(90 days)
Not Found
Not Found
No
The summary describes a mechanical device for bone distraction and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is used for the "distraction of the ascending ramus and mandibular body" in cases of "deficiency or posttraumatic effects of the mandible," which indicates a therapeutic purpose to correct anatomical issues.
No
The device is described as a distractor for the mandible, which is a therapeutic function, not a diagnostic one. It is used to distract or move the mandible, not to identify a disease, condition, or its cause.
No
The device description explicitly states it is an "intra oral device" and describes its physical function ("distraction of the ascending ramus and mandibular body"), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- The description of this device clearly states it is an "intra oral device for the distraction of the ascending ramus and mandibular body." This indicates it is a surgical or therapeutic device used directly on the patient's anatomy, not for analyzing biological samples.
The information provided focuses on the device's mechanical function and anatomical application, which is consistent with a non-IVD medical device.
N/A
Intended Use / Indications for Use
An uni-directional, intra oral device for the distraction of the ascending ramus and mandibular body.
Product codes
MON
Device Description
The KLS-Martin distractor device is designed to distract the mandible in cases of deficiency or posttraumatic effects of the mandible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending ramus and mandibular body
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)
KLS-Martin Intraoral Horizontal Distractor
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
JAN 26 1999
Kag3809
510(K) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
Regulatory & Marketing Services, Inc. (RMS) 3234 Ella Lane . New Port Richey, FL 34655
Phone: 813-376-4154 Fax: 813-376-7186
Ed Ransom or Pat Lamb
October 28, 1998
Contact Person:
Trade Name:
Date of Summary:
KLS-Martin Intraoral Zurich Ramus Distractor
Classification Name:
Predicate Device:
Device Description Comparison:
"
Ridgid External Distractor
KLS-Martin Intraoral Horizontal Distractor
The KLS-Martin distractor device is designed to distract the mandible in cases of deficiency or posttraumatic effects of the mandible.
Intended Use:
An uni-directional, intra oral device for the distraction of the ascending ramus and mandibular body.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2001
KLS-Martin L.P. C/O Mr. Arthur J. Ward Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34655
Re: K983809 KLS Martin Intraoral Zurich Ramus Trade Name: Distractor Requlatory Class: II Product Code: MON December 8, 2000 Dated: December 12, 2000 Received:
Dear Mr. Ransom:
This letter corrects our substantially equivalent letter of December 8, 2000 regarding the Trade Name.
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. તે 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in Please note: this response to your the Federal Register.
2
Page 2 - Mr. Ward
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.
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 that the requlation 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 their toll free number (800) 638-2041 or at (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
3
510(k) Number (if known):
Device Name: Intra-oral Mandibular Distractor
Indications For Use:
An uni-directional, intra-oral device for the distraction of the ascending ramus and mandibular body.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division |
|---|
| of |
| control, |
1.1.51 11.00
Over-The-
Over-The-Counter Use
and
Division of Hospital Devices
(Division Sign-on)
Division of Dental, Infection Control,
(Division Sign-Off)
510(k) Number _
(Optional Format 1-2-96)
1 AM
Prescription Use_ (Per 21 CFR 801.109)
OR