Stryker Maestro Air Motors

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three intertwined snakes forming a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 22, 2015 Stryker Instruments Mr. Deval Patel Senior Regulatory Affairs Specialist 4100 East Milham Avenue Kalamazoo, Michigan 49001 Re: K150801 Trade/Device Name: Stryker® Maestro™ Air Motors Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: Class II Product Code: HBB Dated: April 29, 2015 Received: April 30, 2015 Dear Mr. Patel: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150801 Device Name Stryker Maestro Air Motors ### Indications for Use (Describe) The Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air 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 and sternotomy surgeries. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ 4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 323 7700 f: 269 389 5412 www.stryker.com Image /page/3/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol to the right of the word. The word is likely a company logo or brand name. 510(k) Summary | Applicant | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>US | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Deval Patel<br>Senior Regulatory Affairs Specialist<br>Phone: (269) 389- 5671<br>E-mail: Deval.Patel@stryker.com | | Registration Number | 1811755 | | Date Summary Prepared | March 25, 2015 | | Trade Name | Stryker® Maestro Air™ Motors | | Common Name | Pneumatic Cranial Drill Motor | | Classification Data | 21 CFR 882.4370, Pneumatic Cranial Drill Motor,<br>Product Code HBB, Class II 510(k) | | Predicate Device | Stryker Maestro Pneumatic System, K041754 | | Indication for Use | The Stryker® Consolidated Operating Room<br>Equipment (CORE ^™ ) Maestro Air Pneumatic<br>System is a pneumatically operated surgical<br>instrument system. The pneumatic motor provides<br>power to operate removable rotating surgical<br>cutting tools and their accessories intended for use<br>in neurosurgery, including craniotomy and spinal<br>surgery; as well as ear, nose and throat (ENT),<br>orthopedic, and general surgical applications<br>including maxillofacial, craniofacial and<br>sternotomy surgeries. | ...1 STRYKER® MAESTRO AIR™ MOTORS {4}------------------------------------------------ t: 269 323 7700 f: 269 389 5412 www.stryker.com The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a Device Description regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source. Performance Data The results of the performance testing demonstrate that the (Non-Clinical Tests) functionality, integrity and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence to the predicate device. The following verification tests were performed on the subject device to Summary of Performance demonstrate that the design outputs of the modified device meet the Testing design input requirements. ● Reliability Testing- Motor body, Handswitch mounting, Router Retention, Pneumatic Hose assembly and automated washing ● Packaging Testing ● Cleaning Testing ● Sterilization Testing Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of the substantial equivalence. No Clinical Test was deemed necessary for this 510(k). Clinical Test Predicate Comparison Please refer to Table 6-1: for the predicate comparison. 4100 E. Milham Ave. Kalamazoo, MI 49001 {5}------------------------------------------------ ## Table 6-1: Summary of Predicate Comparison | DESCRIPTION | STRYKER MAESTRO PNEUMATIC<br>SYSTEM [PREDICATE]<br>K041754 | STRYKER® MAESTRO AIR™ MOTORS<br>[SUBJECT] | |------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------| | Classification of Device | Class II | Class II | | Regulation | 21 CFR 882.4370; Pneumatic<br>Cranial Drill Motor | 21 CFR 882.4370; Pneumatic Cranial<br>Drill Motor | | Product Code | HBB | HBB | | Power source | Dry, Filtered, Compressed air or<br>nitrogen | Dry, Filtered, Compressed air or<br>nitrogen | | Patient Population | General | General | | Contraindications | None known | None known | | Motor Type | High Speed, High Torque,<br>Pneumatic Vane | High Speed, High Torque, Pneumatic<br>Vane | | Mode of Action | Footpedal and Handswitch | Footpedal and Handswitch | | Operating Speed | Up to 75,000 rotations per minute | Up to 75,000 rotations per minute | | Stall Torque | 5.6 in-oz. @ 150 psi (per square<br>inch) | 6.7 in-oz. @ 150 psi (per square inch) | | Maximum Operating<br>Pressure | 120 psi (per square inch) | Up to 150 psi (per square inch) | | Grip Design | Smooth | Knurled | | Router Retention<br>Mechanism | Friction | Spring Collar | | Method of Sterilization | Moist Heat (Steam) | Moist Heat (Steam) | | Sterility Assurance Level<br>(SAL) | 10-e | 10-e | | Method of Packaging | Packaged in a polybag case<br>configuration | Packaged in a sealed air Korrvu<br>retention Insert configuration | Image /page/5/Picture/5 description: The image shows the text "510(k) Summary". The text is in a simple, sans-serif font and is left-aligned. The background is plain white, providing a clean and clear presentation of the text. stryker # STRYKER® MAESTRO AIR™ MOTORS {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the word. | Table 6-1: Summary of Predicate Comparison (Continued) | | | | |--------------------------------------------------------|--|--|--| |--------------------------------------------------------|--|--|--| | DESCRIPTION | STRYKER MAESTRO PNEUMATIC<br>SYSTEM [PREDICATE]<br>K041754 | STRYKER® MAESTRO AIR™ MOTORS<br>[SUBJECT] | |---------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Cleaning Method | Manual | Manual and Mechanical (automated) | | Weight of the Motor and<br>Hose | 2.05 lb. | 1.65 lb. | | Housing Material | Stainless Steel | Stainless Steel and Aluminum | | Pneumatic Hose<br>Assembly | Exhaust Hose: Flurosilicone<br>Inlet Hose: Nitrile rubber | Exhaust Hose: Flurosilicone with<br>silicone jacket and Slick Sil coating<br>Inlet Hose: Nitrile rubber and<br>neoprene | ## Conclusion/Substantial Equivalence Rationale The Stryker Maestro Air Motors is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the previously cleared Stryker Maestro Pneumatic System. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker Maestro Air Motors is substantially equivalent to the existing predicate device. Page 4 of 4 STRYKER® MAESTRO AIR™ MOTORS