(68 days)
The MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.
The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.
This document is a 510(k) premarket notification for a medical device, the MicroPower Hand Piece: Oral Max High Speed Drill. It declares that the device is substantially equivalent to a previously cleared predicate device (Universal Drive System, K971059) and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence based on the device's design, intended use, and scientific technology being similar to a predicate device, rather than providing a performance study against acceptance criteria.
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April 6, 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the MicroPower Hand Piece: Oral Max High Speed Drill.
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264FAX
C. Device Name
| Trade Name: | MicroPower Hand Piece: Oral Max High SpeedDrill |
|---|---|
| Common Name: | Surgical Drill System |
| Classification Names: | 872.4120 - Bone cutting instrument and accessories |
| Proposed Class/Device: | Class II |
| Product Code: | DZI |
D. Predicate/Legally Marketed Devices
K971059 - Universal Drive System
MicroPower Hand Piece: Oral Max High Speed Drill Special 510(k) # K060270
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E. Device Description
The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.
Intended Use
The MicroPower Hand Piece: Oral Max High Speed Drill functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application has changed slightly from the predicate device, in that the Oral Max High Speed Drill only includes oral/maxillofacial procedures.
F. Substantial Equivalence
The MicroPower Hand Piece: Oral Max High Speed Drill is substantially equivalent in indication for use, scientific technology and design to the MicroChoice Universal Drive System. The Universal Drive System was cleared by FDA under 510(k) K971059. The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which is a stylized representation of a human figure. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
ConMed Linvatec Corporation c/o Ms. Elizabeth M. Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K060270
Trade/Device Name: MicroPower Hand Piece: OralMax High Speed Drill Regulation Number: 21 CFR 872.4120 Regulation Name: Bone cutting instrument and accessories Regulatory Class: II Product Code: DZI Dated: March 16, 2006 Received: March 17, 2006
Dear Ms. Paul:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
d. O'Mall
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060270
Device Name: MicroPower Hand Piece: OralMax High Speed Drill
Indications for Use:
The MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K
(Division S ign-Off Division of General, Restorative, and Neurological Devices
510(k) Number_K060270
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.