MICROSPEED UNI MOTOR SYSTEM

K053526 · Aesculap, Inc. · HBC · Jan 18, 2006 · Neurology

Device Facts

• Record ID: K053526
• Device Name: MICROSPEED UNI MOTOR SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: HBC · Neurology
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Device Story

Microspeed Uni is an electronic, high-speed surgical motor system for bone and soft tissue manipulation. It supports high-speed dissection (up to 80,000 rpm) and low-speed cutting (up to 40,000 rpm). The system features a control unit designed to minimize heating at high torque. It is compatible with various Aesculap handpieces, including Intra-handpieces, HiLAN, and Microspeed series, allowing universal use during procedures. The device is operated in the sterile field by surgeons or clinical staff using either foot or hand controls. It provides power to surgical attachments, facilitating precise tissue and bone manipulation to benefit patients undergoing spine, ENT, neuro, or maxillofacial surgeries.

Clinical Evidence

Bench testing only. The device complies with IEC 60601-1, IEC 60601-1-2, UL 2601-1, and CAN/CSA-C22.2 No. 601.1-M90 standards for safety and electromagnetic compatibility.

Technological Characteristics

Electronic high-speed motor system; supports 40,000 to 80,000 rpm. Compatible with various mechanical handpieces. Powered by electrical control unit. Complies with IEC 60601-1, IEC 60601-1-2, UL 2601-1, and CAN/CSA-C22.2 standards.

Indications for Use

Indicated for high-speed cutting, sawing, drilling, and manipulation of soft tissue and bone in spine, ENT, neuro, and maxillofacial surgery.

Regulatory Classification

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.

Predicate Devices

• Aesculap Microspeed EC (K003612)
• Stryker Total Performance System (K943589)

Reference Devices

• Aesculap Intra-handpieces (K953968)
• HiLAN handpieces (K980686)
• HiLAN handpieces (K973736)
• Microspeed handpieces (K003612)

Submission Summary (Full Text)

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# JAN 1 8 2006

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#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

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#### Microspeed Uni Motor System December 16, 2005

- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) [e-mail] (email)
- TRADE NAME: Microspeed Uni Motor System
- COMMON NAME: Electric Surgical Motor System
- CLASSIFICATION NAME: Motor, Drill, Electric
- REGULATION NUMBER: 882.4360
- PRODUCT CODE: нвс

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Microspeed Uni Motor System is substantially equivalent to:

- . Aesculap Microspeed EC (K003612)
- Stryker Total Performance System (K943589) .

# DEVICE DESCRIPTION

The Microspeed Uni is an electronic, high-speed motor system, which allows high-speed dissection up to 80,000 rpm while also allowing low speed cutting up to 40,000 rpm. The control system reduces heating to a minimum at high torque.

The low speed motor can make use of all Aesculap Intra-handpieces (K953968) for adapted power at minimum weight. All HiLAN (K980686 and K973736) and Microspeed (K003612) handpieces can also be used for high-speed dissection with the Microspeed Uni. This allows universal use of one motor system during the entire procedure.

All functions of the Microspeed Uni can be controlled from the sterile field by the foot control as well as the hand control for easy handling.

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### INDICATIONS FOR USE

Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillofacial Surgery.

## TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}

The Microspeed Uni Motor System offers similar operating speeds, power sources, and attachments as the predicate devices. The material used for the Aesculap Microspeed Uni Motor System is the same or similar as that used to manufacture the predicate devices.

## PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. Aesculap's Motor System, however, complies with the following standards which appear on the FDA list of Recognized Consensus Standards:

- IEC60601-1: International electrotechnical commission: Medical electrical equipment Part 1: general requirements for safety
- IEC60601-1-2: International electrotechnical commission: Medical electrical equipment Part 1: general requirements for safety; collateral standard: Electromagnetic compatibility - requirements and tests
- UL2601-1: Underwriters laboratories; medical electrical equipment, general requirements for safety

In addition, the Microspeed Uni Motor System meets the requirements of the following Canadian Standard Association standard.

CAN/CSA-C22.2 Medical Electrical Equipment, Part 1: General No. 601.1-M90 Requirements for Safety

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K053526

Trade/Device Name: Microspeed Uni Motor System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: December 16, 2005 Received: December 21, 2005

Dear Ms. Racosky:

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 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.

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#### Page 2 - Ms. Racosky

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### A. INDICATIONS FOR USE STATEMENT

510(k) Number: KOS3526

Device Name: Microspeed Uni Motor System

Indications for Use:

Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K Os 5 26