Who is the manufacturer of STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

Stryker Corporation filed the 510(k) submission for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K112593).

What is the FDA product code for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

ERL. It is classified under 21 CFR 874.4250 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

K112593 · Stryker Corporation · ERL · May 1, 2012 · Ear, Nose, Throat

Device Facts

Record ID	K112593
Device Name	STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant	Stryker Corporation
Product Code	ERL · Ear, Nose, Throat
Decision Date	May 1, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Stryker ® Consolidated Operating Room Equipment (CORE) System 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. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Device Story

Stryker CORE System is an electrically powered surgical console used in operating rooms by surgeons. It drives various handpieces—saws, drills, wire drivers, microdebriders, bone mills—for bone/tooth manipulation and fixation device placement. The console features three handpiece connectors (supporting two simultaneous handpieces) and two footswitch connectors (supporting wired or wireless footswitches). It provides 400W power output. Surgeons interact with the system via an LCD screen to set operating parameters, which are also automatically identified from attached accessories using wireless tag technology. The system allows for torque control to assist in screw implantation. By providing precise power and control to surgical instruments, the device facilitates bone and tissue modification, aiding in orthopedic, dental, and neurosurgical procedures.

Clinical Evidence

Bench testing only. No clinical data was required or provided. Safety and effectiveness were established through software code review, hazard analysis, and verification/validation testing of software revisions, confirming the device performs as well as or better than the predicate devices.

Technological Characteristics

Electrically powered console; 400W power output. Features three handpiece connectors, two footswitch connectors (wired/wireless support), and LCD interface for parameter control. Utilizes wireless tag technology for accessory identification. Software-controlled torque profiles. Non-patient contact device; biocompatibility evaluation not required per ISO 10993-1:2003.

Indications for Use

Indicated for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement, and teeth in dental, ENT, neuro, spine, and endoscopic surgical procedures; also for placement or cutting of screws, metal, wires, pins, and other fixation devices. No specific age or gender contraindications provided.

Regulatory Classification

Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

Predicate Devices

Stryker® Consolidated Operating Room Equipment (CORE) System (K040300, K040369, K032303)
Synthes Electric Pen Drive (EPD) System (K043310)
Stryker® Total Performance System (K032117, K942956, K943589, K943569, K943540)

