(79 days)
Not Found
Not Found
No
The summary describes a device that measures and records sounds and jaw position, but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as measuring and recording sounds to assess the status of the temporomandibular joint, which indicates a diagnostic rather than therapeutic purpose.
Yes
The device "measures and records sounds emitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint," which indicates it is used to evaluate or determine a medical condition.
No
The device description explicitly states it "measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw". This implies the use of hardware components (like microphones and position sensors) to acquire this data, making it a hardware device with likely integrated software, not a software-only device.
Based on the provided information, the ELECTROSONOGRAM ESC-I is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is non-invasive and measures sounds emitted from the temporomandibular joint. It does not involve analyzing samples taken from the body.
Therefore, the ELECTROSONOGRAM ESC-I falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint."
Product codes
NFQ, NFS
Device Description
ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
temporomandibular (jaw) joint
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)
SONOPAK/QS
Reference Device(s)
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
§ 872.2050 Dental sonography device.
(a)
Dental sonography device for monitoring —(1)Identification. A dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint.(2)
Classification. Class I. The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental sonography device for interpretation and diagnosis —(1)Identification. A dental sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful output, either directly or by connection to a personal computer. The device may be part of a system of devices, contributing joint sound information to be considered with data from other diagnostic components.(2)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2005
Mr. Fray Adib President Myotronics-Noromed, Incorporated 15425 53td Ave South Tukwila, Washington 98188
Re: K970116 Trade/Device Name: ESG-1 Electrosonograrn (ESG-1) Regulation Number: 21 CFR 872.2050 Regulation Name: Dental sonography device Regulatory Class: I Product Code: NFQ and NFS Dated: January 10, 1997 Received: January 13, 1997
Dear Mr. Adib
This letter corrects our substantially equivalent letter of April 2, 1997, 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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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,
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
Enclosure
2
510(k) Number (if known): _
)vice Name:_ESG-1 Electrosonogram, Version 3.0-S
Indications For Use:
The original 510(k) for this device, K-905449/A, contained the following indications for use:
"The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------the jaw as a means of assessing the status of the temporomandibular joint."
This 510(k) does not expand upon those indications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Info and General Hospi ત લ 510(k) Number .
escription Use
(Per 21 CFR 801.109)
. OR
Over-The Counter Use
(Optional Format 1-2-96)
్లు ప్రస్తుంది. ప్రస్తుంది. ప్రస్తుంది. ప్రస్తుంది. స్పూర్ స్టాఫ్ వ్యవస్థ నటింగ్ సరఫరాల సంఖ
3
KA70116
Image /page/3/Picture/1 description: The image shows the text "APR -2 1997". The text is in bold, and the date is April 2, 1997. The text is likely from a document or photograph.
Image /page/3/Picture/2 description: The image shows the logo for Myo-Tronics, Inc. The text "MYO-TRONICS, INC." is in a simple, sans-serif font. To the right of the text is a circular logo with a stylized profile of a head and a waveform, possibly representing medical or electronic signals.
510(k) SUMMMARY
1. Submitter's Information
Date of Submission: January 10, 1997 Submitter's name and address:
Myo-tronics, Inc., 15425 - 53 Ave. So., Tukwila, WA 98188 FAX: (206) 243-3625 Tel: (206) 243-4214
Contact Name:
Mr. Fray Adib
-
- Device Trade Name: Common name: Classification name:
ESG-1 Electrosonogram or Sonograph Temporomandibular Joint Sound Recorder Unclassified
- Device Trade Name: Common name: Classification name:
- Myo-tronics' ESG-1 Electrosonogram is substantially equivalent to: SONOPAK/QS manufactured by BioResearch of Milwaukee, Wisconsin.
4. Description of the device:
ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
- The ESG-1 Electrosonogram has the same technological characteristics as the above mentioned predicate device.
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