(137 days)
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Not Found
No
The provided text describes a device for measuring and recording physiological data (electromyograms, sonograms, jaw traces) related to the temporomandibular system. It focuses on data acquisition, display, and comparison for clinical analysis. There is no mention of AI, ML, or any algorithms that would process this data using such techniques for diagnosis or analysis. The text explicitly states that comparisons between patients and population-based measurements are not supported due to insufficient normative data, which is contrary to how AI/ML models often function.
No
The device is described as aiding in diagnosis and monitoring, and for baseline measurements, but not for direct treatment or therapy.
Yes
The "Indications for Use" section explicitly states that the device is intended "To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing" and mentions aiding "in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system."
Unknown
The provided text only includes the Intended Use / Indications for Use section. It describes the functions of the device (Jaw Tracking, Electromyography, Sonography) which inherently require hardware components (sensors, transducers, etc.) to acquire the data (mandibular movement, electrical activity, joint sounds). Without the Device Description section, it's impossible to determine if the submission is for the software component only, which processes data from separate hardware, or if it includes the hardware itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device is described as recording electrical activity of muscles, tracking jaw movement, and recording joint sounds. These are measurements taken on the body, not analyses of samples from the body.
- The intended uses focus on monitoring, tracking, and aiding in diagnosis based on physical measurements and electrical signals. While these can contribute to a diagnosis, they are not the direct analysis of biological samples for disease markers or other in vitro indicators.
The device appears to be a diagnostic tool that uses physiological measurements (electromyography, jaw tracking, sonography) to assess the function and condition of the temporomandibular system. This falls under the category of in vivo diagnostic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made, Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)."
Jaw Tracking
- To track mandibular movement and position
- To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion]
- To identify mandibular rest position and to identify interocclusal distance and freeway space
- To monitor the position of the jaw in three dimensions
- To represent the spatial position of the mandibular incisal edge relative to the skull
- To provide Baseline measurements for future reference
Electromyography
- To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
- To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system.
- To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
- To measure relative (intra-patient) levels of activity of several muscles during a functional act
- To provide Baseline measurements for future reference
Sonography, joint vibration (sound) recording
- To record and display sounds / vibrations from the temporomandibular joint
- To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots
- To aid the clinician in companing a parient's current standard plots to previous recordings before, during and after treatment
- To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
- To provide Baseline measurements for future reference
Product codes (comma separated list FDA assigned to the subject device)
KZM, NFS, NFQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandibular incisal edge, stomatognathic system (temporalis, masseter, digastric muscles), temporomandibular joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 - 2005
Mr. John Radke Bio-Research Associates, Inc. 9275 North 49th Street Brown Deer, Wisconsin 53223
Re: K981563 Trade/Device Name: Biopak Measurement System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM and NFS and NFQ Dated: August 12, 1998 Received: August 14, 1998
Dear Mr. Radke
This letter corrects our substantially equivalent letter of September 15, 1998, 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 Rerister.
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);
1
Page 2 – Mr. John Radke
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 (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,
Qenite H. Michie MD
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: K981563 Device Name: BioPak Measurement System Indications for Use:
22:25 1:30 10
= ADI
At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made,
Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)."
Jaw Tracking
09703: 85
- To track mandibular movement and position 1.
[]=OUT
002/002
- To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion] 2.
- To identify mandibular rest position and to identify interocclusal distance and freeway space rt
- To monitor the position of the jaw in three dimensions 4.
- To represent the spatial position of the mandibular incisal edge relative to the skull ડ .
- To provide Baseline measurements for future reference 6.
Electromyography
- To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter 1. and digastric
- To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by 2. recording the electrical activity of the muscles of the stomatognathic system.
- To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest 3.
- To measure relative (intra-patient) levels of activity of several muscles during a functional act 4.
- To provide Baseline measurements for future reference ર -
Sonography, joint vibration (sound) recording
- To record and display sounds / vibrations from the temporomandibular joint 1 .
- To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in 2. various standard plots
- To aid the clinician in companing a parient's current standard plots to previous recordings before, during ਤੇ . and after treatment
-
- To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
- To provide Baseline measurements for future reference ನ.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumm
(Division Sign-Off)
( - - telefon of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infection of
510(k) Number .
Prescription Use Y (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
OR