(86 days)
Not Found
Not Found
No
The summary describes a mechanical distraction system and explicitly states that AI, DNN, or ML were not found in the document.
Yes
Explanation: The device is intended for "gradual bone lengthening of the mandible," which describes a therapeutic intervention to treat mandibular deficiencies or post-traumatic defects.
No
The device, a "Lorenz Intraoral Linear Mandibular Distraction System," is intended for gradual bone lengthening of the mandible, which is a therapeutic treatment rather than a diagnostic function.
No
The device description explicitly states "Lorenz Intraoral Linear Mandibular Distraction System," which implies a physical system used for bone lengthening, not solely software.
Based on the provided information, the Lorenz Intraoral Linear Mandibular Distraction System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gradual bone lengthening of the mandible." This is a surgical procedure performed in vivo (within the living body) to modify bone structure.
- Device Description: The description points to a system used for physical manipulation of bone.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- 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. The Lorenz system is a surgical device used for bone distraction, which is a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Lorenz Intraoral Linear Mandibular Distraction System is intended for use in the mandibilo [mandible] for bone lengthening as mandibular deficiencies or post traumatic defects require gradual bone distraction.
Product codes
MQN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibilo [mandible]
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes extending to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480
Re : K982906 Lorenz Intraoral Linear Mandibular Trade Name: Distraction System Regulatory Class: Unclassified Product Code: MQN August 17, 1998 Dated: Received: August 18, 1998
Dear Ms. Preston:
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, Druq, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.
1
Page 2 - Ms. Preston
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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cuesta Hoffer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): Unknown
Device Name: Lorenz Intraoral Linear Mandibular Distraction System
The Lorenz Intraoral Linear Mandibular Indications For Use: The Lorenz Incraorar Lintended for use in the Distraction bystem lizer and bone lengthening mandibilo as mandibular deficiecies or post traumatic defects require gradual bone distraction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suoen Puaser
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital , Infect 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)