Stryker Consolidated Operating Room Equipment (CORE) 2 Console

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 15, 2017 Stryker Corporation Nicholas Werner Senior Staff Regulatory Affairs Specialist 4100 E. Milham Ave. Kalamazoo, MI 49001 Re: K171840 Trade/Device Name: Stryker Consolidated Operating Room Equipment (CORE) 2 Console Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: June 19, 2017 Received: June 20, 2017 Dear Nicholas Werner: 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. {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); 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. 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 (DICE) 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" (21 CFR 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 (DICE) 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. Eric A. Mann -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Stryker Instruments Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) ### K171840 Device Name Stryker Consolidated Operating Room Equipment (CORE) 2 Console Indications for Use (Describe) The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:16px;"> </span><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:16px;"> </span><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ### 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." {3}------------------------------------------------ ## Section 5 - 510(k) Summary ### Prepared: 19 June 2017 ### I. SUBMITTER Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 Phone: 269-389-2971 Contact: Nicholas Werner ### II. DEVICE | Name of Device: | Stryker Consolidated Operating Room Equipment (CORE) 2<br>Console | |---------------------|-------------------------------------------------------------------| | Common/Usual Name: | Console | | Regulation Numbers: | 21 CFR 874.4250 | | Regulation Name: | Drill, Surgical, ENT (Electric or Pneumatic) | | Regulatory Class: | II | | Product Codes: | ERL | ### III. PREDICATE DEVICE Primary Predicate Stryker Consolidated Operating Room Equipment (CORE) System, K112593 ### IV. DEVICE DESCRIPTION The Stryker CORE 2 Console is a modernization of the currently marketed CORE Console. The CORE 2 Console supplies power to a variety of devices, which include small and large bone handpieces, footswitches, and a bone mill. The CORE 2 Console contains a touch screen graphical user interface (GUI), which allows the user to program a number of customized settings related to the connected devices and irrigation. ### V. INDICATIONS FOR USE The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to, dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following table identifies technological characteristics shared between the Predicate and Subject device: {4}------------------------------------------------ # Section 5 – 510(k) Summary | | Predicate Device | Subject Device | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Indications for Use | Intended for use in the cutting,<br>drilling, reaming, decorticating,<br>shaping, and smoothing of bone, bone<br>cement and teeth in a variety of<br>surgical procedures, including but not<br>limited to, dental, ENT (ear, nose,<br>throat), neuro, spine, and endoscopic<br>applications. It is also usable in the<br>placement or cutting of screws, metal,<br>wires, pins, and other fixation devices. | Same | | Contraindications | None known | Same | | For use with | Various small and large bone<br>handpieces, footswitches, and a bone<br>mill. | Same | | Patient Contact | No direct or indirect patient contact | Same | | Power Output | Handpiece port output voltage: 40V<br>Footswitch port output voltage: 5V | Same | | Electrical Isolation Type | Class I, Type BF Applied Part | Same | | Electrical Safety & EMC | Tested and compliant with IEC<br>60601-1, IEC 60601-1-2 | Same | | Irrigation | Irrigation Pump and Pump Controller -<br>A DC brush motor with an optical<br>encoder is used to create a peristaltic<br>pump. A micro-controller measures<br>motor speed from the encoder and<br>adjusts the supply voltage to the<br>motor appropriately to achieve the<br>desired speed. Start, stop, and speed<br>indications are received from the main<br>processor. | Same | | User Interface | A color LCD screen allows the user to<br>set the desired operating parameters.<br>Touchscreen interface with GUI<br>workflow. | Same | | | Predicate Device | Subject Device | | Software | Microprocessor | Same | | Wireless Tag Technology<br>(RFID) | Certain accessories are recognized and<br>identified on the console screen. | Same | {5}------------------------------------------------ ## Section 5 – 510(k) Summary The following differences between the subject and predicate device were considered in relation to the substantial equivalence determination: - CORE 2 handpiece and footswitch ports have illumination rings that serve as secondary . identifiers for mapping. - CORE 2 has a modified GUI workflow designed to be less complex. - CORE 2 has a capacitive touchscreen interface. ● - Users are able to transfer saved use-preference profiles via USB between consoles if desired. - The software of CORE 2 was rewritten to accommodate internal circuitry redesigns. ### VII. PERFORMANCE TESTING The following performance testing was conducted to support substantial equivalence: ### Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the CORE 2 Console. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. ### Software Verification and Validation Testing Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. ### Mechanical Testing The following design verification activities have been performed to ensure the correct functionality of the console as it has been specified: - Reliability and Use Life Testing - Compatibility Testing (with defined accessories) ● - . Performance testing for torque mapping capability and capacitive touchscreen ### Human Factors Evaluation Human factors analysis and usability testing was performed in support of the Substantial Equivalence determination and in accordance with FDA's Guidance for Industry and FDA Staff, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1 "Medical Devices – Application of Usability Engineering to Medical Devices." {6}------------------------------------------------ ## Section 5 - 510(k) Summary ### Biocompatibility Biocompatibility data is not required to support a Substantial Equivalence determination as the CORE 2 Console is identical to the predicate device in that there are no components with direct or indirect patient contact. ### Animal Study Not Applicable – data from animal studies was not provided to support the Substantial Equivalence determination. Animal studies are not required to demonstrate safety or feasibility of the CORE 2 Console. ### Clinical Studies Not Applicable – data from clinical studies was not provided to support the Substantial Equivalence determination. Clinical studies are not required to demonstrate safety or feasibility of the CORE 2 Console. ### VIII. CONCLUSIONS The differences that exist between the CORE 2 Console and its predicate do not raise different questions of safety or effectiveness. The results of non-clinical performance testing demonstrate that the CORE 2 Console will perform as intended and is substantially equivalent to the predicate device which is marketed for the same intended use.