Related Devices

K040369 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Instruments · Apr 1, 2004
K032303 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM · Stryker Instruments · Jan 16, 2004
K040300 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) · Stryker Instruments · Mar 3, 2004
K032117 — STRYKER TOTAL PERFORMANCE (TPS) SYSTEM · Stryker Instruments · Aug 8, 2003
K961970 — COMMAND 2 MICOELECTRIC SURGICAL SYSTEM · Stryker Corp. · Jul 26, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ MAY - 1 2012 stryker · ** 4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 269 389 5412 www.stryker.com #### Instruments · # 510(k) Summary | 510(k) Owner: | Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 (p) 269-323-7700 (f) 269-389-5412 | | | | | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------|-------|--------------------| | Contact Person: | Michelle Jump | | | | | | Registration No.: | 1811755 | | | | | | Trade Name: | Stryker® Consolidated Operating Room Equipment (CORE) System | | | | | | Common Name: | Console | | | | | | Classification Name and Regulation Number | Primary Product Code | | | | | | | PRODUCT CODE | DEVICE | REGULATION NUMBER | CLASS | REVIEW PANEL | | | ERL | Drill surgical ent (electric or pneumatic) including handpiece | 21 CFR 874.4250 | II | EAR NOSE THROAT | | | Secondary Product Codes | | | | | | | PRODUCT CODE | DEVICE | REGULATION NUMBER | CLASS | REVIEW PANEL | | | DZI | Drill, bone, powered | 21 CFR 872.4120 | II | DENTAL | | | DZJ | Driver, wire, and bone drill, manual | 21 CFR 872.4120 | II | DENTAL | | | HBE | Drills, burs, trephines & accessories (simple powered) | 21 CFR 882.4310 | II | NEUROLOGY | | Predicate Devices: | Stryker® Consolidated Operating Room Equipment (CORE) System (K040300, K040369, K032303); Synthes Electric Pen Drive (EPD) System (K043310); and Stryker® Total Performance System (K032117, K942956, K943589, K943569, K943540) | | | | | | Device Description: | The Stryker Consolidated Operating Room Equipment (CORE) System is an electrically powered system. This system includes a console, irrigation accessories, footswitches, handswitches, and handpiece cords which drive a variety of devices | | | | | {1}------------------------------------------------ | including saws, drills, wire drivers, microdebriders, and bone mills. | | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Stryker ® Consolidated Operating Room Equipment (CORE) System 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. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | | | | | | Testing | The clarification of the Stryker® Consolidated Operating Room Equipment (CORE) System indications for use statement is not the result of any design changes that have been made to the console. In addition, the use of this device in orthopedic and spine applications do not present any new risks that would require testing. Therefore, no additional performance testing was performed to evaluate this change. | | | | | | Each software revision of the Stryker® CORE Console has undergone a code review by a team of internal experts to review source code, evaluate error messaging, and verify adherence to standards. An analysis of new hazards and software requirements emerging as a result of the changes is evaluated for each revision. This is documented in the CORE Console's Software Requirements Specifications (SRS) and risk analysis, which can be found in Section 16. Subsequent verification/ validation testing, including system and Unit box testing, is performed on the console to confirm the continued safety and effectiveness of the Stryker® CORE Console prior to the release of each software revision to the market. | | | | | | | The results of this testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. | | | | | | | Biocompatibility | Per ISO 10993-1:2003 and FDA G95-1:1995 guidelines, a biocompatibility evaluation for the CORE Console is not required due to the non-patient contact intended use of this medical device. | | | | | | Substantial Equivalence (SE) Rationale: | The Stryker® Consolidated Operating Room Equipment (CORE) System when compared to its predicates has a similar intended use and technology characteristics as the predicate devices. Therefore, this device is substantially equivalent to predicate devices. | | | | | | Predicate Device Comparison Table | | | | | | | Element of Comparison | Stryker ® CORE Console (Under Review) | Stryker ® System (K040300, K040369, K032303) | Synthes Electric Pen Drive (EPD) System (K043310) | Stryker ® Total Performance System (TPS) (K942956, K943589, K943569, K943540, K032117) | Substantial Equivalence | | Indications for Use | The Stryker ® Consolidated Operating Room Equipment (CORE) 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, neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, | The Stryker® Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT, neuro, and endoscopic | The Synthes Electric Pen Drive (EPD) System is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopedic trauma, foot, hand, maxifacial, neurosurgical, oral, | The Stryker ® Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, teeth and other bone related tissue in a variety of surgical procedures, including but not limited to dental, ENT, neuro and endoscopic. It is also usable in the placement or cutting of screws, wires, pins, | The indications for use for all three devices are similar. | | | other fixation devices. | applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | reconstructive and spine surgery. | devices. It can also be used to cut metal. | | | Handpiece Connectors | Three connectors allow handpiece cords to be connected to the console. The console is capable of running two handpieces simultaneously. | Three connectors allow handpiece cords to be connected to the console. The console is capable of running two Handpieces simultaneously. | Two connectors allow for two Electric Pen Drive units to be connected. | Three connectors allow handpiece cords to be connected to the console. | Similar for all three devices. Design feature is identical to previously-cleared Stryker® CORE Console. | | Footswitch Connectors | Two connectors allow up to two footswitches to be run on the console simultaneously. The console can also be controlled by a wireless footswitch. | Two connectors allow up to two footswitches to be run on the console simultaneously. | One connector allows one footswitch to control one drive unit. | One connector allows one footswitch to control one drive unit. | Similar for all three devices. Stryker® CORE Console under review has the capability of connecting to a wireless footswitch. | | Adjustable Operating Parameters | The LCD screen allows the user to set the desired operating parameters. Operating parameters are also obtained from attached accessories. | The LCD screen allows the user to set the desired operating parameters. Operating parameters are also obtained from attached accessories. | Max speed may be controlled using slide controls provided in the console for each drive unit. Torque limiting feature can be controlled using an On/ Off/Calibrate knob. Irrigation can be used with either Drive Unit 1 or Drive Unit 2 and knob control is available to select between continuous and variable irrigation for each drive unit. Irrigation flow can be controlled using a flow rate adjustment knob. OR User sets the operating parameters using the controls available in the console or using the handswitch or footswitch interface. | The LCD screen allows the user to set the desired operating parameters. | TPS and CORE Console have similar software feature. Design feature is identical to previously-cleared Stryker® CORE Console. | | Power Output | 400 Watts | 400 Watts | Information not available. | 400 Watts | TPS and CORE Console power output is identical. Design feature Is identical to . previously-cleared Stryker® CORE Console. | | Wireless Tag Technology | Accessories are recognized and identified on the console screen. | Accessories are recognized and identified on the console screen. | Information not available. | Accessories are recognized and identified on the console screen. | TPS and CORE Console have similar software feature. Design feature is identical to previously- cleared Stryker® CORE Console. | | Torque Control | Mechanism to allow the user to specify the torque profile to be used for handpieces. | N/A | Mechanism to allow the surgeon to implant and tighten screws under power. The user calibrates and sets the desired torque value using the control available in the console. | N/A | The Stryker® CORE Console and Synthes Electric Pen Drive System torque control features are similar. Both devices allow the user to vary torque settings. | : . . . . | {2}------------------------------------------------ # · : : ・・ : . 、 . : . : . ・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : : ・ {3}------------------------------------------------ | Console Accessories | Irrigation accessories Handpiece cord Handswitch Footswitch | Irrigation accessories Handpiece cord Handswitch Footswitch | Irrigation accessories Handpiece cord Handswitch Footswitch | Irrigation accessories Handpiece cord Handswitch Footswitch | Similar for all three devices. | |---------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|--------------------------------| |---------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|--------------------------------| | Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker® Consolidated Operating Room Equipment (CORE) System does not raise any new issues of safety and effectiveness and is substantially equivalent to legally marketed devices. | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by: | Michelle Jump Senior Regulatory Affairs Representative | Signature | Date Submitted: | May 1, 2012 | |-----------------|-------------| |-----------------|-------------| and the comments of the comments of and the country of the country of the country {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/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 or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAY - 1 2012 Stryker Corporation % Ms. Michelle Jump 4100 E. Milham Avenue Kalamazoo, MI 49001 Re: K112593 Trade/Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System 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: April 24, 2012 Received: May 1, 2012 Dear Ms. Jump: 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 1 read on as made a determination that your device complies with other requirements of the Act {5}------------------------------------------------ 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Edith m.b Malyina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use ## 510(K) Number: K 112593 Device Name: Stryker® Consolidated Operating Room Equipment (CORE) System Indications for Use: The Stryker ® Consolidated Operating Room Equipment (CORE) System 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. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. 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) D.M.ls Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K1125 Section 4 -1 .. 21 CFR 801.109) otion Use _ Prescription Use (Per 21 CFR 801.109)

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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