(80 days)
Not Found
None
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 devices. The device description is very simple ("Self-Releasable Force Module").
No
The device is described as a "Self-Releasable Force Module" intended for the "prescribed treatment of malocclusions," indicating it directly provides treatment rather than aiding in diagnosis or prognosis.
No
Explanation: The device is described as being used for the "prescribed treatment of malocclusions," indicating a therapeutic rather than a diagnostic function. There is no mention of it analyzing or interpreting any data to identify or characterize a condition.
No
The provided summary describes a "Self-Releasable Force Module" which strongly suggests a physical component, not a software-only device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "prescribed treatment of malocclusions by dentists." This describes a therapeutic intervention performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device is described as a "Self-Releasable Force Module." This sounds like a component used in orthodontic treatment, which is a therapeutic process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's intended use and description clearly fall outside of that definition.
N/A
Intended Use / Indications for Use
This device is intended to be used for the prescribed treatment of malocclusions by dentists.
Product codes
DZB
Device Description
Self-Releasable Force Module
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 6 1998
Mr. Steven O. Luse ·President Ortho Kinetics Corporation 1611A South Melrose Drive, Suite 16 Vista, California 92083-5407
Re : K980151 Trade Name: Releasable Force Module Regulatory Class: II Product Code: DZB Dated: January 14, 1998 January 16, 1998 Received:
Dear Mr. Luse:
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. A substantially equivalent determination assumes compliance with amou the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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
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Page 2 - Mr. Luse
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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) 638-2047 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ortho Kinctics Corporation 510(K) Submission Premarket Notification Facebow Headgear January 14, 1998
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Exhibit L
510(K) Number: K980151
Device Name: Self-Releasable Force Module
Indications For Use: This device is intended to be used for the prescribed treatment of malocclusions by dentists.
Sunny Rosser
(Division Sign-Off) Division of Dental, Infection Control, --------------------------------------------------------------------------------------------------------------------------------------and General Hospital Devices 510(k) Number_1980)5