MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I

K992694 · Myotronics-Noromed, Inc. · KZM · Sep 10, 1999 · Physical Medicine

Device Facts

• Record ID: K992694
• Device Name: MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
• Applicant: Myotronics-Noromed, Inc.
• Product Code: KZM · Physical Medicine
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.1375
• Device Class: Class 2

Intended Use

For Jaw Tracking functions of this device: - Tracks mandibular movement and position . - . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion - Identification of mandibular rest position . - Identification of interocclusal distance and freeway space . - . Monitors the position of the jaw in three dimensions - Represents the spatial position of the mandibular incisal edge relative to the skull . For electromyographic function of this device: - Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ● - . Designed to perform a limited number of functions in dental diagnosis - For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system - The determination of the degree of relaxation of a particular muscle or muscle group at rest . - The precise measurement of relative levels of contraction of several muscles during a ■ functional test For both functions of this device: - Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.

Device Story

Model K6-I Diagnostic System is a surface electromyography (EMG) and jaw-tracking device. It captures electrical potentials from masticatory muscles and tracks mandibular movement in three dimensions. The system monitors up to eight muscles simultaneously. It provides clinicians with data on muscle relaxation, contraction levels during functional tests, and spatial mandibular position relative to the skull. The device is used in dental clinics for diagnosing TMJ/MPD syndrome, bruxing, and occlusal instability, and for evaluating treatment in orthodontic, denture, and reconstruction patients. The system now includes Fast Fourier Transformation (FFT) for signal analysis. Clinicians use the output to assess muscle function and jaw position, aiding in clinical decision-making for dental disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surface electromyograph and jaw-tracking system. Measures electrical muscle potential and mandibular spatial position. Software includes Fast Fourier Transformation (FFT) for signal processing. Standalone system capable of monitoring up to eight muscles.

Indications for Use

Indicated for patients requiring diagnosis and management of TMJ/MPD disorders, orthodontic, denture, or reconstruction treatment. Used for monitoring masticatory muscles (temporalis, masseter, digastric) and tracking mandibular movement/position.

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Reference Devices

• ProComp DSP (Thought Technology)
• Myosystem 1000 Electromyograph (Noraxon)
• I-330 Physiological Monitor (J & J Engineering)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 23 2005

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

Re: K992694

Trade/Device Name: Model K6-I Diagnostic System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM and NFS Dated: August 11, 1999 Received: August 12, 1999

Dear Mr. Adib

This letter corrects our substantially equivalent letter of September 10, 1999, regarding the classification of your device which was incorrectly identified in the previous letter.

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 (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.

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 specificadvice 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,

Carl

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

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510(k) Number (if known): _ K 99 x 94

Device Name: __ Model K6-I Diapnostic System

Indications for use

For Jaw Tracking functions of this device:

- Tracks mandibular movement and position .
- . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion
- Identification of mandibular rest position .
- Identification of interocclusal distance and freeway space .
- . Monitors the position of the jaw in three dimensions
- Represents the spatial position of the mandibular incisal edge relative to the skull .

For electromyographic function of this device:

- Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ●
- . Designed to perform a limited number of functions in dental diagnosis

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| | |
| | |

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972694

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Page 1

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510(k) Number: K 992694_

Device Name: Model K6-I Diagnostic System

Indications for use = electromyographic functions of this device (continued from page ■ >

- For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system
- The determination of the degree of relaxation of a particular muscle or muscle group at rest .
- The precise measurement of relative levels of contraction of several muscles during a ■ functional test

For both functions of this device:

- Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients.
The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

(PLEASEDO NOT WRITE BELOW THIS LINE = CONTINUE ON ANOTHER PACE TE NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | L992694 |

| Prescription Use | | OR | Over-The-Counter Use |
|----------------------|--|----|----------------------|
| (Per 21 CFR 801.109) | | | |

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SEP 1 0 1999

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MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years

## Attachment 4

K992694

**510(k) SUMMARY**

Kooztez

- 1. Submitter's Information
Date of Submission: Name and address:

August 11, 1999

Myotronics-Noromed. Inc.. 15425 - 53 Ave. So., Tukwila, WA 98188 Tel: [phone] FAX: [phone]

Contact Name:

Mr. Fray Adib

2. Device Trade Name: Common name: Classification name:

Model K6-I Diagnostic System Surface EMG System Electromyograph

3. Myotronics-Noromed's intended addition of Fast Fourier Transformation (FFT) of data to the K6-I Software is substantially equivalent to that feature found in:

> ProComp DSP & ProComp mfg. by Thought Technology Myosystem 1000 Electromyograph mfd. by Noraxon I-330 Physiological Monitor mfd. by J & J Engineering

- 4. Description of the device:
The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion).

5. The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

Image /page/4/Picture/20 description: The image shows two logos. The logo on the left has the word "Intertek" in a circular fashion around a globe with a structure on top. The logo on the right has a triangle inside of a circle with the words "Accredited by the Council for Accreditation (RvA)" below it. Above the two logos are the words "Certified ISO 9001".