(68 days)
Not Found
No
The summary describes a mechanical surgical drill and explicitly states that modifications do not affect the fundamental scientific technology. There is no mention of AI, ML, or any related concepts.
No
The device is described as a high-speed drill used for cutting soft tissue and bone, which is an interventional/surgical function rather than a therapeutic one.
No
The device is described as a high-speed drill and saw system used for cutting soft tissue and bone, which are surgical/interventional procedures, not diagnostic ones. Its function is to perform physical alterations, not to gather information for diagnosis.
No
The device description explicitly states it is an electric handpiece, a physical instrument used for cutting tissue and bone, and connects to controllers for power. This clearly indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "cutting of soft tissue and bone" during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical drill and saw system used directly on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for physical manipulation of tissue and bone during surgery.
N/A
Intended Use / Indications for Use
The MicroPower Hand Piece 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 fields of application have changed slightly from the predicate device, including only: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, trauma and spinal procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBC
Device Description
The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
APR 1 0 2006
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 High Speed Drill.
Submitter A.
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) 399-5264 FAX
C. Device Name
| Trade Name: | MicroPower Hand Piece High Speed Dril |
|---|---|
| Common Name: | Surgical Drill System |
| Classification Names: | 882.4360 -Electric Cranial Drill Motor |
| Proposed Class/Device: | Class II |
| Product Code: | HBC |
D. Predicate/Legally Marketed Devices
K971059 - Universal Drive System
MicroPower Hand Piece High Speed Drill Special 510(k) # _K060260 April 6, 2006,
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E. Device Description
The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in 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 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 fields of application have changed slightly from the predicate device, including only: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, trauma and spinal procedures.
F. Substantial Equivalence
The MicroPower Hand Piece High Speed Drill is substantially equivalent in scientific technology, design and in indication for use 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.
Ig 2 of 2
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human figures in profile, arranged in a row. The figures are connected and appear to be moving forward. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.
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: K060260
Trade/Device Name: MicroPower Hand Piece: High Speed Drill Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: March 15, 2006 Received: March 16, 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, 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 (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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Page 2 - Ms. Elizabeth M. Paul
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,
Mark N. Melkerson
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): K060260
Device Name: MicroPower Hand Piece: High Speed Drill
Indications for Use:
The MicroPower Hand Piece: 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 fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
el.gmall.
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number_k060260