(77 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on direct strength measurement.
No.
The device is intended as a "diagnostic aid for the quantitative evaluation of oro-facial muscle strength," making it a diagnostic device rather than a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength."
No
The device description refers to a "myographic measurement method for direct strength measurement," and the performance studies mention "bench testing (Pressure Validation)." This strongly suggests the device includes hardware components for physical measurement, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength." This involves measuring a physical characteristic (muscle strength) directly from the body, not analyzing a sample (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description confirms it's a "myographic measurement method for direct strength measurement of the oro-facial muscles." Myography is a technique for measuring muscle activity or force, which is a direct physiological measurement.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, using reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.
Therefore, the Oro-Facial Myographic Measurement Instrument is a diagnostic device, but it operates in vivo (within the body) by directly measuring muscle strength, not in vitro by analyzing samples.
N/A
Intended Use / Indications for Use
The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.
Product codes (comma separated list FDA assigned to the subject device)
LBB
Device Description
The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oro-facial cavity
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)
The results of bench testing (Pressure Validation) and biocompatibility evaluation support the substantial equivalence claims of the OMMI™ for its intended use in the oro-facial cavity. Results of the test, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the OMMI's substantial equivalence to the predicate device.
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.
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
§ 888.1240 AC-powered dynamometer.
(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
APR 1 6 1998 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
CONTACT PERSON:
Ronald E. Tura
P.O. Box 1082
Alamo, CA 94507
DEVICE NAME:
Oro-Facial Myographic Measurement Instrument (OMMI™) Class II
DEVICE DESCRIPTION:
The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.
INDICATIONS FOR USE:
The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength.
1
PREDICATE DEVICE:
John Chatillon & Sons, Inc. Dynamometer (K964685).
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
The results of bench testing (Pressure Validation) and biocompatibility evaluation support the substantial equivalence claims of the OMMI™ for its intended use in the oro-facial cavity. Results of the test, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the OMMI's substantial equivalence to the predicate device.
2
SUBSTANTIAL EQUIVALENCE CONCLUSIONS:
Substantial equivalence is based on the fact that the Oro-Facial Myographic Measurement Instrument has the same intended use, although different indications, and similar technological characteristics as the predicate device. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the Oro-Facial Myographic Measurement Instrument. Therefore, it can be concluded that the Oro-Facial Myographic Measurement Instrument is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Mr. Ronald E. Tura President OROFACIAL DYNAMICS P.O. Box 1082 Alamo, California 94507
Re: K980363 Oro-Facial Myographic Measurement Instrument (OMMI™) Requlatory Class: II Product Code: LBB Dated: January 23, 1998 January 29, 1998 Received:
Dear Mr. Tura:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with . the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic. Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Ronald E. Tura
This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stiptran Pluorlu
M. Witten, Ph.D., M.D. irector
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known): K 980363
Device Name: ORo-Fabian/ myographic measurement Instrument (ommi,
Indications For Use:
The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.
(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 General Restorative Devices | |
| 510(k) Number | K980363 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use(Optional Format 1-2-96)