(77 days)
KLS Intraoral Distractor K973275
No
The summary describes a mechanical bone distractor and makes no mention of AI, ML, image processing, or any related technologies.
Yes
The device is used for gradual bone distraction of facial bones due to birth defects, disease, or trauma, which is a therapeutic purpose.
No
The device description indicates its purpose is for the gradual bone distraction of facial bones, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Distractor similar to the KLS distractor," which is a physical, intra-oral device used for bone distraction. 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/Indications for Use: The intended use and indications clearly describe a device used for the mechanical manipulation of bone tissue within the body (in vivo). It's a surgical device for bone distraction.
- Device Description: The description mentions a "distractor," which is a type of surgical implant used to gradually separate bone segments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body to physically alter bone structure.
N/A
Intended Use / Indications for Use
The intended use is for the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or trauma.
The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.
Product codes
MQN
Device Description
Distractor similar to the KLS distractor approved as K973275
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial bones
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 Intraoral Distractor K973275
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
| AUG 18 1999 | ||
|---|---|---|
| 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: | 727-376-4154 | |
| 727-376-7186 | ||
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | June 1,1999 | |
| Trade Name: | K-L-W Intraoral Distractor | |
| Classification Name: | Intraoral Distractor | |
| Predicate Device: | KLS Intraoral Distractor | |
| Device Description/ | ||
| Comparison: | Distractor similar to the KLS distractor approved as | |
| K973275 | ||
| Intended Use: | The intended use is for the gradual bone distraction | |
| of the facial bones that are deformed due to birth | ||
| defects, disease, or trauma. |
1
Image /page/1/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 is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
KLS-Martin L.P. C/O Mr. Edward Ransom Regulatory & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655
Re : K991875 K-L-W Intraoral Distractor Trade Name: Regulatory Class: II Product Code: MQN Dated: July 26, 1999 Received: July 28, 1999
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 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 Regulations, 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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 requlations.
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Page 2 - Mr. Ransom
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.qov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucurullo
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: Intraoral Distractor
Indications For Use: The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Runne
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospity 510(k) Number
(Optional Format 1-2-96)