(22 days)
The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.
KLS-Martin Rigid External Distraction Device
The provided document is a 510(k) premarket notification approval letter for the KLS-Martin Rigid External Distraction (RED) device. This type of document confirms that the device is substantially equivalent to a predicate device already on the market and does not contain information about specific acceptance criteria, device performance studies, or details regarding the test set, training set, or ground truth establishment.
A 510(k) submission generally focuses on demonstrating substantial equivalence, often through comparisons of technological characteristics and intended use, rather than extensive clinical trial data or detailed performance studies with acceptance criteria as would be found in a Premarket Approval (PMA) application or a more detailed technical report.
Therefore, I cannot provide the requested information based on the content of this document. The document primarily serves as an FDA approval for market clearance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
:
JUN 24 1997
Mr. Ed Ransom KLS-Martin C/O Regulatory & Marketing Services, Incorporated 40178 U.S. 19 North Tarpon Springs, Florida 34689
Re : K972047 KLS-Martin Rigid External Distraction Device Trade Name: Requlatory Class: II Product Code: MQN Dated: May 28, 1997 Received: June 2, 1997
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Ransom
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 5.0(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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Crescent /for
Timothy A. Ulatowski Director 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): _______
______________________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russoe
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dr 510(k) Number
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.