STRYKER MAESTRO SYSTEM

K041754 · Stryker Corp. · HBB · Sep 7, 2004 · Neurology

Device Facts

• Record ID: K041754
• Device Name: STRYKER MAESTRO SYSTEM
• Applicant: Stryker Corp.
• Product Code: HBB · Neurology
• Decision Date: Sep 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Maestro Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Device Story

Stryker Maestro Pneumatic System is a high-speed, pneumatically powered surgical instrument system. System comprises a motor (handpiece), hoses, and various removable rotating cutting tools and accessories. Device operates via pneumatic power to drive cutting tools for bone or tissue removal. Used in clinical settings (OR) by surgeons for neurosurgical, ENT, orthopedic, and general surgical procedures. Output is mechanical rotation of cutting accessories, enabling precise bone/tissue cutting. Benefits include efficient surgical access and bone manipulation during complex procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Pneumatic motor-driven surgical drill system. Includes handpiece, hoses, and rotating cutting accessories. Operates via pneumatic energy source. Materials are consistent with predicate device. No software or electronic components described.

Indications for Use

Indicated for patients requiring surgical procedures involving neurosurgery (craniotomy, spinal surgery), ENT, orthopedic, and general surgery (maxillofacial, craniofacial, sternotomy) where rotating surgical cutting tools are required.

Regulatory Classification

Identification

A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• Medtronic Legend®, Motor Drill Pneumatic (K020069)

Submission Summary (Full Text)

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041754

## 510(k) Summary

| Trade Name: | Stryker Maestro Pneumatic System |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Drill motors with accessories |
| Classification: | Pneumatic cranial drill motors for neurosurgery (HBB)<br>Surgical drill for Ear, Nose, & Throat (ERL)<br>Pneumatic cranial drill motor (HBB)<br>Surgical Ear, Nose, & Throatbur (EQL)<br>Powered simple cranial drill, burrs, and accessories (HBE)<br>Blades, saw, surgical cardiovascular (DWH) |
| Equivalent to: | Medtronic Legend®, Motor Drill Pneumatic (K020069), |
| Device Description: | The Stryker Maestro Pneumatic System is a pneumatic, high-speed<br>instrument system consisting of a motor (handpiece), hoses, and a<br>variety of attachments and cutting accessories. |
| Intended Use: | The Stryker Maestro Pneumatic System is a pneumatically operated<br>surgical instrument system. The pneumatic motor provides power to<br>operate removable rotating surgical cutting tools and their accessories<br>intended for use in neurosurgery, including craniotomy and spinal<br>surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and<br>general surgical applications including maxillofacial, craniofacial and<br>sternotomy surgeries. |
| Technological<br>Comparison: | The Stryker Maestro Pneumatic System<br>has the same intended use as the Medtronic Legend®. This device<br>and the predicate device have the same technological characteristics,<br>the same operating principles, use the same patient contacting<br>materials, and have similar performance characteristics. |
| Conclusions: | Based upon the comparison to the predicate devices, the Stryker<br>Maestro Pneumatic System is substantially equivalent to legally<br>marketed devices. |
| Submitted by: | Nicole Petty<br>Stryker Instruments<br>4100 E. Milham Ave.<br>Kalamazoo, MI 49001<br>269-323-7700 |
| Summary Prepared: | August 17, 2004 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 7 2004

Ms. Nicole Petty Associate Manager, Regulatory Affairs Stryker Corporation Instrument Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K041754

Trade/Device Name: Stryker Maestro Pneumatic System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: II Product Code: HBB Dated: August 17, 2004 Received: August 19, 2004

Dear Ms. Petty:

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. Nicole Petty

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,

Miriàm C. Provost

Celia M. Witten, Ph.D., M.D. 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 Statement

KO41754 510(k) Number Stryker Maestro Pneumatic System Device Name Indications The Stryker Maestro Pneumatic system is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear, Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

× Prescription Use (Per 21 CFR 801Subpart D)

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Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________