(29 days)
Not Found
Not Found
No
The document describes standard signal processing techniques (Fast Fourier Transformation) and does not mention AI or ML.
No
The device is primarily described for diagnosis, monitoring, and evaluation of various conditions, not for direct treatment or therapy. Its functions focus on tracking, measuring, and identifying issues related to jaw movement and muscle activity.
Yes
The text explicitly states "For the diagnosis of functional disorders such as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion" and "Designed to perform a limited number of functions in dental diagnosis." It also uses the term "Diagnostic System" in the device description.
No
The device description explicitly states it 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)". This indicates the device includes hardware components for measurement and recording, not just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The description of this device clearly states it is a surface electromyographic device that measures and records electrical potential emanating from muscle and tracks mandibular movement. It does not mention analyzing blood, urine, tissue, or any other bodily fluid or substance.
- The intended uses are related to physiological measurements and tracking. The functions described are focused on measuring muscle activity (EMG) and tracking jaw movement, which are in vivo measurements, not in vitro analysis of specimens.
The device is a diagnostic tool used in a clinical setting (dental diagnosis, clinical monitoring) for assessing physiological function related to the stomatognathic system. This falls under the category of in vivo diagnostic devices, not in vitro diagnostics.
N/A
Intended Use / 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
- 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.
Product codes (comma separated list FDA assigned to the subject device)
KZM, NFS
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles of mastication, especially temporalis, masseter, and digastric
jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The information provided only states that the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. It then lists other devices that feature Fast Fourier Transformation (FFT) for comparison.
ProComp DSP & ProComp mfg. by Thought Technology, Myosystem 1000 Electromyograph mfd. by Noraxon, I-330 Physiological Monitor mfd. by J & J Engineering
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.1375 Diagnostic electromyograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are connected and appear to be flowing into each other.
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.
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
2
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
(continued on page 2)
(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
3
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) |
Page 2
4
SEP 1 0 1999
Image /page/4/Picture/1 description: The image is a black and white circular graphic. The left side of the circle is filled with a black silhouette of a person's face in profile. The right side of the circle is white, and the background of the face is filled with a black and white sound wave pattern.
MYOTRONICS-NOROMED, INC. Leading in Musculoskeletal Evaluation Technologies For Over 25 Years
Attachment 4
510(k) SUMMARY
Kooztez
-
- Submitter's Information
Date of Submission: Name and address:
- Submitter's Information
August 11, 1999
Myotronics-Noromed. Inc.. 15425 - 53 Ave. So., Tukwila, WA 98188 Tel: (206) 243-4214 FAX: (206) 243-3625
Contact Name:
Mr. Fray Adib
- Device Trade Name: Common name: Classification name:
Model K6-I Diagnostic System Surface EMG System Electromyograph
- 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
-
- 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).
- Description of the device:
- 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".