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

Stryker Instruments filed the 510(k) submission for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) (K040300).

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

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 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)?

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

What are the predicate devices for STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)?

Stryker CORE Console (K032303); Stryker TPS Plus (K032117); Stryker TPS Dental (K943540); Stryker TPS ENT (K943569); Stryker TPS Neuro (K943541); TPS Hermes (K991696); Stryker Navigation System (K012380); Dyonics (K771218).

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

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.

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

K040300 · Stryker Instruments · ERL · Mar 3, 2004 · Ear, Nose, Throat

Device Facts

Record ID	K040300
Device Name	STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
Applicant	Stryker Instruments
Product Code	ERL · Ear, Nose, Throat
Decision Date	Mar 3, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4250
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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 other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Device Story

Stryker CORE System is a bench-top console for surgical power tools; used in OR settings by surgeons. System drives drills, shavers, saws, and wire drivers via handpiece connectors. Console features LCD screen for parameter adjustment and system status display; includes irrigation pump. Wireless tag technology identifies connected accessories. Window jog function allows precise cutter positioning. IEEE1394 Firewire interface enables data/control communication with other devices. Auxiliary control mechanism powers and retrieves data from handpiece-mounted subsystems. Non-volatile memory stores settings. Device assists surgeons in bone/tissue resection and fixation, potentially improving surgical efficiency and procedural outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing of the console system.

Technological Characteristics

Bench-top console; microprocessor-controlled; 400W power output; electrical power source. Features LCD interface, three handpiece connectors, two footswitch connectors. Connectivity includes IEEE1394 Firewire and auxiliary control for handpiece subsystems. Includes wireless tag technology for accessory identification. Non-volatile memory for setting storage. System supports window jog functionality.

Indications for Use

Indicated for patients requiring surgical procedures involving cutting, drilling, reaming, decorticating, or smoothing of bone, bone cement, or bone-related tissue, including ENT procedures and the placement or cutting of fixation devices (screws, metal, wires, pins).

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 CORE Console (K032303)
Stryker TPS Plus (K032117)
Stryker TPS Dental (K943540)
Stryker TPS ENT (K943569)
Stryker TPS Neuro (K943541)
TPS Hermes (K991696)
Stryker Navigation System (K012380)
Dyonics (K771218)

Submission Summary (Full Text)

