MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

K060198 · Linvatec Corp. · HRX · May 11, 2006 · Orthopedic

Device Facts

• Record ID: K060198
• Device Name: MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
• Applicant: Linvatec Corp.
• Product Code: HRX · Orthopedic
• Decision Date: May 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw 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.

Device Story

Powered surgical instrument system comprising medium speed drill, sagittal saw, reciprocating saw, and oscillating saw; pencil-grip handhelds. Connects via cord to Advantage, E9000, or PowerPro controllers for power supply. Lever-actuated by surgeon. Uses various bur guards, attachments, drill bits, burs, and saw blades. Used in OR for orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures. Facilitates bone and soft tissue cutting.

Clinical Evidence

No clinical data. Substantial equivalence based on design and technological similarities to the predicate device.

Technological Characteristics

Electric powered surgical hand pieces; pencil-grip form factor. Compatible with Advantage, E9000, and PowerPro controllers. Mechanical actuation via lever. Uses interchangeable burs, drill bits, and saw blades. No software or electronic processing described.

Indications for Use

Indicated for cutting soft tissue and bone in orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Universal Drive System (K971059)

Submission Summary (Full Text)

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March 10, 2006

# KO60198

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: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw.

#### A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

MAY 11 2005

#### B. Company Contact

Elizabeth Paul Manager, Regulatory Affairs [phone] Telephone [phone]FAX

#### ﺰ Device Name

| Trade Name: | MicroPower Hand Piece: Medium Speed Drill,<br>Saggital saw, Reciprocating saw, and Oscillating<br>saw |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Drill System |
| Classification Names: | 878.4820 - Instrument, surgical, orthopedic, AC-<br>powered and accessory/attachment<br>888.1100 - Arthroscope |
| Proposed Class/Device: | Class II |
| Product Code: | HWE, HRX |

#### D. Predicate/Legally Marketed Devices

K971059 - Universal Drive System

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MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw Special 510(k) # K060198 March 10, 2006

#### E. Device Description

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw. Reciprocating saw, and Oscillating saw 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 cord 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: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw 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.

#### F. Substantial Equivalence

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw. Reciprocating saw, and Oscillating saw is substantially equivalent in indication for use, scientific technology and design to the Universal Drive System (Microchoice). 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 logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures in silhouette, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2006

ConMed Linvatec c/o Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K060198

Trade/Device Name: MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: April 7, 2006 Received: April 12, 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 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 [phone]. 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 [phone] or [phone] 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): K060198

Device Name: MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw

Indications For Use:

The MicroPower Hand Piece: Medium Speed Drill, Saggital saw, Reciprocating saw, and Oscillating saw 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)

eoml.

Division of General, Restorative, and Neurological De

510(k) Number. KOGO198

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