(54 days)
Not Found
No
The summary describes a mechanical device for mandibular distraction and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is intended to treat specific medical conditions (mandibular deficiency or post-traumatic effects of the mandible), indicating a therapeutic purpose.
No
Explanation: The device is described as a "distractor" intended for treating mandibular deficiency or post-traumatic effects, indicating a therapeutic or corrective function rather than a diagnostic one.
No
The summary describes a physical device (intra-oral distractor) used to distract the mandible, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "distract the mandible in cases of deficiency or post-traumatic effects of the mandible." This describes a surgical or therapeutic intervention performed directly on the patient's body.
- Device Description: The device is designed to "distract the mandible," which is a mechanical action on a bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for bone distraction.
N/A
Intended Use / Indications for Use
The KLS-Martin intra-oral distractor is intended to be used in the conditions of mandibular deficiency or post-traumatic effects of the mandible.
Product codes
MQN
Device Description
The KLS Martin Distractor device is designed to distract the mandible in cases of deficiency or post-traumatic effects of the mandible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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
NOV 3 0 1998
4-4-4-
.
rang
:
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:
Fax: | 813-376-4154
813-376-7186 |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | October 7,1998 | |
| Trade Name: | Intra-oral Mandibular Distractor | |
| Classification Name: | Rigid External Distractor | |
| Predicate Device: | KLS Distractor K973275 | |
| Device Description/
Comparison: | The KLS Martin Distractor device is designed to
distract the mandible in cases of deficiency or post-
traumatic effects of the mandible. | |
| Intended Use: | The KLS-Martin intra-oral distractor is intended to be
used in the conditions of mandibular deficiency or
post-traumatic effects of the mandible. | |
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
NOV 3 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KLS-Martin L.P. C/O Mr. Ed Ransom Regulatory & Marketing Services, Incorporated (RMS) 3234 Ella Lane New Port Richey, Florida 34652
Re : K983515 KLS Intra-oral Vertical Distractor Trade Name: Regulatory Class: II Product Code: MQN October 6, 1998 Dated: October 7, 1998 Received:
Dear Mr. Ransom:
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 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). 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 (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. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS 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 Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
2
Page 2 - Mr. Ransom
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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.qov/cdrh/dsma/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): ____________________________________________________________________________________________________________________________________________________ Unknown
Intra-oral Mandibular Distractor Device Name:
The KLS-Martin Intro-oral Distractor is intended to be used Indications For Use: in the conditions of mandibular deficieincy or post-traumatic effects of the mandible.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
✓
A-4-A
Over-The-Counter Use
Heavid W. Shipp
(Division Sign-Off)
Division of Dental, Infection Control, (Optional Format 1-2-96) and General Hospital Devices 510(k) Number _ 15835