{0}------------------------------------------------ MAR - 3 2004 ## 510(k) Summary | Trade Name: | Stryker Consolidated Operating Room Equipment (CORE) System | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Console | | Classification Names: | Bone Cutting Instruments and Accessories. (per 21 CFR section 872.4120) Ear, Nose and Throat Electric or Pneumatic Surgical Drill. (per 21 CFR section 874.4250) Powered Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.4310) | | Equivalent to: | Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and Dyonics (K771218). | | Device Description: | The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system. | | Intended Use: | 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 other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | | Technological Comparison: | Technological characteristics are the same as previously cleared for the Stryker CORE Console (K032303), Stryker TPS Plus (K032117), Stryker TPS System (K943540, K943569, K943541, and K991696), Stryker Navigation System (K012380) and Dyonics (K771218). | | Submitted by: | Jean W. Sheppard Regulatory Analyst Stryker Instruments | | Date: | February 19, 2004 | {1}------------------------------------------------ | ELEMENT OF COMPARISON | SUBJECT DEVICE: Stryker CORE ENT System Console | CLAIMED SE DEVICE # 1: TPS Plus System | CLAIMED SE DEVICE #2: Stryker CORE System Console | CLAIMED SE DEVICE #3: Stryker TPS Dental System | CLAIMED SE DEVICE #4: Stryker TPS Hermes System | CLAIMED SE DEVICE #5: Stryker Navigation System | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K040300 | K032117 | K0323003 | K943540 | K991696 | K012380 | | Intended Use | Intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. | 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, and other fixation devices. It can also be used to cut metal. | 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 Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters w be used to debride synovitis, articular cartilag flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnate articular surfaces or osteophytes. | 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. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. | 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 Endoscopic. It is also usable in the placement of cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes. | Intended for use as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any medical condition in which the use of image guided surgery may be appropriate and where reference to a rigid anatomical structure such as the skull or vertebra can be identified relative to medical images. | | Outer Profile | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | Bench-top style console with a liquid display screen and optional irrigation pump. | N/A | | Handpiece Connector | Three connectors allow for three handpiece cords to be connected with two handpieces capable of running simultaneously. | Three connectors allow for three handpiece cords to be connected. | Three connectors allow for three handpiece cords to be connected with two handpieces capable of running simultaneously. | Three connectors allow for three handpiece cords to be connected. | Three connectors allow for three handpiece cords to be connected. | N/A | | Footswitch Connector | Two connectors allow for two footswitches to run simultaneously | Yes | Two connectors allow for two footswitches to run simultaneously | Yes | Yes | N/A | | Adjustable Operating Parameters | User used the LCD screen to set the desired operating parameters | User used the LCD screen to set the desired operating parameters | User used the LCD screen to set the desired operating parameters. | User used the LCD screen to set the desired operating parameters. | User used the LCD screen to set the desired operating parameters. | Speed Control on Handpiece | | System Status Display | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | Displayed on LCD screen. | N/A | | Software | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Microprocessor | N/A | | Non-volatile Memory | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | Yes- all current settings are stored when the power is down. | N/A | | Power Source | Electricity | 12Volt Supply | Electricity | 12Volt Supply | Electricity | 12Volt Battery Power Supply | | Power Output | 400 Watts | 400 Watts | 400 Watts | 200 Watts | 200 Watts | 170 Watts | | Wireless Tag Technology | Accessories are recognized and identified on the console screen | N/A | Accessories are recognized and identified on the console screen | N/A | N/A | N/A | | Window Jog Capability | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | Window Jog allows the cutter to turn slowly which enables the user can stop the cutter in any position in the window. | N/A | N/A | N/A | | Enhanced Serial Interface (IEEE1394 Firewire) | Serial communications channel between the console and other devices allowing the transfer of data and control information | N/A | Serial communications channel between the console and other devices allowing the transfer of data and control information | N/A | N/A | Instrument's position information passed to the host system through a standard serial link | | Auxiliary Control | Mechanism to provide power and control to and retrieve data from handpiece mounted subsystems | N/A | Mechanism to provide power and control to and retrieve data from handpiece mounted subsystems | N/A | N/A | Wireless software control and active LED's are battery driven, but optional wire supplied power available. | . ## TABLE 1-COMPARISON . {2}------------------------------------------------ - : ートに、アイリ {3}------------------------------------------------ and the contraction of the comments of the control of {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, which is composed of three curved lines that suggest wings and a body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR - 3 2004 Stryker Instruments c/o Jean W. Sheppard Regulatory Analyst 4100 East Milham Ave. Kalamazoo, MI 49001 Rc: K040300 Trade/Device Name: The Stryker Consolidated Operating Room Equipment (CORE) System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: February 5, 2004 Received: February 9, 2004 Dear Mr. Sheppard: 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. {5}------------------------------------------------ ## Page 2 - Jean W. Sheppard This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loter natification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Akeryl Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): The Stryker Consolidated Operating Room Equipment (CORE) Device Name System The Stryker Consolidated Operating Room Equipment (CORE)System is Indications ti yker Consondated operating, drilling, reaming, decorticating, and miching of bone, bone cement and other bone related tissue in a sinoounning of bono, come ares, including but not limited to ENT. It variety of surgical proceeded or cutting of screws, mctal, wires, pins, and other fixation devices. Prescription Use X (Per 21 CFR 801Subpart D) AND/OR 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) Kacey A. Baker Dohthalmic Ear, d Threat Devi 510(k) Number K040300

STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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