(68 days)
The KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.
The KLS-Martin Molina Distractor is a mandibular fixation device consisting of Uni-directional and Bi-directional distractors and pins for anchoring. The product is identical to the predicate device except for material which is a titanium alloy rather than stainless steel.
This document is a 510(k) summary for a medical device called the "MOD Line of Molina Distractors." It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or algorithm performance.
Therefore, I cannot provide a response that includes the requested information based solely on the provided text. The document is a regulatory submission for a distraction device made of titanium alloy (which is a material change from a previously approved stainless steel device), and its approval is based on substantial equivalence to an existing device, not on specific performance studies against acceptance criteria in the context of an algorithm or AI.
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FEB 1 5 2000
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)3234 Ella LaneNew Port Richey, FL 34655 |
|---|---|
| Phone: | 727-376-4154 |
| Fax: | 727-376-7186 |
| Contact Person: | Art Ward |
| Date of Summary: | December 2,1999 |
| Trade Name: | MOD Line of Molina Distractors |
| Classification Name: | Plate, Bone |
| Predicate Device: | K945500 Molina Distractor Wells Johnson |
| Device Description/Comparison: | The KLS-Martin Molina Distractor is a mandibularfixation device consisting of Uni-directional andBi-directional distractors and pins for anchoring. Theproduct is identical to the predicate device except formaterial which is a titanium alloy rather than stainlesssteel. |
| Intended Use: | The KLS-Martin Molina Distractors are externalDistractors for bone elongation. It is used for thecorrection of asymmetric mandibular deficiencies andmandibular hypoplasia. The devices are external andare anchored to the mandible by external fixation pins. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, which is a common symbol associated with the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2000
KLS-Martin L.P. c/o Mr. Arthur Ward Regulatory & Marketing Sevices, Incorporated 3234 Ella Lane New Port Richey, Florida 34655
Re : K994154 Trade Name: Mod Line of Molina Distractors, 51-600 Series Regulatory Class: II Product Code: JEY December 2, 1999 Dated: Received: December 9, 1999
Dear Mr. Ward:
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 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 regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Ward
the Federal Register. Please note: this response to your premarket notification submission does not affect any premailon 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 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,
K. Ulatowski
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
KLS-Martin Molina Distractor Device Name:
Indications For Use:
The KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Susan Roane
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number .
§ 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.