOSABLE ELECTRODE

K040400 · Myotronics-Noromed, Inc. · NUW · Jul 20, 2004 · Physical Medicine

Device Facts

• Record ID: K040400
• Device Name: MYO-TRODE SG DISPOSABLE ELECTRODE
• Applicant: Myotronics-Noromed, Inc.
• Product Code: NUW · Physical Medicine
• Decision Date: Jul 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2

Indications for Use

As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models J4, J5, and BNS-40.

Device Story

Myo-trode SG is a disposable, adhesive, cutaneous electrode designed to interface between patient skin and Myotronics-Noromed muscle stimulators. The device consists of a metal snap connector, adhesive foam, and a solid hydrogel conductive surface. It functions as a passive conductive pathway for electrical stimulation. Used in clinical settings by healthcare providers, the electrode facilitates the delivery of stimulation from the stimulator to the patient's muscle tissue. The device is intended to provide a safe, reliable electrical connection, with patient benefit derived from the effective delivery of muscle stimulation therapy. Safety is managed through biocompatible materials tested per ISO 10993 standards.

Clinical Evidence

Bench testing only. Biocompatibility testing performed by an independent laboratory confirmed materials are not irritants and meet ISO 10993 requirements for irritation, cytotoxicity, and allergic potential. Effectiveness was demonstrated through impedance testing.

Technological Characteristics

Disposable cutaneous electrode; materials include metal snap connector, adhesive foam, and solid hydrogel conductive surface. Complies with ISO 10993 standards for biocompatibility. Passive electrical interface; no energy source or software.

Indications for Use

Indicated for use as a disposable, adhesive, conductive interface between a patient's skin and Myotronics-Noromed muscle stimulating devices (Models J4, J5, and BNS-40).

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Lead-Lok neurostimulation electrodes (K010431)
• Uni-Patch TENS Electrodes (K961141)
• Myotrodes II (K921498)
• Model BNS-40 (K842224/A)
• Model J-4 (K842223)
• Model J-5 (K031998)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 13 2005

Mr. Fray Adib President Myotronics-Noromed, Incorporated 15425 53rd Ave South Tukwila, Washington 98188

Re: K040400

Trade/Device Name: Myo-trode SG Disposable Electrodes Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NUW Dated: June 2,2004 Received: June 4,2004

Dear Mr. Adib:

This letter corrects our substantially equivalent letter of July 20, 2004, regarding the classification of your device which was incorrectly identified as "unclassified."

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 (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.

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Page 2 - Mr. Fray Adib

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.

This letter will allow you to continue 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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.

iu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________ Myo-trode SG Electrodes

Indications for Use:

As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.

Prescription Use XX (Per 21 CFR 801.109)

OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runor

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices K6404CD

510(k) Number.

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## JUL 2 0 2004

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

Myo-trode SG Electrodes,

## 510(k) # K-040400

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21CFR 807.92(c)

| Submitter: | Myotronics-Noromed, Inc.<br>15425 – 53rd Avenue South<br>Tukwila, WA 98188<br>Telephone [phone]<br>Contact: Mr. Fray Adib, President |
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| Date Prepared: | February 10, 2004 (Revised July 6, 2004) |
| Device Name: | Myo-trode SG disposable, adhesive, electrodes |
| Common name: | Muscle monitoring devices, accessory |
| Classification: | Unclassified, Product code KZM |
| Predicate devices: | Lead-Lok neurostimulation electrodes, K010431,<br>Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498,<br>Model BNS-40, K842224/A, Model J-4, K842223, Model J-5,<br>K031998 |

Description of the Device: A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.

Intended Use: As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models J4, J5, and BNS-40.

Comparison with equivalent devices: The device is virtually identical to several devices that have previously been legally marketed. K010431 and K961141 (as above) are given as specific examples.

Safety & Effectiveness Information: There are no significant differences between the design and manufacture of the cited equivalent devices. Skin irritation was the only potential hazard identified by risk analysis. Patient contact materials have been tested by an independent testing laboratory and found to be "not an irritant" and to meet pertinent requirements of ISO 10993 (Test results on file.) Effectiveness was demonstrated through impedance testing.

Conclusion: The Myo-trode SG is substantially equivalent to the cited predicate devices, has been certified to meet current standards for irritation, cytotoxicity and allergic potential, and has been tested for effectiveness.